ANGIREL MR Trimetazidine Hydrochloride 35mg Modified-Release Tablet 1's
RXDRUG-DR-XY45017-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Trimetazidine hydrochloride (ANGIREL MR) 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.
Dosage/Direction for Use
Oral: Usual adult dose: The dose is one tablet of 35 mg of Trimetazidine hydrochloride (ANGIREL MR) twice daily during meals.
Special populations: Patients with renal impairment: In patient with moderate renal impairment (creatinine clearance [30-60] mL/min), the recommended dose is 1 tablet of 35 mg in the morning during breakfast.
Elderly patients: Elderly patients may have increased Trimetazidine hydrochloride (ANGIREL MR) 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 hydrochloride (ANGIREL MR) in children aged below 18 years have not been established. No data are available.
Special populations: Patients with renal impairment: In patient with moderate renal impairment (creatinine clearance [30-60] mL/min), the recommended dose is 1 tablet of 35 mg in the morning during breakfast.
Elderly patients: Elderly patients may have increased Trimetazidine hydrochloride (ANGIREL MR) 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 hydrochloride (ANGIREL MR) in children aged below 18 years have not been established. No data are available.
Overdosage
Consult a doctor or a pharmacist immediately.
Administration
Should be taken with food: Patient w/ renal impairment: Take during breakfast.
Contraindications
Hypersensitivity to the active substance or to any excipients.
Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
Severe renal impairment (creatinine clearance <30 mL/min).
Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
Severe renal impairment (creatinine clearance <30 mL/min).
Special Precautions
Trimetazidine hydrochloride (ANGIREL MR) 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 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 hydrochloride (ANGIREL MR) 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 hydrochloride (ANGIREL MR) to patients in whom an increased exposure is expected: moderate renal impairment, elderly patients older than 75 years old.
Effects on ability to drive and use machines: Trimetazidine hydrochloride (ANGIREL MR) does not have hemodynamic effects in clinical studies, however cases of dizziness and drowsiness have been observed in post-marketing experience, which may affect ability to drive and use machines.
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 hydrochloride (ANGIREL MR) 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 hydrochloride (ANGIREL MR) to patients in whom an increased exposure is expected: moderate renal impairment, elderly patients older than 75 years old.
Effects on ability to drive and use machines: Trimetazidine hydrochloride (ANGIREL MR) does not have hemodynamic effects in clinical studies, however cases of dizziness and drowsiness have been observed in post-marketing experience, which may affect ability to drive and use machines.
Use In Pregnancy & Lactation
ANGIREL MR is generally not recommended during breast feeding.
Adverse Reactions
Dizziness, headache, abdominal pain, diarrhea, dyspepsia, nausea & vomiting, rash, pruritus, urticaria, asthenia.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Mechanism of Action: Trimetazidine hydrochloride (ANGIREL MR) inhibits beta oxidation of fatty acids by blocking long-chain 3-ketoacyl-CoA thiolase. which enhances glucose oxidation. In ischemic 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 ischemia.
Pharmacodynamic effects: In patients with ischemic heart disease, Trimetazidine hydrochloride (ANGIREL MR) acts as a metabolic agent, preserving myocardial high-energy phosphate intracellular levels. Anti-ischemic effects are achieved without concomitant hemodynamic effects.
Clinical efficacy and safety: Clinical studies have demonstrated the efficacy and safety of Trimetazidine hydrochloride (ANGIREL MR) in the treatment of patients with chronic angina, either alone or when the benefit from the other antianginal medicinal products was insufficient.
Pharmacodynamic effects: In patients with ischemic heart disease, Trimetazidine hydrochloride (ANGIREL MR) acts as a metabolic agent, preserving myocardial high-energy phosphate intracellular levels. Anti-ischemic effects are achieved without concomitant hemodynamic effects.
Clinical efficacy and safety: Clinical studies have demonstrated the efficacy and safety of Trimetazidine hydrochloride (ANGIREL MR) in the treatment of patients with chronic angina, either alone or when the benefit from the other antianginal medicinal products was insufficient.
MedsGo Class
Anti-Anginal Drugs
Features
Brand
Angirel MR
Full Details
Dosage Strength
35mg
Drug Ingredients
- Trimetazidine
Drug Packaging
Modified-Release Tablet 1's
Generic Name
Trimetazidine Hydrochloride
Dosage Form
Modified-Release Tablet
Registration Number
DR-XY45017
Drug Classification
Prescription Drug (RX)
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