Enaretic Tablets

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. ( 1.1 ) treatment of symptomatic heart failure. ( 1.2 ) treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure. …

• 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
• Hypertension
• Adults : The recommended initial dose
• Adults is 5 mg taken orally once a day
• Titrate upward to maximum of 40 mg daily as needed to help achieve blood pressure goals
• The dose may be divided and administered twice daily if the antihypertensive effect diminishes at the end of the dosing interval
• Use with diuretics: If additional blood pressure reduction is needed, enalapril maleate oral solution may be administered with a low dose of diuretic

Enalapril maleate oral solution is a ready-to-use oral solution that contains 1 mg/mL of enalapril maleate. It is a clear, colorless raspberry flavored solution packaged in a 150 mL white, round, high-density polyethylene bottle with a white, polypropylene, child-resistant cap and tamper-evident seal. Each bottle contains 150 mL. …

• Neonates with a history of in utero exposure to enalapril maleate If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion
• Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function
• Enalapril, which crosses the placenta, has been removed from neonatal circulation by peritoneal dialysis with some clinical benefit, and theoretically may be removed by exchange transfusion, although there is no experience with the latter procedure. …

This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

• Pregnancy Tell female patients of childbearing age about the consequences of exposure to enalapril maleate 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. …

• Enalapril maleate is contraindicated in patients with: a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme (ACE) inhibitor [see Warnings and Precautions ]. hereditary or idiopathic angioedema [see Warnings and Precautions ]
• Do not co-administer aliskiren with enalapril maleate in patients with diabetes [see Drug Interactions ] . …

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. ( 7.1 ) Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia. ( 7.2 ) Avoid potassium sparing agents in patients with heart failure. ( 7.3 ) Monitor serum lithium levels frequently. …

Angioedema and Anaphylactoid Reactions. ( 5.2 ) Impaired Renal Function: Assess renal function. ( 5.5 ) Hyperkalemia. ( 5.6 ) 5.1 Fetal Toxicity Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue enalapril maleate as soon as possible [see Use in Specific Populations (8.1) ] . …

The following adverse reactions are described elsewhere: Angioedema [see Warnings and Precautions (5.2) ] Hypotension [see Warnings and Precautions (5.3) ] Hepatic failure [see Warnings and Precautions (5.4) ] Renal impairment [see Warnings and Precautions (5.5) ] Hyperkalemia [see Warnings and Precautions (5.6) ] The most common adverse reaction for patients treated for hypertension (≥3%) was fatigue. ( 6.1 ) The most common adverse reactions for patients treated for heart failure (>6%) were hypotension and dizziness. ( 6.1 ) 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. …

8.1 Pregnancy Risk Summary Enalapril maleate can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. …

Limited data are available in regard to overdosage in humans. Single oral doses of enalapril above 1,000 mg/kg and ≥1,775 mg/kg were associated with lethality in mice and rats, respectively. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution. Enalaprilat may be removed from general circulation by hemodialysis and has been removed from neonatal circulation by peritoneal dialysis.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.