LOSARTAN POTASSIUM tablet film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

McKesson Packaging Services a business unit of McKesson Corporation

INN (Mezinárodní Name):

LOSARTAN POTASSIUM

Složení:

LOSARTAN POTASSIUM 25 mg

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION
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LOSARTAN POTASSIUM TABLETS, USP
25 MG, 50 MG & 100 MG
RX ONLY
OCTOBER 2011
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, 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 molecular 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, USP 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.
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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 com