CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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's Joint Natio

Product summary:

Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows: NDC 68382-194-06 in bottle of 30 tablets NDC 68382-194-16 in bottle of 90 tablets NDC 68382-194-01 in bottle of 100 tablets NDC 68382-194-10 in bottle of 1,000 tablets NDC 68382-194-77 in carton of 100 tablets (10 x 10 unit-dose) Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows: NDC 68382-195-06 in bottle of 30 tablets NDC 68382-195-16 in bottle of 90 tablets NDC 68382-195-01 in bottle of 100 tablets NDC 68382-195-10 in bottle of 1,000 tablets NDC 68382-195-77 in carton of 100 tablets (10 x 10 unit-dose) Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows: NDC 68382-416-06 in bottle of 30 tablets NDC 68382-416-16 in bottle of 90 tablets NDC 68382-416-01 in bottle of 100 tablets NDC 68382-416-10 in bottle of 1,000 tablets NDC 68382-416-77 in carton of 100 tablets (10 x 10 unit-dose) Storage:   Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE - CANDESARTAN
CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET
ZYDUS PHARMACEUTICALS USA INC.
----------
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS USP, FOR ORAL
USE
WARNING: FETAL TOXICITY
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
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, USP is a white to almost white powder with a
molecular weight of
610.66. It is sparingly soluble in methanol, practically insoluble in
water and soluble in
methylene chloride. 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:
1
33
34
6
6
7
8
3
4 2
Hydrochlorothiazide, USP is a white, or practically white, practically
odorless, crystalline
powder with a molecular weight of 297.74. It is slightly soluble in
water, freely soluble in
sodium hydroxide solution, in n-butylamine, and in dimethylformamide;
sparingly soluble
in methanol; insoluble in ether, in chloroform, and in dilute mineral
acids.
Candesartan cilexetil and hydrochlorothiazide is available for oral
administration in three
tablet strengths.
Candesartan