Enalapril is an angiotensin converting enzyme inhibitor sold in the U.S. under 4 brand and generic names, for rheumatoid arthritis, bartter syndrome and diabetic nephropathies. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Epaned (application NDA208686). Other enalapril products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Hypertension Adult: recommended initial dose is 5 mg once daily. Maximum dose is 40 mg daily ( 2.1 ). Pediatrics: recommended starting dose is 0.08 mg/kg (up to 5 mg) once daily ( 2.1 ). Heart Failure: Initiate at 2.5 mg twice daily. Titrate up to 20 mg twice daily as tolerated ( 2.2 ). Asymptomatic Left Ventricular Dysfunction: Initiate at 2.5 mg twice daily. Titrate up to 10 mg twice daily ( 2.3 ). Enalapril maleate oral solution is a ready-to-use solution intended for oral use only. 2.1 Hypertension Adults :The recommended initial dose in 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 may be administered with a low dose of diuretic. The recommended initial dose in patients taking diuretics is 2.5 mg daily. Dosage Adjustment for Renal Impairment: See table below. The dosage may be titrated upward as needed to a maximum of 40 mg daily. Renal Status Creatinine-Clearance mL/min Initial Dose mg/day Normal or Mild Impairment of Renal Function >30 mL/min 5 mg Moderate to Severe Impairment ≤30 mL/min 2.5 mg Dialysis Patients [See Warnings and Precautions ( 5.2)] . Should be taken after…
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 Wilshire Pharmaceuticals, Inc. at 1-877-495-6856 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Enalapril has been evaluated for safety in more than 10,000 patients, including over 1,000 patients treated for one year or more. In clinical trials, discontinuation of therapy for clinical adverse experiences was required in 3.3% of patients with hypertension and in 5.7% of patients with heart failure. Hypertension Adverse reactions (where rate on enalapril exceeds the rate on placebo by at least 0.2%)…
Potassium-rich foods & salt substitutes
Don't use potassium-based salt substitutes unless your clinician approves, and ask before taking potassium supplements. Your clinician may check your potassium level with blood tests.
Lisinopril (an ACE inhibitor) — MedlinePlus (U.S. National Library of Medicine) ↗Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Solution | Generic | $0 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| T4 | 5 mg / 12.5 mg | white | oval | — |
| T;3 | 10 mg / 25 mg | pink | oval | — |
| VASE;10;25 | 10 mg / 25 mg | red | oval | — |
| C133 | 5 mg / 12.5 mg | white | round | — |
| C134 | 10 mg / 25 mg | white | round | — |
| T3 | 10 mg / 25 mg |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
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 ( 5.2 )]. •hereditary or idiopathic angioedema [see Warnings and Precautions ( 5.2 )] . Do not co-administer aliskiren with enalapril maleate in patients with diabetes [see Drug Interactions ( 7.2 )] . Enalapril maleate is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer enalapril maleate within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions ( 5.2 )] . Hypersensitivity related to previous treatment with an ACEI ( 4 ). Hereditary or idiopathic angioedema ( 4 ). Do not co-administer aliskiren in patients with diabetes ( 4 ). In combination with a neprilysin inhibitor ( 4 ).
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 ( 7.4 ). 7.1 Non-Steroidal Anti-Inflammatory Agents (NSAIDs) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including enalapril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving enalapril and NSAID therapy. 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…
| 72/100 |
| Prescription |
| Solution |
| Generic |
| $0 |
| View → |
| 3 | 70/100 | Prescription | Solution | Generic | $0 | View → |
| 4 | Not yet rated | Prescription | Tablet | Generic | $0 | View → |
| pink |
| oval |
| — |
| APO;5;12;5 | 5 g / 12.5 mg | red | round | — |
|---|
| APO;10;25 | 10 mg / 25 mg | red | round | — |
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| 333 | 2.5 mg | white | round | — |
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| 334 | 5 mg | white | round | — |
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| 335 | 10 mg | white | round | — |
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| 336 | 20 mg | white | round | — |
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