CANDESARTAN CILEXETIL tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Bryant Ranch Prepack

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

Tablets candesartan cilexetil, 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 as follows: NDC 63629-2126-1 unit of use bottles of 90. Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Statutul autorizaţiei:

New Drug Application Authorized Generic

Caracteristicilor produsului

CANDESARTAN CILEXETIL- CANDESARTAN CILEXETIL TABLET
BRYANT RANCH PREPACK
----------
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:
•
•
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).
Do not co-administer aliskiren with candesartan cilexetil in patients
with diabetes (4).
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
•
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 infarction