vastarel 35mg medicine >> Generic drug of the therapeutic class:Cardiology and angiology
active ingredients: Trimetazidine
This drug is recommended in adults in combination with other medicines to treat angina (chest pain due to coronary artery disease).
What is the use of Vastarel and indication?
Trimetazidine is indicated in combination for the symptomatic treatment of adult patients with stable angina pectoris (angina) who are insufficiently controlled or who are intolerant to first-line anti-anginal therapy.
vastarel 35 mg dosage
One tablet of trimetazidine 35 mg twice a day at mealtimes
The benefit of the treatment should be reassessed after three months and trimetazidine should be stopped in the absence of response
Special populations
Renal insufficiency
- The recommended dosage in patients with moderate renal impairment (creatinine clearance [30 – 60ml / min]) (see sections Warnings and Precautions and Pharmacokinetic Properties ), is one tablet of 35 mg on morning at breakfast.
Elderly
- An increase in trimetazidine exposure due to age-related renal impairment (see section 5.2 ) may occur in elderly subjects. In patients with moderate renal impairment (creatinine clearance [30-60ml / min]), the recommended dose is one 35mg tablet in the morning at breakfast.
- In elderly patients, dose adjustment should be performed with caution (see Warnings and Precautions).
Pediatric population
- The safety and efficacy of trimetazidine have not been established in children under 18 years of age. No data available
how does vastarel work
Orally, the maximum concentration is observed on average 5 hours after taking the tablet.
Over 24 hours, the plasma concentration is maintained at concentrations greater than or equal to 75% of the maximum concentration for 11 hours.
The steady state is reached at the latest at the 60th hour.
The pharmacokinetics of VASTAREL 35 mg are not influenced by the meal.
The apparent volume of distribution is 4.8 l / kg; the protein binding of trimetazidine is low: its value measured in vitro is 16%.
The elimination of trimetazidine is primarily through the urinary tract essentially as unchanged product.
The elimination half-life of VASTAREL 35 mg is 7 hours on average in healthy young volunteers, 12 hours in subjects over 65 years of age.
The total clearance of trimetazidine is the result of a predominant renal clearance directly correlated with creatinine clearance and, to a lesser extent, hepatic clearance that decreases with age.
A specific clinical study conducted in an elderly population, at a dosage of 2 tablets per day in 2 doses, analyzed by a population kinetics approach, showed an increase in plasma exposure
vastarel 35 mg side effects
For adverse effects associated with the use of trimetazidine,.
The table below includes adverse reactions from spontaneous reports and scientific literature.
Very common (≥1 / 10) frequent (≥1 / 100, <1/10); uncommon (≥1 / 1000, <1/100); rare (≥1 / 10,000, <1/1000); very rare (<1 / 10,000), not known (can not be calculated from available data).
|
System – organ – class |
Frequency |
Side effects |
|
Nervous system disorders |
Frequent |
Dizziness, headache |
|
indeterminate |
Parkinsonian symptoms (tremor, akinesia, hypertonia), postural instability, restless legs syndrome, other related motor abnormalities, usually reversible upon discontinuation of treatment Sleep disorders (insomnia, drowsiness) |
|
|
Affections of the ear and labyrinth |
indeterminate |
Fear of heights |
|
Heart conditions |
Rare |
Palpitations, extrasystoles, tachycardia |
|
Vascular disorders |
Rare |
Hypotension, orthostatic hypotension may be associated with malaise, dizziness or falling, especially in patients receiving antihypertensive therapy, flushing |
|
Gastrointestinal disorders |
Frequent |
Abdominal pain, diarrhea, dyspepsia, nausea and vomiting |
|
indeterminate |
Constipation |
|
|
Skin and subcutaneous tissue disorders |
Frequent |
Rash, pruritus, urticaria |
|
indeterminate |
PEAG (generalized acute exanthematous pustulosis), angioedema |
|
|
General disorders and administration site conditions |
Frequent |
Asthenia |
|
Blood and lymphatic system disorders |
indeterminate |
Agranulocytosis Thrombocytopenia Thrombocytopenic purpura |
|
Hepatobiliary disorders |
indeterminate |
Hepatitis |
vastarel drug interactions
Vastarel Warnings and Precautions
This medication is not a cure for the angina attack, nor is it indicated as an initial treatment for unstable angina, or myocardial infarction, either in the pre-hospital phase or during the first days of hospitalization.
In the event of an angina attack, a reassessment of the coronary artery disease is necessary, and an adaptation of the treatment must be discussed (drug treatment and possibly revascularisation).
Trimetazidine may induce or aggravate parkinsonian symptoms (tremor, akinesia, hypertonia), which should be regularly sought, especially in the elderly. If in doubt, patients should be referred to a neurologist for appropriate examinations.
The occurrence of movement disorders such as parkinsonian symptoms, restless leg syndrome, tremors, postural instability, should lead to the definitive cessation of trimetazidine.
The incidence of these cases is low and they are usually reversible upon discontinuation of treatment. The majority of patients recover within 4 months after stopping trimetazidine. If parkinsonian symptoms persist more than 4 months after stopping treatment, seek the advice of a neurologist.
Falls may occur as a result of postural instability or hypotension, particularly in patients on antihypertensive therapy .
Trimetazidine should be prescribed with caution in patients for whom an increase in exposure is expected:
- Moderate renal impairment (see sections Dosage and Administration and Pharmacokinetics )
- Subjects over 75 years of age.
This medicine is generally not recommended during breastfeeding (see section Pregnancy and breastfeeding ).
Drive and use machines
Vastarel and PREGNANCY / BREAST FEEDING / FERTILITY
vastarel in pregnancy
vastarel in Breastfeeding
vastarel in Fertility
Reprotoxicity studies did not show an effect on the fertility of male and female rats ( see Preclinical Safety ).
Tell your doctor.
What is Forms and Composition Vastarel?
| FORMS and PRESENTATIONS |
- Release-modified film-coated tablet (pink): Box of 60, under blister packs.
Hospital model: Box of 100.
| COMPOSITION |
| p cp | |
| Trimetazidine (INN) dihydrochloride | 35 mg |
- Excipients: calcium hydrogen phosphate dihydrate, hypromellose, povidone, anhydrous colloidal silica, magnesium stearate.
- Film coating: titanium dioxide (E 171), glycerol, hypromellose, macrogol 6000, red iron oxide (E 172), magnesium stearate.
NOT’s
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general information:
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Additional information:
- General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
- For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
- It treats possible side effects and drug interactions that require attention and its effect on continuous use.
- The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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