CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

可用日期:

ANI Pharmaceuticals, Inc.

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Candesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with candesartan cilexetil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’

產品總結:

Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are peach, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACS on one side. They are supplied in bottles of 90 tablets (NDC 62559-660-90). Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are yellow, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACJ on one side. They are supplied in bottles of 90 tablets (NDC 62559-661-90). Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are pink, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACD on one side. They are supplied in bottles of 90 tablets (NDC 62559-662-90). Store at 20° to 25°C (68° to 77°F); excursions permitted at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Manufactured under the license from Takeda Pharmaceutical Company, Ltd. Manufactured by: AstraZeneca AB, SE-151 85 Södertälje, Sweden Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 10118 Rev 05/20

授权状态:

New Drug Application Authorized Generic

产品特点

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE- CANDESARTAN CILEXETIL
AND
HYDROCHLOROTHIAZIDE TABLET
ANI PHARMACEUTICALS, INC.
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CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS USP
WARNING: FETAL TOXICITY
•
•
DESCRIPTION
Candesartan Cilexetil and Hydrochlorothiazide Tablets USP combine an
angiotensin II receptor (type
AT ) antagonist and a diuretic, hydrochlorothiazide.
Candesartan cilexetil, a nonpeptide, is chemically described as
(±)-1-Hydroxyethyl 2-ethoxy-1-[_p_-(_o_-
1_H_-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate,
cyclohexyl carbonate (ester).
Its empirical formula is C
H N O and its structural formula is:
Candesartan cilexetil is a white to off-white powder with a molecular
weight of 610.67. It is practically
insoluble in water and sparingly soluble in methanol. Candesartan
cilexetil is a racemic mixture
containing one chiral center at the cyclohexyloxycarbonyloxy ethyl
ester group. Following oral
administration, candesartan cilexetil undergoes hydrolysis at the
ester link to form the active drug,
candesartan, which is achiral.
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:
WHEN PREGNANCY IS DETECTED, DISCONTINUE CANDESARTAN CILEXETIL 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
1
33
34
6
6
7
8
3
4
2
Hydrochlorothiazide is a white, or practically white, crystalline
powder with a molecular weight of
297.72, which is slightly soluble in water, but freely soluble in
sodium hydroxide solution.
Candesartan cilexetil and hydrochlorothiazide tablets are available
for oral administration in three tablet
strengths of candesartan cilexetil and hydrochlorothiazide.
Candesartan cilexetil and hydrochlorothiazide tablets contain 16 mg or
32 mg of candesartan cilexetil
and 12.5 mg or 25 mg of hydrochlorothiazide providing for the