Vastec 20

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Barcode: 8935206008067
Description

VASTEC

COMPOSITION:

Trimetazidine dihydrochloride................................ 20 mg

Excipients q.s ..................................................... 1 tablet

(Lactose, avicel, PVP K30, stearic acid, aerosil, sepifilm, HPMC, PEG 6000, talc, titanium dioxide, ponceau lake color).

DOSAGE FORM: Film coated tablets.

PRESENTATION: Box of 2 blisters x 30 film coated tablets.

PHARMACODYNAMICS:

Mechanism of action: Trimetazidine inhibits beta oxidation of fatty acids by blocking long-chain 3-ketoacyl-CoA thiolase.  In an ischaemic cell, energy obtained during glucose oxidation requires less oxygen consumption than in the beta-oxidation process. Potentiation of glucose oxidation optimizes cellular energy processes, thereby maintaining proper energy metabolism during ischaemia.

Pharmacodynamic effects: In patients with ischaemic heart disease, trimetazidine acts as a metabolic agent, preserving the myocardial high-energy phosphate intracellular levels. Anti-ischemic effects are achieved without concomitant haemodynamic effects.

PHARMACOKINETICS:

Absorption is rapid, with a plasma peak time at prior 2 hrs after administration and balanced state at 24 to 36 hrs after repeating a dose and stabilizing highly during the treatment. The elimination half-life of trimetazidine is 6 hrs. Elimination of trimetazidine is principally urinary as unchanged.

INDICATIONS:

Trimetazidine is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies.

CONTRAINDICATIONS:

- Hypersensitivity to the active ingredient or to any of the excipients listed in the composition.

- Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.

- Severe renal impairment (creatinine clearance < 30ml/ min).

SPECIAL WARNINGS AND PRECAUTIONS FOR USE:

Trimetazidine can cause or worsen parkinsonian symptoms (tremor, akinesia, hypertonia), which should be regularly investigated, especially in elderly patients. In doubtful cases, patients should be referred to a neurologist for appropriate investigations. The occurrence of movement disorders such as parkinsonian symptoms, restless leg syndrome, tremors, gait instability should lead to definitive withdrawal of trimetazidine. These cases have a low incidence and are usually reversible after treatment discontinuation. The majority of the patients recovered within 4 months after trimetazidine withdrawal. If parkinsonian symptoms persist more than 4 months after drug discontinuation, a neurologist opinion should be sought. Falls may occur, related to gait instability or hypotension, in particular in patients taking antihypertensive treatment (see Adverse effects).

Caution should be exercised when prescribing trimetazidine to patients in whom an increased exposure is expected (see Dosage and administration):

- Patients with moderate renal impairment.

- Elderly patients older than 75 years old.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

Trimetazidine may cause dizziness and drowsiness, which may affect ability to drive and use machine.

PREGNANCY AND LACTATION:

Clinical studies have not proved the safety of trimetazidine; so, Vastec should not be administered to these subjects.

INTERACTIONS:

No drug interactions have been identified. However, concomitant administration of Vastec and other drugs should be monitored.

ADVERSE EFFECTS:

Inform your physician about any adverse effects occur during the treatment.

OVERDOSAGE:

No documents have been reported.

DOSAGE & ADMINISTRATION:

The dose should be one tablet of 20 mg three times a day during meals.

Special populations:

Patients with renal impairment: In patients with moderate renal impairment (creatinine clearance [30-60] ml/ min), the recommended dose is 1 tablet of 20 mg twice daily, i.e., one in the morning and one in the evening during meals. (See more in Contraindications, Warnings and Cautions)

Elderly patients: Elderly patients may have increased trimetadizine exposure due to age-related decrease in renal function.

In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 20 mg twice daily in the morning and evening during meals.

Dose titration in elderly patients should be exercised with caution. (See more in Contraindications, Warnings and Cautions)

Paediatric population: The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available.

Or as prescribed by the physician.

Read the directions carefully before use.                   

Consult the physician for more information.                       

This drug is for prescriptions only.

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

Specifications: Manufacturer's.

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