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:

Physicians Total Care, Inc.

INN (Միջազգային անվանումը):

LOSARTAN POTASSIUM

Կազմը:

LOSARTAN POTASSIUM 25 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Losartan potassium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents, including diuretics. Losartan potassium tablets 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 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 reduce 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) (see CLINICAL PHARMACOLOGY , Phar

Ապրանքի ամփոփագիր:

Losartan potassium tablets USP are available as follows: 25 mg - light green, oval-shaped, film-coated tablets, debossed with “93” on one side and “7364” on the other side, in 50 mg - green, oval-shaped, film-coated tablets. On one side of the tablet debossed with "7365", on the other side of the tablet debossed with "9" on one side of the breakline and "3" on the other side of the breakline, in 100 mg - dark green, oval-shaped, film-coated tablets, debossed with “93” on one side and “7366” on the other side, in Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. F 11/2011 Distributed and Repackaged by: Physicians Total Care, Inc. Tulsa, Oklahoma      74146

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

LOSARTAN POTASSIUM - LOSARTAN POTASSIUM TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
----------
LOSARTAN POTASSIUM TABLETS USP
7364
7365
7366
RX ONLY
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 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 structural formula is:
C
H ClKN O M.W. 461.01
Losartan potassium 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 is available as tablets for oral administration
containing either 25 mg, 50 mg or 100
mg of losartan potassium 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:
1
22
22
6
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