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:

Avera McKennan Hospital

INN (nume internaţional):

CANDESARTAN CILEXETIL

Compoziție:

CANDESARTAN CILEXETIL 8 mg

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

CANDESARTAN CILEXETIL- CANDESARTAN CILEXETIL TABLET
AVERA MCKENNAN HOSPITAL
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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); candesar