MAVIK

Clinical safety rating: caution

Comprehensive clinical and safety monograph for MAVIK (MAVIK).

How it works

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.

What the body does with it

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.

Classification & Brands

Dosing & administration

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.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for MAVIK (MAVIK).

Breastfeeding	No human data; M/P ratio unknown; due to potential for serious adverse reactions in nursing infants, including hypotension and renal impairment, use is not recommended; consider alternative antihypertensive agents.
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.

Warnings & precautions

■ 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.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to trandolapril or any ACE inhibitor","History of angioedema related to previous ACE inhibitor therapy","Hereditary or idiopathic angioedema","Pregnancy (especially second and third trimesters)"]

Clinical Precautions

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."]

Clinical Tips & Counseling

Drug interactions

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MAVIK

Clinical safety rating: caution

Comprehensive clinical and safety monograph for MAVIK (MAVIK).

How it works

What the body does with it

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.

Classification & Brands

Dosing & administration

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.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for MAVIK (MAVIK).

Breastfeeding	No human data; M/P ratio unknown; due to potential for serious adverse reactions in nursing infants, including hypotension and renal impairment, use is not recommended; consider alternative antihypertensive agents.
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.

Warnings & precautions

■ 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.