The Ivermectin the Scabies and Sars-Cov2 !
El ivermectin la SARNA o escabiosis y el virus Sars-Cov2!
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Hello DERMAGIC friends, IVERMECTIN is an anti parasitic and anti
inflammatory drug widely used in diseases such as the cutaneous
larva Migrans, Strongyloidiasis, Onchocerciasis, filariasis
(bancroftiasis), pediculosis capitis (lice) Scabies, and lately approved
its use for the treatment of The rosacea. Presentation of the product:
Tablets, lotion, shampoo, cream at 1%, and and injections for systemic use
in animals.
Due to the increase of scabies in an epidemic form in some countries
and the absence of lindane due to its proven toxicity, ivermectin has
been available as a treatment for it. In these bibliographical
references, you will be able to find out about the uses of this drug, in
SCABIES and other pathologies. At the end a monograph of the
product.
The dose is calculated at 150 - 250 Micrograms per kilo weight, if we
calculate it to 100 micrograms per kilo weight in an adult of 60 kgs,
would be 6,000 mcg that would be 6 mgrs, that is to say a tablet of 6 mgrs
of IVERMECTIN or 2 tables of 3 mgs.
Its results for many Scientists and doctors, others combine it with
topical treatments like sulfur lotions and or Crotamiton.
Following the emergence of the pandemic in 2020, reports began to appear
that IVERMECTIN was and is effective against the Sars-Cov2 virus or
COVID-19, and the European Parliament on December 10, 2023 declared the
following:
"The drug ivermectin, on the other hand, has been studied in 99 of
137,000 patients under the direction of 1,089 scientists, with a
prevention success rate of 85% and an early treatment success rate of 62%,
and was launched in 2019 approved for the early treatment of COVID-19. "
(reference 24)
Some studies have shown that the drug is ineffective, usually at doses
that are too high or too low. In addition to ivermectin, there are other
treatments that are safe, effective and inexpensive.
The FDA today 2024 has not approved its use for the treatment of this
virus, claiming that it is ineffective.
Greetings to all
Dr. José M Lapenta
EDITORIAL ESPAÑOL
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Hola amigos DERMAGICOS , el IVERMECTIN es una droga anti parasitaria y
anti inflamatoria ampliamente utilizada en enfermedades como la larva
Migrans cutánea, Estrongiloidiasis, Oncocercosis, filariasis
(bancroftiasis), pediculosis capitis (piojos) Escabiosis, y últimamente se
aprobó su uso para el tratamiento de la rosácea. La presentación del
producto: Tabletas, loción, champú, crema al 1% e inyección para uso
sistémico en animales.
Ante la epidemia de SARNA o escabiosis que se presenta en algunos paises y
la ausencia del Lindano por su probada toxicidad, el ivermectin se ha
polarizado como tratamiento para la misma. En estas referencias
bibliográficas, podrás enterarte de los usos de esta droga, en la SARNA O
ESCABIOSIS y otras patologías. Al final una Monografía del producto.
Para el tratamiento de la SARNA o ESCABIOSIS La dosis se calcula a 150 -
250 Microgramos por kilo peso, si la calculamos a 100 microgramos por kilo
peso en un adulto de 60 kgs, serian 6.000 mcg que vendrían siendo 6 mgrs,
es decir una tableta de 6 mgrs de ivermectina o 2 de 3 mgrs.
Sus resultados para muchos científicos y doctores es efectivo, otros la
combinan con otros tratamientos típicos como lociones azufradas y o
Crotamiton.
IVERMECTINA Y Sars-COV2
A raíz de la aparición de la pandemia en el año 2020, comenzaron a aparecer
reportes de que la IVERMECTINA era y es eficaz contra el virus Sars-Cov2 o
COVID-19, y el parlamento Europeo el 10 de Diciembre del 2023 declaro lo
siguiente:
" El medicamento ivermectina, por otro lado, se ha estudiado en 99 de
137.000 pacientes bajo la dirección de 1.089 científicos, con una tasa de
éxito en la prevención del 85% y una tasa de éxito en el tratamiento temprano
del 62%, y se lanzó en 2019 aprobado para el tratamiento temprano de COVID-19.
"
Algunos estudios han demostrado que el fármaco es ineficaz, generalmente en
dosis demasiado altas o demasiado bajas. Además de la ivermectina, existen
otros tratamientos que son seguros, eficaces y económicos. (referencia 24)
La FDA hoy día 2024 no ha aprobado su uso para el tratamiento de este virus,
alegando que es ineficaz.
Saludos a todos,,,
Dr. José Lapenta.
Dr. José M Lapenta
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REFERENCIAS BIBLIOGRAFICAS / BIBLIOGRAPHICAL REFERENCES
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1.) The treatment of scabies with ivermectin.
2.) Comparison of ivermectin and benzyl benzoate for treatment of scabies.
3.) Successful use of ivermectin in the treatment of endemic scabies in a nursing home.
4.) Treatment of HIV-related scabies with emphasis on the efficacy of ivermectin.
5.) Ivermectin-responsive crusted scabies in HTLV1 carrier.
6.) Crusted ("Norwegian") scabies in a specialist HIV unit: successful use of ivermectin and failure to prevent nosocomial transmission [see comments]
7.) Crusted scabies of the scalp in dermatomyositis patients: three cases treated with oral ivermectin.
8.) Ivermectin for Sarcoptes scabiei hyperinfestation.
9.) Topical application of ivermectin for human ectoparasites.
10.) An assessment of topical and oral prescription and over-the-counter treatments for head lice.
11.) Efficacy of ivermectin for the treatment of head lice (Pediculosis capitis).
12.) Physiology, pharmacology and parasitology.
13.) Efficacy of ivermectin in the treatment of strongyloidiasis complicating AIDS.
14.) Efficacy of ivermectin against Strongyloides stercoralis in humans.
15.) Efficacy of ivermectin in the therapy of cutaneous larva migrans [letter]
16.) Ivermectin 1% Cream (Soolantra) for Inflammatory Lesions of Rosacea.
17.) of rosacea with topical ivermectin cream: a series of 34 cases.
18.)The efficacy, safety, and tolerability of ivermectin compared with current topical treatments for the inflammatory lesions of rosacea: a network meta-analysis.
19.) The efficacy of topical and oral ivermectin in the treatment of human scabies.
20.) Assessment of oral ivermectin versus shampoo in the treatment of pediculosis (head lice infestation) in rural areas of Sine-Saloum, Senegal.
21.) Head lice probably resistant to ivermectin recovered from two rural girls in Dielmo, a village in Sine-Saloum, Senegal.
22.) Over 25 Years of Clinical Experience With Ivermectin: An Overview of Safety for an Increasing Number of Indications.
23.) IVERMECTIN TABLETS MONOGRAPH
24.) Approval of ivermectin for COVID-19 treatment
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1.) The treatment of scabies with ivermectin.
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SO - N Engl J Med 1995 Jul 6;333(1):26-30
AU - Meinking TL; Taplin D; Hermida JL; Pardo R; Kerdel FA
AD - Department of Dermatology and Cutaneous Surgery, University of Miami School of Medicine, FL, USA.
PT - CLINICAL TRIAL; JOURNAL ARTICLE
AB - BACKGROUND. Ivermectin is an anthelmintic agent that has been a safe, effective treatment for onchocerciasis (river blindness) when given in a single oral dose of 150 to 200 micrograms per kilogram of body weight. Anecdotal reports of improvement in patients who suffered from infestation with the mite Sarcoptes scabiei suggest that the ectoparasitic disease scabies might be treated with ivermectin. METHODS. We conducted an open-label study in which ivermectin was administered in a single oral dose of 200 micrograms per kilogram to 11 otherwise healthy patients with scabies and to 11 patients with scabies who were also infected with the human immunodeficiency virus (HIV), 7 of whom had the acquired immunodeficiency syndrome. All patients received a full physical and dermatologic examination; scrapings from the skin of all patients tested positive for scabies. Patients were reexamined two and four weeks after treatment, when the scrapings for scabies were repeated. The patients used no other scabicides during the 30 days before ivermectin treatment or during the 4-week study period. RESULTS. None of the 11 otherwise healthy patients had evidence of scabies four weeks after a single dose of ivermectin. Of the 11 HIV-infected patients, 2 had or = 10 scabies lesions before treatment, 3 had 11 to 49 lesions, 4 had or = 50 lesions, and 2 had heavily crusted skin lesions. In eight of the patients the scabies was cured after a single dose of ivermectin. Two patients received a second dose two weeks after the first. Ten of the 11 patients with HIV infection (91 percent) had no evidence of scabies four weeks after their first treatment with ivermectin. CONCLUSIONS. The anthelmintic agent ivermectin, given in a single oral dose, is an effective treatment for scabies in otherwise healthy patients and in many patients with HIV infection.
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2.) Comparison of ivermectin and benzyl benzoate for treatment of scabies.
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SO - Trop Med Parasitol 1993 Dec;44(4):331-2
AU - Glaziou P; Cartel JL; Alzieu P; Briot C; Moulia-Pelat JP; Martin PM
AD - Institut Territoreal de Recherches Medicales Louis Malarde, Papeete, Tahiti, French Polynesia.
PT - CLINICAL TRIAL; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
AB - A randomized investigator-blinded trial of oral ivermectin 100 micrograms/kg single dose vs. benzyl benzoate 10% application in the treatment of scabies, was conducted in 1992 in French Polynesia. In total, 44 patients aged 5-56 years were included in the study: 23 in the group ivermectin (IVER) and 21 in the group benzyl benzoate (BB). At day 30 after treatment, the cumulative recovery rates were 70% (16/23) in the group IVER, and 48% (10/21) in the group BB, 95% confidence intervals 51-87% and 29-70% respectively. The rates of recovery were greater in the group IVER at day 7, 14 and 30, but the difference was not statistically significant. Our results show that oral ivermectin is a valuable alternative to benzyl benzoate local treatment.
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3.) Successful use of ivermectin in the treatment of endemic scabies in a nursing home.
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Author
Sullivan JR; Watt G; Barker B
Address
Department of Dermatology, Royal Newcastle Hospital, New South Wales, Australia.
Source
Australas J Dermatol, 38(3):137-40 1997 Aug
Abstract
Ivermectin, an antiparasitic agent, was successfully used as a sole agent to combat endemic
scabies in a closed 33-bed ward of a rural nursing home. Previous topical therapies,
including multiple applications of permethrin, gamma-benzene hexachloride, benzyl benzoate
and precipitated sulfur in white soft paraffin, had failed. Several patients exhibited
hyperkeratotic crusted scabies with head and neck involvement and all residents except one
recently arrived resident had evidence of active infestation. All residents were treated with
200 micrograms/kg of ivermectin and this dose was repeated 2 weeks later in all subjects.
Four weeks after the first dose of ivermectin there was no evidence of active scabies and
all rashes were totally resolved by 6 weeks. The action of ivermectin, its safety and its
indications are discussed.
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4.) Treatment of HIV-related scabies with emphasis on the efficacy of ivermectin.
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Author
Taplin D; Meinking TL
Address
Department of Dermatology, University of Miami School of Medicine, FL 33101, USA.
Source
Semin Cutan Med Surg, 16(3):235-40 1997 Sep
Abstract
Since the mid-1980s, worldwide reports confirm that scabies in individuals infected with the
human immunodeficiency virus (HIV) result in a wide range of-clinical manifestations which
differ from those seen in immunocompetent patients. There is also general agreement that
HIV-related scabies is more difficult to treat. Oral ivermectin has been shown in several
countries to be a safe and effective therapy. In otherwise healthy persons, one dose of 200
microg/kg is usually curative. In HIV-related scabies, one treatment may be curative but
repeated doses may be required. Crusted scabies in these individual requires a combination
of oral ivermectin, total body treatments with 5% permethrin cream, and keratolytic agents
to hasten removal of crusts.
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5.) Ivermectin-responsive crusted scabies in HTLV1 carrier.
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Author
Cordoliani F; Vasseur E; Baccard M; Fournier S; Feuilhade de Chauvin M; Tancrede E;
Morel P
Address
Department of Dermatology, H^opital Saint-Louis, Paris, France.
Source
Dermatology, 192(4):351-2 1996
Abstract
We report a case of HTLV1 infection revealed by crusted scabies and widespread
dermatophytosis in an African woman. HTLV1 infection was not complicated by adult T cell
leukemia or myelopathy. Crusted scabies is a marker of HTLV1 infection. The importance
of oral ivermectin therapy in crusted scabies is emphasized.
