LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Legacy Pharmaceutical Packaging

INN (International Name):

LOSARTAN POTASSIUM

Composition:

LOSARTAN POTASSIUM 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Losartan potassium and hydrochlorothiazide tablets 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 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 potassium and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product. Because of the hydr

Product summary:

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg: Light yellow to yellow colored, Oval, biconvex, film coated tablets with “APO” debossed on one side and “50 12.5” on the other side. Dose Pack of 30 (NDC 68645-412-70) Storage Store at 20° to 25°C (68° to 77°F) [see USP controlled room temperature]. Protect from light. Trademark Information: *COZAAR® is a trademark of MERCK & CO., Inc. APOTEX CORP. LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS , USP 50 mg/12.5 mg, 100 mg/12.5 mg AND 100 mg/25 mg Manufactured by:  Apotex Research Pvt. Ltd. Bangalore - 560 099 India Manufactured for: Apotex Corp. Weston, FL 33326 Distributed by: WAL-MART Bentonville, Arkansas 72716 Packaged by: Legacy Pharmaceutical Packaging LLC Earth City, MO 63045 Revised: May 2012

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
LEGACY PHARMACEUTICAL PACKAGING
----------
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS, USP
50 MG/12.5 MG, 100 MG/12.5 MG AND 100 MG/25 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 and hydrochlorothiazide
tablets should be discontinued
as soon as possible. See WARNINGS, _Fetal/Neonatal Morbidity and
Mortality._
DESCRIPTION
Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg, losartan
potassium and hydrochlorothiazide
100 mg/12.5 mg and losartan potassium and hydrochlorothiazide 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 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.
Hydrochlorothiazide is
6-chloro-3,4-dihydro-2_H_-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 are available for
oral administration in three tablet
combinations of losartan and hydrochlorothiazide.