IRBESARTAN

Manufacturer: Hisun Pharmaceuticals USA Inc.

Score: 148.0

Quick Summary

Irbesartan is an angiotensin II receptor antagonist used to treat hypertension and diabetic nephropathy. It works by blocking the effects of angiotensin II, a potent vasoconstrictor, and reducing blood pressure. The recommended initial dose is 150 mg once daily, which can be increased to a maximum of 300 mg once daily as needed. Irbesartan is contraindicated in patients with hypersensitivity to any component of the product and in patients with diabetes who are also taking aliskiren. Special considerations are needed for use during pregnancy, in nursing mothers, and in pediatric and geriatric patients.

Key Clinical Findings and Indications

Treatment of hypertension to lower blood pressure
Treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension
Reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions

Important Safety Information

Warning

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus

Contraindications

Hypersensitivity to any component of the product
Coadministration with aliskiren in patients with diabetes

Adverse Reactions

Hyperkalemia
Dizziness
Orthostatic dizziness
Orthostatic hypotension

Dosing Recommendations

General Guidance

No dosage adjustment is necessary in patients with mild to severe renal impairment unless a patient with renal impairment is also volume depleted

Hypertension

Adult Dose

150-300 mg once daily

Pediatric Dose

Not recommended for pediatric patients less than 6 years old

Diabetic Nephropathy

Adult Dose

300 mg once daily

Pediatric Dose

Not recommended for pediatric patients

Special Population Considerations

Pregnancy

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death
Discontinue irbesartan as soon as possible when pregnancy is detected

Nursing Mothers

It is not known whether irbesartan is excreted in human milk
Discontinue nursing or discontinue irbesartan

Pediatric Use

Irbesartan has not been studied in pediatric patients less than 6 years old
Observe for hypotension, oliguria, and hyperkalemia in infants with histories of in utero exposure to an angiotensin II receptor antagonist

Geriatric Use

No overall differences in effectiveness or safety were observed between geriatric subjects and younger subjects
Greater sensitivity of some older individuals cannot be ruled out