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Preductal od 80mg 60 pcs. extended-release capsules laboratory servier

pharmachologic effect

Antiangial agent.

Composition and release form Preductal od 80 mg 60 pcs. extended-release capsules laboratory servier

Capsules - 1 capsule:

Active ingredient: trimetazidine dihydrochloride - 80.00 mg;
Excipients: sugar spheres (sucrose, corn starch) (710-850 microns), hypromellose;
film coating: ethylcellulose, tributylacetyl citrate, talc; mixture for dusting granules: talc, magnesium stearate;
Capsule body: titanium dioxide (E 171), gelatin; capsule cover: titanium dioxide (E 171), red iron oxide (E 172), gelatin;
Ink: Shellac, Titanium dioxide, Simethicone, Propylene glycol, Ammonium hydroxide.

10 capsules per blister made of cold-formed foil (PA/Al/PVC) and printed varnished aluminum foil. 3 or 6 blisters with instructions for medical use in a cardboard pack.

9 capsules per blister made of cold-formed foil (PA/Al/PVC) and printed varnished aluminum foil. 3 blisters with instructions for medical use per cardboard pack.

Description of the dosage form

Hard gelatin capsules No. 2 with a white body and an orange-red cap. The lid has a white logo printed on it. Capsule contents: spherical granules of white or almost white color.

Directions for use and doses

Orally, 1 capsule 1 time per day, in the morning, during breakfast.

Capsules should be taken whole, without chewing, with water.

The benefit of treatment can be assessed after three months of taking the drug. Taking the drug Preductal® OD should be stopped if no improvement has occurred during this time.

The duration of treatment is determined by the doctor.

Special groups

Patients with impaired renal function

In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), a dose reduction is recommended, i.e. 1 tablet containing 35 mg trimetazidine per day.

Patients with liver dysfunction

Caution should be exercised when treating patients with severe hepatic impairment due to the fact that the available data are limited and cannot completely exclude the absence of an influence of impaired liver function on the metabolism of trimetazidine.

Elderly patients

Elderly patients may experience increased trimetazidine exposure due to age-related decline in renal function. In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), a dose reduction is recommended, i.e. 1 tablet containing 35 mg trimetazidine per day.

Dose selection in patients over 75 years of age should be done with caution.

Patients under 18 years of age

The safety and effectiveness of trimetazidine in patients under 18 years of age have not been established. No data available.

Pharmacodynamics

Mechanism of action

Trimetazidine prevents a decrease in intracellular adenosine triphosphate (ATP) concentration by maintaining the energy metabolism of cells in a state of hypoxia. Thus, the drug ensures the normal functioning of membrane ion channels, transmembrane transport of potassium and sodium ions and the preservation of cellular homeostasis.

Trimetazidine inhibits the oxidation of fatty acids due to the selective inhibition of the enzyme 3-ketoacyl-CoA thiolase (3-CAT) of the mitochondrial long-chain isoform of fatty acids, which leads to increased oxidation of glucose and acceleration of glycolysis with oxidation of glucose, which determines the protection of the myocardium from ischemia. The switch of energy metabolism from fatty acid oxidation to glucose oxidation underlies the pharmacological properties of trimetazidine.

Pharmacodynamic properties:

supports energy metabolism of the heart and neurosensory tissues during ischemia;
reduces the severity of intracellular acidosis and changes in transmembrane ion flow that occur during ischemia;
reduces the level of migration and infiltration of polynuclear neutrophils in ischemic and reperfused heart tissues;
reduces the size of myocardial damage;
does not have a direct effect on hemodynamic parameters.

In patients with angina, trimetazidine:

increases coronary reserve, thereby slowing down the onset of ischemia caused by physical activity, starting from the 15th day of therapy;
limits exercise-induced blood pressure fluctuations without significant changes in heart rate;
significantly reduces the frequency of angina attacks and the need for short-acting nitroglycerin;
improves contractile function of the left ventricle in patients with ischemic dysfunction.

The results of clinical studies have confirmed the effectiveness and safety of trimetazidine in patients with stable angina, both in monotherapy and as part of combination therapy when the effect of other antianginal drugs is insufficient.

In a study of 426 patients with stable angina, the addition of trimetazidine (60 mg/day) to metoprolol 100 mg/day (50 mg twice daily) for 12 weeks statistically significantly improved exercise test scores and clinical symptoms compared with placebo: total duration of exercise tests, total exercise time, time to 1 mm ST segment depression, time to angina attack, number of angina attacks per week, and short-acting nitrate intake per week, without hemodynamic changes.

