Trandolapril


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO HTN Initial: 0.5 mg once daily, 1st dose preferably given at bedtime. Maintenance: 1-2 mg once daily up to 4 mg/day as a single or in 2 divided doses. Post MI Initial: 0.5 mg once daily to be started 3 days after infarction. Max: 4 mg once daily.
Dosage Details
Oral
Hypertension
Adult: Initially, 0.5 mg once daily, 1st dose preferably given at bedtime to avoid precipitous fall in BP. Maintenance: 1-2 mg once daily up to 4 mg/day as a single or in 2 divided doses.

Oral
Post-myocardial infarction
Adult: Initially, 0.5 mg once daily to be started 3 days after infarction, may increase to max 4 mg once daily.
Renal Impairment
CrCl Dosage
<10 Initially, 0.5 mg/day. Max: 2 mg/day.
Hepatic Impairment
No dosage adjustment needed.
Administration
May be taken with or without food.
Contraindications
History of angioedema related to previous ACE inhibitor treatment, hereditary/idiopathic angioedema. Pregnancy and lactation.
Special Precautions
Patients w/ diarrhoea, collagen vascular disease, severe volume and/or salt depletion. Patients on dialysis and dietary salt restriction. Patients w/ unilateral or bilateral renal-artery stenosis. Increased risk of angioedema in Black patients. Renal impairment.
Adverse Reactions
Cough, headache, hypotension, hyperkalemia, fatigue, dizziness, diarrhoea, asthenia; neutropenia/agranulocytosis; intestinal angioedema.
Potentially Fatal: Anaphylactic reactions and angioedema (e.g. laryngeal angioedema and tongue oedema). Rarely, fulminant hepatic necrosis.
Patient Counseling Information
Patients should be informed to refrain from activities involving mental alertness and physical coordination after drug intake.
MonitoringParameters
Monitor renal function, BP, leukocytes, serum creatinine and K levels. Correct volume and/or salt depletion prior to treatment.
Overdosage
Symptoms: Severe hypotension, bradycardia, shock, stupor, electrolyte disturbance and renal failure. Management: Perform haemodialysis and stomach emptying.
Drug Interactions
Additive hyperkalaemic effect w/ K-sparing diuretics, K-containing salt substitutes and supplements. May increase serum levels and toxicity of lithium. May increase hypoglycaemic effect of antidiabetics. Increased risk of renal function deterioration w/ NSAIDs.
Food Interaction
May worsen HTN w/ licorice.
Action
Description: Trandolapril, a prodrug of trandolaprilat, competitively inhibits ACE from converting angiotensin I to angiotensin II (a potent vasoconstrictor) resulting in increased plasma renin activity and reduced aldosterone (a hormone that causes water and Na retention) secretion. This promotes vasodilation and BP reduction.
Onset: 1-2 hr.
Duration: At least 24 hr.
Pharmacokinetics:
Absorption: Rapidly absorbed. Bioavailability: 40-60% (trandolaprilat); 10% (trandolapril). Time to peak plasma concentration: 4-6 hr (trandolaprilat).
Distribution: Volume of distribution: Approx 18 L. Plasma protein binding: >80% (trandolaprilat).
Metabolism: Hepatically hydrolysed to trandolaprilat (active metabolite) and inactive metabolites.
Excretion: Via urine (approx 33%, as trandolaprilat); faeces (66%). Half-life: 16-24 hr (trandolaprilat).
Storage
Store between 20-25°C.
References
Anon. Trandolapril. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 21/11/2013.

Buckingham R (ed). Trandolapril. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 21/11/2013.

Joint Formulary Committee. Trandolapril. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 21/11/2013.

Mavik Tablets. U.S. FDA. https://www.fda.gov/. Accessed 21/11/2013.

McEvoy GK, Snow EK, Miller J et al (eds). Trandolapril. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 21/11/2013.

Disclaimer: This information is independently developed by MIMS based on Trandolapril from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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