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Indications and Dosage
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.
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Renal Impairment
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Hepatic Impairment
No dosage adjustment needed.
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Administration
May be taken with or without food.
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Contraindications
History of angioedema related to previous ACE inhibitor treatment, hereditary/idiopathic angioedema. Pregnancy and lactation.
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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.
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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. |
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Patient Counseling Information
Patients should be informed to refrain from activities involving mental alertness and physical coordination after drug intake.
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Monitoring Parameters
Monitor renal function, BP, leukocytes, serum creatinine and K levels. Correct volume and/or salt depletion prior to treatment.
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Overdosage
Symptoms: Severe hypotension, bradycardia, shock, stupor, electrolyte disturbance and renal failure. Management: Perform haemodialysis and stomach emptying.
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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.
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Food Interaction
May worsen HTN w/ licorice.
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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). |
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Storage
Store between 20-25°C.
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MIMS Class
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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.
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