DOSAGE AND ADMINISTRATION
LEXXEL is an effective treatment for hypertension. This fixed combination drug is not indicated for initial therapy of hypertension.
The recommended initial dose of enalapril maleate for hypertension in patients not receiving diuretics is 5 mg once a day. The usual dosage range of enalapril maleate for hypertension is 10-40 mg per day administered in a single dose or two divided doses. In some patients treated once daily with enalapril, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered. The recommended initial dose of felodipine ER is 5 mg once a day with a usual dosage range of 2.5 mg-10 mg once a day. In elderly or hepatically impaired patients, the recommended initial dose of felodipine is 2.5 mg. When LEXXEL is taken with food, the peak concentration of felodipine is almost doubled, and the trough (24-hour) concentration is approximately halved (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism).
In clinical trials of enalapril-felodipine ER combination therapy using enalapril doses of 5-20 mg and felodipine ER doses of 2.5-10 mg once daily, the antihypertensive effects increased with increasing doses of each component in all patient groups.
The hazards (see WARNINGS and ADVERSE REACTIONS) of enalapril are generally independent of dose; those of felodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter. Therapy with any combination of enalapril and felodipine will thus be associated with both sets of dose-independent hazards.
Rarely, the dose-independent hazards associated with enalapril or felodipine are serious. To minimize dose-independent hazards, it is usually appropriate to begin therapy with LEXXEL only after a patient has failed to achieve the desired antihypertensive effect with one or the other monotherapy.
Replacement Therapy: Although the felodipine component of LEXXEL has not been shown to be bioequivalent to the available extended-release felodipine (PLENDIL), patients receiving enalapril and felodipine from separate tablets once a day may instead wish to receive the tablets of LEXXEL containing the same component doses.
Therapy Guided By Clinical Effect: A patient whose blood pressure is not adequately controlled with felodipine (or another dihydropyridine) or enalapril (or another ACE inhibitor) alone may be switched to combination therapy with LEXXEL, initially one tablet daily of LEXXEL. If blood pressure control is inadequate after a week or two, the dose may be increased to 2 tablets administered once daily. If control remains unsatisfactory, consider addition of a thiazide diuretic.
Use in Patients with Metabolic Impairments: Regimens of therapy with LEXXEL need not be adjusted for renal function as long as the patient’s creatinine clearance is >30 mL/min/1.73m2 (serum creatinine roughly ≤3 mg/dL or 265 mmol/L). In patients with more severe renal impairment, the recommended initial dose of enalapril is 2.5 mg.
LEXXEL should regularly be taken either without food or with a light meal (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism). LEXXEL should be swallowed whole and not divided, crushed or chewed.