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6.) Crusted ("Norwegian") scabies in a specialist HIV unit: successful use of ivermectin and failure to prevent nosocomial transmission [see comments]
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Author
Corbett EL; Crossley I; Holton J; Levell N; Miller R; De Cock KM
Address
HIV/AIDS Unit Camden & Islington Community Health Services NHS Trust, Middlesex
Hospital, London, UK.
Source
Genitourin Med, 72(2):115-7 1996 Apr
Abstract
A nosocomial outbreak of scabies in a specialist inpatient HIV unit resulted from a patient
admitted with crusted scabies. Treatment of his infestation with topical scabicides alone failed
and he remained infectious for several weeks. His infestation was then eradicated with
combined topical treatment and oral ivermectin. In total, 14 (88%) out of 19 ward staff
became symptomatic, and 4 (21%) had evidence of scabies on potassium hydroxide
examination of skin scrapings. The ward infection control policy was changed to distinguish
patients with crusted scabies from those with ordinary scabies. A second patient with
crusted scabies was treated with combined oral and topical therapy early in his admission
and nursed with more stringent isolation procedures. No nosocomial transmission occurred
and his infestation responded rapidly to treatment. Patients with crusted scabies require strict
barrier nursing if nosocomial transmission is to be avoided. Ivermectin combined with
topical scabicides may be a more efficacious treatment than topical scabicides alone in such
patients.
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7.) Crusted scabies of the scalp in dermatomyositis patients: three cases treated with oral ivermectin.
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Author
Dourmishev AL; Serafimova DK; Dourmishev LA; Mualla MA; Papaharalambous V;
Malchevsky T
Address
Department of Dermatology and Venereology, University of Medicine, Sofia, Bulgaria.
Source
Int J Dermatol, 37(3):231-4 1998 Mar
Abstract
BACKGROUND: Cutaneous features in the scalp area among adult patients are rarely
considered as a manifestation of scabies. METHODS: Three patients with clinical and
laboratory data of dermatomyositis with scalp involvement (fulfill three or four of Bohan and
Peter's criteria), of 4 years, 8 months, and 3 years duration, were seen at our department
between 1995 and 1996. For relapses of ordinary scabies, they were treated repeatedly
with local scabicide with temporary effect. After a symptom-free period during the treatment
of dermatomyositis with corticosteroids and azathioprine, they developed diffuse redness with
scales and crusts on the scalp areas. Light microscopy examination of material taken from
these crusts showed an abundance of live mites. RESULTS: All patients were successfully
cured of scabies with a twice oral dose of 200 microg/kg ivermectin within 8 days.
CONCLUSIONS: Our patients with crusted scabies of the scalp and dermatomyositis
prompted us to change our standard diagnostic and therapeutic regimens. Fascinating
features included mimicry of scabies in patients with dermatomyositis, location of parasites
on the scalp, suppressed cell-mediated immunity and successful cure of mange by
ivermectin.
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8.) Ivermectin for Sarcoptes scabiei hyperinfestation.
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Author
Huffam SE; Currie BJ
Address
Royal Darwin Hospital, Menzies School of Health Research, Darwin, Northern Territory,
Australia.
Source
Int J Infect Dis, 2(3):152-4 1998 Jan-Mar
Abstract
OBJECTIVES: Crusted (Norwegian) scabies is an unusual variant of scabies caused by
hyperinfestation with Sarcoptes scabiei. It has high morbidity, and secondary bacterial skin
sepsis may result in life-threatening bacteremia. An open label study of oral ivermectin was
carried out in patients with crusted scabies refractory to topical therapy. METHODS:
Patients with refractory crusted scabies were prescribed oral ivermectin, one to three doses
of 200 mg/kg at 14-day intervals, combined with topical scabicide and keratolytic therapy.
RESULTS: Of the 20 patients who received ivermectin, 8 had a complete initial clinical
response, a partial response was achieved in 9, and minimal improvement occurred in 3.
Three doses of ivermectin were curative for 8 of 10 cases, but recurrence of scabies from
presumed reinfestation occurred in at least half of these. CONCLUSION: The authors
conclude that ivermectin is effective for crusted scabies; however, multiple doses may be
required to achieve a cure, and recurrence 6 or more weeks after completing treatment is
common.
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9.) Topical application of ivermectin for human ectoparasites.
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Author
Youssef MY; Sadaka HA; Eissa MM; el-Ariny AF
Address
Department of Parasitology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.
Source
Am J Trop Med Hyg, 53(6):652-3 1995 Dec
Abstract
Ivermectin is used in veterinary practice against many ectoparasites and endoparasites and
is the drug of choice for treatment of human onchocerciasis. This study was carried out to
investigate the effect of topical application of this drug against human ectoparasites
(Sarcoptes scabiei and Pediculus humanus capitis). Ivernectin was found to have a curative
effect on head lice after a single topical application. In patients with scabies, the drug was
also found to be effective after a single application. However, in 50% of the cases, another
application was needed five days later.
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10.) An assessment of topical and oral prescription and over-the-counter treatments for head lice.
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Author
Burkhart CG; Burkhart CN; Burkhart KM
Address
Department of Medicine, Medical College of Ohio at Toledo, USA.
Source
J Am Acad Dermatol, 38(6 Pt 1):979-82 1998 Jun
Abstract
A plethora of head lice cases that require optimal therapeutic assessments are developing in
elementary schools. Over-the-counter therapies continue to be the mainstream solution for
most cases of pediculosis capitis, but the onset of resistant cases dictates a review of
available treatment modalities. The increased efficacy of prescription drugs, namely topical
5% permethrin and oral ivermectin, underline the expanding role that physicians will serve in
the eradication of head lice in our communities.
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11.) Efficacy of ivermectin for the treatment of head lice (Pediculosis capitis).
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SO - Trop Med Parasitol 1994 Sep;45(3):253-4
AU - Glaziou P; Nyguyen LN; Moulia-Pelat JP; Cartel JL; Martin PM
AD - Institut Territorial de Recherches Medicales Louis Malarde, Papeete, Tahiti, French Polynesia.
PT - CLINICAL TRIAL; JOURNAL ARTICLE
AB - Twenty six male and female patients aged 5 to 17 years who had head lice infestation confirmed by eggs presence and received treatments with a single 200 mu/kg oral dose of ivermectin in open fashion. At day 14 after treatment, 20 responded to the treatment (77%), and 6 patients (23%) presented with a complete disappearance of eggs and all clinical symptoms. At day 28, 7 patients were healed (27%), but 4 patients of the 6 healed at day 14 presented with signs of reinfestation. This study suggests that ivermectin is a promising treatment of head lice, and a second dose at day 10 should be appropriate for a further comparative trial.
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12.) Physiology, pharmacology and parasitology.
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Author
Hennessy DR
Address
CSIRO Division of Animal Production, McMaster Laboratory, Blacktown, NSW, Australia.
Source
Int J Parasitol, 27(2):145-52 1997 Feb
Abstract
The developing resistance to current chemical classes of broad-spectrum anthelmintics and
insecticides presents an undeniable threat to the long-term viability of the animal health
industry. Alternative treatment strategies including vaccines, biological control and breeding of
parasite-resistant animals are unlikely to be widely available in the near future and even then
they will be integrated with chemotherapy. The significant cost of research and development
of new therapeutics for food-producing animals, together with the small market share of
animal health products, particularly in Australia and New Zealand, is a positive disincentive
for drug development. The chemical actives that are currently available are all that we are
likely to have for the foreseeable future and they must be used more efficiently.
Understanding the pharmacokinetic behaviour of antiparasitics and recognising the potential
for the animal's physiological characteristics to assist drug action is crucial. Careful
administration, coupled with a reduction of feed intake before oral anthelmintic treatment,
maximises drug availability and therefore increases efficacy of the benzimidazole and
ivermectin compounds. This is a cost-effective option that can be employed immediately,
which not only increases efficacy of "older" compounds but will be instrumental in prolonging
the useful life of the newer drugs. Taking care to apply topical insecticide formulations directly
along the backline immediately after shearing will maximise even diffusion of active around the
sheep flanks to contact lice inhabiting sites remote from the point of drug application. The use
of "intelligent" formulation and delivery of existing compounds, based on knowledge of host
physiological and pharmacological responses, holds the key to effective antiparasitic
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13.) Efficacy of ivermectin in the treatment of strongyloidiasis complicating AIDS.
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SO - Clin Infect Dis 1993 Nov;17(5):900-2
AU - Torres JR; Isturiz R; Murillo J; Guzman M; Contreras R
AD - Instituto de Medicina Tropical Felix Pifano C., Universidad Central de Venezuela.
PT - JOURNAL ARTICLE
AB - Nine adult male homosexuals who were infected with the human immunodeficiency virus (five with AIDS-defining conditions) and harbored Strongyloides stercoralis received ivermectin on a compassionate basis for persistent intestinal infection. Hyperinfection was present in all cases. Ivermectin was given either as a single oral dose (200 micrograms/kg) or on a multidose schedule (200 micrograms/kg.d) on days 1, 2, 15, and 16. All seven patients who received multiple doses showed sustained clinical and parasitological cure, whereas one of two patients who received single-dose therapy relapsed promptly and fatally. Remissions have been maintained for at least 7 months and up to 3 years of follow-up. Ivermectin appears promising in the treatment of strongyloidiasis in patients with AIDS. Because of the risk of hyperinfection and/or disseminated disease, multidose courses are warranted. We are not aware of other reports describing the efficacy of antiparasitic drugs for strongyloidiasis in patients with AIDS.
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14.) Efficacy of ivermectin against Strongyloides stercoralis in humans.
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SO - Intern Med 1992 Mar;31(3):310-2
AU - Shikiya K; Kinjo N; Uehara T; Uechi H; Ohshiro J; Arakaki T; Kinjo F; Saito A; Iju M; Kobari K
AD - First Department of Internal Medicine, Faculty of Medicine, University of the Ryukyus, Okinawa, Japan.
PT - JOURNAL ARTICLE
AB - Okinawa Prefecture is an endemic area of Strongyloides stercoralis infection. Since treatment of this infection remains unsatisfactory, we evaluated the efficacy of ivermectin. Twenty-three patients were treated with a single oral dose of ivermectin (mean +/- SD, 105.5 +/- 20.8 mcg/kg of body weight), followed by a second dose two weeks later. The rate of cure was 85.7% at 2 weeks after the first treatment, and 90.5% at 2 weeks after the second treatment. Side effects occurred in 2 patients (8.7%), but they were mild and transient. The results indicate that ivermectin might be useful and relatively safe for the therapy of Strongyloides stercoralis infection as an alternative to thiabendazole or mebendazole.
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15.) Efficacy of ivermectin in the therapy of cutaneous larva migrans [letter]
SO - Arch Dermatol 1992 Jul;128(7):994-5
AU - Caumes E; Datry A; Paris L; Danis M; Gentilini M; Gaxotte P
PT - LETTER
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16.) Ivermectin 1% Cream (Soolantra) for Inflammatory Lesions of Rosacea.
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Am Fam Physician. 2016 Sep 15;94(6):512-3.
Gazewood JD1, Johnson K1.
Author information
University of Virginia Health System, Charlottesville, VA, USA.
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17.) of rosacea with topical ivermectin cream: a series of 34 cases.
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Dermatol Online J. 2016 Aug 15;22(8). pii: 13030/qt9ks1c48n.
Mendieta Eckert M1, Landa Gundin N.
Author information
Department of Dermatology,Clínica Dermitek (Bilbao), Spain. mmendieta@dermitek.com.
Abstract
Rosacea is a highly prevalent, chronic inflammatory disease. The use of topical ivermectin cream has recently been described in the treatment of rosacea in three clinical trials. We report our experience in a series of 34 patients treated with topical ivermectin cream. The results are a reflection of the reality of clinical practice and the perception of patients of the treatment. We also evaluate the efficacy in cases of mild rosacea and erythematotelangiectatic rosacea which have not been studied in trials.
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18.)The efficacy, safety, and tolerability of ivermectin compared with current topical treatments for the inflammatory lesions of rosacea: a network meta-analysis.
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Springerplus. 2016 Jul 22;5(1):1151. doi: 10.1186/s40064-016-2819-8. eCollection 2016.
Siddiqui K1, Stein Gold L2, Gill J1.
Author information
PAREXEL Access Consulting, PAREXEL International, 3rd Floor, DLF Tower E, Rajiv Gandi IT Park, Chandigarh, UT 160101 India.
