LOSARTAN POTASSIUM tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Golden State Medical Supply, Inc.

DCI (Denominação Comum Internacional):

LOSARTAN POTASSIUM

Composição:

LOSARTAN POTASSIUM 25 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Losartan potassium tablets, USP are indicated for the treatment of hypertension. They 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 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 reduce the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (nee

Resumo do produto:

Losartan potassium tablets, USP 25 mg, are light-green, film-coated, teardrop-shaped biconvex tablet with “LK 25” on one side and ">" on the other side. They are supplied as follows: NDC 60429-316-30 unit of use bottles of 30 NDC 60429-316-90 bottles of 90 NDC 60429-316-10 bottles of 1000 Losartan potassium tablets, USP 50 mg, are green, film-coated, oval-shaped biconvex tablets with “LK│50” on one side and ">" on the other side. They are supplied as follows: NDC 60429-317-30 unit of use bottles of 30 NDC 60429-317-90 bottles of 90 NDC 60429-317-10 bottles of 1000 Losartan potassium tablets, USP 100 mg, are dark green, film-coated, oval-shaped biconvex tablets with “LK100” on one side and ">" on the other side. They are supplied as follows: NDC 60429-318-30 unit of use bottles of 30 NDC 60429-318-90 bottles of 90 NDC 60429-318-10 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. Manufactured by: Cobalt Pharmaceuticals Inc. Mississauga, Canada, L5N 2B8 Distributed by: Watson Pharma, Inc. Parsippany, NJ 07054 USA Marketed/Packaged by GSMS, Incorporated Camarillo, CA 93012 Revised: January 2013               105-803-03

Status de autorização:

Abbreviated New Drug Application

Características técnicas

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
GOLDEN STATE MEDICAL SUPPLY, INC.
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LOSARTAN POTASSIUM TABLETS
LOSARTAN POTASSIUM TABLETS, USP
25 MG, 50 MG AND 100 MG
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 tablets should be
discontinued as soon as possible. See
WARNINGS, _Fetal/Neonatal Morbidity and Mortality_.
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_-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 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:
lactose monohydrate,
microcrystalline cellulose, pregelatinized starch, silicon dioxide,
magnesium stearate, polyvinyl
alcohol-part.hydrolyzed, macrogol/PEG 3350, talc, titanium dioxide,
D&C yellow No. 10 aluminum
lake and FD&C blue No. 2 indigo carmine aluminum lake.
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.
CLINICAL PHARMACOLOGY
_MECHANISM OF ACTION_
1
22
22
6
Angiotensin II [formed from angiotensin I in a reaction catalyzed by
angiotensin converting enzyme
(ACE, kininase II)], is a potent vasoco