CANDESARTAN CILEXETIL tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

American Health Packaging

INN (mednarodno ime):

CANDESARTAN CILEXETIL

Sestava:

CANDESARTAN CILEXETIL 8 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Candesartan cilexetil 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

Povzetek izdelek:

Candesartan Cilexetil 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: Unit dose packages of 30 (5 x 6) NDC 60687-119-25 Candesartan Cilexetil 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: Unit dose packages of 30 (5 x 6) NDC 60687-241-25 Candesartan Cilexetil 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: Unit dose packages of 30 (5 x 6) NDC 60687-130-25 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted at 15° to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Status dovoljenje:

New Drug Application Authorized Generic

Lastnosti izdelka

CANDESARTAN CILEXETIL- CANDESARTAN CILEXETIL TABLET
AMERICAN HEALTH PACKAGING
----------
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 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 is 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 cilexetil
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
DOSAGE FORMS AND STRENGTHS
Tablets 4 mg, 8 mg, 16 mg, 32 mg (3).
CONTRAINDICATIONS
Known hypersensitivity to product components (4).
Do not co-administer aliskiren with candesartan cilexetil in patients
with diabetes (4).
WARNINGS AND PRECAUTIONS
Observe for signs and sy