Preductal OD caps 80mg #60

Instruction for Preductal OD

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Preductal OD is an antianginal drug.

Release form and composition

The drug is produced in the form of capsules with prolonged release: size No. 2, hard gelatinous, with a white body and an orange-red lid, the number “80” and the company logo are printed on the lid in white; the contents of the capsules are white or almost white spherical granules (in blisters: 9 pcs., in a cardboard box 3 blisters; 10 pcs., in a cardboard box 3 or 6 blisters; each pack also contains instructions for the use of Preductal OD 80 mg).
1 capsule contains:
    active substance: trimetazidine dihydrochloride - 80 mg (in the form of film-coated granules);
    auxiliary components: sugar spheres 710–850 microns in size (sucrose, corn starch, starch hydrolysis products, dyes), hypromellose;
    the composition of the film shell of the granules: ethyl cellulose, tributyl acetyl citrate, talc;
    composition for dusting granules: talc, magnesium stearate;
    composition of the capsule body: titanium dioxide (E171), gelatin;
    the composition of the capsule caps: gelatin, titanium dioxide (E171), iron oxide red (E172);
    ink composition: shellac, simethicone, propylene glycol, titanium dioxide, ammonium hydroxide.

Pharmacodynamics

Preductal OD is an antianginal drug that provides membrane ion channels with the maintenance of normal functioning, transmembrane transport of sodium and potassium ions, and maintenance of cellular homeostasis. The mechanism of action of the drug is due to the ability of trimetazidine to maintain the energy metabolism of cells in a state of hypoxia and, thus, to prevent a decrease in the intracellular concentration of adenosine triphosphate (ATP).
The pharmacological properties of the drug are based on switching energy metabolism from fatty acid oxidation to glucose oxidation. Selective inhibition by trimetazidine of the enzyme 3-ketoacyl-CoA thiolase (3-CAT) of the mitochondrial long-chain fatty acid isoform causes inhibition of fatty acid oxidation. This enhances glucose oxidation and accelerates glycolysis with glucose oxidation, which determines the protection of the myocardium from ischemia.
Trimetazidine has the following pharmacodynamic properties:
    maintaining energy metabolism of the heart and neurosensory tissues during ischemia;
    a decrease in the severity of intracellular acidosis and a change in the transmembrane ion flux characteristic of ischemia;
    lowering the level of migration and infiltration of polynuclear neutrophils in reperfused and ischemic heart tissues;
    reduction in the size of myocardial damage;
    lack of direct impact on hemodynamic parameters.
In patients with angina pectoris, after 15 days of therapy with trimetazidine, the coronary reserve increases, which leads to a slowdown in the onset of ischemia due to exercise. Without significant changes in heart rate (heart rate), the drug limits the fluctuations in blood pressure (BP) caused by exercise. There is a significant decrease in the incidence of angina attacks and the need for short-acting nitroglycerin. The contractile function of the left ventricle improves in patients with ischemic dysfunction.
During clinical trials, it was found that in the absence of a sufficient effect of other antianginal drugs in the treatment of stable angina pectoris, the use of trimetazidine for monotherapy or as part of combination therapy turned out to be effective and safe.
When combined with metoprolol, there was a statistically significant improvement in the results of stress tests and clinical symptoms. The use with atenolol increases the time to the development of ischemic ST segment depression by 1 mm.

Pharmacokinetics

After taking capsules inside, trimetazidine has a linear pharmacokinetic profile, the maximum concentration (Cmax) in plasma reaches approximately 14 hours. Simultaneous food intake does not affect the bioavailability of trimetazidine at a dose of 80 mg. The equilibrium state is achieved after 3 days of therapy.
Trimetazidine is well distributed in tissues, its Vd (volume of distribution) is 4.8 l / kg.
Plasma protein binding is quite low, approximately 16% of the dose taken.
T1 / 2 (half-life) in young patients - about 7 hours, over the age of 65 - about 12 hours.
The drug is excreted mainly through the kidneys, mostly unchanged.
The renal clearance of trimetazidine is correlated with creatinine clearance (CC) and decreases with the patient's age.
With a moderate degree of renal failure (CC 30-60 ml / min), the exposure of trimetazidine increases 2.4 times, with a severe degree (CC less than 30 ml / min) - on average 4 times.
Due to the age-related decrease in renal function in elderly patients (after 75 years), an increase in the exposure of trimetazidine is possible. In a special study conducted in patients of this age category, when taking tablets at a dose of 35 mg 2 times a day, it was found that in severe renal failure (CC less than 30 ml / min), the exposure of the active substance in the blood plasma is on average 2 times higher than in patients with CC more than 60 ml / min. There is no information about other features of the use of Preductal OD in old age.
The safety and efficacy of trimetazidine in patients under the age of 18 have not been established.

Indications for use

The use of Preductal OD is indicated for long-term therapy of ischemic heart disease (IHD) in order to prevent attacks of stable angina pectoris (as monotherapy or as part of a combination treatment).

