Calcium-channel blocker + ACE Inhibitor;
The combination of Amlodipine and Benazepril is used to treat high blood pressure. Benazepril and benazeprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and in animals. While the mechanism through which Benazepril lowers blood pressure is believed to be primarily suppression of the renin-angiotensin aldosterone system, Benazepril has an antihypertensive effect even in patients with low-renin hypertension. Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
The rate and extent of absorption of Benazepril and Amlodipine are not significantly different, respectively, from the rate and extent of absorption of Benazepril and Amlodipine from individual tablet formulations. Following oral administration of this capsule, peak plasma concentrations of Benazepril are reached in 0.5-2 hours. Peak plasma concentrations of Amlodipine are reached 6-12 hours after administration of this capsule; the extent of absorption is 64%-90%. Over 700 patients received Benazepril/Amlodipine once daily in five double-blind, placebo-controlled studies. Benazepril/Amlodipine lowered blood pressure within 1 hour, with peak reductions achieved 2-8 hours after dosing. The antihypertensive effect of a single dose persisted for 24 hours. Once-daily doses of Benazepril/Amlodipine using Benazepril doses of 10-20 mg and Amlodipine doses of 2.5-10 mg decreased seated pressure (systolic/diastolic) 24 hours after dosing by about 10-25/6-13 mmHg.
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.
Diuretics: Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with Benazepril/Amlodipine.
Potassium Supplements and Potassium-Sparing Diuretics: Benazepril can attenuate potassium loss caused by thiazide diuretics. Potassium-sparing diuretics (Spironolactone, Amiloride, Triamterene and others) or potassium supplements can increase the risk of hyperkalemia. If concomitant use of such agents is indicated, they should be given with caution, and the patient's serum potassium should be monitored frequently.
Others: Benazepril has been used concomitantly with oral anticoagulants, beta-adrenergic-blocking agents, calcium-blocking agents, Cimetidine, diuretics, Digoxin, Hydralazine, and Naproxen without evidence of clinically important adverse interactions.
In clinical trials, Amlodipine has been safely administered with thiazide diuretics, beta blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, Digoxin, Warfarin, nonsteroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs.
In patients who are hypersensitive to Benazepril, to any other ACE inhibitor, or to Amlodipine. Impaired Renal Function: Should be used with caution in patients with severe renal disease. Patients with Congestive Heart Failure: Calcium channel blockers should be used with caution in patients with heart failure. Patients with Hepatic Failure: In patients with impaired hepatic function, caution should be exercised when administering this combination.
Generally mild & transient. The most common reasons for discontinuation of therapy with this combination were cough. Body as a whole: Asthenia & fatigue. CNS: Insomnia, nervousness, anxiety, tremor & decreased libido. Dermatologic: Flushing, hot flashes, rash, skin nodule & dermatitis. Digestive: Dry mouth, nausea, abdominal pain, constipation, diarrhea, dyspepsia & esophagitis. Metabolic & Nutritional: Hypokalemia. Musculoskeletal: Back pain, musculoskeletal pain, cramps & muscle cramps. Respiratory: Pharyngitis. Urogenital: Sexual problems such as impotence, & polyuria
Pregnancy Category C (first trimester) & D (second & third trimesters). Nursing Mothers: It is recommended that nursing should be discontinued while this combination is administered.
Human overdoses with any combination of Amlodipine and Benazepril have not been reported. In scattered reports of human overdoses with Benazepril and other ACE inhibitors, there are no reports of death.
Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
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