LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- losartan potassium and hydrochlorothiazide tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

losartan potassium (UNII: 3ST302B24A) (losartan - UNII:JMS50MPO89), hydrochlorothiazide (UNII: 0J48LPH2TH) (hydrochlorothiazide - UNII:0J48LPH2TH)

제공처:

Sandoz Inc.

INN (International Name):

losartan potassium

구성:

losartan potassium 50 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 hydroch

제품 요약:

No. 6517—Losartan Potassium and Hydrochlorothiazide Tablets 50/12.5 mg are yellow, oval, film-coated tablets coded 717 on one side and plain on the other. Each tablet contains 50 mg losartan potassium and 12.5 mg of hydrochlorothiazide. They are supplied as follows: NDC 0781-5816-31 unit of use bottles of 30 NDC 0781-5816-92 unit of use bottles of 90 NDC 0781-5816-10 bottles of 1000. No.6729—Losartan Potassium and Hydrochlorothiazide Tablets 100/12.5 mg are white, oval, film-coated tablets coded 745 on one side and plain on the other. Each tablet contains 100 mg losartan potassium and 12.5 mg of hydrochlorothiazide. They are supplied as follows: NDC 0781-5817-31 unit of use bottles of 30 NDC 0781-5817-92 unit of use bottles of 90 NDC 0781-5817-10 bottles of 1000. No.6596—Losartan Potassium and Hydrochlorothiazide Tablets 100/25 mg are light yellow, oval, film-coated tablets coded 747 on one side and plain on the other. Each tablet contains 100 mg losartan potassium and 25 mg of hydrochlorothiazide. They are supplied as follows: NDC 0781-5818-31 unit of use bottles of 30 NDC 0781-5818-92 unit of use bottles of 90 NDC 0781-5818-10 bottles of 1000. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. Manufactured by MERCK SHARP & DOHME LTD. Cramlington, Northumberland, UK NE23 3JU for Sandoz Inc. Princeton, NJ 08540 Issued June 2010 9937101 NDC 0781-5816-31 Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/12.5 mg Rx only 30 Tablets SANDOZ Each tablet contains 50 mg losartan potassium and 12.5 mg hydrochlorothiazide. Usual Adult Dosage: See accompanying circular. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Manufactured by MERCK SHARP & DOHME LTD. Cramlington, Northumberland, UK NE23 3JU for Sandoz Inc., Princeton, NJ 08540 Formulated in UK 12-2009M 9971400 30 | No. 6517

승인 상태:

New Drug Application

제품 특성 요약

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
SANDOZ INC.
----------
SANDOZ
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS 50/12.5 MG
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS 100/12.5 MG
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS 100/25 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 tablets 50/12.5 mg,
losartan potassium and
hydrochlorothiazide tablets 100/12.5 mg and losartan potassium and
hydrochlorothiazide tablets
100/25 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
ora