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RXDRUG-DRP-7136

Whilst Trimetazidine Hydrochloride 35mg Modified-Release Tablet 30's

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Description

Indications/Uses

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.
 

Dosage/Direction for Use

1 tablet at meal times in the morning and evening.
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 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 1 tablet of 35 mg 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.
 

Administration

Should be taken with food.
 

Contraindications

Trimetazidine is contraindicated in-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 <30 ml/min).
 

Special Precautions

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 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.
Use in 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.
Use in Lactation: This medicinal product is generally not recommended during lactation.
In the absence of data, breastfeeding is not recommended during treatment.
 

Use In Pregnancy & Lactation

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.
 

Adverse Reactions

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

Storage

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

Action

Trimetazidine HCl (Whilst) 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.
 

MedsGo Class

Anti-Anginal Drugs

Features

Dosage
35 mg
Ingredients
  • Trimetazidine
Packaging
Modified-Release Tablet 30's
Generic Name
Trimetazidine Hydrochloride
Registration Number
DRP-7136
Classification
Prescription Drug (RX)
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