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:

Apotex Corp.

INN (nume internaţional):

CANDESARTAN CILEXETIL

Compoziție:

CANDESARTAN CILEXETIL 4 mg

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

CANDESARTAN CILEXETIL- CANDESARTAN CILEXETIL TABLET
APOTEX CORP.
----------
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)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING
FETUS. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions (5.5) 02/2016
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
tablets 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
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