Tazicon

Each modified release tablet contains Trimetazidine Hydrochloride BP 35mg.

Pharmacology: Trimetazidine HCl (Tazicon) has been proven to exert anti-anginal properties due to its specific metabolic mechanism of action. Indeed, Trimetazidine Hydrochloride reduces the metabolic damage caused during ischemia, by acting on a critical step in cardiac metabolism: fatty acid B-oxidation. This is made possible by selective inhibition of an enzyme of fatty acid B-oxidation: the long-chain 3-ketoacyl CoA thiolase (3-KAT). This inhibition results in reduction in fatty acid oxidation & stimulation of glucose oxidation. Thus, the coupling of glycolysis with glucose oxidation is improved, and ATP production is further increased, while the deleterious consequences of acidosis and of Ca²⁺ overload are limited.
Pharmacodynamics: 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: Trimetazidine after oral administration and absorption from the digestive tract reaches the maximum concentration in the serum after about 5 hours from administration of the drug. The steady concentration of the drug in the serum is reached after 60 hours and is stable throughout the period of treatment. No interactions with food stuffs have been found.
Distribution: The drug binds to plasma proteins at about 16%. The volume of distribution is 4.8 l/kg, which means good penetration of the drug into the tissues.
Elimination: Trimetazidine is eliminated mainly in the urine, in unchanged form. The average half-life is 7 hours, in patients over age 65 years it increases to 12 hours.
Pharmacokinetics in special populations: No pharmacokinetic data are available for the use of trimetazidine in hepatically impaired patients.

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 anti-anginal therapies.

1 tablet at meal times in the morning and evening.
Special populations: Patents with renal impairment: In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 35mg in the morning during breakfast.
Elderly patients: Elderly patients may have increased Trimetazidine 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 l tablet of 35mg in the morning during breakfast. Dose titration in elderly patients should be exercised with caution.
Pediatric population: The safety and efficacy of Trimetazidine in children aged below 18 years have not been established. No data are available.

If one or several doses have been missed, resume treatment normally. Do not take double dose to compensate for the missed dose.
If the patient takes more than the prescribed dose, report to the doctor or pharmacist immediately.

Trimetazidine is contraindicated with: Patients with a known hypersensitivity to its components; Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders; Severe renal impairment (creatinine clearance < 30ml/min).

This medicinal product is generally not recommended during lactation.
This medicine is not a curative treatment for angina attacks, nor is it indicated as an initial treatment for unstable angina or myocardial infarction, nor in the pre-hospital phase or during the first days of hospitalization.
In the event of an angina attack, the coronaropathy should be reevaluated and an adaptation of the treatment considered (medicinal treatment and possibly revascularization).
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, and instability should lead to definitive withdrawal of Trimetazidine.
These cases have a low prevalence 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.
Caution should be exercised when prescribing Trimetazidine to patients in whom an increase exposure is expected: Moderate renal impairment; Elderly patients older than 75 years old.

Pregnancy: Studies in animals have not demonstrated a teratogenic effect. However, in the absence of clinical data and for safety reasons, prescription should be avoided during pregnancy.
Breastfeeding: In the absence of data, breastfeeding is not recommended during treatment.

Common adverse effects include dizziness, headache, gastrointestinal disorders such as abdominal pain, diarrhea, dyspepsia, nausea and vomiting, rashes, pruritus, urticaria, and asthenia.

No Drug interactions so far have been reported. In particular, no interactions have been reported with beta-blocker, calcium antagonists, nitrates, heparin, hypolipidemic agents or digitalis preparation.

Store at temperatures not exceeding 30° C. Protect from light.

Anti-Anginal Drugs

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

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