LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- losartan potassium and hydrochlorothiazide tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH), LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)

제공처:

Preferred Pharmaceuticals, Inc.

INN (International Name):

HYDROCHLOROTHIAZIDE

구성:

HYDROCHLOROTHIAZIDE 25 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Losartan potassium and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, and DOSAGE AND ADMINISTRATION). Losartan potassium and hydrochlorothiazide tablets USP 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, CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke, Race , and DOSAGE AND ADMINISTRATION .) Losartan and hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothia

제품 요약:

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/ 25 mg are supplied as yellow, tear drop shaped, biconvex, film-coated tablets, debossed with 'LU' on one side and 'M43' on the other side. NDC 68799-9461-3: Bottles of 30 Tablets NDC 68799-94616-6: Bottles of 60 Tablets NDC 68799-9461-9: Bottles of 90 Tablets NDC 68799-9461-100: Bottles of 100 Tablets Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States MADE IN INDIA Revised: February 2015                                                                             ID#: 240071 Repackaged By: Preferred Pharmaceuticals, Inc.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS USP
RX ONLY
WARNING: FETAL TOXICITY
• WHEN PREGNANCY IS DETECTED, DISCONTINUE LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE
TABLETS AS SOON AS POSSIBLE.
• DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE
DEVELOPING FETUS. SEE WARNINGS, FETAL TOXICITY.
DESCRIPTION
Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg,
losartan potassium and
hydrochlorothiazide tablets USP, 100 mg/12.5 mg and losartan potassium
and hydrochlorothiazide
tablets USP, 100 mg/25 mg combine an angiotensin II receptor (type AT
) antagonist and a diuretic,
hydrochlorothiazide.
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 amorphous 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.
Hydrochlorothiazide is
6-chloro-3,4-dihydro-_2H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide.
Its empirical formula is C H ClN O S and its structural formula is:
1
22
22
6
7
8
3
4
2
Hydrochlorothiazide is a white, or practically white, crystalline
powder with a molecular weight of
297.74, which is slightly soluble in water, but freely soluble in
sodium hydroxide solution.
Losartan potassium and hydrochlorothiazide tablets USP are available
for oral administration in three
tablet combinations of losartan and hydrochlorothiazide. Losartan
potassium and hydrochlorothiazide
tablets USP, 50 mg/12.5 mg contain 50 mg of losartan potassium and
12.5