Generic
Amlodipine Besilate + Benazepril Hydrochloride
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. It is usually appropriate to begin therapy with this capsule only after a patient has either- Failed to achieve the desired antihypertensive effect with one or the other monotherapy, or Demonstrated inability to achieve adequate antihypertensive effect with Amlodipine therapy without developing edema. Dose Titration Guided by Clinical Effect: A patient whose blood pressure is not adequately controlled with Amlodipine (or another dihydropyridine) alone or with Benazepril (or another ACE inhibitor) alone may be switched to combination therapy with this capsule. All patient groups benefit from the reduction in Amlodipine-induced edema. Dosage must be guided by clinical response; steady-state levels of Benazepril an Amlodipine will be reached after approximately 2 and 7 days of dosing respectively. In patients whose blood pressures are adequately controlled with Amlodipine but who experience unacceptable edema, combination therapy may achieve similar (or better) blood-pressure control without edema. Especially in nonblacks, it may be prudent to minimize the risk of excessive response by reducing the dose of Amlodipine as Benazepril is added to the regimen. Replacement Therapy: For convenience, patients receiving Amlodipine and Benazepril from separate tablets may instead wish to receive this capsule containing the same component doses. In small, elderly, or hepatically impaired patients, the recommended initial dose of Amlodipine, as monotherapy or as a component of combination therapy, is 2.5 mg.
Contraindications
This capsule is contraindicated in patients who are hypersensitive to Benazepril, to any other ACE inhibitor, or to Amlodipine.
Side Effects
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 And Lactation
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.
Therapeutic
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.
Storage Conditions
Combined antihypertensive preparations
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