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Enalapril Maleate / FelodipinePronouncation: (EH-NAL-uh-prill MAL-ee-ate/feh-LOW-dih-peen)
Class: Antihypertensive combination
- Extended-release tablets enalapril maleate 5 mg/felodipine 2.5 mg
- Extended-release tablets enalapril maleate 5 mg/felodipine 5 mg
The 2 components have complementary antihypertensive actions. Enalapril suppresses the renin-angiotension-aldosterone system. Felodipine dihydropyridine calcium channel blocker produces peripheral vasodilation.
Indications and UsageHypertension
Not indicated for initial treatment of hypertension.
History of angioedema.
Dosage and AdministrationAdult
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.
- Administer without regard to meals. Administer with food if GI upset occurs.
- Have patient swallow whole. Do not crush, chew, or divide.
Store tablets at controlled room temperature (59° to 86°F). Protect from moisture and light.
Enalapril may increase risk of hypersensitivity.Antacids
Enalapril bioavailability may be decreased. Separate administration times by 1 to 2 h.Barbiturates
Effects of felodipine may be decreased.Capsaicin
Enalapril-induced cough may be exacerbated.Carbamazepine
Plasma levels of felodipine may be decreased, reducing effect.CYP3A4 inhibitors (eg, erythromycin)
Increased effect of felodipine.Diuretics
Excessive reduction in BP may occur.Food
Effects of felodipine may increase if given with grapefruit juice.Hydantoins
Serum felodipine levels may be decreased, reducing effects.Indomethacin
Hypotensive effects may be reduced, especially in low-renin or volume-dependent hypertensive patients.Lithium
Increased lithium levels and symptoms of lithium toxicity may occur.Phenothiazine
Enalapril may increase pharmacological effect of phenothiazines.Potassium preparations, potassium-sparing diuretics
Enalapril may increase serum potassium levels.Rifampin
Pharmacologic effects of enalapril may be decreased.
Laboratory Test Interactions
None well documented.
Peripheral edema (4%); angina; arrhythmias; AV block; chest pain; hypotension; MI; orthostatic hypotension; palpitation; syncope; tachycardia; vasculitis.
Headache (10%); dizziness (4%); asthenia, fatigue (2%); anxiety; insomnia; irritability; lightheadedness; nervousness; paresthesias; psychiatric disturbances; somnolence; vertigo.
Flushing (2%); pruritus; rash.
Abdominal discomfort; constipation; cramps; diarrhea; dry mouth; dyspepsia; flatulence; nausea; thirst; vomiting.
Micturition disorders; sexual difficulties; UTI.
Agranulocytosis; decreased hemoglobin and hematocrit; eosinophilia; epistaxis; neutropenia; pancytopenia; thrombocytopenia.
Cough (2%); bronchitis; dyspnea; nasal or chest congestion; pharyngitis; respiratory infections; rhinitis; shortness of breath; sinusitis; sneezing; wheezing.
Arthralgia; arthritis; fever; gingival hyperplasia; hyperkalemia; muscle cramps; myalgia; pain; inflammation.
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, discontinue therapy as soon as possible.
Category C (first trimester); Category D (second and third trimesters).
Secreted into breast milk.
Safety and efficacy have not been determined.
May have greater hypotensive effects and increased risk of peripheral edema with higher doses.
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.
Use with caution in patients with hepatic function impairment or reduced hepatic blood flow.
Angioedema may occur; use is contraindicated in patients with history of angioedema.
Aortic stenosis/Hypertrophic cardiomyopathy
Use with caution.
Use felodipine with caution. Transient hypotension may occur.
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.
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.
Abrupt withdrawal of calcium channel blockers may cause increased frequency and duration of angina. Taper dose gradually.
- 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.