Carvidon/Carvidon MR

Carvidon/Carvidon MR

trimetazidine

Manufacturer:

Micro Labs

Distributor:

Zizawa Healthcare
Full Prescribing Info
Contents
Trimetazidine HCl.
Action
Antianginal and anti-ischaemic.
Pharmacology: Carvidon: Trimetazidine belongs to a new class of compounds that display anti-ischaemic effects without inducing haemodynamic changes and improves the status of the ischaemic myocardium. It exerts its antianginal effects through a direct cytoprotective action on the myocardium, thereby, avoiding the side effects of impaired left ventricular function, excessive peripheral vasodilation and other disadvantages associated with the use of comparative antianginal agents.
Carvidon MR: Mechanism of Action: There are several possible mechanisms of action by which trimetazidine promotes preservation of membrane structures and cellular function, thereby allowing the ischaemic myocardial cell to more rapidly restore its energy reserves. The main mechanisms are: Limitation of intracellular acidosis; improvement in transmembrane ion exchanges and calcium overload; prevention of excessive free radical production; inhibition of the inflammatory reaction and preservation of mitochondrial function.
Pharmacokinetics: Trimetazidine is >95% non-ionized at physiological pH, permitting the drug to pass through lipoprotein membranes. It is rapidly and completely absorbed from the gastrointestinal tract after oral ingestion. Cmax is 1.8 hrs and plasma half-life is 6 hrs. Plasma protein-binding is low and the volume of distribution is 320 L. Four pathways of metabolism are known but metabolism is not extensive, with 51% of unchanged drug eliminated in urine. Elimination is rapid (t½=6 hrs) and predominantly renal. Sixty percent of the drug is excreted unchanged in the urine. Food intake does not interfere with the pharmacokinetics of trimetazidine.
Indications/Uses
Carvidon: Treatment of ischaemic heart disease (angina pectoris, sequelae of infarction).
Carvidon MR: Treatment of coronary insufficiency, angina pectoris, sequelae of infarction and in ischaemia of neurosensorial tissue.
Dosage/Direction for Use
Carvidon: 1 tab thrice daily with meals. Trimetazidine can be combined with calcium-channel blockers or β-blockers.
Carvidon MR: 1 tab twice daily.
Impaired Renal and Hepatic Function: No dosage adjustment is required in patients with impaired renal and hepatic functions.
Overdosage
Trimetazidine is extremely safe, the maximum tolerated dosage being 2000 times the therapeutic dosage.
Contraindications
Hypersensitivity to trimetazidine.
Special Precautions
Appropriate dosage reduction may be necessary in patients with major kidney failure or severe liver failure.
Use in pregnancy: There is insufficient evidence to recommend the use of trimetazidine in pregnancy. Animal studies do not reveal any teratogenic effect.
Use in lactation: There is no information on the secretion of trimetazidine into breast milk. However, breastfeeding should be discontinued if the use of trimetazidine is considered essential.
Use in children: There is no experience with trimetazidine in children.
Use In Pregnancy & Lactation
Use in pregnancy: There is insufficient evidence to recommend the use of trimetazidine in pregnancy. Animal studies do not reveal any teratogenic effect.
Use in lactation: There is no information on the secretion of trimetazidine into breast milk. However, breastfeeding should be discontinued if the use of trimetazidine is considered essential.
Side Effects
The most commonly encountered side effects are gastric discomfort, nausea, headache and vertigo. However, the side effects are mild and nonspecific.
Drug Interactions
No drug interactions have been reported. In particular, no interactions have been reported between trimetazidine and β-blockers, calcium antagonists, nitrates, heparin, hypolipidaemic agents or digitalis preparation.
Storage
Carvidon: Store below 25°C, in a dry place.
Carvidon MR: Store in a cool, dry place.
MIMS Class
ATC Classification
C01EB15 - trimetazidine ; Belongs to the class of other cardiac preparations.
Presentation/Packing
Carvidon: Tab 20 mg x 10 x 10's.
Carvidon MR: Tab 35 mg (modified-release, film-coated) x 10 x 10's.
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