CANDESARTAN CILEXETIL- 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:

Sandoz Inc

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 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 (J

Product summary:

Candesartan cilexetil tablets, USP are available containing 4 mg, 8 mg, 16 mg or 32 mg of candesartan cilexetil, USP. 4 mg, white to off-white, round tablets debossed with M on left side of the score and C on right side of the score on one side of the tablet and 24 on the other side. They are available as follows: 8 mg, pink, mottled round tablets debossed with M on left side of the score and C on right side of the score on one side of the tablet and 25 on the other side. They are available as follows: 16 mg, pink, mottled round tablets debossed with M on left side of the score and C on right side of the score on one side of the tablet and 31 on the other side. They are available as follows: 32 mg, pink, mottled round tablets debossed with MC above the score and 32 below the score on one side of the tablet and blank on the other side. They are available as follows: Storage

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CANDESARTAN CILEXETIL- CANDESARTAN CILEXETIL TABLET
SANDOZ INC
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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._
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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:
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DOSAGE AND ADMINISTRATION
*
STARTING DOSE
TARGET DOSE
Adult Hypertension (2.1)
16 mg tablet once daily
8 to32 mg tablet total daily dose
Pediatric Hypertension (1 to <6
years) (2.2)
0.20 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
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 tablets in
patients with diabetes (4).
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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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)
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