LOSARTAN POTASSIUM tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)

Предлага се от:

MedVantx, Inc.

INN (Международно Name):

LOSARTAN POTASSIUM

Композиция:

LOSARTAN POTASSIUM 50 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Losartan potassium tablets USP are indicated for the treatment of hypertension. Losartan potassium may be used alone or in combination with other antihypertensive agents, including diuretics. Losartan potassium tablets USP are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. (See PRECAUTIONS, Race and CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke, Race.) Losartan potassium is contraindicated in patients who are hypersensitive to any component of this product.

Каталог на резюме:

Losartan Potassium Tablets USP are available as follows: 25 mg – Each white, round, biconvex film coated tablets debossed with ‘572’ on one side and the on the opposite side. Tablets are supplied in bottles of 30 (NDC 16714-581-01), 90 (NDC 16714-581-02), and 1000 (NDC 416714-581-03). 50 mg – Each white, round, biconvex film coated tablets debossed with ‘573’ on one side and the on the opposite side. Tablets are supplied in bottles of 30 (NDC 16714-582-01), 90 (NDC 16714-582-02), and 1000 (NDC 16714-582-03). 100mg –  Each white, oval, biconvex film coated tablets debossed with ‘574’ on one side and the on the opposite side. Tablets are supplied in bottles of 30 (NDC 16714-583-01), 90 (NDC 16714-583-02), and 1000 (NDC 16714-583-03. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. Dispense in a tight, light-resistant container as defined in USP. Manufactured for: Northstar Rx LLC Memphis, TN 38141 Toll Free: 1-800-206-7821 Manufactured by: Actavis Pharma Manufacturing Pvt Ltd. Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex Alathur, Kanchipuram Dist.-603 110 Tamilnadu, India. 50402649-00 Revised – February 2010

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
MEDVANTX, INC.
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LOSARTAN POTASSIUM TABLETS USP
50402649-00
Revised – February 2010
RX ONLY
USE IN PREGNANCY
WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, DRUGS
THAT ACT DIRECTLY ON
THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND EVEN DEATH TO THE
DEVELOPING FETUS. When
pregnancy is detected, losartan potassium should be discontinued as
soon as possible. See
WARNINGS, Fetal/Neonatal Morbidity and Mortality.
DESCRIPTION
Losartan potassium USP is an angiotensin II receptor (type AT )
antagonist. Losartan potassium, a non-
peptide molecule, is chemically described as
2-butyl-4-chloro-1-[_p_-(_o_-1_H _-tetrazol-5-
ylphenyl)benzyl]imidazole-5-methanol monopotassium salt.
Its empirical formula is C
H ClKN O, and its structural formula is:
Losartan potassium USP is a white to off-white free-flowing
crystalline powder with a molecular
weight of 461.00. It is freely soluble in water, soluble in alcohols,
and slightly soluble in common
organic solvents, such as acetonitrile and methyl ethyl ketone.
Oxidation of the 5-hydroxymethyl group
on the imidazole ring results in the active metabolite of losartan.
Losartan potassium USP is available as tablets for oral administration
containing either 25 mg, 50 mg or
100 mg of losartan potassium and the following inactive ingredients:
croscarmellose sodium,
hypromellose, magnesium stearate, mannitol, microcrystalline
cellulose, povidone, propylene glycol,
talc, titanium dioxide.
Losartan potassium tablets USP 25 mg, 50 mg and 100 mg contain
potassium in the following amounts:
2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq),
respectively. Losartan potassium
25 mg, losartan potassium 50 mg, and losartan potassium 100 mg may
also contain carnauba wax.
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CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Angiotensin II [formed from angiotensin I in a reaction catalyzed by
angiotensin converting enzyme
(ACE, kininase II)], is a potent vasoconstrictor, the primary
vasoactive hormone of