Department of Dermatology, Henry Ford Medical Centre, Detroit, MI USA.
Abstract
BACKGROUND:
Rosacea is a common chronic skin condition that manifests as recurrent inflammatory lesions. Long-term treatment is required to control symptoms and disease progression, with topical treatments being the first-line choice. Ivermectin 1 % cream is a new once-daily (QD) topical treatment for the inflammatory lesions of rosacea, and it is important to compare the efficacy, safety, and tolerability of ivermectin with other currently available topical treatments.
METHODS:
A systematic literature review was performed from January 2011 to June 2015, with articles published prior to 2011 retrieved from a Cochrane review on rosacea. Randomized controlled trials of the topical treatment of adult patients with moderate-to-severe papulopustular rosacea were identified from electronic databases and trial registers, and supplemented with data from clinical study reports. Mixed treatment comparisons (MTCs) were conducted to compare different treatments according to Bayesian methodology.
RESULTS:
57 studies were identified, with 19 providing data suitable for MTC. Ivermectin 1 % cream QD led to a significantly greater likelihood of success compared with azelaic acid 15 % gel twice-daily (BID) [relative risk (95 % credible interval): 1.25 (1.14-1.37)], and metronidazole 0.75 % cream BID [1.17 (1.08-1.29)] at 12 weeks. Ivermectin 1 % cream QD also demonstrated a significant reduction in inflammatory lesion count compared with azelaic acid 15 % gel BID [-8.04 (-12.69 to -3.43)] and metronidazole 0.75 % cream BID [-9.92 (-13.58 to -6.35)] at 12 weeks. Ivermectin 1 % cream QD led to a significantly lower risk of developing any AE or TRAE compared with azelaic acid 15 % gel BID [0.83 (0.71-0.97) and 0.47 (0.32-0.67), respectively].
CONCLUSIONS:
Ivermectin 1 % cream QD appears to be a more effective topical treatment than other current options for the inflammatory lesions of rosacea, with at least an equivalent safety and tolerability profile, and could provide physicians and dermatologists with an alternative first-line treatment option.
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19.) The efficacy of topical and oral ivermectin in the treatment of human scabies.
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Ann Parasitol. 2015;61(1):11-6.
Panahi Y1, Poursaleh Z1, Goldust M2.
Author information
1Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Teheran, Iran.
2Tabriz University of Medical Sciences, Tabriz, Iran.
Abstract
Scabies is an itchy skin condition caused by the microscopic mite Sarcoptes scabei. The itching is caused by an allergic reaction to the mites. The treatment of choice is still controversial. It is commonly treated with topical insecticides. The aim of this study was to assess the efficacy of topical and oral ivermectin in the treatment of human scabies. We searched electronic databases (Cochrane Occupational Safety and Health Review Group Specialised Register, CENTRAL (The Cochrane Library), MEDLINE (Ovid), Pubmed, EMBASE, LILACS, CINAHL, Open Grey and WHO ICTRP) up to September 2014. Randomized controlled trials (RCTs) or cluster RCTs which compared the efficacy of ivermectin with other medications in the treatment of scabies. Interventions could be compared to each other, or to placebo or to no treatment. The author intended to extract dichotomous data (developed infection or did not develop infection) for the effects of interventions. We intended to report any adverse outcomes similarly. It has been sated that ivermectin was as effective as permethrin in the treatment of scabies. In comparison to other medications such as lindane, benzyl benzoate, crotamiton and malathion, ivermectin was more effective in the treatment of scabies. Ivermectin is an effective and cost-comparable alternative to topical agents in the treatment of scabies infection.
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20.) Assessment of oral ivermectin versus shampoo in the treatment of pediculosis (head lice infestation) in rural areas of Sine-Saloum, Senegal.
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Int J Antimicrob Agents. 2016 Dec;48(6):627-632. doi: 10.1016/j.ijantimicag.2016.07.014. Epub 2016 Aug 31.
Leulmi H1, Diatta G2, Sokhna C2, Rolain JM1, Raoult D3.
Author information
1Aix-Marseille Université, Unité de Recherche en Maladies Infectieuses et Tropicales Emergentes (URMITE), UM63, CNRS 7278, IRD 198 (Dakar), Inserm 1095, Marseille, France.
2Institut de Recherche pour le Développement (IRD), UMR 198 IRD, Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Campus International de Recherche IRD-UCAD, Hann, BP. 1386, Dakar, Senegal.
3Aix-Marseille Université, Unité de Recherche en Maladies Infectieuses et Tropicales Emergentes (URMITE), UM63, CNRS 7278, IRD 198 (Dakar), Inserm 1095, Marseille, France; Institut de Recherche pour le Développement (IRD), UMR 198 IRD, Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Campus International de Recherche IRD-UCAD, Hann, BP. 1386, Dakar, Senegal. Electronic address: didier.raoult@gmail.com.
Abstract
Reports of treatment failure and the emergence of resistance to topical head lice treatments have become increasingly common, driving the need for continued development of new therapeutic options for pediculosis. Ivermectin has been proposed as a potential alternative for the treatment of pediculosis but has not been sufficiently evaluated. In this study, the effectiveness of oral ivermectin versus shampoo in the treatment of pediculosis in Senegal was compared. The study was conducted in two neighbouring villages of Sine-Saloum, Senegal: Dielmo (ivermectin trial group; 201 female participants) and Ndiop (shampoo trial group; 239 female participants). In the ivermectin group, patients received two doses of oral ivermectin (400 µg/kg body weight; Mectizan®) 7 days apart. In contrast, the shampoo group received a shampoo treatment based on d-phenothrin (0.23%; Hégor®). At the beginning of the study, 70 (34.8%) of 201 participants in the ivermectin group were infested by head lice versus 145 (60.7%) of 239 participants in the shampoo group. At Day 15 post-treatment, the efficacy of the treatment against head lice reached 41/53 (77.4%) in the ivermectin group (53 patients were tested in this group) versus 42/130 (32.3%) in the shampoo group (130 patients were tested in this group) (P <10-7). However, 4 (7.5%) of the 53 females in the ivermectin group exhibited probable ivermectin treatment failure, suggesting the emergence of ivermectin-resistant lice. This study demonstrates that oral ivermectin is highly effective for the treatment of pediculosis compared with shampoo, but also suggests that ivermectin resistance may emerge during treatment.
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21.) Head lice probably resistant to ivermectin recovered from two rural girls in Dielmo, a village in Sine-Saloum, Senegal.
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Int J Antimicrob Agents. 2016 Jun;47(6):501-2. doi: 10.1016/j.ijantimicag.2016.03.013. Epub 2016 Apr 25.
Diatta G1, Abat C2, Sokhna C1, Tissot-Dupont H3, Rolain JM3, Raoult D4.
Author information
1Institut de recherche pour le développement (IRD), UMR 198 IRD, Unité de recherche sur les maladies infectieuses et tropicales emergentes (URMITE), Campus International de Recherche IRD-UCAD, Hann, BP 1386 Dakar, Senegal.
2Institut de recherche pour le développement (IRD), UMR 198 IRD, Unité de recherche sur les maladies infectieuses et tropicales emergentes (URMITE),Campus International de Recherche IRD-UCAD, Hann, BP 1386 Dakar, Senegal; Aix-Marseille Université, URMITE, Unité mixte (UM) 63, Centre national de la recherche scientifique (CNRS) 7278, IRD 198, Institut national de la santé et de la recherche médicale (INSERM) 1905, 13005 Marseille, France.
3Aix-Marseille Université, URMITE, Unité mixte (UM) 63, Centre national de la recherche scientifique (CNRS) 7278, IRD 198, Institut national de la santé et de la recherche médicale (INSERM) 1905, 13005 Marseille, France.
4Aix-Marseille Université, URMITE, Unité mixte (UM) 63, Centre national de la recherche scientifique (CNRS) 7278, IRD 198, Institut national de la santé et de la recherche médicale (INSERM) 1905, 13005 Marseille, France. Electronic address: didier.raoult@gmail.com.
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22.) Over 25 Years of Clinical Experience With Ivermectin: An Overview of Safety for an Increasing Number of Indications.
========================================================================
Kircik LH, Del Rosso JQ, Layton AM, Schauber J.
Abstract
Although the broad-spectrum anti-parasitic effects of the avermectin derivative ivermectin are well documented, its anti-inflammatory activity has only recently been demonstrated. For over 25 years, ivermectin has been used to treat parasitic infections in mammals, with a good safety profile that may be attributed to its high affinity to invertebrate neuronal ion channels and its inability to cross the blood-brain barrier in humans and other mammals. Numerous studies report low rates of adverse events, as an oral treatment for parasitic infections, scabies and head lice. Ivermectin has been used off-label to treat diseases associated with Demodex mites, such as blepharitis and demodicidosis. New evidence has linked Demodex mites to rosacea, a chronic inflammatory disease. Ivermectin has recently received FDA and EU approval for the treatment of adult patients with inflammatory lesions of rosacea, a disease in which this agent has been shown to be well tolerated. After more than 25 years of use, ivermectin continues to provide a high margin of safety for a growing number of indications based on its anti-parasitic and anti-inflammatory activities.
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23.) IVERMECTIN TABLETS MONOGRAPH
========================================================================
Source: http://www.fda.gov/Drugs/default.htm
TABLETS
STROMECTOL®
(IVERMECTIN)
DESCRIPTION
STROMECTOL* (Ivermectin) is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is
derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the
fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5-O
demethyl-22,23-dihydroavermectin A1a and less than 10% 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro
25-(1-methylethyl)avermectin A1a, generally referred to as 22,23-dihydroavermectin B1a and B1b, or H2B1a and
H2B1b, respectively. The respective empirical formulas are C48H74O14 and C47H72O14, with molecular weights of
875.10 and 861.07, respectively. The structural formulas are:
Component B1a, R = C2H5
Component B1b, R = CH3
Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about
155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol.
STROMECTOL is available in 3-mg tablets containing the following inactive ingredients: microcrystalline
cellulose, pregelatinized starch, magnesium stearate, butylated hydroxyanisole, and citric acid powder
(anhydrous).
CLINICAL PHARMACOLOGY
Pharmacokinetics
Following oral administration of ivermectin, plasma concentrations are approximately proportional to the
dose. In two studies, after single 12-mg doses of STROMECTOL in fasting healthy volunteers (representing a
mean dose of 165 mcg/kg), the mean peak plasma concentrations of the major component (H2B1a) were 46.6
(±21.9) (range: 16.4-101.1) and 30.6 (±15.6) (range: 13.9-68.4) ng/mL, respectively, at approximately 4 hours
after dosing. Ivermectin is metabolized in the liver, and ivermectin and/or its metabolites are excreted almost
exclusively in the feces over an estimated 12 days, with less than 1% of the administered dose excreted in the
urine. The plasma half-life of ivermectin in man is approximately 18 hours following oral administration.
The safety and pharmacokinetic properties of ivermectin were further assessed in a multiple-dose clinical
pharmacokinetic study involving healthy volunteers. Subjects received oral doses of 30 to 120 mg (333 to 2000
mcg/kg) ivermectin in a fasted state or 30 mg (333 to 600 mcg/kg) ivermectin following a standard high-fat
(48.6 g of fat) meal. Administration of 30 mg ivermectin following a high-fat meal resulted in an approximate 2.5
fold increase in bioavailability relative to administration of 30 mg ivermectin in the fasted state.
Microbiology
Ivermectin is a member of the avermectin class of broad-spectrum antiparasitic agents which have a unique
mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion
channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the
cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and
death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such
as those gated by the neurotransmitter gamma-aminobutyric acid (GABA).
The selective activity of compounds of this class is attributable to the facts that some mammals do not have
glutamate-gated chloride channels and that the avermectins have a low affinity for mammalian ligand-gated
chloride channels. In addition, ivermectin does not readily cross the blood-brain barrier in humans.
*
Registered trademark of MERCK & CO., Inc.
COPYRIGHT © 1996, 2007 MERCK & CO., Inc.
All rights reserved
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NDA 50-742/S-022
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Ivermectin is active against various life-cycle stages of many but not all nematodes. It is active against the
tissue microfilariae of Onchocerca volvulus but not against the adult form. Its activity against Strongyloides
stercoralis is limited to the intestinal stages.
Clinical Studies
Strongyloidiasis
Two controlled clinical studies using albendazole as the comparative agent were carried out in international
sites where albendazole is approved for the treatment of strongyloidiasis of the gastrointestinal tract, and three
controlled studies were carried out in the U.S. and internationally using thiabendazole as the comparative agent.
