国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)
McKesson Contract Packaging
LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 50 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED MCKESSON CONTRACT PACKAGING ---------- LOSARTAN POTASSIUM TABLETS USP 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 tablets USP are an angiotensin II receptor (type AT ) antagonist. Losartan potassium, USP, 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 structural formula is: C H ClKN O M.W. 461.01 Losartan potassium, USP is a white to off-white free-flowing crystalline powder. 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 tablets USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: D&C Yellow #10 aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, and titanium dioxide. Additionally, 50 mg and 100 mg tablets contain FD&C Yellow #6/sunset yellow FCF 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 1 22 22 6 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 vas 完全なドキュメントを読む