MAVIK
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MAVIK (MAVIK).
Angiotensin-converting enzyme (ACE) inhibitor; inhibits ACE, preventing conversion of angiotensin I to angiotensin II, reducing vasoconstriction and aldosterone secretion, leading to decreased blood pressure and reduced cardiac workload.
| Metabolism | Primarily hepatic metabolism via esterase hydrolysis to active metabolite (trandolaprilat). Trandolaprilat undergoes further glucuronidation and is excreted renally. |
| Excretion | Renal: trandolapril ~33% (as trandolaprilat and metabolites), trandolaprilat ~33% (as unchanged and metabolites); biliary/fecal: ~66% of total radioactivity. |
| Half-life | Trandolaprilat: terminal half-life ~24 hours (range 15–35 hours) for once-daily dosing; effective half-life ~6–10 hours at steady state. |
| Protein binding | Trandolapril: ~80% (primarily to albumin); trandolaprilat: ~94% (primarily to albumin). |
| Volume of Distribution | Trandolaprilat: ~16 L (0.23 L/kg for 70 kg adult), indicating extensive tissue distribution. |
| Bioavailability | Oral: trandolapril ~10% (prodrug), trandolaprilat ~10–15% after oral dose (after first-pass hydrolysis). |
| Onset of Action | Oral: 1–2 hours (peak effect at 4–8 hours). |
| Duration of Action | Approximately 24 hours; once-daily dosing for hypertension and heart failure. |
| Molecular Weight | 585.67 Da |
Oral, 1-4 mg once daily for hypertension; 2-4 mg once daily for heart failure.
| Dosage form | TABLET |
| Renal impairment | CrCl <40 mL/min: initial dose 0.5 mg once daily, titrate cautiously; maximum 2 mg/day. CrCl <20 mL/min: not recommended. |
| Liver impairment | Child-Pugh Class A: initial dose 0.5 mg once daily; Class B: 0.25 mg once daily; Class C: avoid use. |
| Pediatric use | Not approved for pediatric use; safety and efficacy not established. |
| Geriatric use | Initial dose 0.5 mg once daily; titrate slowly due to increased sensitivity and renal impairment. |
| 1st trimester | Avoid; risk of fetal renal impairment and oligohydramnios; use only if no alternative. |
| 2nd trimester | Avoid; associated with oligohydramnios, fetal renal dysfunction, and skull ossification defects. |
| 3rd trimester | Avoid; risk of neonatal hypotension, hyperkalemia, and renal failure. |
Clinical note
Comprehensive clinical and safety monograph for MAVIK (MAVIK).
| Placental transfer | Crosses placenta in animal studies; human data limited but likely transfer occurs. |
| Breastfeeding | Excreted in human milk in low amounts; use with caution in breastfeeding due to potential adverse effects on infant renal function. |
| Lactation Rating |
■ FDA Black Box Warning
Fetal toxicity: Drugs acting directly on the renin-angiotensin system can cause fetal injury and death. Discontinue as soon as possible when pregnancy is detected.
| Serious Effects |
History of angioedema related to previous ACE inhibitor therapyBilateral renal artery stenosisPregnancy (second and third trimesters)
| Precautions | Angioedema: Risk of airway obstruction; discontinue immediately and treat appropriately., Hypotension: May occur, especially in volume-depleted patients., Neutropenia/Agranulocytosis: Risk in patients with collagen vascular disease, renal impairment, or immunosuppression; monitor white blood cell counts., Renal impairment: May worsen renal function; monitor renal function periodically., Hyperkalemia: Risk factors include renal impairment, diabetes, and concomitant use of potassium-sparing diuretics or supplements., Cough: Persistent, nonproductive cough may occur. |
| Food/Dietary | Avoid high-potassium foods (e.g., bananas, oranges, spinach, potatoes, tomatoes, avocados) in large amounts without monitoring potassium levels. Do not use potassium-containing salt substitutes. Grapefruit juice may increase trandolaprilat levels; limit or avoid consumption. |
Loading safety data…
| L3 (Moderately Safe) |
| Teratogenic Risk | First trimester: Exposure associated with potential risk of congenital malformations based on ACE inhibitor class effects; second and third trimesters: Fetal renal hypoperfusion, oligohydramnios, skull ossification defects, hypotension, and anuria; risk of neonatal renal failure and death; contraindicated in second and third trimesters. |
| Fetal Monitoring | Monitor maternal blood pressure, renal function (serum creatinine, BUN), and electrolytes; fetal ultrasound for amniotic fluid volume and renal function if inadvertent exposure after first trimester; neonatal monitoring for hypotension and oliguria. |
| Fertility Effects | No specific data on trandolapril; ACE inhibitors may theoretically affect fertility through effects on the renin-angiotensin system, but no significant impairment has been reported in animal studies or clinical use. |
| Clinical Pearls | MAVIK (trandolapril) is an ACE inhibitor. Monitor serum potassium and renal function within 1-2 weeks of initiation or dose change. Avoid in pregnancy (black box warning). Cough is a common side effect; consider switching to an ARB if intolerable. For heart failure, titrate to target dose (4 mg once daily) as tolerated. Use with caution in renal artery stenosis. |
| Patient Advice | Take exactly as prescribed, usually once daily. Do not skip doses or stop without consulting your doctor. · Avoid salt substitutes containing potassium unless approved by your healthcare provider. · Report any signs of angioedema (swelling of face, lips, tongue, or difficulty breathing) immediately. · If you become pregnant or plan to become pregnant, stop the medication and notify your doctor right away. · You may experience a persistent dry cough; if bothersome, inform your doctor. · Drink plenty of fluids to stay hydrated, especially if you experience vomiting or diarrhea. |