Efficacy, as measured by cure rate, was defined as the absence of larvae in at least two follow-up stool
examinations 3 to 4 weeks post-therapy. Based on this criterion, efficacy was significantly greater for
STROMECTOL (a single dose of 170 to 200 mcg/kg) than for albendazole (200 mg b.i.d. for 3 days).
STROMECTOL administered as a single dose of 200 mcg/kg for 1 day was as efficacious as thiabendazole
administered at 25 mg/kg b.i.d. for 3 days.
Summary of Cure Rates for Ivermectin Versus Comparative Agents in the
Treatment of Strongyloidiasis
Cure Rate* (%)
Ivermectin**
Comparative Agent
Albendazole*** Comparative
International Study
WHO Study
24/26 (92)
126/152 (83)
12/22 (55)
67/149 (45)
Thiabendazole† Comparative
International Study
US Studies
9/14 (64)
14/14 (100)
13/15 (87)
16/17 (94)
*
Number and % of evaluable patients
**
170-200 mcg/kg
*** 200 mg b.i.d. for 3 days
†
25 mg/kg b.i.d. for 3 days
In one study conducted in France, a non-endemic area where there was no possibility of reinfection, several
patients were observed to have recrudescence of Strongyloides larvae in their stool as long as 106 days
following ivermectin therapy. Therefore, at least three stool examinations should be conducted over the three
months following treatment to ensure eradication. If recrudescence of larvae is observed, retreatment with
ivermectin is indicated. Concentration techniques (such as using a Baermann apparatus) should be employed
when performing these stool examinations, as the number of Strongyloides larvae per gram of feces may be
very low.
Onchocerciasis
The evaluation of STROMECTOL in the treatment of onchocerciasis is based on the results of clinical
studies involving 1278 patients. In a double-blind, placebo-controlled study involving adult patients with
moderate to severe onchocercal infection, patients who received a single dose of 150 mcg/kg STROMECTOL
experienced an 83.2% and 99.5% decrease in skin microfilariae count (geometric mean) 3 days and 3 months
after the dose, respectively. A marked reduction of >90% was maintained for up to 12 months after the single
dose. As with other microfilaricidal drugs, there was an increase in the microfilariae count in the anterior
chamber of the eye at day 3 after treatment in some patients. However, at 3 and 6 months after the dose, a
significantly greater percentage of patients treated with STROMECTOL had decreases in microfilariae count in
the anterior chamber than patients treated with placebo.
In a separate open study involving pediatric patients ages 6 to 13 (n=103; weight range: 17-41 kg), similar
decreases in skin microfilariae counts were observed for up to 12 months after dosing.
INDICATIONS AND USAGE
STROMECTOL is indicated for the treatment of the following infections:
Strongyloidiasis of the intestinal tract. STROMECTOL is indicated for the treatment of intestinal (i.e.,
nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis.
This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of
infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL
PHARMACOLOGY, Clinical Studies.)
Onchocerciasis. STROMECTOL is indicated for the treatment of onchocerciasis due to the nematode
parasite Onchocerca volvulus.
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NDA 50-742/S-022
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This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted
in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used
diethylcarbamazine citrate (DEC-C).
NOTE: STROMECTOL has no activity against adult Onchocerca volvulus parasites. The adult parasites
reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules
(nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will
eliminate the microfilariae-producing adult parasites.
CONTRAINDICATIONS
STROMECTOL is contraindicated in patients who are hypersensitive to any component of this product.
WARNINGS
Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might
cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological
reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory
responses to the death of microfilariae. Patients treated with STROMECTOL for onchocerciasis may experience
these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself.
(See ADVERSE REACTIONS, Onchocerciasis.)
The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. Oral hydration,
recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural
hypotension. Antihistamines and/or aspirin have been used for most mild to moderate cases.
PRECAUTIONS
General
After treatment with microfilaricidal drugs, patients with hyperreactive onchodermatitis (sowda) may be more
likely than others to experience severe adverse reactions, especially edema and aggravation of
onchodermatitis.
Rarely, patients with onchocerciasis who are also heavily infected with Loa loa may develop a serious or
even fatal encephalopathy either spontaneously or following treatment with an effective microfilaricide. In these
patients, the following adverse experiences have also been reported: pain (including neck and back pain), red
eye, conjunctival hemorrhage, dyspnea, urinary and/or fecal incontinence, difficulty in standing/walking, mental
status changes, confusion, lethargy, stupor, seizures, or coma. This syndrome has been seen very rarely
following the use of ivermectin. In individuals who warrant treatment with ivermectin for any reason and have
had significant exposure to Loa loa-endemic areas of West or Central Africa, pretreatment assessment for
loiasis and careful post-treatment follow-up should be implemented.
Information for Patients
STROMECTOL should be taken on an empty stomach with water. (See CLINICAL PHARMACOLOGY,
Pharmacokinetics.)
Strongyloidiasis: The patient should be reminded of the need for repeated stool examinations to document
clearance of infection with Strongyloides stercoralis.
Onchocerciasis: The patient should be reminded that treatment with STROMECTOL does not kill the adult
Onchocerca parasites, and therefore repeated follow-up and retreatment is usually required.
Drug Interactions
Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when
ivermectin was co-administered with warfarin.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of ivermectin.
Ivermectin was not genotoxic in vitro in the Ames microbial mutagenicity assay of Salmonella typhimurium
strains TA1535, TA1537, TA98, and TA100 with and without rat liver enzyme activation, the Mouse Lymphoma
Cell Line L5178Y (cytotoxicity and mutagenicity) assays, or the unscheduled DNA synthesis assay in human
fibroblasts.
Ivermectin had no adverse effects on the fertility in rats in studies at repeated doses of up to 3 times the
maximum recommended human dose of 200 mcg/kg (on a mg/m2/day basis).
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NDA 50-742/S-022
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Pregnancy, Teratogenic Effects
Pregnancy Category C
Ivermectin has been shown to be teratogenic in mice, rats, and rabbits when given in repeated doses of 0.2,
8.1, and 4.5 times the maximum recommended human dose, respectively (on a mg/m2/day basis).
Teratogenicity was characterized in the three species tested by cleft palate; clubbed forepaws were additionally
observed in rabbits. These developmental effects were found only at or near doses that were maternotoxic to
the pregnant female. Therefore, ivermectin does not appear to be selectively fetotoxic to the developing fetus.
There are, however, no adequate and well-controlled studies in pregnant women. Ivermectin should not be used
during pregnancy since safety in pregnancy has not been established.
Nursing Mothers
STROMECTOL is excreted in human milk in low concentrations. Treatment of mothers who intend to breast-
feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to
the newborn.
Pediatric Use
Safety and effectiveness in pediatric patients weighing less than 15 kg have not been established.
Geriatric Use
Clinical studies of STROMECTOL did not include sufficient numbers of subjects aged 65 and over to
determine whether they respond differently from younger subjects. Other reported clinical experience has not
identified differences in responses between the elderly and younger patients. In general, treatment of an elderly
patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and
of concomitant disease or other drug therapy.
Strongyloidiasis in Immunocompromised Hosts
In immunocompromised (including HIV-infected) patients being treated for intestinal strongyloidiasis,
repeated courses of therapy may be required. Adequate and well-controlled clinical studies have not been
conducted in such patients to determine the optimal dosing regimen. Several treatments, i.e., at 2-week
intervals, may be required, and cure may not be achievable. Control of extra-intestinal strongyloidiasis in these
patients is difficult, and suppressive therapy, i.e., once per month, may be helpful.
ADVERSE REACTIONS
Strongyloidiasis
In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of
STROMECTOL, the following adverse reactions were reported as possibly, probably, or definitely related to
STROMECTOL:
Body as a Whole: asthenia/fatigue (0.9%), abdominal pain (0.9%)
Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%)
Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%)
Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%).
In comparative trials, patients treated with STROMECTOL experienced more abdominal distention and chest
discomfort than patients treated with albendazole. However, STROMECTOL was better tolerated than
thiabendazole in comparative studies involving 37 patients treated with thiabendazole.
The Mazzotti-type and ophthalmologic reactions associated with the treatment of onchocerciasis or the
disease itself would not be expected to occur in strongyloidiasis patients treated with STROMECTOL. (See
ADVERSE REACTIONS, Onchocerciasis.)
Laboratory Test Findings
In clinical trials involving 109 patients given either one or two doses of 170 to 200 mcg/kg STROMECTOL,
the following laboratory abnormalities were seen regardless of drug relationship: elevation in ALT and/or AST
(2%), decrease in leukocyte count (3%). Leukopenia and anemia were seen in one patient.
Onchocerciasis
In clinical trials involving 963 adult patients treated with 100 to 200 mcg/kg STROMECTOL, worsening of the
following Mazzotti reactions during the first 4 days post-treatment were reported: arthralgia/synovitis (9.3%),
axillary lymph node enlargement and tenderness (11.0% and 4.4%, respectively), cervical lymph node
enlargement and tenderness (5.3% and 1.2%, respectively), inguinal lymph node enlargement and tenderness
(12.6% and 13.9%, respectively), other lymph node enlargement and tenderness (3.0% and 1.9%, respectively),
pruritus (27.5%), skin involvement including edema, papular and pustular or frank urticarial rash (22.7%), and
fever (22.6%). (See WARNINGS.)
In clinical trials, ophthalmological conditions were examined in 963 adult patients before treatment, at day 3,
and months 3 and 6 after treatment with 100 to 200 mcg/kg STROMECTOL. Changes observed were primarily
deterioration from baseline 3 days post-treatment. Most changes either returned to baseline condition or
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NDA 50-742/S-022
Page 7
improved over baseline severity at the month 3 and 6 visits. The percentages of patients with worsening of the
following conditions at day 3, month 3 and 6, respectively, were: limbitis: 5.5%, 4.8%, and 3.5% and punctate
opacity: 1.8%, 1.8%, and 1.4%. The corresponding percentages for patients treated with placebo were: limbitis:
6.2%, 9.9%, and 9.4% and punctate opacity: 2.0%, 6.4%, and 7.2%. (See WARNINGS.)
In clinical trials involving 963 adult patients who received 100 to 200 mcg/kg STROMECTOL, the following
clinical adverse reactions were reported as possibly, probably, or definitely related to the drug in ≥1% of the
patients: facial edema (1.2%), peripheral edema (3.2%), orthostatic hypotension (1.1%), and tachycardia
(3.5%). Drug-related headache and myalgia occurred in <1% of patients (0.2% and 0.4%, respectively).
However, these were the most common adverse experiences reported overall during these trials regardless of
causality (22.3% and 19.7%, respectively).
A similar safety profile was observed in an open study in pediatric patients ages 6 to 13.
The following ophthalmological side effects do occur due to the disease itself but have also been reported
after treatment with STROMECTOL: abnormal sensation in the eyes, eyelid edema, anterior uveitis,
conjunctivitis, limbitis, keratitis, and chorioretinitis or choroiditis. These have rarely been severe or associated
with loss of vision and have generally resolved without corticosteroid treatment.
Laboratory Test Findings
In controlled clinical trials, the following laboratory adverse experiences were reported as possibly, probably,
or definitely related to the drug in ≥1% of the patients: eosinophilia (3%) and hemoglobin increase (1%).
Post-Marketing Experience for All Indications
The following adverse reactions have been reported since the drug was registered overseas: hypotension
(mainly orthostatic hypotension), worsening of bronchial asthma, toxic epidermal necrolysis, Stevens-Johnson
syndrome, seizures, elevation of liver enzymes, and elevation of bilirubin.
OVERDOSAGE
Significant lethality was observed in mice and rats after single oral doses of 25 to 50 mg/kg and 40 to
50 mg/kg, respectively. No significant lethality was observed in dogs after single oral doses of up to 10 mg/kg.
At these doses, the treatment-related signs that were observed in these animals include ataxia, bradypnea,
tremors, ptosis, decreased activity, emesis, and mydriasis.
In accidental intoxication with, or significant exposure to, unknown quantities of veterinary formulations of
ivermectin in humans, either by ingestion, inhalation, injection, or exposure to body surfaces, the following
adverse effects have been reported most frequently: rash, edema, headache, dizziness, asthenia, nausea,
vomiting, and diarrhea. Other adverse effects that have been reported include: seizure, ataxia, dyspnea,
abdominal pain, paresthesia, urticaria, and contact dermatitis.
