Quick Facts

• Part of a strategy for the management of stable angina pectoris.
• Used when other first-line therapies are insufficient.
• May assist in maintaining quality of life by helping to address symptoms.

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Предуктал ОД, which contains the active substance trimetazidine, is an established therapeutic option utilized in adults. It is primarily indicated as an add-on treatment for the symptomatic management of stable angina pectoris. This condition involves chest pain caused by reduced blood flow to the heart muscle.

This medication is typically considered for individuals whose symptoms are not adequately controlled by, or who are intolerant to, standard first-line anti-anginal therapies. Its purpose is to provide therapeutic support within a comprehensive treatment plan.

By helping to address the discomfort and functional limitations associated with angina, the medication contributes to the management of the patient’s overall condition. It may assist in maintaining quality of life for those living with stable angina.

The official regulatory profile for Предуктал ОД (Trimetazidine dihydrochloride) strictly defines the population eligible for its use. The medicine is approved only for adult patients.

Absolute Contraindications

Official labeling states that the medicine must not be used in patients with the following conditions:

• Hypersensitivity to the active substance or any ingredient.
• Severe renal impairment, defined as a creatinine clearance of less than 30 ml/min.
• Established Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, or other related movement disorders.

Age- and Condition-Based Restrictions

Use is limited or conditional for several specific groups:

• Pediatric Use: The medicine is not recommended for children and adolescents under 18 years of age because its safety and efficacy have not been established in this population.
• Renal Impairment: Patients with moderate renal impairment (creatinine clearance [30-60] ml/min) require caution and a specific dosage reduction.
• Older Adults: Patients over 75 years old should be treated with caution due to the increased risk of exposure linked to age-related changes in kidney function.
• Reproductive Status: As a precautionary measure, use is preferable to avoid during pregnancy and should not be used during breastfeeding.

Interactions with other medicines and products

The official regulatory documentation for Trimetazidine dihydrochloride (Предуктал ОД) establishes a low potential for clinically significant drug-drug interactions, based on specific pharmacological findings.

Interaction Scope

Property	Official Regulatory Finding
Medicinal product categories with documented interactions	None documented.
Specific interacting medicines (if explicitly listed)	The official label confirms no pharmacokinetic interactions were observed with co-administration of Digoxin, Metformin, or Propranolol. No interactions are reported with classes such as calcium antagonists, nitrates, or hypolipidaemic agents.
Mechanistic basis of interactions (only if stated in label)	The drug does not exhibit clinically relevant inhibitory or inducing effects on the major cytochrome P450 enzymes, confirming a low risk of pharmacokinetic interaction.
Timing-based interaction rules (if applicable)	None documented. No mandatory separation rules are stipulated for other medicines or food.
Population-specific interaction notes (if applicable)	The clearance of Trimetazidine is officially documented as reduced in patients with moderate renal impairment and in elderly patients over 75 years of age, leading to increased exposure of the medicine itself.
Interaction-related restrictions	No formal prohibitions are listed regarding co-administration with food, alcohol, herbal products, or supplements.

Interaction Classifications (High-Level)

Property	Official Regulatory Finding
Interaction severity classification	No Formal Contraindications. Official regulatory labeling does not classify any combination as strictly contraindicated based on interaction risk.

Connection to the overall interaction profile

The official interaction profile is defined by a consistent finding of a low intrinsic risk, with regulatory studies confirming no clinically significant effects on major metabolic pathways or modification of exposure of tested cardiovascular drugs. This low-risk profile means the official prescribing information cites no mandatory restrictions, prohibitions, or timing-based separation rules.

Предуктал ОД contains trimetazidine, which modulates cardiac energy metabolism through the selective inhibition of mitochondrial long-chain 3-ketoacyl coenzyme A ( CoA) thiolase (LC 3-KAT), the final enzyme in the fatty acid beta-oxidation pathway.

This interaction, an inhibitory type, decreases the rate of fatty acid oxidation within myocardial cells. The resulting metabolic shift increases the compensatory utilization of glucose as a primary energy substrate for adenosine triphosphate ( ATP) production. Glucose oxidation is an inherently more oxygen-efficient process compared to fatty acid beta-oxidation, yielding more ATP per unit of oxygen consumed.

