trandolapril (Rx)Brand and Other Names:Mavik

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 1mg
  • 2mg
  • 4mg
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Hypertension

In patients not taking a diuretic

Initial dose

  • 1 mg PO qDay in nonblack patients
  • 2 mg PO qDay in black patients

Maintenance dose

  • 2-4 mg PO qDay; may divide q12hr if BP response diminishes

Congestive Heart Failure or Left Ventricular Dysfunction Post-MI

Initial: 1 mg PO qDay

Maintenance: 4 mg PO qDay

Dosage Modifications

Renal impairment (CrCl <30 mL/min): 0.5 mg PO qDay

Hepatic impairment (cirrhosis): 0.5 mg PO qDay

Dosing Considerations

Monitor potassium levels

Beneficial for many patients at risk for heart disease; reduce risk of MI, stroke, diabetic nephropathy , microalbuminuria, new onset DM

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

May prolong survival in CHF, may preserve renal function in DM

May help to prevent migraine HA

No sexual dysfunction side effect

Good choice in hyperlipidemia patients

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

Abrupt discontinuance not associated with rapid increase in BP

<18 years old: safety & efficacy not established

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Interactions

Interaction Checker

trandolapril and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Cough (1.9-35%)

            Elevated Uric Acid (15%)

            Hypotension (1-11%)

            1-10%

            Syncope (5.9%)

            Hyperkalemia (5.3%)

            Hypocalcemia (4.7%)

            Stroke (3.8%)

            Bradycardia (1-5%)

            Dizziness (1.3-2.3%)

            Frequency Not Defined

            Angioedema

            ARF if renal artery stenosis

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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

            History of hereditary or angioedema associated with previous ACE inhibitor treatment

            Bilateral renal artery stenosis

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

            Pregnancy (2nd and 3rd trimesters): significant risk of fetal/neonatal morbidity and mortality (see Black Box Warnings)

            Cautions

            Less effective in Blacks

            Excessive hypotension if concomitant diuretics, hypovolemia, hyponatremia

            Renal impairment may occur

            Coadministration with mTOR inhibitors (eg, temsirolimus, sirolimus, everolimus) may increased risk for angioedema

            Neutropenia/agranulocytosis reported

            Cough may occur within the first few months

            Cholestatic jaundice may occur  

            Risk of hyperkalemia, especially in renal impairment, diabetes melliuts, or coadministration with potassium-elevating drugs

            ACE inhibition also causes increased bradykinin levels which putatively mediates angioedema; higher incidence of angioedema in black than nonblack patients

            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

            Intestinal angioedema reported in patients treated with ACE inhibitors; it should be included in differential diagnosis of patients, taking ACE inhibitors and presenting with abdominal pain

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            Pregnancy & Lactation

            Pregnancy Category: C (1st trimester); D (2nd/3rd trimesters)

            Lactation: possibly excreted in breast milk; nursing not recommended

            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

            Distribution

            Protein Bound: 80% (trandolapril); 65-94% (trandolaprilat)

            Vd: 18 L

            Absorption

            Onset: 1-2 hr

            Duration: 72 hr after single dose

            Peak Plasma Time: 1 hr

            Elimination

            Half-Life: 6 hr trandolapril; 22.5 hr trandolaprilat

            Excretion

            Urine: 33%

            Feces: 66%

            Dialyzable

            Clearance

            • CrCl <30 mL/min may result in accumulation of active metabolite

            Metabolism

            Metabolite: Trandolaprilat (active)

            Metabolism: Liver

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            Formulary

            FormularyPatient Discounts

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            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.
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