ATACAND- 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:

ANI Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ATACAND is 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 (JNC). Numerous an

Product summary:

ATACAND Tablets, 4 mg, are white to off-white, circular/biconvex-shaped, non-film-coated scored tablets, coded ACF on one side and 004 on the other. They are supplied in bottles of 30 tablets (NDC 62559-640-30). ATACAND Tablets, 8 mg, are light pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACG on one side and 008 on the other. They are supplied in bottles of 30 tablets (NDC 62559-641-30). ATACAND Tablets, 16 mg, are pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACH on one side and 016 on the other. They are supplied in bottles of 30 tablets (NDC 62559-642-30) and bottles of 90 tablets (NDC 62559-642-90). ATACAND Tablets, 32 mg, are pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACL on one side and 032 on the other. They are supplied in bottles of 30 tablets (NDC 62559-643-30) and bottles of 90 tablets (NDC 62559-643-90). Storage 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.

Authorization status:

New Drug Application

Summary of Product characteristics

ATACAND- CANDESARTAN CILEXETIL TABLET
ANI PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATACAND SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ATACAND.
ATACAND (CANDESARTAN CILEXETIL) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
INDICATIONS AND USAGE
ATACAND is an angiotensin II receptor blocker (ARB) indicated for:
•
•
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
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
Known hypersensitivity to product components (4).
Do not co-administer aliskiren with ATACAND in patients with diabetes
(4).
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
•
®
WHEN PREGNANCY IS DETECTED, DISCONTINUE ATACAND 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)
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); ATACAND reduces
cardiovascular death and heart failure
hospitalization (1.2).
T he target dose is 32 mg once daily, which is achieved by doubling
the dose at approximately 2-week intervals, as