IVERMECTIN tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Asclemed USA, Inc.

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 (no

Toote kokkuvõte:

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 76420-619-20 unit dose packages of 20. (relabeled from NDC 42799-806-01) Store at temperatures below 30°C (86°F).

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

IVERMECTIN- IVERMECTIN TABLET
ASCLEMED USA, 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
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 and pharmacokinet