STROMECTOL- ivermectin tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Merck Sharp & Dohme LLC

SNN (starptautisko nepatentēto nosaukumu):

IVERMECTIN

Kompozīcija:

IVERMECTIN 3 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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. STROMECTOL is contraindicated in patients who are hypersensitive to any component of this product.

Produktu pārskats:

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. Store at temperatures below 30°C (86°F). Stromectol® 3 mg (Ivermectin Tablets) Manuf. by: Merck Sharp & Dohme BV 2031 BN Haarlem, Netherlands Ivermectin (active ingred.) Made in Macao. Formulated in The Netherlands. Distributed by: Merck Sharp & Dohme LLC Rahway, NJ 07065, USA Each tablet contains 3 mg of ivermectin. USUAL DOSAGE: See accompanying circular. Store at temperatures below 30°C (86°F). Rx only 20 Tablets (2 Foil Strips of 10 tablets each) 32 NDC 0006-0032-20 This is a bulk package and not intended for dispensing. The aluminum foil strip is not child resistant. Remove tablets from aluminum foil strip and dispense tablets in appropriate container.

Autorizācija statuss:

New Drug Application

Produkta apraksts

STROMECTOL- IVERMECTIN TABLET
MERCK SHARP & DOHME LLC
----------
STROMECTOL
(IVERMECTIN)
TABLETS
DESCRIPTION
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
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
®
®
1a
1a
1a
1b
2
1a
2
1b
48
74
14
47
72
14
melting point of about 155°C. It is insoluble in water but is freely
soluble in methanol and
soluble in 95% ethanol.
STROMECTOL is available in 3-mg tablets containing the following
inactive ingredients:
microcrystalline cellulose, pregelatinized starch, magnesium stearate,
butylated
hydroxyanisole, and citric acid powder (anhydrous).
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
STROMECTOL 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-
101.1) and 30.6 (±15.6) (range: 13.9-68.4) 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 ora