enalapril (Rx)

Brand and Other Names:enalaprilat, Epaned, more...Vasotec, Vasotec IV
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 1.25mg/mL

tablet

  • 2.5mg
  • 5mg
  • 10mg
  • 20mg

powder for oral solution (Epaned)

  • 150 mg bottle (1mg/mL after reconstitution)
more...

Hypertension

Oral

  • Initial: 2.5-5 mg PO qDay
  • Maintenance: 10-40 mg/day PO qDay or divided q12hr

IV

  • 1.25 mg/dose IV over 5 minutes q6hr; doses up to 5 mg/dose IV q6hr have been administered

Left Ventricular Dysfunction

Initial: 2.5 mg PO q12hr

May titrate up to 20 mg/day

Congestive Heart Failure

Initial: 2.5 mg PO qDay or q12hr

Maintenance: 5-40 mg/Day PO divided q12hr; titrate slowly q2Weeks

IV: 1.25-5 mg q6hr; avoid IV administration in unstable heart failure or acute myocardial infarction

Conversion from IV to oral dosage form

If not concurrently receiving diuretics, initiate enalapril 5 mg PO qDay; if concurrently receiving diuretics and responding to 0.625 mg IV q6hr, initiate at 2.5 mg PO qDay; titrate upwards as necessary

Dosage Modifications

Hepatic impairment: No dosage adjustment required

Renal impairment

  • CrCl <30 mL/min: (PO) Initiate 2.5 mg; titrate to response; not to exceed 40 mg
  • Dialysis: 2.5 mg PO on day of dialysis; adjust dose on nondialysis days according to BP
  • CrCl <30 mL/min: (IV) Initiate 0.625 mg q6hr; titrate based on response
  • CrCl ≥30 mL/min: (PO) Initiate 5 mg/day; titrate to maximum of 40 mg
  • CrCl ≥30 mL/min: (IV) 1.25 mg q6hr; titrate based on response

Dosing Considerations

Beneficial for many patients at risk for heart disease

Reduces risk of MI, stroke, diabetic nephropathy, microalbuminuria, new-onset DM

Consider starting an ACE inhibitor in high-risk patients, even if no HTN or CHF

May prolong survival in CHF

May preserve renal function in DM

May help to prevent migraine headache

Good choice in hyperlipidemia patients

Requires weeks for full effect; to start, use low dose and titrate q1-2Weeks

Abrupt discontinuation not associated with rapid increase in BP

Dosage Forms & Strengths

injectable solution

  • 1.25mg/mL

tablet

  • 2.5mg
  • 5mg
  • 10mg
  • 20mg

powder for oral solution (Epaned)

  • 150 mg bottle (1mg/mL after reconstitution)
more...

Hypertension

1 month to 16 years (oral)

  • Initial: 0.08 mg/kg/day PO or divided q12hr; not to exceed 5 mg/day 
  • May increase PRN q2Weeks according to blood pressure not to exceed 0.58 mg/kg/day (or 40 mg/day)

1 month to 16 years (IV)

  • 0.01-0.02 mg/kg/day divided q12hr by IV infusion

Hypertensive Crisis

0.05-0.1 mg/kg by direct IV injection 

Renal Impairment

GFR <30 mL/min/1.73 m&sup;: Not recommended

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Interactions

Interaction Checker

and enalapril

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Dizziness (4-8%)

            Hypotension (0.9-6.7%)

            Headache (2-5%)

            Chest pain (2%)

            Cough (1-2%)

            Rash (1.5%)

            Frequency Not Defined

            Asthenia

            Nausea

            Vomiting

            Hyperkalemia

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            Warnings

            Black Box Warnings

            Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system, causing oligohydramnios, which may result in fetal injury and/or death

            Contraindications

            Hypersensitivity to enalapril/other ACE inhibitors

            History of ACE inhibitor-induced angioedema, hereditary or idiopathic angioedema

            Coadministration of neprilysin inhibitors (eg, sacubitril) with ACE inhibitors may increase angioedema risk; do not administer ACE inhibitors within 36 hr of switching to or from sacubitril/valsartan

            Do not coadminister with aliskiren in patients with diabetes mellitus or with renal impairment (ie, GFR <60 mL/min/1.73 m²)

