Amlodipine/benazepril instructions for administration

Instructions for administration
Treatment of Hypertension Hazards of dosing for Hypertension Dose Titration Guided by Clinical Effect Use in Patients With Metabolic Impairments Replacement Therapy

Treatment of Hypertension
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 2.5-10 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 nonblack groups. All patient groups benefited from the reduction in amlodipine-induced edema. Return to top

Hazards of dosing for Hypertension
The hazards of benazepril are generally independent of dose; those of amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter. When benazepril is added to a regimen of amlodipine, the incidence of edema is substantially reduced. Therapy with any combination of amlodipine andbenazepril will thus be associated with both sets of dose-independent hazards, but the incidence of edema will generally be less than that seen with similar (or higher) doses of amlodipine monotherapy. Rarely, the dose-independent hazards of benazepril are serious. To minimize dose-independent hazards, it is usually appropriate to begin therapy with Lotrel only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema. Return to top

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 Lotrel. The addition of benazepril to a regimen of amlodipine should not be expected to provide additional antihypertensive effect in African-Americans. However, all patient groups benefit from the reduction in amlodipine-induced edema. Dosage must be guided by clinical response; steady-state levels of benazepril and 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. Return to top

Use in Patients With Metabolic Impairments
Regimens of therapy with Lotrel need not take account of renal function as long as the patient’s creatinine clearance is >30 mL/min/1.73m2 (serum creatinine roughly ≤3 mg/dL or 265 μmol/L). In patients with more severe renal impairment, the recommended initial dose of benazepril is 5 mg. Lotrel is not recommended in these patients. In small, elderly, frail, or hepatically impaired patients, the recommended initial dose of amlodipine, as monotherapy or as a component of combination therapy, is 2.5 mg. Return to top

Replacement Therapy
For convenience, patients receiving amlodipine and benazepril from separate tablets may instead wish to receive capsules of Lotrel containing the same component doses. Return to top