Stromectol (Ivermectin) - Indications and Dosage

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.

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.

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

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).

Dist. by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Manufactured by:
Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
Netherlands

Issued May 2010

Printed in the Netherlands

9032319

87447/080610

8495