In a study of 223 patients with stable angina, adding trimetazidine 35 mg twice daily to atenolol 50 mg once daily for 8 weeks increased the time to development of ischemic ST segment depression by 1 mm during exercise tests in a subgroup of patients compared with placebo. A significant difference was also shown for the time of development of angina attacks. There were no significant differences between groups for other secondary endpoints (total exercise test duration, total exercise time, and clinical endpoints).

In a study of 1962 patients with stable angina, trimetazidine (70 mg/day and 140 mg/day) was added to atenolol 50 mg/day compared with placebo. In the general population, including both asymptomatic and symptomatic patients with angina, trimetazidine did not demonstrate benefit on ergometric and clinical endpoints. However, in a retrospective analysis of a subgroup of patients with symptomatic angina, trimetazidine (140 mg) significantly improved total exercise test time and time to onset of angina.

Pharmacokinetics

Absorption

After oral administration of the Preductal® OD capsule, trimetazidine has a linear pharmacokinetic profile and reaches maximum plasma concentration approximately 14 hours after administration. In the intervals between doses of the drug (i.e., within 24 hours), the concentration of trimetazidine in the blood plasma for 15 hours after taking the drug remains at a level of at least 75% of the maximum concentration.

An equilibrium state is achieved after taking the 3rd dose (after 3 days). Food intake does not affect the bioavailability of trimetazidine when taking the drug Preductal® OD 80 mg.

Distribution

The volume of distribution is 4.8 l/kg, which indicates good distribution of trimetazidine in tissues (the degree of binding to plasma proteins is quite low, about 16% in vitro).

Removal

Trimetazidine is excreted mainly by the kidneys, mainly unchanged. The half-life in young healthy volunteers is about 7 hours, in patients over 65 years of age - about 12 hours.

Renal clearance of trimetazidine directly correlates with creatinine clearance (CC), hepatic clearance decreases with patient age.

Special groups

Elderly patients

A special clinical study conducted in a population of elderly patients using a dose of trimetazidine MB 35 mg, 2 tablets per day (in 2 divided doses), showed an increase in plasma levels of the drug according to population pharmacokinetic analysis.

Elderly patients may experience increased trimetazidine exposure due to age-related decline in renal function. A special pharmacokinetic study involving elderly patients (75-84 years) or very elderly (> 85 years) patients showed that moderate renal impairment (creatinine clearance 30-60 ml/min) increased trimetazidine exposure by 1.0 and 1.3 times, respectively, compared with younger patients (30-65 years) with moderate renal impairment.

Patients with impaired renal function

Trimetazidine exposure was increased on average by 1.7 times in patients with moderate renal impairment (creatinine clearance 30-60 ml/min), and on average by 3.1 times in patients with severe renal failure (creatinine clearance below 30 ml/min ) compared to healthy volunteers with normal kidney function.

No significant safety differences were observed in this patient population compared with the general population.

Use in children and adolescents

The pharmacokinetics of trimetazidine in children and adolescents under 18 years of age have not been studied.

Indications for use Preductal od 80 mg 60 pcs. extended-release capsules laboratory servier

Long-term therapy of coronary heart disease: prevention of attacks of stable angina as part of mono- or combination therapy.

Contraindications

Hypersensitivity to the active substance or any of the excipients included in the drug.

Parkinson's disease, parkinsonian symptoms, tremors, restless legs syndrome and other related movement disorders.

Severe renal failure (creatinine clearance below 30 ml/min).

Fructose/sucrose intolerance, the presence of glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency and other enzymopathies associated with intolerance to sucrose, which is part of the drug.

Due to the lack of sufficient clinical data, prescribing the drug is not recommended for patients under 18 years of age.

Pregnancy and breastfeeding period.

Carefully:

Patients with severe liver failure (from 10 to 15 points on the Child-Pugh scale).

Patients with moderate renal impairment (creatinine clearance 30-60 ml/min).

Patients over 75 years of age.

Application Preductal od 80 mg 60 pcs. extended-release capsules laboratory servier during pregnancy and lactation

Pregnancy

There are no data on the use of trimetazidine in pregnant women. Animal studies have not revealed any direct or indirect negative effects on reproductive function.

The use of the drug Preductal® OD during pregnancy is contraindicated.

