CANDESARTAN CILEXETIL

Manufacturer: Alembic Pharmaceuticals Limited

Score: 144.0

Quick Summary

Candesartan cilexetil is an angiotensin II receptor antagonist used to treat hypertension in adults and children 1 to < 17 years of age, and heart failure in adults. It works by blocking the action of angiotensin II, a potent vasoconstrictor, which is part of the renin-angiotensin system that regulates blood pressure. The drug has been shown to be effective in reducing blood pressure and the risk of cardiovascular events, and is generally well-tolerated. However, it is contraindicated in patients with a history of hypersensitivity to the drug, and should be used with caution in patients with renal impairment, hepatic impairment, and those taking other medications that affect the renin-angiotensin system. The recommended initial dose for adults with hypertension is 16 mg once daily, and for heart failure is 4 mg once daily, with titration to a target dose of 32 mg once daily as tolerated.

Key Clinical Findings and Indications

Treatment of hypertension in adults and children 1 to < 17 years of age
Treatment of heart failure in adults
Reduces blood pressure and the risk of cardiovascular events
Effective in patients with diabetes and those with renal impairment

Important Safety Information

Warning

When pregnancy is detected, discontinue candesartan cilexetil as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Contraindications

Hypersensitivity to candesartan cilexetil
Do not co-administer aliskiren with candesartan cilexetil in patients with diabetes

Adverse Reactions

Headache
Dizziness
Upper respiratory tract infection
Pharyngitis
Rhinitis

Dosing Recommendations

General Guidance

No initial dosage adjustment is necessary in patients with renal insufficiency or geriatric patients.

Hypertension

Adult Dose

16 mg once daily, with titration to 8-32 mg once daily as needed

Pediatric Dose

0.20 mg/kg oral suspension once daily, with titration to 0.05-0.4 mg/kg once daily as needed

Heart Failure

Adult Dose

4 mg once daily, with titration to 32 mg once daily as tolerated

Pediatric Dose

Special Population Considerations

Pregnancy

Discontinue candesartan cilexetil as soon as possible when pregnancy is detected
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus

Nursing Mothers

It is not known whether candesartan is excreted in human milk
A decision should be made whether to discontinue nursing or discontinue candesartan cilexetil, taking into account the importance of the drug to the mother

Pediatric Use

Candesartan cilexetil is indicated for the treatment of hypertension in children 1 to < 17 years of age
Children < 1 year of age must not receive candesartan cilexetil for hypertension

Geriatric Use

No initial dosage adjustment is necessary in geriatric patients
The pharmacokinetics of candesartan have been studied in the elderly (≥ 65 years) and are similar to those in healthy, younger patients