IVERMECTIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

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 palp

Product summary:

Ivermectin tablets USP, 3 mg are white, round, flat, bevel-edged tablets debossed with 806 on one side and plain on the other side. They are supplied as follows: NDC 68071-2242-3 UNIT DOSE PACKAGE OF 20 Store at temperatures below 30°C (86°F).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IVERMECTIN- IVERMECTIN TABLET
NUCARE PHARMACEUTICALS,INC.
----------
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
1a
1a
1a
1b
2
1a
2
1b
48
74
14
47
72
14
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
urin