Vastarel Mr Servier treats angina (2 blisters x 30 tablets)

Dosage form Box of 2 blisters x 30 tablets
Specifications Trimetazidine dihydrochloride

Ingredient

Composition information	Content
Trimetazidine dihydrochloride	35mg

Uses

Indications

Vastarel MR is indicated for adults in supplementary therapy/support for existing treatments to treat symptoms in stable angina patients with adequate control or non -tolerated patients with other angina treatment therapy.

Pharmacokology

By conserving metabolic energy in cells deficient in oxygen or anemia, trimetazidin prevents the reduction of intracellular ATP levels, thus ensuring the reasonable function of ionic pump and na/k channel piercing while maintaining cellular balance of cell tissue.

trimetazidin inhibits oxidation of fatty acids by inhibiting 3-ketoacyl-coa thiolase enzymes, promoting glucose oxidation.

In ischemic cells, energy obtained during oxidation of glucose requires less oxygen consumption than β-oxidation. Glucose oxidation will help optimize cell energy processes, thus maintaining appropriate energy metabolism during anemia.

In patients with ischemic anemia, trimetazidine acts as a metabolite, which helps conserve high intra -intra -intra -intra -intra -intra -intracellular energy levels in myocardial cell. Trimetazidin has anti -anemia effect but does not affect hemodynamics.

pharmacokinetics

absorption: After drinking, the maximum concentration reaches the average after 5 hours. After 24 hours of plasma concentration is still on or equivalent to 75% of the maximum concentration in 11 hours. Stable state reached the latest after about 60 hours. Pharmacokinetic characteristics of Vastarel MR are not affected by food.

Distribution: The distribution volume is 4.8L/kg, mounted low plasma proteins, measuring in vitro for 16%.

Elimination: Trimetazidin is excreted mainly through urine, in the form of air. Vastarel MR's exhaust time is 7 hours in young volunteers and 12 hours in people over 65 years old. The total clearance of trimetazidin is largely through the kidneys, directly related to creatinine clearance, at less than the liver purification, the purification of the liver decreases with age.

Elderly patients may have an increase in trimetazidine concentration due to age -related renal function. Trimetazidine concentration increased by an average of 1.7 times in patients with average renal impairment and about 3.1 times in patients with severe renal impairment.

Before taking Vastarel Mr Servier treats angina (2 blisters x 30 tablets)

How to use

Take oral use. Two times a day, that is, once in the morning and once in the evening, at meals.

Dosage

Adults:

Dosage is a trimetazidin 35mg at a time, twice a day, that is, once in the morning and once in the evening, at a meal. The effectiveness of treatment should be evaluated after 3 months and trimetazidine should be stopped if there is no response to treatment.

Patients with renal impairment: In patients with average renal impairment (the clearinine clearance of 30 - 60 ml/ minute), the recommended dose is a 35 mg tablet in the morning, taken for breakfast.

Elderly patients: In elderly patients, trimetazidine levels may increase due to age -related renal function. The dose adjustment in elderly patients should be conducted cautious.

Children: The safety and effectiveness of trimetazidin in children under 18 have not been established.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose? The management should be related to the treatment of symptoms.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Vastarel MR, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Neurological: dizziness, headache;

digestive: abdominal pain, diarrhea, indigestion, nausea, vomiting; skin: rash, itching, hives, pustules.

Rare, 1/10,000

Cardiovascular: Brushing chest drums, extra -syllable, tachycardia, hypotension.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindications:

Vastarel MR is contraindicated in the following cases:

Sensitive to trimetazidin or any excipients.

Parkinson, Run.

vacuum syndrome and other relevant movement disorders.

Severe renal failure (Creatinine clearance

Caution when using

The product is not a cure for angina, nor is it prescribed as the first treatment for unstable angina or myocardial infarction as well as the time before admission or on the first hospital.

When there is angina, coronary artery disease should be re -evaluated and considered response treatment.

Trimetazidin can cause or worsen Parkinson's symptoms (tremor, exercise, muscle tone), so these symptoms need to be evaluated regularly, especially in elderly patients. In suspicious cases, patients should consult a neurologist for an appropriate assessment.

When movement disorders such as Parkinson symptoms, vacuum syndrome, tremor, unstable posture, need to stop using trimetazidin.

These cases have low rates and often recover after stopping treatment. Most patients will recover within 4 months after stopping trimetazidine treatment. If Parkinson's symptoms still exist for more than 4 months after stopping the drug, it is advisable to consult a neurologist.

Falls can occur, related to unstable or hypotension, especially in patients who are being treated with anti -blood pressure drugs.

Be cautious when prescribing trimetazidin in patients with the ability to increase trimetazidine levels: Average renal failure, patients older than 75.

The ability to drive and operate machinery

trimetazidin does not show hemodynamic effects in clinical studies, but cases of dizziness and dreams have been observed when the drug is circulated on the market, these cases can affect the ability to drive and operate machinery.

Pregnancy

There is no data on the use of trimetazidin in pregnant women. Animal studies show that direct and indirect effects related to reproductive toxicity. Vastarel should be avoided during pregnancy.

The period of breastfeeding

It is unclear whether trimetazidin/ metabolites are excreted through breast milk. The risk of newborn/ newborns is not excluded. Therefore, Vastarel should not be used during breastfeeding.

Drug interaction

no interaction has been reported.

Storage

less than 300C.

Other drugs

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