This altered metabolic profile supports the maintenance of cellular energy homeostasis by preserving intracellular ATP levels. Downstream, this action mitigates intracellular acidosis and helps regulate transmembrane ionic gradients, including sodium and calcium, which contributes to the cytoprotective effect on the myocardial cell.

The administration of Предуктал ОД 80 mg is established to ensure correct use of the prolonged-release formulation. This medicine is for oral use only, and the dosing schedule dictates a fixed regimen.

Official Administration Guidelines

The table below summarizes the core instructions for taking this medicine:

Usage Domain	Official Instruction	Practical Implication
Route & Preparation	Swallow the prolonged-release tablet whole with water. Do not chew, crush, or divide.	Ensures the active substance is released slowly over the day.
Standard Dosing	One 80 mg prolonged-release tablet once daily.	Establishes the standard 24-hour treatment dose.
Timing & Food	The tablet should be taken in the morning. It can be taken with a meal.	Promotes consistent absorption and facilitates adherence to the daily schedule.
Missed Dose	If a dose is forgotten, do not take a double dose. Take the next dose at the usual time.	Prevents potential overexposure to the medicine.

Special Population Administration

Specific dosage adjustments are required for certain patient groups, and must be implemented by a healthcare professional:

• Patients with Moderate Kidney Impairment (creatinine clearance 30-60 mL/min): A lower dose is required; a 35 mg modified-release tablet once daily is used for this population. The Предуктал ОД 80 mg formulation is not suitable for this adjustment.
• Elderly Patients (over 75 years): The dose may need careful adjustment by a physician, particularly in patients with reduced kidney function due to age, in line with the requirements for renal impairment.
• Children and Adolescents (under 18 years): The safety and efficacy of this medicine have not been established in this patient population, and therefore, its use is not recommended.

These instructions define the standardized procedure for using the medicine, controlling the method, timing, and dosage for adult patients, with adjustments based on specific patient health factors.

Предуктал ОД: Recent Clinical Evidence (Trimetazidine 80 mg MR)

The modified-release (MR) formulation of trimetazidine (Предуктал ОД) has been investigated in clinical studies, primarily as an add-on treatment for stable angina pectoris.

Efficacy in Stable Angina

Clinical research generally supports the use of trimetazidine as an anti-anginal therapy when symptoms are not adequately controlled by or when patients are intolerant to first-line agents (such as beta-blockers or calcium channel blockers).

• Reduction in Symptoms: Trials, including large observational studies (e.g., ODA, Modus Vivendi), assessed the effect of adding trimetazidine 80 mg once daily to existing treatment regimens. These studies reported a reduction in the frequency of weekly angina attacks and a decrease in the consumption of short-acting nitrates.
• Exercise Tolerance: Randomized controlled trials (RCTs) examining earlier formulations noted that trimetazidine was associated with improved exercise parameters, such as the time to 1mm ST-segment depression (a measure of ischemia) during stress tests, compared to placebo.
• Quality of Life: Observational data suggests that the addition of the 80 mg once-daily formulation was associated with improvements in patient-reported quality of life over a 3-month follow-up period.

Safety and Tolerability

The overall tolerability profile of trimetazidine is generally considered favorable in clinical practice. Regulatory reviews recommend restricting its use in certain populations:

• Specific Risk Factors: Study and regulatory guidelines advise against using trimetazidine in patients with Parkinson's disease or Parkinsonian symptoms, as movement disorders have been reported as a rare, though often reversible, adverse effect. It is also contraindicated in patients with severely reduced kidney function.
• Tolerability: In observational studies, the tolerability of the 80 mg once-daily formulation was typically rated by physicians as good to very good.

Common questions about Предуктал ОД (FAQ)

Q: Is Предуктал ОД a type of heart medicine?

A: According to the official product information, this medicine is formally classified as a metabolic agent. However, it is officially indicated for the symptomatic treatment of a heart condition called stable angina pectoris. Its action is designed to support the energy metabolism of heart cells.