Breastfeeding period

There are no data on the excretion of trimetazidine or its metabolites into breast milk. Risk to the newborn/child cannot be excluded. If necessary

When using the drug Preductal® OD during lactation, breastfeeding should be stopped.

Fertility

Reproductive toxicity studies did not reveal any effect of the drug on male or female rats.

special instructions

The drug Preductal® OD is not intended for the relief of angina attacks and is not indicated for the initial course of treatment of unstable angina or myocardial infarction in the prehospital stage or in the first days of hospitalization.

In the event of an attack of angina, the degree of damage to the coronary arteries should be re-evaluated and, if necessary, treatment should be adapted (drug therapy or a possible revascularization procedure). Trimetazidine may cause or worsen symptoms of parkinsonism (tremor, akinesia, increased tone), so patients should be regularly monitored, especially the elderly. In doubtful cases, patients should be referred to a neurologist for appropriate examination.

If movement disorders appear, such as symptoms of parkinsonism, restless legs syndrome, tremor, gait instability, trimetazidine should be permanently discontinued.

Such cases are rare and symptoms usually resolve after discontinuation of therapy: in most patients, within 4 months after discontinuation of trimetazidine. If symptoms of parkinsonism persist more than 4 months after discontinuation of the drug, you should consult a neurologist. Falls associated with gait instability or hypotension may occur, especially in patients taking antihypertensive drugs.

Trimetazidine should be prescribed with caution to patients who may have increased exposure:

In cases of moderate renal dysfunction.

In elderly patients over 75 years of age.

The drug contains sucrose, so the drug is not recommended for patients with fructose intolerance, glucose-galactose malabsorption syndrome and sucrase-isomaltase deficiency.

Impact on the ability to drive vehicles and operate machinery

Clinical studies did not reveal the effect of trimetazidine on hemodynamic parameters, however, during post-registration use, cases of dizziness and drowsiness were observed, which may affect the ability to drive vehicles and perform work that requires an increased speed of physical and mental reactions.

Overdose

There is only very limited information on trimetazidine overdose. In case of overdose, symptomatic therapy should be carried out.

Side effects Preductal od 80 mg 60 pcs. extended-release capsules laboratory servier

Adverse reactions, defined as adverse events that are at least possibly related to treatment with trimetazidine, are listed as follows: very often (≥1/10); often (≥1/100,

MedDRA Classes and Organ Systems	Adverse reactions	Frequency
Nervous system disorders	Dizziness	Often
	Headache	Often
	Symptoms of parkinsonism (tremor, akinesia, increased tone), gait instability, restless legs syndrome, other associated movement disorders, usually reversible after cessation of therapy	Unspecified frequency
	Sleep disorders (insomnia, drowsiness)	Unspecified frequency
Hearing and labyrinth disorders	Vertigo	Unspecified frequency
Heart disorders	Feeling of heartbeat	Rarely
	Extrasystole	Rarely
	Tachycardia	Rarely
Vascular disorders	Arterial hypotension, orthostatic hypotension, which may be accompanied by general malaise, dizziness or falling, especially when taking antihypertensive drugs simultaneously	Rarely
Vascular disorders	“Rushes” of blood to the skin of the face	Rarely
Gastrointestinal disorders	Abdominal pain	Often
	Diarrhea	Often
	Dyspepsia	Often
	Nausea	Often
	Vomit	Often
	Constipation	Unspecified frequency
Skin and subcutaneous tissue disorders	Skin rash	Often
	Itchy skin	Often
	Hives	Often
	Acute generalized exanthematous pustulosis (AGEP)	Unspecified frequency
	Angioedema	Unspecified frequency
General and administration site disorders	Asthenia	Often
Blood and lymphatic system disorders	Agranulocytosis	Unspecified frequency
	Thrombocytopenia	Unspecified frequency
	Thrombocytopenic purpura	Unspecified frequency
Disorders of the liver and biliary tract	Hepatitis	Unspecified frequency

Drug interactions

There were no interactions with other drugs.

Side effects

When taking Preductal, various undesirable reactions may develop that affect the functioning of the digestive, nervous, cardiovascular, circulatory, lymphatic and other systems.

This manifests itself as: abdominal pain, diarrhea , nausea, vomiting, constipation , dyspepsia , dizziness , headaches , tachycardia , irregular heartbeat, and so on.

Possible side effects on the skin: rash, itching and urticaria .