In case of accidental poisoning, supportive therapy, if indicated, should include parenteral fluids and
electrolytes, respiratory support (oxygen and mechanical ventilation if necessary) and pressor agents if clinically
significant hypotension is present. Induction of emesis and/or gastric lavage as soon as possible, followed by
purgatives and other routine anti-poison measures, may be indicated if needed to prevent absorption of ingested
material.
DOSAGE AND ADMINISTRATION
Strongyloidiasis
The recommended dosage of STROMECTOL for the treatment of strongyloidiasis is a single oral dose
designed to provide approximately 200 mcg of ivermectin per kg of body weight. See Table 1 for dosage
guidelines. Patients should take tablets on an empty stomach with water. (See CLINICAL PHARMACOLOGY,
Pharmacokinetics.) In general, additional doses are not necessary. However, follow-up stool examinations
should be performed to verify eradication of infection. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
Table 1
Dosage Guidelines for STROMECTOL for Strongyloidiasis
Body Weight (kg)
Single Oral Dose
Number of 3-mg Tablets
15-24
1 tablet
25-35
2 tablets
36-50
3 tablets
51-65
4 tablets
66-79
5 tablets
≥80
200 mcg/kg
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Onchocerciasis
The recommended dosage of STROMECTOL for the treatment of onchocerciasis is a single oral dose
designed to provide approximately 150 mcg of ivermectin per kg of body weight. See Table 2 for dosage
guidelines. Patients should take tablets on an empty stomach with water. (See CLINICAL PHARMACOLOGY,
Pharmacokinetics.) In mass distribution campaigns in international treatment programs, the most commonly
used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at
intervals as short as 3 months.
Table 2
Dosage Guidelines for STROMECTOL for Onchocerciasis
Body Weight (kg)
Single Oral Dose
Number of 3-mg Tablets
15-25
1 tablet
26-44
2 tablets
45-64
3 tablets
65-84
4 tablets
≥85
150 mcg/kg
HOW SUPPLIED
No. 8495 — Tablets STROMECTOL 3 mg are white, round, flat, bevel-edged tablets coded MSD on one side
and 32 on the other side. They are supplied as follows:
NDC 0006-0032-20 unit dose packages of 20.
Storage
Store at temperatures below 30°C (86°F).
Manufactured by:
MSD BV
Waarderweg 39
2031 BN Haarlem
Netherlands
Issued
Printed in the Netherland
1.) The treatment of scabies with ivermectin.
================================================================
SO - N Engl J Med 1995 Jul 6;333(1):26-30
AU - Meinking TL; Taplin D; Hermida JL; Pardo R; Kerdel FA
AD - Department of Dermatology and Cutaneous Surgery, University of Miami School of Medicine, FL, USA.
PT - CLINICAL TRIAL; JOURNAL ARTICLE
AB - BACKGROUND. Ivermectin is an anthelmintic agent that has been a safe, effective treatment for onchocerciasis (river blindness) when given in a single oral dose of 150 to 200 micrograms per kilogram of body weight. Anecdotal reports of improvement in patients who suffered from infestation with the mite Sarcoptes scabiei suggest that the ectoparasitic disease scabies might be treated with ivermectin. METHODS. We conducted an open-label study in which ivermectin was administered in a single oral dose of 200 micrograms per kilogram to 11 otherwise healthy patients with scabies and to 11 patients with scabies who were also infected with the human immunodeficiency virus (HIV), 7 of whom had the acquired immunodeficiency syndrome. All patients received a full physical and dermatologic examination; scrapings from the skin of all patients tested positive for scabies. Patients were reexamined two and four weeks after treatment, when the scrapings for scabies were repeated. The patients used no other scabicides during the 30 days before ivermectin treatment or during the 4-week study period. RESULTS. None of the 11 otherwise healthy patients had evidence of scabies four weeks after a single dose of ivermectin. Of the 11 HIV-infected patients, 2 had or = 10 scabies lesions before treatment, 3 had 11 to 49 lesions, 4 had or = 50 lesions, and 2 had heavily crusted skin lesions. In eight of the patients the scabies was cured after a single dose of ivermectin. Two patients received a second dose two weeks after the first. Ten of the 11 patients with HIV infection (91 percent) had no evidence of scabies four weeks after their first treatment with ivermectin. CONCLUSIONS. The anthelmintic agent ivermectin, given in a single oral dose, is an effective treatment for scabies in otherwise healthy patients and in many patients with HIV infection.
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2.) Comparison of ivermectin and benzyl benzoate for treatment of scabies.
================================================================
SO - Trop Med Parasitol 1993 Dec;44(4):331-2
AU - Glaziou P; Cartel JL; Alzieu P; Briot C; Moulia-Pelat JP; Martin PM
AD - Institut Territoreal de Recherches Medicales Louis Malarde, Papeete, Tahiti, French Polynesia.
PT - CLINICAL TRIAL; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
AB - A randomized investigator-blinded trial of oral ivermectin 100 micrograms/kg single dose vs. benzyl benzoate 10% application in the treatment of scabies, was conducted in 1992 in French Polynesia. In total, 44 patients aged 5-56 years were included in the study: 23 in the group ivermectin (IVER) and 21 in the group benzyl benzoate (BB). At day 30 after treatment, the cumulative recovery rates were 70% (16/23) in the group IVER, and 48% (10/21) in the group BB, 95% confidence intervals 51-87% and 29-70% respectively. The rates of recovery were greater in the group IVER at day 7, 14 and 30, but the difference was not statistically significant. Our results show that oral ivermectin is a valuable alternative to benzyl benzoate local treatment.
================================================================
3.) Successful use of ivermectin in the treatment of endemic scabies in a nursing home.
================================================================
Author
Sullivan JR; Watt G; Barker B
Address
Department of Dermatology, Royal Newcastle Hospital, New South Wales, Australia.
Source
Australas J Dermatol, 38(3):137-40 1997 Aug
Abstract
Ivermectin, an antiparasitic agent, was successfully used as a sole agent to combat endemic
scabies in a closed 33-bed ward of a rural nursing home. Previous topical therapies,
including multiple applications of permethrin, gamma-benzene hexachloride, benzyl benzoate
and precipitated sulfur in white soft paraffin, had failed. Several patients exhibited
hyperkeratotic crusted scabies with head and neck involvement and all residents except one
recently arrived resident had evidence of active infestation. All residents were treated with
200 micrograms/kg of ivermectin and this dose was repeated 2 weeks later in all subjects.
Four weeks after the first dose of ivermectin there was no evidence of active scabies and
all rashes were totally resolved by 6 weeks. The action of ivermectin, its safety and its
indications are discussed.
================================================================
4.) Treatment of HIV-related scabies with emphasis on the efficacy of ivermectin.
================================================================
Author
Taplin D; Meinking TL
Address
Department of Dermatology, University of Miami School of Medicine, FL 33101, USA.
Source
Semin Cutan Med Surg, 16(3):235-40 1997 Sep
Abstract
Since the mid-1980s, worldwide reports confirm that scabies in individuals infected with the
human immunodeficiency virus (HIV) result in a wide range of-clinical manifestations which
differ from those seen in immunocompetent patients. There is also general agreement that
HIV-related scabies is more difficult to treat. Oral ivermectin has been shown in several
countries to be a safe and effective therapy. In otherwise healthy persons, one dose of 200
microg/kg is usually curative. In HIV-related scabies, one treatment may be curative but
repeated doses may be required. Crusted scabies in these individual requires a combination
of oral ivermectin, total body treatments with 5% permethrin cream, and keratolytic agents
to hasten removal of crusts.
================================================================
5.) Ivermectin-responsive crusted scabies in HTLV1 carrier.
================================================================
Author
Cordoliani F; Vasseur E; Baccard M; Fournier S; Feuilhade de Chauvin M; Tancrede E;
Morel P
Address
Department of Dermatology, H^opital Saint-Louis, Paris, France.
Source
Dermatology, 192(4):351-2 1996
Abstract
We report a case of HTLV1 infection revealed by crusted scabies and widespread
dermatophytosis in an African woman. HTLV1 infection was not complicated by adult T cell
leukemia or myelopathy. Crusted scabies is a marker of HTLV1 infection. The importance
of oral ivermectin therapy in crusted scabies is emphasized.
================================================================
6.) Crusted ("Norwegian") scabies in a specialist HIV unit: successful use of ivermectin and failure to prevent nosocomial transmission [see comments]
================================================================
Author
Corbett EL; Crossley I; Holton J; Levell N; Miller R; De Cock KM
Address
HIV/AIDS Unit Camden & Islington Community Health Services NHS Trust, Middlesex
Hospital, London, UK.
Source
Genitourin Med, 72(2):115-7 1996 Apr
Abstract
A nosocomial outbreak of scabies in a specialist inpatient HIV unit resulted from a patient
admitted with crusted scabies. Treatment of his infestation with topical scabicides alone failed
and he remained infectious for several weeks. His infestation was then eradicated with
combined topical treatment and oral ivermectin. In total, 14 (88%) out of 19 ward staff
became symptomatic, and 4 (21%) had evidence of scabies on potassium hydroxide
examination of skin scrapings. The ward infection control policy was changed to distinguish
patients with crusted scabies from those with ordinary scabies. A second patient with
crusted scabies was treated with combined oral and topical therapy early in his admission
and nursed with more stringent isolation procedures. No nosocomial transmission occurred
and his infestation responded rapidly to treatment. Patients with crusted scabies require strict
barrier nursing if nosocomial transmission is to be avoided. Ivermectin combined with
topical scabicides may be a more efficacious treatment than topical scabicides alone in such
patients.
================================================================
7.) Crusted scabies of the scalp in dermatomyositis patients: three cases treated with oral ivermectin.
================================================================
Author
Dourmishev AL; Serafimova DK; Dourmishev LA; Mualla MA; Papaharalambous V;
Malchevsky T
Address
Department of Dermatology and Venereology, University of Medicine, Sofia, Bulgaria.
Source
Int J Dermatol, 37(3):231-4 1998 Mar
Abstract
BACKGROUND: Cutaneous features in the scalp area among adult patients are rarely
considered as a manifestation of scabies. METHODS: Three patients with clinical and
laboratory data of dermatomyositis with scalp involvement (fulfill three or four of Bohan and
Peter's criteria), of 4 years, 8 months, and 3 years duration, were seen at our department
between 1995 and 1996. For relapses of ordinary scabies, they were treated repeatedly
with local scabicide with temporary effect. After a symptom-free period during the treatment
of dermatomyositis with corticosteroids and azathioprine, they developed diffuse redness with
scales and crusts on the scalp areas. Light microscopy examination of material taken from
these crusts showed an abundance of live mites. RESULTS: All patients were successfully
cured of scabies with a twice oral dose of 200 microg/kg ivermectin within 8 days.
CONCLUSIONS: Our patients with crusted scabies of the scalp and dermatomyositis
prompted us to change our standard diagnostic and therapeutic regimens. Fascinating
features included mimicry of scabies in patients with dermatomyositis, location of parasites
on the scalp, suppressed cell-mediated immunity and successful cure of mange by
ivermectin.
===============================================================
8.) Ivermectin for Sarcoptes scabiei hyperinfestation.
================================================================
Author
Huffam SE; Currie BJ
Address
Royal Darwin Hospital, Menzies School of Health Research, Darwin, Northern Territory,
Australia.
Source
Int J Infect Dis, 2(3):152-4 1998 Jan-Mar
Abstract
OBJECTIVES: Crusted (Norwegian) scabies is an unusual variant of scabies caused by
hyperinfestation with Sarcoptes scabiei. It has high morbidity, and secondary bacterial skin
sepsis may result in life-threatening bacteremia. An open label study of oral ivermectin was
carried out in patients with crusted scabies refractory to topical therapy. METHODS:
Patients with refractory crusted scabies were prescribed oral ivermectin, one to three doses
of 200 mg/kg at 14-day intervals, combined with topical scabicide and keratolytic therapy.
RESULTS: Of the 20 patients who received ivermectin, 8 had a complete initial clinical
response, a partial response was achieved in 9, and minimal improvement occurred in 3.
Three doses of ivermectin were curative for 8 of 10 cases, but recurrence of scabies from
presumed reinfestation occurred in at least half of these. CONCLUSION: The authors
conclude that ivermectin is effective for crusted scabies; however, multiple doses may be
required to achieve a cure, and recurrence 6 or more weeks after completing treatment is
common.
================================================================
9.) Topical application of ivermectin for human ectoparasites.