Contraindications

    Parkinson's symptoms, including tremors, restless legs syndrome, and other movement disorders;
    Parkinson's disease;
    severe renal failure with CC less than 30 ml / min;
    intolerance to fructose and / or sucrose, glucose-galactose malabsorption syndrome, sucrase and isomaltase deficiency;
    age under 18;
    hypersensitivity to the components of the drug.
Caution should be exercised when prescribing the drug to patients with severe hepatic impairment (10-15 points on the Child-Pugh scale), moderate renal impairment (CC 30-60 ml / min), over the age of 75 years.
Since there are no data on the safety of the use of the drug during pregnancy and during breastfeeding, the appointment of the drug during these periods of a woman's life is not recommended.

Preductal OD, instructions for use: method and dosage

Preductal OD capsules are taken orally, swallowed and washed down with water, in the morning during breakfast.
Recommended dosage: 1 pc. 1 per day. The doctor determines the duration of the course of treatment individually. Evaluation of the effectiveness of therapy can be carried out only after 90 days of regular administration of the drug. In the absence of the expected therapeutic result, the use of Preductal OD should be discontinued.
With a moderate degree of renal failure (CC 30-60 ml / min) and in patients over the age of 75, the daily dose of trimetazidine should not exceed 35 mg.

Side effects

    on the part of the cardiovascular system: rarely - a pronounced decrease in blood pressure, palpitations, tachycardia, extrasystole, orthostatic hypotension (including accompanied by general weakness, loss of balance or dizziness, more often with the simultaneous use of antihypertensive drugs), rush of blood to the skin of the face;
    from the central nervous system: often - headache, dizziness; frequency not established - insomnia, drowsiness, symptoms of parkinsonism (including tremor, akinesia, increased tone), reversible movement disorders (including unsteadiness of gait, "restless" legs syndrome);
    on the part of the lymphatic system and the hematopoietic system: the frequency has not been established - agranulocytosis, thrombocytopenic purpura, thrombocytopenia;
    from the digestive system: often - dyspepsia, abdominal pain, nausea, vomiting, diarrhea; frequency not established - constipation, hepatitis;
    dermatological reactions: often - itchy skin, rash, urticaria; frequency not established - Quincke's edema, acute generalized exanthematous pustulosis;
    general disorders: often - asthenia.

Overdose

Overdose symptoms have not been established.
When taking an increased dose of the drug orally, you should immediately consult a doctor for symptomatic therapy.

Special instructions

Preductal OD should not be used to relieve angina attacks. The drug is not intended for the initial course of treatment of unstable angina pectoris and the treatment of myocardial infarction at the stage before hospitalization or during the first days of hospitalization.
With the development of an attack of angina pectoris, therapy (treatment or revascularization procedure) should be reviewed and adapted.
Due to the possible appearance or worsening of symptoms of parkinsonism, regular and appropriate monitoring of patients should be carried out, especially in old age. In cases of suspicion, a neurologist's examination is required.
The occurrence of movement disorders during therapy (tremor, increased tone, akinesia, “restless” legs syndrome, “unsteadiness” of gait) is the basis for canceling Preductal OD. Parkinson's symptoms are usually transient and usually resolve within four months after stopping therapy. If they persist longer, it is advisable to see a neurologist.
It should be borne in mind that in case of instability in the Romberg position, a wobbly gait or a pronounced decrease in blood pressure, cases of falling are possible, especially against the background of simultaneous intake of antihypertensive drugs.

Influence on the ability to drive vehicles and complex mechanisms

There is a risk of dizziness and / or drowsiness during the use of the drug, therefore, it is recommended to be careful when driving and performing work that requires an increased speed of psychomotor reactions.

Application during pregnancy and lactation

It is not recommended to prescribe trimetazidine during gestation and breastfeeding.
If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Childhood use

The safety and efficacy of trimetazidine for the treatment of children and adolescents has not been established, therefore, the appointment of Preductal OD to patients under 18 years of age is contraindicated.

With impaired renal function

The appointment of the drug is contraindicated in severe renal failure (CC less than 30 ml / min).
It is recommended to use Preductal OD with caution in case of moderate renal dysfunction. In patients with CC 30-60 ml / min, the daily dose of trimetazidine should not exceed 35 mg.

For violations of liver function

It is recommended to use Preductal OD with caution for the treatment of patients with severe hepatic insufficiency, in view of the fact that the effect of functional liver disorders on the metabolism of trimetazidine cannot be completely excluded.

Use in the elderly

Due to the age-related decrease in renal function, an increase in the exposure of trimetazidine is possible, therefore, the drug should be used with caution for the treatment of patients over the age of 75 years.
The daily dose of trimetazidine for this category of patients should not exceed 35 mg.

Drug interactions

When prescribing the drug, the doctor must take into account all the drugs taken by the patient.

Terms and conditions of storage

Keep out of the reach of children.
Store at temperatures up to 25 ° C.
Shelf life is 2 years.

Reviews about Preductal OD

The few reviews about Preductal OD are positive. Patients note that a single dose of the drug ensures the maintenance of the desired therapeutic effect for the whole day.

Terms of sell

You don't need a prescription to buy Preductal OD.