LOSARTAN POTASSIUM- losartan potassium tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

LOSARTAN POTASSIUM

Composition:

LOSARTAN POTASSIUM 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Losartan potassium tablets USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics. Hypertensive Patients with Left Ventricular Hypertrophy 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 tablets USP are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, Losartan potassium tablets USP are reduce the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for di

Product summary:

Losartan potassium tablets USP, 50 mg, are white to off-white, round, convex, beveled edge, film-coated, scored tablets, debossed with S on one side and 112 on the other side with the score line between 11 and 2. They are supplied as follows: NDC 68071-3014-3 bottles of 30 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088. Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512, USA Revised: 03/2015 07777-01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
NUCARE PHARMACEUTICALS, INC.
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LOSARTAN POTASSIUM TABLETS, USP, FOR ORAL USE
RX ONLY
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE LOSARTAN POTASSIUM AS SOON AS
POSSIBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE
DEVELOPING FETUS. SEE WARNINGS, FETAL TOXICITY.
DESCRIPTION
Losartan potassium 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-1H_-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 461.01. 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 is available as tablets for oral administration
containing either 25 mg, 50 mg or 100
mg of losartan potassium and the following inactive ingredients:
microcrystalline cellulose, lactose
monohydrate, pregelatinized starch, magnesium stearate, hydroxypropyl
cellulose, hypromellose and
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
tablets USP, 25 mg and 50 mg meet USP Dissolution Test 1 and Losartan
potassium tablets USP, 100 mg
meet USP dissolution Test 3.
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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 the renin-angiotensin
system and an important component in the pathophy