LOSARTAN POTASSIUM tablet film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

McKesson Contract Packaging

INN (International Name):

LOSARTAN POTASSIUM

Sammensetning:

LOSARTAN POTASSIUM 50 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
MCKESSON CONTRACT PACKAGING
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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
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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