CANDESARTAN CILEXETIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX)

Available from:

Alembic Pharmaceuticals Limited

INN (International Name):

CANDESARTAN CILEXETIL

Composition:

CANDESARTAN CILEXETIL 32 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, 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. 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 National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood

Product summary:

Candesartan cilexetil tablets USP, 32 mg are light pink, round, biconvex, uncoated mottled tablets debossed with ‘L171’on one side and scoring on other side. They are supplied as follows: NDC 46708-060-30         bottle of 30 tablets NDC 46708-060-90         bottle of 90 tablets NDC 46708-060-10         carton of 100 (10 x 10) unit dose tablets Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CANDESARTAN CILEXETIL - CANDESARTAN CILEXETIL TABLET
ALEMBIC PHARMACEUTICALS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CANDESARTAN CILEXETIL
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CANDESARTAN
CILEXETIL TABLETS.
CANDESARTAN CILEXETIL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• WHEN PREGNANCY IS DETECTED, DISCONTINUE CANDESARTAN CILEXETIL
TABLETS AS SOON AS
POSSIBLE. (5.1)
• DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO
THE DEVELOPING FETUS. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions (5.5) 02/2016
INDICATIONS AND USAGE
Candesartan cilexetil tablets are an angiotensin II receptor blocker
(ARB) indicated for: (1)
· Treatment of hypertension in adults and children 1 to <17 years of
age, to lower blood pressure.
Lowering blood pressure reduces the risk of fatal and non-fatal
cardiovascular events, primarily strokes
and myocardial infarctions (1.1). (1)
· Treatment of heart failure (NYHA class II-IV); candesartan
cilexetil tablets reduces cardiovascular
death and heart failure hospitalization (1.2) (1)
DOSAGE AND ADMINISTRATION
STARTING DOSE
TARGET DOSE
Adult Hypertension (2.1)
16 mg tablet once daily
8 to 32 mg tablet total daily dose
Pediatric Hypertension (1 to ˂6 years)
(2.2)
0.2 mg/kg oral suspension
once daily
0.05 to 0.4 mg/kg oral suspension
once daily or consider divided dose
Pediatric Hypertension (6 to ˂17 years)
(2.2)
<50 kg 4 to 8 mg tablet
once daily
>50 kg 8 to 16 mg tablet
once daily
<50 kg 4 to 16 mg tablet once daily or
consider divided dose
>50 kg 4 to 32 mg tablet once daily
or consider divided dose
Adult Heart Failure (2.3)
4 mg tablet once daily (2)
The target dose is 32 mg once daily, which is achieved by doubling the
dose at approximately
2-week intervals, as tolerated by patient (2)
DOSAGE FORMS AND STRENGTHS
Tablets 32 mg (3).
CONTRAIND