"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
LEXXEL (enalapril maleate-felodipine) is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension. (See DOSAGE AND ADMINISTRATION.)
In using LEXXEL (enalapril maleate-felodipine) , consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril (a component of LEXXEL) does not have a similar risk. (See WARNINGS, Neutropenia/Agranulocytosis.)
In considering use of LEXXEL (enalapril maleate-felodipine) , it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks. (See WARNINGS, Angioedema.)
DOSAGE AND ADMINISTRATION
LEXXEL (enalapril maleate-felodipine) 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 (enalapril maleate-felodipine) 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 (enalapril maleate-felodipine) 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 (enalapril maleate-felodipine) 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 (enalapril maleate-felodipine) 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 (enalapril maleate-felodipine) , initially one tablet daily of LEXXEL (enalapril maleate-felodipine) . 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 (enalapril maleate-felodipine) 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 (enalapril maleate-felodipine) should regularly be taken either without food or with a light meal (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism). LEXXEL (enalapril maleate-felodipine) should be swallowed whole and not divided, crushed or chewed.
No. 3661 - Tablets LEXXEL (enalapril maleate-felodipine) , 5-5 are white, round/biconvex-shaped, film-coated tablets, coded LEXXEL (enalapril maleate-felodipine) 1, 5-5 on one side and no markings on the other. Each tablet contains 5 mg of enalapril maleate and 5 mg of felodipine as an extended-release formulation. They are supplied as follows:
NDC 0186-0001-31 unit of use bottles of 30 (with desiccants)
NDC 0186-0001-68 bottles of 100 (with desiccants)
Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from moisture and light. Dispense in a tight container, if product package is subdivided.
Revised 12/04. LEXXEL (enalapril maleate-felodipine) is a trademark of the AstraZeneca group of companies. Manufactured for: AstraZeneca LP, Wilmington, DE 19850. By: Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. FDA rev date: 10/4/2007This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/25/2007
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