Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)
NuCare Pharmaceuticals, Inc.
LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 50 mg
ORAL
PRESCRIPTION DRUG
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 st
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 68071-1517-9 Bottles of 90 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
Abbreviated New Drug Application
LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED NUCARE PHARMACEUTICALS,INC. ---------- 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. 1 22 22 6 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 pathophys Citiți documentul complet