This is indicated for the treatment of hypertension.
Dosage & Administration
Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10 mg while benazepril is effective in doses of 10-80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5-5 mg and benazepril doses of 10-20 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in non black groups.
Pregnancy & Lactation
Pregnancy: Categories C (first trimester) and D (second and third trimesters).
Nursing Mothers: Minimal amounts of unchanged benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with benazepril, so that a newborn child ingesting nothing but breast milk would receive less than 0.1% of the maternal doses of benazepril and benazeprilat. It is not known whether amlodipine is excreted in human milk. In the absence of this information, it is recommended that nursing be discontinued while this combination is administered.
Precautions & Warnings
Impaired Renal Function: Amlodipine & Benazepril should be used with cautionin patients with severe renal disease.
Hyperkalemia: This may occur in only a few patients but generallyare reversible.
Patients With Hepatic Failure: Since Amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t½) is 56 hours in patients with impaired hepatic function, caution should be exercised when administering Amlodipine & Benazepril to patients with severe hepatic impairment.
Cough: ACE inhibitor-induced cough should be considered in the differential diagnosis of cough.
Surgery/Anesthesia: In patients undergoing surgery or during anesthesia with agents that produce hypotension, Benazepril will block the angiotensin II formation that could otherwise occur secondary to compensatory renin release. Hypotension that occurs as a result of this mechanism can be corrected by volume expansion.
Carcinogenesis, Mutagenesis, Impairment of Fertility: No evidence of carcinogenicity, mutagenicity or impairment of fertility was found when the Benazepril/Amlodipine combination were given orally.
Use in Special Populations
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.