================================================================
Author
Youssef MY; Sadaka HA; Eissa MM; el-Ariny AF
Address
Department of Parasitology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.
Source
Am J Trop Med Hyg, 53(6):652-3 1995 Dec
Abstract
Ivermectin is used in veterinary practice against many ectoparasites and endoparasites and
is the drug of choice for treatment of human onchocerciasis. This study was carried out to
investigate the effect of topical application of this drug against human ectoparasites
(Sarcoptes scabiei and Pediculus humanus capitis). Ivernectin was found to have a curative
effect on head lice after a single topical application. In patients with scabies, the drug was
also found to be effective after a single application. However, in 50% of the cases, another
application was needed five days later.
================================================================
10.) An assessment of topical and oral prescription and over-the-counter treatments for head lice.
================================================================
Author
Burkhart CG; Burkhart CN; Burkhart KM
Address
Department of Medicine, Medical College of Ohio at Toledo, USA.
Source
J Am Acad Dermatol, 38(6 Pt 1):979-82 1998 Jun
Abstract
A plethora of head lice cases that require optimal therapeutic assessments are developing in
elementary schools. Over-the-counter therapies continue to be the mainstream solution for
most cases of pediculosis capitis, but the onset of resistant cases dictates a review of
available treatment modalities. The increased efficacy of prescription drugs, namely topical
5% permethrin and oral ivermectin, underline the expanding role that physicians will serve in
the eradication of head lice in our communities.
================================================================
11.) Efficacy of ivermectin for the treatment of head lice (Pediculosis capitis).
================================================================
SO - Trop Med Parasitol 1994 Sep;45(3):253-4
AU - Glaziou P; Nyguyen LN; Moulia-Pelat JP; Cartel JL; Martin PM
AD - Institut Territorial de Recherches Medicales Louis Malarde, Papeete, Tahiti, French Polynesia.
PT - CLINICAL TRIAL; JOURNAL ARTICLE
AB - Twenty six male and female patients aged 5 to 17 years who had head lice infestation confirmed by eggs presence and received treatments with a single 200 mu/kg oral dose of ivermectin in open fashion. At day 14 after treatment, 20 responded to the treatment (77%), and 6 patients (23%) presented with a complete disappearance of eggs and all clinical symptoms. At day 28, 7 patients were healed (27%), but 4 patients of the 6 healed at day 14 presented with signs of reinfestation. This study suggests that ivermectin is a promising treatment of head lice, and a second dose at day 10 should be appropriate for a further comparative trial.
================================================================
12.) Physiology, pharmacology and parasitology.
================================================================
Author
Hennessy DR
Address
CSIRO Division of Animal Production, McMaster Laboratory, Blacktown, NSW, Australia.
Source
Int J Parasitol, 27(2):145-52 1997 Feb
Abstract
The developing resistance to current chemical classes of broad-spectrum anthelmintics and
insecticides presents an undeniable threat to the long-term viability of the animal health
industry. Alternative treatment strategies including vaccines, biological control and breeding of
parasite-resistant animals are unlikely to be widely available in the near future and even then
they will be integrated with chemotherapy. The significant cost of research and development
of new therapeutics for food-producing animals, together with the small market share of
animal health products, particularly in Australia and New Zealand, is a positive disincentive
for drug development. The chemical actives that are currently available are all that we are
likely to have for the foreseeable future and they must be used more efficiently.
Understanding the pharmacokinetic behaviour of antiparasitics and recognising the potential
for the animal's physiological characteristics to assist drug action is crucial. Careful
administration, coupled with a reduction of feed intake before oral anthelmintic treatment,
maximises drug availability and therefore increases efficacy of the benzimidazole and
ivermectin compounds. This is a cost-effective option that can be employed immediately,
which not only increases efficacy of "older" compounds but will be instrumental in prolonging
the useful life of the newer drugs. Taking care to apply topical insecticide formulations directly
along the backline immediately after shearing will maximise even diffusion of active around the
sheep flanks to contact lice inhabiting sites remote from the point of drug application. The use
of "intelligent" formulation and delivery of existing compounds, based on knowledge of host
physiological and pharmacological responses, holds the key to effective antiparasitic
================================================================
13.) Efficacy of ivermectin in the treatment of strongyloidiasis complicating AIDS.
================================================================
SO - Clin Infect Dis 1993 Nov;17(5):900-2
AU - Torres JR; Isturiz R; Murillo J; Guzman M; Contreras R
AD - Instituto de Medicina Tropical Felix Pifano C., Universidad Central de Venezuela.
PT - JOURNAL ARTICLE
AB - Nine adult male homosexuals who were infected with the human immunodeficiency virus (five with AIDS-defining conditions) and harbored Strongyloides stercoralis received ivermectin on a compassionate basis for persistent intestinal infection. Hyperinfection was present in all cases. Ivermectin was given either as a single oral dose (200 micrograms/kg) or on a multidose schedule (200 micrograms/kg.d) on days 1, 2, 15, and 16. All seven patients who received multiple doses showed sustained clinical and parasitological cure, whereas one of two patients who received single-dose therapy relapsed promptly and fatally. Remissions have been maintained for at least 7 months and up to 3 years of follow-up. Ivermectin appears promising in the treatment of strongyloidiasis in patients with AIDS. Because of the risk of hyperinfection and/or disseminated disease, multidose courses are warranted. We are not aware of other reports describing the efficacy of antiparasitic drugs for strongyloidiasis in patients with AIDS.
================================================================
14.) Efficacy of ivermectin against Strongyloides stercoralis in humans.
================================================================
SO - Intern Med 1992 Mar;31(3):310-2
AU - Shikiya K; Kinjo N; Uehara T; Uechi H; Ohshiro J; Arakaki T; Kinjo F; Saito A; Iju M; Kobari K
AD - First Department of Internal Medicine, Faculty of Medicine, University of the Ryukyus, Okinawa, Japan.
PT - JOURNAL ARTICLE
AB - Okinawa Prefecture is an endemic area of Strongyloides stercoralis infection. Since treatment of this infection remains unsatisfactory, we evaluated the efficacy of ivermectin. Twenty-three patients were treated with a single oral dose of ivermectin (mean +/- SD, 105.5 +/- 20.8 mcg/kg of body weight), followed by a second dose two weeks later. The rate of cure was 85.7% at 2 weeks after the first treatment, and 90.5% at 2 weeks after the second treatment. Side effects occurred in 2 patients (8.7%), but they were mild and transient. The results indicate that ivermectin might be useful and relatively safe for the therapy of Strongyloides stercoralis infection as an alternative to thiabendazole or mebendazole.
================================================================
15.) Efficacy of ivermectin in the therapy of cutaneous larva migrans [letter]
SO - Arch Dermatol 1992 Jul;128(7):994-5
AU - Caumes E; Datry A; Paris L; Danis M; Gentilini M; Gaxotte P
PT - LETTER
==========================================================
16.) Ivermectin 1% Cream (Soolantra) for Inflammatory Lesions of Rosacea.
==========================================================
Am Fam Physician. 2016 Sep 15;94(6):512-3.
Gazewood JD1, Johnson K1.
Author information
University of Virginia Health System, Charlottesville, VA, USA.
===================================================================
17.) of rosacea with topical ivermectin cream: a series of 34 cases.
==================================================================
Dermatol Online J. 2016 Aug 15;22(8). pii: 13030/qt9ks1c48n.
Mendieta Eckert M1, Landa Gundin N.
Author information
Department of Dermatology,Clínica Dermitek (Bilbao), Spain. mmendieta@dermitek.com.
Abstract
Rosacea is a highly prevalent, chronic inflammatory disease. The use of topical ivermectin cream has recently been described in the treatment of rosacea in three clinical trials. We report our experience in a series of 34 patients treated with topical ivermectin cream. The results are a reflection of the reality of clinical practice and the perception of patients of the treatment. We also evaluate the efficacy in cases of mild rosacea and erythematotelangiectatic rosacea which have not been studied in trials.
=============================================================================
18.)The efficacy, safety, and tolerability of ivermectin compared with current topical treatments for the inflammatory lesions of rosacea: a network meta-analysis.
==============================================================================
Springerplus. 2016 Jul 22;5(1):1151. doi: 10.1186/s40064-016-2819-8. eCollection 2016.
Siddiqui K1, Stein Gold L2, Gill J1.
Author information
PAREXEL Access Consulting, PAREXEL International, 3rd Floor, DLF Tower E, Rajiv Gandi IT Park, Chandigarh, UT 160101 India.
Department of Dermatology, Henry Ford Medical Centre, Detroit, MI USA.
Abstract
BACKGROUND:
Rosacea is a common chronic skin condition that manifests as recurrent inflammatory lesions. Long-term treatment is required to control symptoms and disease progression, with topical treatments being the first-line choice. Ivermectin 1 % cream is a new once-daily (QD) topical treatment for the inflammatory lesions of rosacea, and it is important to compare the efficacy, safety, and tolerability of ivermectin with other currently available topical treatments.
METHODS:
A systematic literature review was performed from January 2011 to June 2015, with articles published prior to 2011 retrieved from a Cochrane review on rosacea. Randomized controlled trials of the topical treatment of adult patients with moderate-to-severe papulopustular rosacea were identified from electronic databases and trial registers, and supplemented with data from clinical study reports. Mixed treatment comparisons (MTCs) were conducted to compare different treatments according to Bayesian methodology.
RESULTS:
57 studies were identified, with 19 providing data suitable for MTC. Ivermectin 1 % cream QD led to a significantly greater likelihood of success compared with azelaic acid 15 % gel twice-daily (BID) [relative risk (95 % credible interval): 1.25 (1.14-1.37)], and metronidazole 0.75 % cream BID [1.17 (1.08-1.29)] at 12 weeks. Ivermectin 1 % cream QD also demonstrated a significant reduction in inflammatory lesion count compared with azelaic acid 15 % gel BID [-8.04 (-12.69 to -3.43)] and metronidazole 0.75 % cream BID [-9.92 (-13.58 to -6.35)] at 12 weeks. Ivermectin 1 % cream QD led to a significantly lower risk of developing any AE or TRAE compared with azelaic acid 15 % gel BID [0.83 (0.71-0.97) and 0.47 (0.32-0.67), respectively].
CONCLUSIONS:
Ivermectin 1 % cream QD appears to be a more effective topical treatment than other current options for the inflammatory lesions of rosacea, with at least an equivalent safety and tolerability profile, and could provide physicians and dermatologists with an alternative first-line treatment option.
=================================================================
19.) The efficacy of topical and oral ivermectin in the treatment of human scabies.
==================================================================
Ann Parasitol. 2015;61(1):11-6.
Panahi Y1, Poursaleh Z1, Goldust M2.
Author information
1Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Teheran, Iran.
2Tabriz University of Medical Sciences, Tabriz, Iran.
Abstract
Scabies is an itchy skin condition caused by the microscopic mite Sarcoptes scabei. The itching is caused by an allergic reaction to the mites. The treatment of choice is still controversial. It is commonly treated with topical insecticides. The aim of this study was to assess the efficacy of topical and oral ivermectin in the treatment of human scabies. We searched electronic databases (Cochrane Occupational Safety and Health Review Group Specialised Register, CENTRAL (The Cochrane Library), MEDLINE (Ovid), Pubmed, EMBASE, LILACS, CINAHL, Open Grey and WHO ICTRP) up to September 2014. Randomized controlled trials (RCTs) or cluster RCTs which compared the efficacy of ivermectin with other medications in the treatment of scabies. Interventions could be compared to each other, or to placebo or to no treatment. The author intended to extract dichotomous data (developed infection or did not develop infection) for the effects of interventions. We intended to report any adverse outcomes similarly. It has been sated that ivermectin was as effective as permethrin in the treatment of scabies. In comparison to other medications such as lindane, benzyl benzoate, crotamiton and malathion, ivermectin was more effective in the treatment of scabies. Ivermectin is an effective and cost-comparable alternative to topical agents in the treatment of scabies infection.
========================================================================
20.) Assessment of oral ivermectin versus shampoo in the treatment of pediculosis (head lice infestation) in rural areas of Sine-Saloum, Senegal.
========================================================================
Int J Antimicrob Agents. 2016 Dec;48(6):627-632. doi: 10.1016/j.ijantimicag.2016.07.014. Epub 2016 Aug 31.
Leulmi H1, Diatta G2, Sokhna C2, Rolain JM1, Raoult D3.
