AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

The rate and extent of absorption of benazepril and amlodipine from amlodipine and benazepril hydrochloride capsules are the same as when administered as individual tablets. Absorption from the individual tablets is not influenced by the presence of food in the gastrointestinal tract; food effects on absorption from amlodipine and benazepril hydrochloride capsules have not been studied.

AbsorptionFollowing oral administration of amlodipine and benazepril hydrochloride capsules, peak plasma conc...

Over 950 patients received amlodipine and benazepril hydrochloride capsule once-daily in 6 double-blind, placebo-controlled studies. The antihypertensive effect of a single dose persisted for 24 hours, with peak reductions achieved 2 to 8 hours after dosing. Once-daily doses of benazepril/amlodipine using benazepril doses of 10 to 20 mg and amlodipine doses of 2.5 to10 mg decreased seated pressure (systolic/diastolic) 24 hours after dosing by about 10 to 25/6 to13 mmHg. In 2 studies in patients not adequately controlled on either benazepril 40 mg alone (n = 329) or amlodipine 10 mg alone (n = ...

Discontinuation because of adverse reactions occurred in 4% of amlodipine and benazepril hydrochloride-treated patients and 3% of placebo-treated patients. The most common reasons for discontinuation of therapy with amlodipine and benazepril hydrochloride were cough and edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted u...

Do not coadminister aliskiren with ACE inhibitors, including amlodipine and benazepril hydrochloride, in patients with diabetes. ( 4 ) Amlodipine and benazepril hydrochloride is contraindicated in patients with a history of angioedema or patients who are hypersensitive to benazepril or to amlodipine. ( 4 ) Amlodipine and benazepril hydrochloride is contraindicated in combination with a neprilysin ...

Anaphylactoid reactions, including angioedema ( 5.1 ). Myocardial infarction or increased angina in patients with obstructive coronary artery disease ( 5.2 ). Assess for hypotension and hyperkalemia ( 5.4 , 5.8 ). Titrate slowly in patients with impaired hepatic or severely impaired renal function ( 5.6 , 5.7 ). 5.1 Fetal Toxicity Amlodipine and benazepril hydrochloride can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the se...

7 DRUG INTERACTIONS Potassium supplements/potassium-sparing diuretics: hyperkalemia. ( 7.1 ) Lithium: Increased serum lithium levels; toxicity symptoms. ( 7.1 ) Injectable gold: facial flushing, nausea, vomiting, hypotension. ( 7.1 ) Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Risk of renal dysfunction, loss of antihypertensive effect. ( 7.1 ) Do not exceed doses greater than 20 mg daily of sim...