Description

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.

Benazepril/Amlodipine has been evaluated for safety in patients with hypertension for at least 6 months and more than 1 year. The reported side effects were generally mild and transient, and there was no relationship between side effects and age, sex, race or duration of therapy. Discontinuation of therapy due to side effects was required in approximately 4% of patients treated with Benazepril/Amlodipine and in 3% of patients treated with placebo. The most common reasons for discontinuation of therapy with Benazepril/Amlodipine in U.S. studies were cough and edema. The side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in more than 1% of patients treated with Benazepril/Amlodipine are cough, headache, dizziness and edema. The incidence of edema was statistically greater in patients treated with Amlodipine monotherapy than in patients treated with the combination. Edema and certain other side effects are associated with Amlodipine monotherapy in a dose-dependent manner, and appear to affect women more than men. The addition of Benazepril resulted in lower incidences as shown in study; the protective effect of Benazepril was independent of race and (within the range of doses tested) of dose. Other rare side effects are angioedema, asthenia, fatigue, insomnia, nervousness, anxiety, tremor, decreased libido, flushing, hot flashes, rash, skin nodule, dermatitis, dry mouth, nausea, abdominal pain, constipation, diarrhea, dyspepsia, esophagitis, hypokalemia, pharyngitis etc.

Pregnancy Categories C (first trimester) and D (second and third trimesters). ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the world literature. When pregnancy is detected, this capsule should be discontinued as soon as possible. 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 capsule is administered.

Impaired Renal Function: This capsule should be used with caution in patients with severe renal disease. Hyperkalemia: This may occur in only a few patients but generally are reversible. Patients With Hepatic Failure: Since Amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t ½) is 56 hours in patients with impaired hepatic function, caution should be exercised when administering this capsule 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.

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. Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

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.

Combined antihypertensive preparations