Enalaprilat
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
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, enalaprilat injection should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality .
Dosing in kidney impairment
For conversion from intravenous to oral therapy, the recommended initial dose of oral enalapril maleate for patients who have responded to 0.625 mg of enalaprilat every six hours is 2.5 mg once a day with subsequent dosage adjustment as necessary. Dosage Adjustment in Renal Impairment The usual dose of 1.25 mg of enalaprilat injection every six hours is recommended for patients with a creatinine clearance > 30 mL/min (serum creatinine of up to approximately 3 mg/dL).
For patients with creatinine clearance ≤ 30 mL/min (serum creatinine ≥ 3 mg/dL), the initial dose is 0.625 mg (see WARNINGS ). If after one hour there is an inadequate clinical response, the 0.625 mg dose may be repeated. Additional doses of 1.25 mg may be administered at six hour intervals. For dialysis patients, see below, Patients at Risk of Excessive Hypotension .
For conversion from intravenous to oral therapy, the recommended initial dose of oral enalapril maleate is 5 mg once a day for patients with creatinine clearance > 30 mL/min and 2.5 mg once daily for patients with creatinine clearance ≤ 30 mL/min. Dosage should then be adjusted according to blood pressure response. Patients at Risk of Excessive Hypotension Hypertensive patients at risk of excessive hypotension include those with the following concurrent conditions or characteristics: heart failure, hyponatremia, high dose diuretic therapy, recent intensive diuresis or increase in diuretic dose, renal dialysis, or severe volume and/or salt depletion of any etiology (see WARNINGS ).
Preparation and administration
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Patients should be followed closely whenever the dose of enalaprilat injection is adjusted and/or diuretic is increased. Administration Enalaprilat injection should be administered as a slow intravenous infusion, as indicated above. It may be administered as provided or diluted with up to 50 mL of a compatible diluent. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use whenever solution and container permit.
Compatibility and Stability Enalaprilat injection as supplied and mixed with the following intravenous diluents has been found to maintain full activity for 24 hours at room temperature: 5 percent Dextrose Injection 0.9 percent Sodium Chloride Injection 0.9 percent Sodium Chloride Injection in 5 percent Dextrose 5 percent Dextrose in Lactated Ringer's Injection ISOLYTE *** E ( *** Registered trademark of B.
Drug interactions
Check enalaprilat against a medication listLabel text (5 paragraphs)
Drug Interactions Hypotension-Patients on Diuretic Therapy : Patients on diuretics and especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with enalaprilat. The possibility of hypotensive effects with enalaprilat can be minimized by administration of an intravenous infusion of normal saline, discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with enalaprilat. If it is necessary to continue the diuretic, provide close medical supervision for at least one hour after the initial dose of enalaprilat (see WARNINGS ).
Agents Causing Renin Release : The antihypertensive effect of enalaprilat injection appears to be augmented by antihypertensive agents that cause renin release (e.g., diuretics). Non-Steroidal Anti-Inflammatory Agents : In some patients with compromised renal function who are being treated with non-steroidal anti-inflammatory drugs, the coadministration of enalapril may result in a further deterioration of renal function. These effects are usually reversible. In a clinical pharmacology study, indomethacin or sulindac was administered to hypertensive patients receiving enalapril maleate. In this study there was no evidence of a blunting of the antihypertensive action of enalapril maleate.
However, reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE inhibitors. Other Cardiovascular Agents: Enalaprilat injection has been used concomitantly with digitalis, beta adrenergic-blocking agents, methyldopa, nitrates, calcium-blocking agents, hydralazine and prazosin without evidence of clinically significant adverse interactions. Agents Increasing Serum Potassium : Enalaprilat injection attenuates potassium loss caused by thiazide-type diuretics.
Potassium-sparing diuretics (e.g., spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. Therefore, if concomitant use of these agents is indicated because of demonstrated hypokalemia, they should be used with caution and with frequent monitoring of serum potassium. Lithium : Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs which cause elimination of sodium, including ACE inhibitors. A few cases of lithium toxicity have been reported in patients receiving concomitant enalapril and lithium and were reversible upon discontinuation of both drugs.
It is recommended that serum lithium levels be monitored frequently if enalapril is administered concomitantly with lithium. Gold : Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy.
Contraindications
Enalaprilat injection is contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema related to previous treatment with an angiotensin-converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for enalaprilat. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
Pregnancy Pregnancy Categories C (first trimester) and D (second and third trimesters) See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
Lactation
Nursing Mothers Enalapril and enalaprilat have been detected in human breast milk. Because of the potential for serious adverse reactions in nursing infants from enalapril, a decision should be made whether to discontinue nursing or to discontinue enalaprilat injection, taking into account the importance of the drug to the mother.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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