Looking up the FDA label…
Looking up the FDA label…
Also sold as Enalapril Maleate, Enalapril maleate oral solution
FDA boxed warning
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue enalapril maleate oral solution as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. When pregnancy is detected, discontinue enalapril maleate oral solution as soon as possible.
Enalapril maleate oral solution is an angiotensin-converting enzyme inhibitor indicated for: treatment of hypertension in adults and children older than one month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. treatment of symptomatic heart failure. treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure. 1.1 Hypertension Enalapril maleate oral solution is indicated for the treatment of hypertension, to lower blood pressure in adults and children older than one month. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. …
Pregnancy Tell female patients of childbearing age about the consequences of exposure to enalapril maleate oral solution during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible. Angioedema Angioedema, including laryngeal edema, may occur at any time during treatment with angiotensin-converting enzyme inhibitors, including enalapril. Advise patients to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, or tongue, or difficulty in swallowing or breathing) and to consult with the prescribing physician before taking more drug. Hypotension Caution patients to report lightheadedness, especially during the first few days of therapy. If actual syncope occurs, tell patients to discontinue the drug until they have consulted with the prescribing physician. Tell patients that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; advise patients to consult with their physician. Hyperkalemia Tell patients to consult their physician prior to using salt substitutes containing potassium. Vasotec is a registered trademark of Valeant International Bermuda. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 U.S. Patents: 9,669,008; 9,808,442; 10,039,745; 10,154,987; 10,772,868; 10,786,482; 11,040,023 PN: 69238-00570 Rev. 00
The following adverse reactions are described elsewhere: Angioedema Hypotension Hepatic failure Renal impairment Hyperkalemia The most common adverse reaction for patients treated for hypertension (≥3%) was fatigue. The most common adverse reactions for patients treated for heart failure (>6%) were hypotension and dizziness. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials…
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Ask a doctor — $19.99Enalapril maleate oral solution is contraindicated in patients with: a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme (ACE) inhibitor. hereditary or idiopathic angioedema. Do not co-administer aliskiren with enalapril maleate oral solution in patients with diabetes. Enalapril maleate oral solution is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer enalapril maleate oral solution within 36 hours of switchi…
Hypertension Adult: recommended initial dose is 5 mg once daily. Maximum dose is 40 mg daily. Pediatrics: recommended starting dose is 0.08 mg/kg (up to 5 mg) once daily. Heart Failure: Initiate at 2.5 mg twice daily. Titrate up to 20 mg twice daily as tolerated. Asymptomatic Left Ventricular Dysfunction: Initiate at 2.5 mg twice daily. Titrate up to 10 mg twice daily. Enalapril maleate oral solution is a ready-to-use solution intended for oral use only. 2.1 Hypertension Adults: The recommended initial dose in adul…
In patients who are elderly, volume-depleted (as on diuretic therapy), or with compromised renal function, use with NSAIDs, including selective COX-2 inhibitors, may result in deterioration of renal function, including renal failure. Monitor renal function periodically. Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia. Avoid potassium sparing agents in patients with heart failure. Monitor serum lithium levels frequently. 7.1 Non-Steroidal Anti-Inflamm…
Taking something else alongside it?
Interaction warnings are written per drug, not for your particular combination. A doctor can check yours.
Ask about my combinationSame medicine, sold as
Works in a similar way — ace inhibitors
These are different medicines in the same family, not swaps for each other. Which one suits you is a prescribing decision.