CANDESARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Macleods Pharmaceuticals Limited

INN (International Name):

CANDESARTAN CILEXETIL

Composition:

CANDESARTAN CILEXETIL 4 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 Pressure

Product summary:

Candesartan cilexetil tablets, USP 4 mg, are white to off-white, circular, biconvex, uncoated tablets, debossed with "ML 52" on one side and breakline on other side.  They are supplied as follows: NDC 33342-114-07 unit of use bottles of 30 NDC 33342-114-10 unit of use bottles of 90 NDC 33342-114-51 unit of use bottles of 300 NDC 33342-114-12 unit dose blister packages of 100. Candesartan cilexetil tablets, USP 8 mg, are light pink, circular, biconvex, uncoated tablets, debossed with "ML 53" on one side and breakline on other side. They are supplied as follows: NDC 33342-115-07 unit of use bottles of 30 NDC 33342-115-10 unit of use bottles of 90 NDC-33342-115-51 unit of use bottles of 300 NDC 33342-115-12 unit dose blister packages of 100. Candesartan cilexetil tablets, USP 16 mg, are pink, circular, biconvex, uncoated tablets, debossed with "ML 54" on one side and breakline on other side.They are supplied as follows: NDC 33342-116-07 unit of use bottles of 30 NDC 33342-116-10 unit of use bottles of 90 NDC 33342-116-51 unit of use bottles of 300 NDC 33342-116-12 unit dose blister packages of 100. Candesartan cilexetil tablets, USP 32 mg, are pink, circular, biconvex, uncoated tablets, debossed with "ML 55" on one side and breakline on other side. They are supplied as follows: NDC 33342-117-07 unit of use bottles of 30 NDC 33342-117-10 unit of use bottles of 90 NDC 33342-117-51 unit of use bottles of 300 NDC 33342-117-12 unit dose blister packages of 100. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C 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 - CANDESARTAN TABLET
MACLEODS PHARMACEUTICALS LIMITED
----------
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, 8.1)
· DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO
THE DEVELOPING FETUS. (5.1, 8.1)
INDICATIONS AND USAGE
Candesartan cilexetil tablets are an angiotensin II receptor blocker
(ARB) indicated for:
· 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).
· Treatment of heart failure (NYHA class II-IV); candesartan reduces
cardiovascular death and heart failure
hospitalization (1.2).
DOSAGE AND ADMINISTRATION
Starting Dose
Target Dose
Adult Hypertension (2.1)
16 mg tablet once daily
8 - 32 mg tablet total daily dose
Pediatric Hypertension (1 to <
6 years) (2.2)
0.20 mg/kg oral
suspension once daily
0.05 - 0.4 mg/kg oral suspension once daily or
consider divided dose
Pediatric Hypertension (6 to <
17 years) (2.2)
< 50 kg 4 – 8 mg tablet
once daily
> 50 kg 8 – 16 mg tablet
once daily
< 50 kg 4 – 16 mg tablet once daily or consider
divided dose
> 50 kg 4 – 32 mg tablet once daily or consider
divided dose
Adult Heart Failure (2.3)
4 mg tablet once daily
32 mg tablet once daily
The target dose is 32 mg once daily, which is achieved by doubling the
dose at approximately 2-week
intervals, as tolerated by patient.
DOSAGE FORMS AND STRENGTHS
Tablets 4 mg, 8 mg, 16 mg, 32 mg (3).
CONTRAINDICATIONS
Known hypersensitivity to product components (4