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:

Macleods Pharmaceuticals Limited

INN (International Name):

CANDESARTAN CILEXETIL

Composition:

CANDESARTAN CILEXETIL 16 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Candesartan cilexitil 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 cilexitil 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’s J

Product summary:

Candesartan cilexetil and hydrochlorothiazide tablets 16 mg/12.5 mg , are Pink, oval, biconvex, uncoated tablets debossed with "ML 71" on one side and break line on both sides They are supplied as follows: NDC 33342-131-12 unit dose package of 100 NDC 33342-131-10 bottle of 90 NDC 33342-131-51 bottle of 300 NDC 33342-131-15 bottle of 500 Candesartan cilexetil and hydrochlorothiazide tablets 32 mg/12.5 mg , are Yellow oval, biconvex, uncoated tablets debossed with "ML 58" on one side and break line on both sides. They are supplied as follows: NDC 33342-132-12 unit dose package of 100 NDC 33342-132-10 bottle of 90 NDC 33342-132-51 bottle of 300 NDC 33342-132-15 bottle of 500 Candesartan cilexetil and hydrochlorothiazide tablets 32 mg/25 mg , are Pink, oval, biconvex, uncoated tablets debossed with "ML 57" on one side and break line on both sides. They are supplied as follows: NDC 33342-133-12 unit dose package of 100 NDC 33342-133-10 bottle of 90 NDC 33342-133-51 bottle of 300 NDC 33342-133-15 bottle of 500 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Manufactured for : Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufactured by : Macleods Pharmaceuticals Ltd. Daman (U.T.), INDIA Rev: 10/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE - CANDESARTAN
CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET
MACLEODS PHARMACEUTICALS LIMITED
----------
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS, FOR ORAL USE
RX ONLY
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 combines an
angiotensin II
receptor (type AT ) antagonist and a diuretic, hydrochlorothiazide.
Candesartan cilexetil, USP 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
1
33
34
6
6
Candesartan cilexetil USP 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 USP is a racemic mixture containing one chiral center at the
cyclohexyloxycarbonyloxy ethyl ester group. Following oral
administration, candesartan
cilexetil USP undergoes hydrolysis at the ester link to form the
active drug, candesartan,
which is achiral.
Hydrochlorothiazide USP 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
Hydrochlorothiazide USP 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 cilexitil and hydrochlorothiazide tablets are available
for oral administration
in three tablet strengths of candesartan cilexetil USP and
hydrochlorothiazide USP.
Candesartan cilexetil and hydrochlorothiazide tablets 16 mg/12.5 mg
contain 16 mg of
candesartan cilexetil USP and 12