Enalaprilat 1.25 mg/mL
enalaprilat · INJECTION · Hikma Pharmaceuticals USA Inc.
Enalaprilat is an ACE inhibitor medication given by injection into the vein to help lower blood pressure and treat heart failure. It works by relaxing blood vessels to improve blood flow and reduce the workload on the heart.
Key Facts
- Brand Name
- Enalaprilat
- Generic Name
- enalaprilat
- NDC Code (Product)
0143-9787- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 1.25 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA078687
- Marketing Start
- 12/23/2008
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Enalaprilat injection is indicated for the treatment of hypertension when oral therapy is not practical. Enalaprilat injection has been studied with only one other antihypertensive agent, furosemide, which showed approximately additive effects on blood pressure. Enalapril, the pro-drug of enalaprilat, has been used extensively with a variety of other antihypertensive agents, without apparent difficulty except for occasional hypotension. In using enalaprilat injection, 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 enalaprilat injection does not have a similar risk (see WARNINGS ). In considering use of enalaprilat, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, 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, Angioede…
Dosage & Administration
DOSAGE AND ADMINISTRATION FOR INTRAVENOUS ADMINISTRATION ONLY The dose in hypertension is 1.25 mg every six hours administered intravenously over a five minute period. A clinical response is usually seen within 15 minutes. Peak effects after the first dose may not occur for up to four hours after dosing. The peak effects of the second and subsequent doses may exceed those of the first. No dosage regimen for enalaprilat injection has been clearly demonstrated to be more effective in treating hypertension than 1.25 mg every six hours. However, in controlled clinical studies in hypertension, doses as high as 5 mg every six hours were well tolerated for up to 36 hours. There has been inadequate experience with doses greater than 20 mg per day. In studies of patients with hypertension, enalaprilat has not been administered for periods longer than 48 hours. In other studies, patients have received enalaprilat for as long as seven days. The dose for patients being converted to enalaprilat injection from oral therapy for hypertension with enalapril maleate is 1.25 mg every six hours. For conversion from intravenous to oral therapy, the recommended initial dose of oral enalapril maleate, is…
Warnings
WARNINGS Hypotension Excessive hypotension is rare in uncomplicated hypertensive patients but is a possible consequence of the use of enalaprilat especially in severely salt/volume depleted persons such as those treated vigorously with diuretics or patients on dialysis. Patients at risk for excessive hypotension, sometimes associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death, include those with the following 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. It may be advisable to eliminate the diuretic, reduce the diuretic dose or increase salt intake cautiously before initiating therapy with enalaprilat injection in patients at risk for excessive hypotension who are able to tolerate such adjustments (see PRECAUTIONS, Drug Interactions ; ADVERSE REACTIONS , and DOSAGE AND ADMINISTRATION ). In patients with heart failure, with or without associated renal insufficiency, excessive hypotension has been observed and may be associated with oliguria and/or progressive azotemia…
Contraindications
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.
Drug Interactions
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 admi…
Adverse Reactions
ADVERSE REACTIONS Enalaprilat has been found to be generally well tolerated in controlled clinical trials involving 349 patients (168 with hypertension, 153 with congestive heart failure and 28 with coronary artery disease). The most frequent clinically significant adverse experience was hypotension (3.4 percent), occurring in eight patients (5.2 percent) with congestive heart failure, three (1.8 percent) with hypertension and one with coronary artery disease. Other adverse experiences occurring in greater than one percent of patients were: headache (2.9 percent) and nausea (1.1 percent). Adverse experiences occurring in 0.5 to 1 percent of patients in controlled clinical trials included: myocardial infarction, fatigue, dizziness, fever, rash and constipation. Angioedema : Angioedema has been reported in patients receiving enalaprilat, with an incidence higher in black than in non-black patients. Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis and/or larynx occurs, treatment with enalaprilat should be discontinued and appropriate therapy instituted immediately (see WARNINGS ). Cough: See PRECAUTIONS, Cough . Ena…
Frequently Asked Questions
What is Enalaprilat used for?
Enalaprilat is an ACE inhibitor medication given by injection into the vein to help lower blood pressure and treat heart failure. It works by relaxing blood vessels to improve blood flow and reduce the workload on the heart.
Is Enalaprilat a controlled substance?
Enalaprilat is not classified as a controlled substance by the DEA.
What is the generic name for Enalaprilat?
The generic name for Enalaprilat is enalaprilat. There are 1 other brand versions of enalaprilat.
What is the NDC code for Enalaprilat 1.25 mg/mL?
The NDC (National Drug Code) for Enalaprilat 1.25 mg/mL is 0143-9787, listed by Hikma Pharmaceuticals USA Inc..