LOSARTAN POTASSIUM tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Bryant Ranch Prepack

INN (Միջազգային անվանումը):

LOSARTAN POTASSIUM

Կազմը:

LOSARTAN POTASSIUM 25 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Losartan Potassium Tablets, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics. Losartan Potassium Tablets USP is 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 .) Nephropathy in Type 2 Diabetic Patients   Losartan potassium is 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 reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) (se

Ապրանքի ամփոփագիր:

Losartan Potassium Tablets USP 25 mg White, round, biconvex film-coated tablets with “APO” debossed on one side and “LS” over “25” on the other side. Supplied in the following presentations Bottles of 30 (NDC 60505-3160-3) Bottles of 90 (NDC 60505-3160-9) Bottles of 1000 (NDC 60505-3160-8) Unit dose Blisters of 100 (10x10s) (NDC 60505-3160-0)          Losartan Potassium Tablets USP 50 mg White to off white, round, biconvex, film-coated, scored tablets debossed “APO” on one side and “LS” bisect “50” on the other side. Supplied in the following presentations Bottles of 30 (NDC 60505-3161-3) Bottles of 90 (NDC 60505-3161-9) Bottles of 1000 (NDC 60505-3161-8)  Unit dose Blisters of 100 (10x10s) (NDC 60505-3161-0)  Losartan Potassium Tablets USP 100 mg White, oval, biconvex film-coated tablets with “APO” debossed on one side and “LS100” on the other side. Supplied in the following presentations Bottles of 30 (NDC 60505-3162-3) Bottles of 90 (NDC 60505-3162-9) Bottles of 1000 (NDC 60505-3162-8) Unit dose Blisters of 100 (10x10s) (NDC 60505-3162-0) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light resistant container [see USP].  ** Trademark of Paddock Laboratories, Inc APOTEX CORP. LOSARTAN POTASSIUM TABLETS USP 25 mg, 50 mg and 100 mg Revised: May 2012

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
LOSARTAN POTASSIUM TABLETS USP
25 MG, 50 MG AND 100 MG
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 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, pregelatinised starch, magnesium stearate, hypromellose 6
cp, hydroxy propyl cellulose,
titanium dioxide and carnauba wax.
Losartan potassium 25 mg, 50 mg and 100 mg tablets 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_
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 pathophysiology of
hypertension. It also stim