vastarel 35mg Drug (Trimetazidine) Uses,Dosage, Side Effects & Warnings

What is the use of Vastarel
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vastarel 35mg medicine >> Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Trimetazidine

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

No drug interactions have been identified.

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

There are no data on the use of trimetazidine in pregnant women. Studies in animals have not shown any direct or indirect harmful effects on reproduction ( see Preclinical safety ).
As a precaution, it is best to avoid the use of Vastarel during pregnancy.

vastarel in Breastfeeding

It is not known whether trimetazidine / metabolites are excreted in breast milk.
A risk for newborns / infants can not be ruled out. Vastarel should not be used while breastfeeding.

vastarel in Fertility

Reprotoxicity studies did not show an effect on the fertility of male and female rats ( see Preclinical Safety ).

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) dihydrochloride35 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:

  • Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

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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