Trizedon OD Dosage & Drug Information

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Trimetazidine diHCl

Indications/Uses

Adjunctive to established antiangina.

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Dosage/Direction for Use

1 cap once daily. Elderly/patient w/ moderate renal impairment (CrCl 30-60 mL/min) Recommended dose: Reduce by ½ (1 tab of 35 mg) in the morning.

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Overdosage

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Administration

Should be taken with food: Take during breakfast.

Contraindications

Hypersensitivity. Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, & other related movement disorders. Severe renal impairment (CrCl <30 mL/min). Use in nursing mothers is generally inadvisable.

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Special Precautions

Should not be used as monotherapy. Benefit of the treatment should be assessed after 3 mth, & should be discontinued if there is no treatment response. This drug is not a curative treatment for angina attacks, nor is it indicated as an initial treatment for unstable angina or MI, nor in the pre-hospital phase or during the 1st day of hospitalization. In the event of an angina attack, the coronaropathy should be reevaluated & an adaptation of the treatment considered. Trimetazidine can cause or worsen parkinsonian symptoms (tremor, akinesia, hypertonia), which should be regularly investigated, especially in elderly patients. Falls may occur, related to gait instability or hypotension, in particular in patients taking antihypertensive treatment. This medicine contains an active substance which may give a +ve reaction in doping test in athletes.

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Use In Pregnancy & Lactation

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Adverse Reactions

Dizziness, headache, abdominal pain, diarrhoea, dyspepsia, nausea, vomiting, rash, pruritus, urticaria, asthenia. Palpitations, extrasystoles, tachycardia, arterial hypotension, orthostatic hypotension that may be associated w/ malaise, dizziness, or a fall, in particular in patients taking antihypertensive treatment, flushing. Parkinsonian symptoms (tremor, akinesia, hypertonia), gait instability, restless leg syndrome, other related movement disorders, usually reversible after treatment discontinuation, sleep disorders (insomnia, drowsiness), vertigo, constipation, AGEP (acute generalized exanthematous pustulosis), angioedema, agranulocytosis, thrombocytopenia, thrombocytopenic purpura, hepatitis.

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Storage

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Description

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Action

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MIMS Class

Anti-Anginal Drugs

ATC Classification

C01EB15 - trimetazidine ; Belongs to the class of other cardiac preparations.

Regulatory Classification

Presentation/Packing

Form

Trizedon OD PR cap 80 mg

Packing/Price

30's (Rp215,700/pak)

Trizedon OD

trimetazidine

Manufacturer:

Servier