Author information
1Aix-Marseille Université, Unité de Recherche en Maladies Infectieuses et Tropicales Emergentes (URMITE), UM63, CNRS 7278, IRD 198 (Dakar), Inserm 1095, Marseille, France.
2Institut de Recherche pour le Développement (IRD), UMR 198 IRD, Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Campus International de Recherche IRD-UCAD, Hann, BP. 1386, Dakar, Senegal.
3Aix-Marseille Université, Unité de Recherche en Maladies Infectieuses et Tropicales Emergentes (URMITE), UM63, CNRS 7278, IRD 198 (Dakar), Inserm 1095, Marseille, France; Institut de Recherche pour le Développement (IRD), UMR 198 IRD, Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Campus International de Recherche IRD-UCAD, Hann, BP. 1386, Dakar, Senegal. Electronic address: didier.raoult@gmail.com.
Abstract
Reports of treatment failure and the emergence of resistance to topical head lice treatments have become increasingly common, driving the need for continued development of new therapeutic options for pediculosis. Ivermectin has been proposed as a potential alternative for the treatment of pediculosis but has not been sufficiently evaluated. In this study, the effectiveness of oral ivermectin versus shampoo in the treatment of pediculosis in Senegal was compared. The study was conducted in two neighbouring villages of Sine-Saloum, Senegal: Dielmo (ivermectin trial group; 201 female participants) and Ndiop (shampoo trial group; 239 female participants). In the ivermectin group, patients received two doses of oral ivermectin (400 µg/kg body weight; Mectizan®) 7 days apart. In contrast, the shampoo group received a shampoo treatment based on d-phenothrin (0.23%; Hégor®). At the beginning of the study, 70 (34.8%) of 201 participants in the ivermectin group were infested by head lice versus 145 (60.7%) of 239 participants in the shampoo group. At Day 15 post-treatment, the efficacy of the treatment against head lice reached 41/53 (77.4%) in the ivermectin group (53 patients were tested in this group) versus 42/130 (32.3%) in the shampoo group (130 patients were tested in this group) (P <10-7). However, 4 (7.5%) of the 53 females in the ivermectin group exhibited probable ivermectin treatment failure, suggesting the emergence of ivermectin-resistant lice. This study demonstrates that oral ivermectin is highly effective for the treatment of pediculosis compared with shampoo, but also suggests that ivermectin resistance may emerge during treatment.
=======================================================================
21.) Head lice probably resistant to ivermectin recovered from two rural girls in Dielmo, a village in Sine-Saloum, Senegal.
========================================================================
Int J Antimicrob Agents. 2016 Jun;47(6):501-2. doi: 10.1016/j.ijantimicag.2016.03.013. Epub 2016 Apr 25.
Diatta G1, Abat C2, Sokhna C1, Tissot-Dupont H3, Rolain JM3, Raoult D4.
Author information
1Institut de recherche pour le développement (IRD), UMR 198 IRD, Unité de recherche sur les maladies infectieuses et tropicales emergentes (URMITE), Campus International de Recherche IRD-UCAD, Hann, BP 1386 Dakar, Senegal.
2Institut de recherche pour le développement (IRD), UMR 198 IRD, Unité de recherche sur les maladies infectieuses et tropicales emergentes (URMITE),Campus International de Recherche IRD-UCAD, Hann, BP 1386 Dakar, Senegal; Aix-Marseille Université, URMITE, Unité mixte (UM) 63, Centre national de la recherche scientifique (CNRS) 7278, IRD 198, Institut national de la santé et de la recherche médicale (INSERM) 1905, 13005 Marseille, France.
3Aix-Marseille Université, URMITE, Unité mixte (UM) 63, Centre national de la recherche scientifique (CNRS) 7278, IRD 198, Institut national de la santé et de la recherche médicale (INSERM) 1905, 13005 Marseille, France.
4Aix-Marseille Université, URMITE, Unité mixte (UM) 63, Centre national de la recherche scientifique (CNRS) 7278, IRD 198, Institut national de la santé et de la recherche médicale (INSERM) 1905, 13005 Marseille, France. Electronic address: didier.raoult@gmail.com.
========================================================================
22.) Over 25 Years of Clinical Experience With Ivermectin: An Overview of Safety for an Increasing Number of Indications.
========================================================================
Kircik LH, Del Rosso JQ, Layton AM, Schauber J.
Abstract
Although the broad-spectrum anti-parasitic effects of the avermectin derivative ivermectin are well documented, its anti-inflammatory activity has only recently been demonstrated. For over 25 years, ivermectin has been used to treat parasitic infections in mammals, with a good safety profile that may be attributed to its high affinity to invertebrate neuronal ion channels and its inability to cross the blood-brain barrier in humans and other mammals. Numerous studies report low rates of adverse events, as an oral treatment for parasitic infections, scabies and head lice. Ivermectin has been used off-label to treat diseases associated with Demodex mites, such as blepharitis and demodicidosis. New evidence has linked Demodex mites to rosacea, a chronic inflammatory disease. Ivermectin has recently received FDA and EU approval for the treatment of adult patients with inflammatory lesions of rosacea, a disease in which this agent has been shown to be well tolerated. After more than 25 years of use, ivermectin continues to provide a high margin of safety for a growing number of indications based on its anti-parasitic and anti-inflammatory activities.
=======================================================================
23.) IVERMECTIN TABLETS MONOGRAPH
========================================================================
Source: http://www.fda.gov/Drugs/default.htm
TABLETS
STROMECTOL®
(IVERMECTIN)
DESCRIPTION
STROMECTOL* (Ivermectin) is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is
derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the
fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5-O
demethyl-22,23-dihydroavermectin A1a and less than 10% 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro
25-(1-methylethyl)avermectin A1a, generally referred to as 22,23-dihydroavermectin B1a and B1b, or H2B1a and
H2B1b, respectively. The respective empirical formulas are C48H74O14 and C47H72O14, with molecular weights of
875.10 and 861.07, respectively. The structural formulas are:
Component B1a, R = C2H5
Component B1b, R = CH3
Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about
155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol.
STROMECTOL is available in 3-mg tablets containing the following inactive ingredients: microcrystalline
cellulose, pregelatinized starch, magnesium stearate, butylated hydroxyanisole, and citric acid powder
(anhydrous).
CLINICAL PHARMACOLOGY
Pharmacokinetics
Following oral administration of ivermectin, plasma concentrations are approximately proportional to the
dose. In two studies, after single 12-mg doses of STROMECTOL in fasting healthy volunteers (representing a
mean dose of 165 mcg/kg), the mean peak plasma concentrations of the major component (H2B1a) were 46.6
(±21.9) (range: 16.4-101.1) and 30.6 (±15.6) (range: 13.9-68.4) ng/mL, respectively, at approximately 4 hours
after dosing. Ivermectin is metabolized in the liver, and ivermectin and/or its metabolites are excreted almost
exclusively in the feces over an estimated 12 days, with less than 1% of the administered dose excreted in the
urine. The plasma half-life of ivermectin in man is approximately 18 hours following oral administration.
The safety and pharmacokinetic properties of ivermectin were further assessed in a multiple-dose clinical
pharmacokinetic study involving healthy volunteers. Subjects received oral doses of 30 to 120 mg (333 to 2000
mcg/kg) ivermectin in a fasted state or 30 mg (333 to 600 mcg/kg) ivermectin following a standard high-fat
(48.6 g of fat) meal. Administration of 30 mg ivermectin following a high-fat meal resulted in an approximate 2.5
fold increase in bioavailability relative to administration of 30 mg ivermectin in the fasted state.
Microbiology
Ivermectin is a member of the avermectin class of broad-spectrum antiparasitic agents which have a unique
mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion
channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the
cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and
death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such
as those gated by the neurotransmitter gamma-aminobutyric acid (GABA).
The selective activity of compounds of this class is attributable to the facts that some mammals do not have
glutamate-gated chloride channels and that the avermectins have a low affinity for mammalian ligand-gated
chloride channels. In addition, ivermectin does not readily cross the blood-brain barrier in humans.
*
Registered trademark of MERCK & CO., Inc.
COPYRIGHT © 1996, 2007 MERCK & CO., Inc.
All rights reserved
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Ivermectin is active against various life-cycle stages of many but not all nematodes. It is active against the
tissue microfilariae of Onchocerca volvulus but not against the adult form. Its activity against Strongyloides
stercoralis is limited to the intestinal stages.
Clinical Studies
Strongyloidiasis
Two controlled clinical studies using albendazole as the comparative agent were carried out in international
sites where albendazole is approved for the treatment of strongyloidiasis of the gastrointestinal tract, and three
controlled studies were carried out in the U.S. and internationally using thiabendazole as the comparative agent.
Efficacy, as measured by cure rate, was defined as the absence of larvae in at least two follow-up stool
examinations 3 to 4 weeks post-therapy. Based on this criterion, efficacy was significantly greater for
STROMECTOL (a single dose of 170 to 200 mcg/kg) than for albendazole (200 mg b.i.d. for 3 days).
STROMECTOL administered as a single dose of 200 mcg/kg for 1 day was as efficacious as thiabendazole
administered at 25 mg/kg b.i.d. for 3 days.
Summary of Cure Rates for Ivermectin Versus Comparative Agents in the
Treatment of Strongyloidiasis
Cure Rate* (%)
Ivermectin**
Comparative Agent
Albendazole*** Comparative
International Study
WHO Study
24/26 (92)
126/152 (83)
12/22 (55)
67/149 (45)
Thiabendazole† Comparative
International Study
US Studies
9/14 (64)
14/14 (100)
13/15 (87)
16/17 (94)
*
Number and % of evaluable patients
**
170-200 mcg/kg
*** 200 mg b.i.d. for 3 days
†
25 mg/kg b.i.d. for 3 days
In one study conducted in France, a non-endemic area where there was no possibility of reinfection, several
patients were observed to have recrudescence of Strongyloides larvae in their stool as long as 106 days
following ivermectin therapy. Therefore, at least three stool examinations should be conducted over the three
months following treatment to ensure eradication. If recrudescence of larvae is observed, retreatment with
ivermectin is indicated. Concentration techniques (such as using a Baermann apparatus) should be employed
when performing these stool examinations, as the number of Strongyloides larvae per gram of feces may be
very low.
Onchocerciasis
The evaluation of STROMECTOL in the treatment of onchocerciasis is based on the results of clinical
studies involving 1278 patients. In a double-blind, placebo-controlled study involving adult patients with
moderate to severe onchocercal infection, patients who received a single dose of 150 mcg/kg STROMECTOL
experienced an 83.2% and 99.5% decrease in skin microfilariae count (geometric mean) 3 days and 3 months
after the dose, respectively. A marked reduction of >90% was maintained for up to 12 months after the single
dose. As with other microfilaricidal drugs, there was an increase in the microfilariae count in the anterior
chamber of the eye at day 3 after treatment in some patients. However, at 3 and 6 months after the dose, a
significantly greater percentage of patients treated with STROMECTOL had decreases in microfilariae count in
the anterior chamber than patients treated with placebo.
In a separate open study involving pediatric patients ages 6 to 13 (n=103; weight range: 17-41 kg), similar
decreases in skin microfilariae counts were observed for up to 12 months after dosing.
INDICATIONS AND USAGE
STROMECTOL is indicated for the treatment of the following infections:
Strongyloidiasis of the intestinal tract. STROMECTOL is indicated for the treatment of intestinal (i.e.,
nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis.
This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of
infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL
PHARMACOLOGY, Clinical Studies.)
Onchocerciasis. STROMECTOL is indicated for the treatment of onchocerciasis due to the nematode
parasite Onchocerca volvulus.
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This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted
in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used
diethylcarbamazine citrate (DEC-C).
NOTE: STROMECTOL has no activity against adult Onchocerca volvulus parasites. The adult parasites
reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules
(nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will
eliminate the microfilariae-producing adult parasites.
CONTRAINDICATIONS
STROMECTOL is contraindicated in patients who are hypersensitive to any component of this product.
WARNINGS
Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might
cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological
reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory
responses to the death of microfilariae. Patients treated with STROMECTOL for onchocerciasis may experience
these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself.
(See ADVERSE REACTIONS, Onchocerciasis.)
The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. Oral hydration,
recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural
hypotension. Antihistamines and/or aspirin have been used for most mild to moderate cases.
PRECAUTIONS
General
After treatment with microfilaricidal drugs, patients with hyperreactive onchodermatitis (sowda) may be more
likely than others to experience severe adverse reactions, especially edema and aggravation of
onchodermatitis.
