IVERMECTIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D)

Available from:

Central Texas Community Health Centers

INN (International Name):

IVERMECTIN

Composition:

IVERMECTIN 3 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ivermectin is indicated for the treatment of the following infections: Ivermectin 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). Ivermectin 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: Ivermectin 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 b

Product summary:

Product: 76413-155 NDC: 76413-155-02 2 TABLET in a BOTTLE NDC: 76413-155-04 4 TABLET in a BOTTLE NDC: 76413-155-06 6 TABLET in a BOTTLE NDC: 76413-155-08 8 TABLET in a BOTTLE NDC: 76413-155-10 10 TABLET in a BOTTLE NDC: 76413-155-12 12 TABLET in a BOTTLE NDC: 76413-155-14 14 TABLET in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IVERMECTIN- IVERMECTIN TABLET
CENTRAL TEXAS COMMUNITY HEALTH CENTERS
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IVERMECTIN TABLETS USP, 3MG
(IVERMECTIN)
DESCRIPTION
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 and less than 10%
5-_O-_demethyl-25-de(1-methylpropyl)-22,23-
dihydro-25-(1-methylethyl)avermectin A , generally referred to as
22,23-dihydroavermectin B and
B
, or H B and H B
, respectively. The respective empirical formulas are C
H O and
C
H O , with molecular weights of 875.10 and 861.07, respectively. The
structural formulas are:
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.
Ivermectin tablets are available as 3-mg tablets containing the
following inactive ingredients: colloidal
silicon dioxide, croscarmellose sodium, magnesium stearate,
microcrystalline cellulose, and
pregelatinized starch.
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 ivermectin in
fasting healthy volunteers
(representing a mean dose of 165 mcg/kg), the mean peak plasma
concentrations of the major component
(H B ) were 46.6 (±21.9) (range: 16.4 to 101.1) and 30.6 (±15.6)
(range: 13.9 to 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 a