Stromectol (Ivermectin) - Summary

STROMECTOL SUMMARY

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 A_1a and less than 10% 5- O -demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A_1a, generally referred to as 22,23-dihydroavermectin B_1a and B_1b, H₂ B_1a and H₂ B_1b, respectively.

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 from 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.

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.

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NEWS HIGHLIGHTS

Published Studies Related to Stromectol (Ivermectin)

Anthelmintic efficacies of a tablet formula of ivermectin-praziquantel on horses experimentally infected with three Strongylus species. [2009.09]
In this blinded randomized and controlled study, the anthelmintic efficacy of a tablet formula of ivermectin-praziquantel was evaluated in horses experimentally infected with three species of Strongylus larvae. Eighteen previously dewormed horses were inoculated on study day 0 with third-stage larvae of Strongylus vulgaris, Strongylus equinus, and Strongylus edentatus...

Ivermectin versus benzyl benzoate applied once or twice to treat human scabies in Dakar, Senegal: a randomized controlled trial. [2009.06]
OBJECTIVE: To compare the effectiveness of oral ivermectin (IV) and two different modalities of topical benzyl benzoate (BB) for treating scabies in a community setting... CONCLUSION: Topical BB was clearly more effective than oral IV for treating scabies in a Senegalese community.

A randomised, double-blind field trial of ivermectin alone and in combination with albendazole for the treatment of Mansonella perstans infections in Uganda. [2009.03]
The effect of a single dose of ivermectin alone (150-200microg/kg body weight) or in combination with albendazole (total of 400mg) in Mansonella perstans infection was assessed in a randomised, double-blind field trial in two endemic communities in Mukono and Luwero districts of Uganda... However, in general both treatment regimens in both communities had limited effect on microfilarial intensities, and only one individual (given combination treatment in Luwero) was mf-negative at 6 months and 12 months after treatment.

Efficacy of ivermectin and albendazole alone and in combination for treatment of soil-transmitted helminths in pregnancy and adverse events: a randomized open label controlled intervention trial in Masindi district, western Uganda. [2008.12]
A randomized open-label trial, including 834 pregnant women, examined efficacy and recorded adverse events of ivermectin (ivc) and albendazole (alb) alone and combined (comb) on soil-transmitted helminth infections (STHs) in the second trimester of pregnancy... No severe adverse events were reported by the women after the administration of ivc, alb, or comb during the second trimester of pregnancy, but long-term pharmacovigillance is needed to assess safety of ivc, alb, or comb in pregnancy.

Endectocide activity of a new long-action formulation containing 2.25% ivermectin+1.25% abamectin in cattle. [2008.08.17]
The present work aimed to evaluate the endectocide activity of a new injectable long-action formulation, containing ivermectin (IVM) and abamectin (ABA). In each one of the four experiments performed, the following groups were formed: group I: 2.25% IVM (450 microg/kg)+1.25% ABA (250 microg/kg), group II: 3.15% IVM (630 microg/kg) and group III: control...

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Clinical Trials Related to Stromectol (Ivermectin)

Ivermectin Versus Albendazole for Chronic Strongyloidiasis [Recruiting]
A prospective controlled trial to compare the efficacy and safety of 7-day albendazole, single dose ivermectin, and 2-single dose ivermectin in 72 patients with chronic strongyloidiasis will be conducted at Siriraj Hospital, Bangkok, Thailand.

Study Comparing Moxidectin and Ivermectin in Subjects With Onchocerca Volvulus Infection [Recruiting]
This is a Phase 3 study comparing the efficacy, safety and tolerability of moxidectin and ivermectin in subjects infected with Onchocerca volvulus, which is the parasite that causes river blindness. Subjects participating in the study will be randomly assigned (by a 2 to1 ratio) to receive one orally-administered dose of either moxidectin or ivermectin.

Comparison of the Efficacy and Safety of Ivermectin to Permethrin [Completed]

Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections [Completed]
The aim of this study is to compare the efficacy and impact on growth of two drug treatments against intestinal worms in schoolchildren from a rural area of Guatemala. According to the World Bank, these intestinal worms are one of the top causes of childhood health problems in many areas of the developing world (The World Bank, 1993). Infected children are more likely to have inadequate nutrition due to the worm infections and are more likely to be shorter in height and weigh less than children who are not infected. After collecting height and weight information, we will split the children into two groups. One group will receive albendazole and the other group will receive combined albendazole/ivermectin. Both groups will be receiving albendazole, the current standard of care treatment. Ivermection is expected to improve efficacy and nutritional benefit as well as add increased scope of treatment for the worm Strongyloides, and ectoparasites such as scabies and head lice. Both treatment regimens and the combination have been used millions of times in the developing world and are safe to use. Co-administration of drugs would be a more efficient use of the opportunity to access schoolchildren and provide deworming treatment.

Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects [Recruiting]
The purpose of this study is to compare the safety and efficacy of a 0. 5% ivermectin cream to a placebo in subjects infested with head lice when used in an "at home" environment.

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