Rarely, patients with onchocerciasis who are also heavily infected with Loa loa may develop a serious or
even fatal encephalopathy either spontaneously or following treatment with an effective microfilaricide. In these
patients, the following adverse experiences have also been reported: pain (including neck and back pain), red
eye, conjunctival hemorrhage, dyspnea, urinary and/or fecal incontinence, difficulty in standing/walking, mental
status changes, confusion, lethargy, stupor, seizures, or coma. This syndrome has been seen very rarely
following the use of ivermectin. In individuals who warrant treatment with ivermectin for any reason and have
had significant exposure to Loa loa-endemic areas of West or Central Africa, pretreatment assessment for
loiasis and careful post-treatment follow-up should be implemented.
Information for Patients
STROMECTOL should be taken on an empty stomach with water. (See CLINICAL PHARMACOLOGY,
Pharmacokinetics.)
Strongyloidiasis: The patient should be reminded of the need for repeated stool examinations to document
clearance of infection with Strongyloides stercoralis.
Onchocerciasis: The patient should be reminded that treatment with STROMECTOL does not kill the adult
Onchocerca parasites, and therefore repeated follow-up and retreatment is usually required.
Drug Interactions
Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when
ivermectin was co-administered with warfarin.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of ivermectin.
Ivermectin was not genotoxic in vitro in the Ames microbial mutagenicity assay of Salmonella typhimurium
strains TA1535, TA1537, TA98, and TA100 with and without rat liver enzyme activation, the Mouse Lymphoma
Cell Line L5178Y (cytotoxicity and mutagenicity) assays, or the unscheduled DNA synthesis assay in human
fibroblasts.
Ivermectin had no adverse effects on the fertility in rats in studies at repeated doses of up to 3 times the
maximum recommended human dose of 200 mcg/kg (on a mg/m2/day basis).
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Pregnancy, Teratogenic Effects
Pregnancy Category C
Ivermectin has been shown to be teratogenic in mice, rats, and rabbits when given in repeated doses of 0.2,
8.1, and 4.5 times the maximum recommended human dose, respectively (on a mg/m2/day basis).
Teratogenicity was characterized in the three species tested by cleft palate; clubbed forepaws were additionally
observed in rabbits. These developmental effects were found only at or near doses that were maternotoxic to
the pregnant female. Therefore, ivermectin does not appear to be selectively fetotoxic to the developing fetus.
There are, however, no adequate and well-controlled studies in pregnant women. Ivermectin should not be used
during pregnancy since safety in pregnancy has not been established.
Nursing Mothers
STROMECTOL is excreted in human milk in low concentrations. Treatment of mothers who intend to breast-
feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to
the newborn.
Pediatric Use
Safety and effectiveness in pediatric patients weighing less than 15 kg have not been established.
Geriatric Use
Clinical studies of STROMECTOL did not include sufficient numbers of subjects aged 65 and over to
determine whether they respond differently from younger subjects. Other reported clinical experience has not
identified differences in responses between the elderly and younger patients. In general, treatment of an elderly
patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and
of concomitant disease or other drug therapy.
Strongyloidiasis in Immunocompromised Hosts
In immunocompromised (including HIV-infected) patients being treated for intestinal strongyloidiasis,
repeated courses of therapy may be required. Adequate and well-controlled clinical studies have not been
conducted in such patients to determine the optimal dosing regimen. Several treatments, i.e., at 2-week
intervals, may be required, and cure may not be achievable. Control of extra-intestinal strongyloidiasis in these
patients is difficult, and suppressive therapy, i.e., once per month, may be helpful.
ADVERSE REACTIONS
Strongyloidiasis
In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of
STROMECTOL, the following adverse reactions were reported as possibly, probably, or definitely related to
STROMECTOL:
Body as a Whole: asthenia/fatigue (0.9%), abdominal pain (0.9%)
Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%)
Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%)
Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%).
In comparative trials, patients treated with STROMECTOL experienced more abdominal distention and chest
discomfort than patients treated with albendazole. However, STROMECTOL was better tolerated than
thiabendazole in comparative studies involving 37 patients treated with thiabendazole.
The Mazzotti-type and ophthalmologic reactions associated with the treatment of onchocerciasis or the
disease itself would not be expected to occur in strongyloidiasis patients treated with STROMECTOL. (See
ADVERSE REACTIONS, Onchocerciasis.)
Laboratory Test Findings
In clinical trials involving 109 patients given either one or two doses of 170 to 200 mcg/kg STROMECTOL,
the following laboratory abnormalities were seen regardless of drug relationship: elevation in ALT and/or AST
(2%), decrease in leukocyte count (3%). Leukopenia and anemia were seen in one patient.
Onchocerciasis
In clinical trials involving 963 adult patients treated with 100 to 200 mcg/kg STROMECTOL, worsening of the
following Mazzotti reactions during the first 4 days post-treatment were reported: arthralgia/synovitis (9.3%),
axillary lymph node enlargement and tenderness (11.0% and 4.4%, respectively), cervical lymph node
enlargement and tenderness (5.3% and 1.2%, respectively), inguinal lymph node enlargement and tenderness
(12.6% and 13.9%, respectively), other lymph node enlargement and tenderness (3.0% and 1.9%, respectively),
pruritus (27.5%), skin involvement including edema, papular and pustular or frank urticarial rash (22.7%), and
fever (22.6%). (See WARNINGS.)
In clinical trials, ophthalmological conditions were examined in 963 adult patients before treatment, at day 3,
and months 3 and 6 after treatment with 100 to 200 mcg/kg STROMECTOL. Changes observed were primarily
deterioration from baseline 3 days post-treatment. Most changes either returned to baseline condition or
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improved over baseline severity at the month 3 and 6 visits. The percentages of patients with worsening of the
following conditions at day 3, month 3 and 6, respectively, were: limbitis: 5.5%, 4.8%, and 3.5% and punctate
opacity: 1.8%, 1.8%, and 1.4%. The corresponding percentages for patients treated with placebo were: limbitis:
6.2%, 9.9%, and 9.4% and punctate opacity: 2.0%, 6.4%, and 7.2%. (See WARNINGS.)
In clinical trials involving 963 adult patients who received 100 to 200 mcg/kg STROMECTOL, the following
clinical adverse reactions were reported as possibly, probably, or definitely related to the drug in ≥1% of the
patients: facial edema (1.2%), peripheral edema (3.2%), orthostatic hypotension (1.1%), and tachycardia
(3.5%). Drug-related headache and myalgia occurred in <1% of patients (0.2% and 0.4%, respectively).
However, these were the most common adverse experiences reported overall during these trials regardless of
causality (22.3% and 19.7%, respectively).
A similar safety profile was observed in an open study in pediatric patients ages 6 to 13.
The following ophthalmological side effects do occur due to the disease itself but have also been reported
after treatment with STROMECTOL: abnormal sensation in the eyes, eyelid edema, anterior uveitis,
conjunctivitis, limbitis, keratitis, and chorioretinitis or choroiditis. These have rarely been severe or associated
with loss of vision and have generally resolved without corticosteroid treatment.
Laboratory Test Findings
In controlled clinical trials, the following laboratory adverse experiences were reported as possibly, probably,
or definitely related to the drug in ≥1% of the patients: eosinophilia (3%) and hemoglobin increase (1%).
Post-Marketing Experience for All Indications
The following adverse reactions have been reported since the drug was registered overseas: hypotension
(mainly orthostatic hypotension), worsening of bronchial asthma, toxic epidermal necrolysis, Stevens-Johnson
syndrome, seizures, elevation of liver enzymes, and elevation of bilirubin.
OVERDOSAGE
Significant lethality was observed in mice and rats after single oral doses of 25 to 50 mg/kg and 40 to
50 mg/kg, respectively. No significant lethality was observed in dogs after single oral doses of up to 10 mg/kg.
At these doses, the treatment-related signs that were observed in these animals include ataxia, bradypnea,
tremors, ptosis, decreased activity, emesis, and mydriasis.
In accidental intoxication with, or significant exposure to, unknown quantities of veterinary formulations of
ivermectin in humans, either by ingestion, inhalation, injection, or exposure to body surfaces, the following
adverse effects have been reported most frequently: rash, edema, headache, dizziness, asthenia, nausea,
vomiting, and diarrhea. Other adverse effects that have been reported include: seizure, ataxia, dyspnea,
abdominal pain, paresthesia, urticaria, and contact dermatitis.
In case of accidental poisoning, supportive therapy, if indicated, should include parenteral fluids and
electrolytes, respiratory support (oxygen and mechanical ventilation if necessary) and pressor agents if clinically
significant hypotension is present. Induction of emesis and/or gastric lavage as soon as possible, followed by
purgatives and other routine anti-poison measures, may be indicated if needed to prevent absorption of ingested
material.
DOSAGE AND ADMINISTRATION
Strongyloidiasis
The recommended dosage of STROMECTOL for the treatment of strongyloidiasis is a single oral dose
designed to provide approximately 200 mcg of ivermectin per kg of body weight. See Table 1 for dosage
guidelines. Patients should take tablets on an empty stomach with water. (See CLINICAL PHARMACOLOGY,
Pharmacokinetics.) In general, additional doses are not necessary. However, follow-up stool examinations
should be performed to verify eradication of infection. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
Table 1
Dosage Guidelines for STROMECTOL for Strongyloidiasis
Body Weight (kg)
Single Oral Dose
Number of 3-mg Tablets
15-24
1 tablet
25-35
2 tablets
36-50
3 tablets
51-65
4 tablets
66-79
5 tablets
≥80
200 mcg/kg
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Onchocerciasis
The recommended dosage of STROMECTOL for the treatment of onchocerciasis is a single oral dose
designed to provide approximately 150 mcg of ivermectin per kg of body weight. See Table 2 for dosage
guidelines. Patients should take tablets on an empty stomach with water. (See CLINICAL PHARMACOLOGY,
Pharmacokinetics.) In mass distribution campaigns in international treatment programs, the most commonly
used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at
intervals as short as 3 months.
Table 2
Dosage Guidelines for STROMECTOL for Onchocerciasis
Body Weight (kg)
Single Oral Dose
Number of 3-mg Tablets
15-25
1 tablet
26-44
2 tablets
45-64
3 tablets
65-84
4 tablets
≥85
150 mcg/kg
HOW SUPPLIED
No. 8495 — Tablets STROMECTOL 3 mg are white, round, flat, bevel-edged tablets coded MSD on one side
and 32 on the other side. They are supplied as follows:
NDC 0006-0032-20 unit dose packages of 20.
Storage
Store at temperatures below 30°C (86°F).
Manufactured by:
MSD BV
Waarderweg 39
2031 BN Haarlem
Netherlands
Issued
Printed in the Netherland
=================================================================
24.) Approval of ivermectin for COVID-19 treatment European Parliament
24.) Approval of ivermectin for COVID-19 treatment European Parliament
=================================================================
Priority question for written answer P-003029/2023
to the Commission
Rule 138
Ivan Vilibor Sinčić (NI)
The Commission, pharmaceutical companies and EU Member States’
governments have knowingly promoted vaccines against COVID-19 as
products that prevent the spread of the disease. These products were not
tested for spread reduction at the time of first approval by the
European Medicines Agency (EMA) and the Commission’s claims about the
effectiveness of the vaccine were not true, as was ultimately proven and
was confirmed by the Commission itself during October 2022 sessions of
the special committee on the COVID-19 pandemic in Parliament.
On the other hand, the drug ivermectin has undergone 99 studies on 137
000 patients run by 1 089 scientists with a success rate of 85 % in
prophylaxis and 62 % in early treatment and has been officially approved
for early treatment of COVID-19 in 28 countries[1]. The few studies that
find the drug to be ineffective often use doses that are either too
large or too small. Besides ivermectin, there are other safe, effective
and cheap treatment protocols.
1. When will the Commission
finally accept these scientifically verified studies that show that the
safe, cheap and effective drug ivermectin, for which a Nobel Prize has
even been awarded[2], gives excellent results in the early treatment of
COVID-19?
1. When will the Commission
finally accept these scientifically verified studies that show that the
safe, cheap and effective drug ivermectin, for which a Nobel Prize has
even been awarded[2], gives excellent results in the early treatment of
COVID-19?
2. Why is the Commission not
putting the same pressure on the EMA as it did in the case of COVID-19
vaccines?
Submitted: 12.10.2023
Produced by Dr. Jose Lapenta R. Dermatologist
Maracay Estado Aragua Venezuela 2.017-2024
Telf: 04142976087-04127766810
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