Comparison of ease of use of Preductal MV and Preductal OD

This includes dose selection taking into account various conditions and frequency of doses. At the same time, it is important not to forget about the release form of the drug; it is also important to take it into account when making an assessment.

The ease of use of Preductal MV is approximately the same as Preductal OD. However, they are not convenient enough to use.

The drug ratings were compiled by experienced pharmacists who studied international research. The report is generated automatically.

Last update date: 2020-12-13 10:32:32

Use of the drug for alcoholism

Chronic dependence on alcoholic beverages causes hepatitis, liver failure, nephritis, glomerulonephritis. These conditions are contraindications for taking capsules. The active component increases the damage, and the organ gradually stops working.

People with alcoholism experience brain damage. Delusions, hallucinations, insomnia, neurological disorders, and delirium tremens develop. The condition is aggravated by the influence of the drug. It penetrates the central nervous system and causes extrapyramidal pathologies.

The therapeutic effect is eliminated, since the load on the cardiovascular system is high. Severe hypotension appears, causing fatigue, weakness, drowsiness, and loss of consciousness. Pressure changes lead to heart attack and angina.

Consequences of drinking alcohol

If you combine a substance with alcohol, the following consequences arise:

nausea, vomiting, heartburn, flatulence, constipation, diarrhea;
trembling of arms and legs, unsteady gait, insomnia, difficulty coordinating in space, headache;
increased heart rate, extrasystoles, hypotension;
increased bleeding of wounds due to a decrease in the number of platelets;
inflammation of the liver parenchyma, cirrhosis, liver failure;
kidney inflammation, worsening diuresis;
local allergies in the form of rash, itching, redness;
systemic allergies in the form of angioedema, urticaria, which is dangerous to health and life;
exhaustion of the body.

Serious consequences appear when a person drinks alcohol together with capsules. If the rule is violated once, dyspepsia and inflammation of internal organs will occur.

Contraindications

Taking Preductal is contraindicated if:

sensitivity to it;
Parkinson's disease , symptoms of parkinsonism , tremor , restless legs syndrome and other movement disorders;
severe renal failure ;
under 18 years of age;
lactation , pregnancy .

Caution is necessary when prescribing the drug to patients with severe or moderate hepatic and renal insufficiency.

special instructions

It has been established that Preductal is not designed to relieve attacks of angina, so it is not recommended for use for the treatment of unstable angina , as well as myocardial infarction at the initial stage or in the first days of hospitalization.

The fact is that Preductal often causes or intensifies symptoms of parkinsonism , for example, tremor , akinesia and increased tone. For this reason, regular monitoring of patients is required. If the treatment is in doubt, then an appropriate examination by a neurologist is necessary.

If movement disorders appear, for example: symptoms of parkinsonism , restless legs syndrome, tremors , instability and “wobbly” gait, you must immediately stop taking the pills. Such cases occur quite rarely and usually the symptoms disappear after discontinuation of the drug.

dizziness and drowsiness may occur . Therefore, during the treatment period, you should drive vehicles and perform work that requires quick reactions with the utmost caution.

Analogues of Preductal

Level 4 ATX code matches:
Vazonat

Phosphaden

Hawthorn fruit

Meldonium

Angiosil Retard

Ranexa

Lily of the valley tincture

Neocardil

Rimecore

Triductane

ATF-Long

Hawthorn tincture

Triductan MV

Trimectal MV

Trimectal

Neoton

Predisin

Trimetazidine

Tivortin Aspartate

Metamax

The drug Preductal and its analogues ATP-Long , Triductan , Kratal and Trimetazidine can only be sold with a prescription. Similar drugs are prescribed by a doctor, and you can choose a substitute only with a responsible approach.

The price of analogues may differ depending on the country and city, so it is better to find out the price of a specific medicine at the pharmacy.

Comparison of addiction between Preductal MV and Preductal OD

Like safety, addiction also involves many factors that must be considered when evaluating a drug.

So, the totality of the values of such parameters as “syndrome o” in Preductal MV is quite similar to the similar values in Preductal OD. Withdrawal syndrome is a pathological condition that occurs after the cessation of intake of addictive or dependent substances into the body. And resistance is understood as initial immunity to a drug; in this it differs from addiction, when immunity to a drug develops over a certain period of time. The presence of resistance can only be stated if an attempt has been made to increase the dose of the drug to the maximum possible. At the same time, Preductal MV has a fairly low “syndrome” value, just like Preductal OD.