            Bilateral renal artery stenosis

            Cautions

            Apheresis (LDL) with dextran sulfate, hypertrophic cardiomyopathy, collagen vascular disease, hemodialysis with high flux membrane, renal or aortic stenosis

            For HTN patients on diuretics, if possible discontinue diuretics 2-3 days before starting enalapril

            Excessive hypotension if concomitant diuretics, hypovolemia, hyponatremia

            Risk of hyperkalemia, especially in patients with renal impairment or DM or in those taking concomitant K+-elevating drugs

            Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy

            Injection contains benzyl alcohol preservative (linked to potentially fatal "gasping syndrome" in preemies)

            ACE inhibition also causes an increase in bradykinin levels, which putatively mediates angioedema

            Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with angiotensin-converting enzyme inhibitors

            If laryngeal stridor or angioedema of the face, tongue, or glottis occurs discontinue therapy and institute appropriate therapy immediately

            Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g. temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema Intestinal angioedema has been reported in patients treated with ACE inhibitors

            Dry hacking nonproductive cough may occur within few months of treatment; consider other causes of cough prior to discontinuation

            Agranulocytosis, neutropenia, or leukopenia with myeloid hypoplasia reported with other ACE inhibitor; patients with renal impairment are at high risk; monitor CBC with differential in these patients

            Discontinue STAT if patient becomes pregnant

            Less effective in blacks

            Renal impairment

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            Pregnancy & Lactation

            Pregnancy

            May cause fetal harm when administered to a pregnant woman; use of drugs that act on renin-angiotensin system during second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death; when pregnancy is detected, discontinue therapy as soon as possible

            Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage); hypertension increases fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly

            Lactation

            Enalapril and enalaprilat have been detected in human breast milk; because of potential for serious adverse reactions in breastfed infant, including hypotension, hyperkalemia, and renal impairment, advise women not to breastfeed during therapy

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Angiotensin converting enzyme (ACE) inhibitors dilate arteries and veins by competively inhibiting the conversion of angiotensin I to angiotensin II (a potent endogenous vasoconstrictor) and by inhibiting bradykinin metabolism; these actions result in preload and afterload reductions on the heart

            ACE inhibitors also promote sodium and water excretion by inhibiting angiotensin-II induced aldosterone secretion; elevation in potassium may also be observed

            ACE inhibitors also elicit renoprotective effects through vasodilation of renal arterioles

            ACE inhibitors reduce cardiac and vascular remodeling associated with chronic hypertension, heart failure, and myocardial infarction

            Absorption

            Bioavailability: 60%

            Onset: 1 hr

            Duration: 6 hr (IV), 12-24 hr (PO)

            Peak plasma time: 15 min (IV), 1 hr (PO)

            Distribution

            Protein bound: 50-60%

            Metabolism

            Liver (70%); enalapril undergoes hepatic biotransformation to enalaprilat within 4 hr following oral administration

            Metabolites: Enalaprilat (active)

            Initial response for HTN: 15 min (IV), 1 hr (PO)

            Peak response for HTN: 1-4 hr (IV), 4-6 hr (PO)

            Elimination

            Half-life elimination: 2 hr (parent drug), 35-38 hr (active metabolite [enalaprilat])

            Dialyzable: Yes (hemodialysis)

            Excretion: Urine (61%); feces (6% as enalapril, 27% as enalaprilat)

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            Administration

            IV Incompatibilities

            Y-site: Ampho B, ampho B chol SO4, cefepime, phenytoin

            IV Compatibilities

            Solution: D5W, Normosol R

            Additive: Dobutamine, dopamine, heparin, meropenem, nitroglycerin, KCl, sodium nitroprusside

            Y-site (partial list): Allopurinol, ampicillin, ampicillin-sulbactam, cefazolin, clindamycin, dobutamine, dopamine, esmolol, fentanyl, heparin, labetalol, linezolid, MgSO4, metronidazole, morphine SO4, nicardipine, KCl, propofol, tobramycin, TMP-SMX, vancomycin

            IV Administration

            Slow IVP over at least 5 minutes if undiluted, OR

            Infused in up to 50 mL of compatible IV infusion solution

            Storage

            Clear, colorless solution

            Store below 30°C

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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