enalapril maleate


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enalapril maleate

Apo-Enalapril (CA), CO Enalapril (CA), Gen-Enalapril (CA), Innovace (UK), Novo-Enalapril (CA), PMS-Enalapril (CA), Ratio-Enalapril (CA), Riva-Enalapril (CA), Sandoz-Enalapril (CA), Taro-Enalapril (CA), Vasotec

enalaprilat

Vasotec IV

Pharmacologic class: Angiotensin-converting enzyme (ACE) inhibitor

Therapeutic class: Antihypertensive

Pregnancy risk category C (first trimester), D (second and third trimesters)

FDA Box Warning

• When used during second or third trimester of pregnancy, drug can cause fetal injury and even death. Discontinue as soon as pregnancy is detected.

Action

Inhibits conversion of angiotensin I to angiotensin II, a potent vasoconstrictor; inactivates bradykinin and prostaglandins. Also increases plasma renin and potassium levels and reduces aldosterone levels, resulting in systemic vasodilation.

Availability

Injection: 1.25 mg/ml

Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg

Indications and dosages

Hypertension

Adults: For patients not taking concomitant diuretics-initially, 5 mg P.O. once daily, increased after 1 to 2 weeks as needed to a maintenance dosage of 10 to 40 mg P.O. daily given as a single dose or in two divided doses; or 1.25 mg I.V. q 6 hours. For patients taking diuretics-initially, 2.5 mg P.O. or 0.625 mg I.V.

Children: 0.08 mg/kg P.O. once daily; may be increased based on blood pressure response up to 5 mg daily. Maximum dosage is 0.58 mg/kg/dose.

Heart failure

Adults: Initially, 2.5 mg P.O. once or twice daily, increased after 1 to 2 weeks as needed to maintenance dosage of 5 to 40 mg P.O. daily given as a single dose or in two divided doses

Asymptomatic left ventricular dysfunction

Adults: Initially, 2.5 mg P.O. once or twice daily, increased after 1 to 2 weeks as needed to a maximum of 20 mg/day in divided doses

Dosage adjustment

• Renal impairment

Off-label uses

• Diabetic nephropathy

• Hypertensive emergency

Contraindications

• Hypersensitivity to drug or other ACE inhibitors

• Angioedema

• Pregnancy

Precautions

Use cautiously in:

• renal or hepatic impairment, hypovolemia, hyponatremia, aortic stenosis, hypertrophic cardiomyopathy, cerebrovascular or cardiac insufficiency

• concurrent diuretic use

• elderly patients

• breastfeeding patients

• children.

Administration

• Give oral doses with food or beverage.

• Discontinue diuretics for 2 to 3 days before starting drug, if possible.

• Know that I.V. administration is usually reserved for patients who cannot take P.O. form.

• Be aware that I.V. administration isn't recommended for pediatric patients.

• Administer I.V. dose either undiluted or diluted in 50 ml of dextrose 5% in water, normal saline solution, dextrose 5% in normal saline solution, or dextrose 5% in lactated Ringer's solution.

• Give single I.V. dose by push or piggyback over 5 minutes. If patient is at risk for hypotension, infusion may be given over 1 hour.

• Be aware that black patients have a higher risk of angioedema.

Adverse reactions

CNS: dizziness, fatigue, headache, insomnia, drowsiness, vertigo, asthenia, paresthesia, ataxia, confusion, depression, nervousness,cerebrovascular accident

CV: orthostatic hypotension, palpitations, angina pectoris, tachycardia, peripheral edema,arrhythmias, cardiac arrest

EENT: sinusitis

GI: nausea, vomiting, constipation, dyspepsia, abdominal pain, dry mouth, pancreatitis

GU: proteinuria, urinary tract infection, erectile dysfunction, decreased libido,oliguria

Hematologic: agranulocytosis, bone marrow depression

Hepatic: hepatitis

Metabolic: hyponatremia,hyperkalemia Respiratory: cough, upper respiratory tract infection, asthma, bronchitis, dyspnea,eosinophilic pneumonitis

Skin: rash, alopecia, photosensitivity, diaphoresis, exfoliative dermatitis, angioedema,erythema multiforme

Other: altered taste, fever, increased appetite, anaphylactoid reactions

Interactions

Drug-drug. Allopurinol: increased risk of hypersensitivity reaction

Antacids: decreased enalapril absorption Cyclosporine, indomethacin, potassiumsparing diuretics, potassium supplements: hyperkalemia

Digoxin, lithium: increased blood levels of these drugs, possible toxicity

Diuretics, nitrates, other antihypertensives, phenothiazines: additive hypotension

Nonsteroidal anti-inflammatory drugs: decreased antihypertensive response

Rifampin: decreased enalapril efficacy

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen (BUN), creatinine, potassium: increased levels Antinuclear antibodies: positive titer Sodium: decreased level

Drug-food. Salt substitutes containing potassium: hyperkalemia

Drug-herbs. Capsaicin: increased incidence of cough

Drug-behaviors. Acute alcohol ingestion: additive hypotension

Sun exposure: photosensitivity reaction

Patient monitoring

Assess for rapid blood pressure drop leading to cardiovascular collapse, especially when giving with diuretics.

In patient with renal insufficiency or renal artery stenosis, monitor for worsening renal function.

• After initial dose, observe patient closely for at least 2 hours until blood pressure has stabilized. Then continue to observe for additional hour.

• Monitor vital signs, fluid intake and output, and daily weight.

• Supervise patient during ambulation until effects of drug are known.

• Monitor liver function tests, BUN, and creatinine and electrolyte levels.

Patient teaching

• Inform patient that drug's full effect may not occur for several weeks.

• Advise patient to report persistent dry cough with nasal congestion.

Tell patient to immediately report swelling of face, eye area, tongue, lips, hands, or feet; rash, hives, or severe itching; unexplained fever; unusual tiredness; yellowing of skin or eyes; abdominal pain; or easy bruising.

• Instruct patient to move slowly when sitting up or standing, to avoid dizziness or light-headedness from sudden blood pressure decrease.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.

enalapril maleate

Teczem®, Vasotec® Cardiology A long-acting IV ACE inhibitor/antihypertensive Adverse effects  Fatigue orthostatic hypotension, diarrhea, N&V, dizziness, headache, cough, dyspnea. See ACE inhibitor, CONSENSUS II, SOLVD.
References in periodicals archive ?
The launch of enalapril maleate tablets demonstrates our ability to expand our range of products in other ways.
taking enalapril maleate. Gastroenterol Clin Biol 1987; 11:174.
It combines two key ingredients: diltiazem maleate, a calcium channel blocker that's a variation of the active ingredient (diltiazem HCl) in Marion Merrell Dow's Cardizem; and enalapril maleate, the active ingredient in Merck's Vasotec, which acts as an ACE inhibitor.
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