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:

MedVantx, Inc.

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

Product summary:

Losartan potassium and hydrochlorothiazide tablets are available as: 50 mg/12.5 mg are yellow, film-coated, oval-shaped tablets, debossed with “93” on one side and “7367” on the other in bottles of 30, 90, and 1000. 100 mg/12.5 mg are white to off-white, film-coated, oval-shaped tablets, debossed with “93” on one side and “7369” on the other in bottles of 30, 90, and 1000. 100 mg/25 mg are light yellow, film-coated, oval-shaped tablets, debossed with “93” on one side and “7368” on the other in bottles of 30, 90, and 1000. 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. E 9/2010

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
MEDVANTX, INC.
----------
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS
7367
7369
7368
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 and hydrochlorothiazide
tablets should be discontinued
as soon as possible. See WARNINGS, FETAL/NEONATAL MORBIDITY AND
MORTALITY.
DESCRIPTION
Losartan potassium and hydrochlorothiazide tablets, 50 mg/12.5 mg,
losartan potassium and
hydrochlorothiazide tablets, 100 mg/12.5 mg, and losartan potassium
and hydrochlorothiazide tablets,
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 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.
Hydrochlorothiazide is
6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide.
Its structural formula is:
1
22
22
6
C H ClN O S M.W. 297.74
Hydrochlorothiazide is a white, or practically white, crystalline
powder, 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. Losartan potassium
and hydrochlorothiazide tablets,
50 mg/12.5 mg contain 50 mg of losartan potassium and 12.5 mg of
hydrochlorothiaz