Enalapril Maleate / Felodipine

Trade Names:Lexxel- Extended-release tablets enalapril maleate 5 mg/felodipine 2.5 mg- Extended-release tablets enalapril maleate 5 mg/felodipine 5 mg

Pharmacology

The 2 components have complementary antihypertensive actions. Enalapril suppresses the renin-angiotension-aldosterone system. Felodipine dihydropyridine calcium channel blocker produces peripheral vasodilation.

Indications and Usage

Not indicated for initial treatment of hypertension.

Contraindications

History of angioedema.

Dosage and Administration

PO 1 tablet every day for patients whose BP is not adequately controlled with felodipine or enalapril monotherapy. If inadequate BP control persists beyond 1 to 2 wk, increase to 2 tablets/day.

General Advice

• Administer without regard to meals. Administer with food if GI upset occurs.
• Have patient swallow whole. Do not crush, chew, or divide.

Storage/Stability

Store tablets at controlled room temperature (59° to 86°F). Protect from moisture and light.

Drug Interactions

Enalapril may increase risk of hypersensitivity.

Enalapril bioavailability may be decreased. Separate administration times by 1 to 2 h.

Effects of felodipine may be decreased.

Enalapril-induced cough may be exacerbated.

Plasma levels of felodipine may be decreased, reducing effect.

Increased effect of felodipine.

Excessive reduction in BP may occur.

Effects of felodipine may increase if given with grapefruit juice.

Serum felodipine levels may be decreased, reducing effects.

Hypotensive effects may be reduced, especially in low-renin or volume-dependent hypertensive patients.

Increased lithium levels and symptoms of lithium toxicity may occur.

Enalapril may increase pharmacological effect of phenothiazines.

Enalapril may increase serum potassium levels.

Pharmacologic effects of enalapril may be decreased.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Peripheral edema (4%); angina; arrhythmias; AV block; chest pain; hypotension; MI; orthostatic hypotension; palpitation; syncope; tachycardia; vasculitis.

CNS

Headache (10%); dizziness (4%); asthenia, fatigue (2%); anxiety; insomnia; irritability; lightheadedness; nervousness; paresthesias; psychiatric disturbances; somnolence; vertigo.

Dermatologic

Flushing (2%); pruritus; rash.

GI

Abdominal discomfort; constipation; cramps; diarrhea; dry mouth; dyspepsia; flatulence; nausea; thirst; vomiting.

Genitourinary

Micturition disorders; sexual difficulties; UTI.

Hematologic

Agranulocytosis; decreased hemoglobin and hematocrit; eosinophilia; epistaxis; neutropenia; pancytopenia; thrombocytopenia.

Hepatic

Hepatic failure.

Respiratory

Cough (2%); bronchitis; dyspnea; nasal or chest congestion; pharyngitis; respiratory infections; rhinitis; shortness of breath; sinusitis; sneezing; wheezing.

Miscellaneous

Arthralgia; arthritis; fever; gingival hyperplasia; hyperkalemia; muscle cramps; myalgia; pain; inflammation.

Precautions

Pregnancy

Category C (first trimester); Category D (second and third trimesters).

Lactation

Secreted into breast milk.

Children

Safety and efficacy have not been determined.

Elderly

May have greater hypotensive effects and increased risk of peripheral edema with higher doses.

Renal Function

Reduce dose and give less frequently. Dose reduction or discontinuation may be necessary. Monitor renal function during first few weeks of therapy and adjust dosage.

Hepatic Function

Use with caution in patients with hepatic function impairment or reduced hepatic blood flow.

Angioedema

Angioedema may occur; use is contraindicated in patients with history of angioedema.

Aortic stenosis/Hypertrophic cardiomyopathy

Use with caution.

CHF

Use felodipine with caution. Transient hypotension may occur.

Cough

Chronic dry cough may occur during treatment; higher incidence in women.

Neutropenia and agranulocytosis

Neutropenia and agranulocytosis have occurred; risk appears greater with renal dysfunction and collagen vascular disease; monitor WBC counts frequently.

Surgery/Anesthesia

During major surgery or anesthesia, with agents that produce hypotension, enalapril may block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be caused by this mechanism, it can be corrected by volume expansion.

Withdrawal effects

Abrupt withdrawal of calcium channel blockers may cause increased frequency and duration of angina. Taper dose gradually.

Patient Information

• Advise patient that medication will be started at a low dose and then gradually increased as tolerated until max benefit has been obtained.
• Advise patient to take every day as prescribed at about the same time each day.
• Instruct patient to swallow tablets whole and to not crush, chew, or divide the tablets.
• Advise patient to take without regard to meals but to take with food if GI upset occurs.
• Inform patient that drug controls, but does not cure, hypertension and to continue taking drug as prescribed even when BP is not elevated.
• Caution patient not to change the dose or stop taking unless advised by health care provider.
• Instruct patient to continue taking other BP medications as prescribed by health care provider.
• Instruct patient in BP and pulse measurement skills.
• Advise patient to monitor and record BP and pulse at home and to inform health care provider should abnormal measurements be noted. Also advise patient to take record of BP and pulse to each follow-up visit.
• Caution patient to avoid sudden position changes to prevent orthostatic hypotension.
• Instruct patient to lie or sit down if experiencing dizziness or lightheadedness when standing and to inform health care provider if this happens frequently.
• Caution patient that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to excessive fall in BP resulting in lightheadedness or fainting.
• Emphasize to hypertensive patient importance of other modalities on BP: weight control, regular exercise, smoking cessation, and moderate intake of alcohol and salt.
• Inform patient that swelling of the gums can occur but that good oral hygiene will help prevent this from occurring or keep it from becoming severe.
• Instruct patient to stop taking drug and immediately report any of these symptoms to health care provider: fainting, swelling of the face, lips, eyelids, or tongue, difficulty breathing, sore throat, fever or other signs of infection, yellowing of the skin or eyes.
• Instruct patient to inform health care provider if a persistent cough or other bothersome side effects develop while taking this medication.
• Caution patient not to take any prescription or OTC medications, potassium-containing salt substitutes, potassium supplements, or dietary supplements unless advised by health care provider.