Q: What kind of medical conditions is Предуктал ОД typically used for?

A: Official regulatory documents state that this medicine is indicated for the symptomatic treatment of stable angina pectoris in adults. It is typically used as an add-on therapy when symptoms are not adequately controlled by or when patients are intolerant to other standard first-line therapies.

Q: How is Предуктал ОД different from the standard Предуктал tablet?

A: The 'ОД' designation indicates that this is a modified-release or prolonged-release formulation. This design ensures that the active substance is released slowly over a 24-hour period. In contrast, the standard, non-OD tablet is an immediate-release form and is typically used in a different dosing schedule.

Q: Is it supposed to be taken for a long time?

A: Official guidance states that the benefit of the treatment should be assessed after three months of use. Official documents state that the medicine is typically discontinued if no treatment response is observed.

Q: How quickly do people typically start noticing the intended effects?

A: Pharmacological studies indicate that the medicine reaches a consistent level in the bloodstream, known as the steady-state concentration, within about two and a half days of starting treatment. Clinical benefits, such as a reduction in angina attacks, are typically assessed in clinical trials over a longer time frame, such as a three-month period.

Q: What happens if a dose of Предуктал ОД is missed?

A: Regulatory guidelines state that a double dose is not to be taken to compensate for a missed dose. The next dose is taken at the time established in the patient's daily schedule.

Q: Can Предуктал ОД cause changes in sleep patterns?

A: Adverse effects listed in official documents include sleep disorders, which can involve both insomnia (difficulty sleeping) and drowsiness. The frequency of these effects is classified as 'Not known,' meaning it cannot be reliably estimated from available data.

Q: Can people with kidney issues take Предуктал ОД?

A: Official information clearly defines the limits for use related to kidney function. The medicine's use is contraindicated (should not be used) in patients with severe renal impairment (severely reduced kidney function). Patients with moderate renal impairment require a specific lower dose using a different formulation of the medicine.

Q: Is Предуктал ОД suitable for elderly patients?

A: Regulatory warnings indicate that caution is advised when the medicine is prescribed to patients older than 75 years. This is primarily due to age-related changes that may reduce kidney function and potentially increase the medicine's exposure in the body. Official documentation indicates that a dose adjustment may be required.

Q: What should be done if an overdose is suspected?

A: Official documents do not detail specific actions for overdose. Clinical reports suggest that symptoms associated with an overdose may include a drop in blood pressure, loss of consciousness, and problems with muscle control or coordination. In the event of suspected overdose, standard medical care is the recommended course of action.

Q: What is the difference between a side effect and an allergic reaction?

A: Official documents list expected, common side effects (like headache or dizziness) separately from allergic reactions. Severe allergic reactions, such as swelling of the face, lips, tongue, or a serious generalized rash with blistering, are noted as rare but potentially serious. Hypersensitivity to the active substance is also listed as an absolute contraindication.

Q: Are there any specific foods or drinks to avoid while taking it?

A: Official regulatory documents state that the occurrence of interactions with other medicinal products or foodstuffs has not been found or documented. The findings suggest a low intrinsic risk of interaction, and the official label cites no mandatory restrictions on specific foods or drinks.

Q: Is it mentioned in official documents if Предуктал ОД can interact with anti-diabetic drugs?

A: Official documents confirm that no pharmacokinetic interaction was observed when the medicine was co-administered with Metformin, a commonly used anti-diabetic medicine. In general, the drug is classified as having a low potential for clinically significant interactions.

Q: Is Предуктал ОД a preventative drug?

A: The medicine is officially indicated for the symptomatic treatment of stable angina pectoris. Its role is described as providing a cytoprotective (cell-protecting) effect against reduced oxygen supply, rather than being used for primary prevention.

Q: Are there restrictions on operating machinery while taking Предуктал ОД?

A: Official product information advises caution because this medicine may make you feel dizzy and drowsy. Side effects like these, as well as unsteadiness or gait disturbance, may impact the ability to drive or use machinery, and caution is advised.

Q: What does the drug's description say about its use in patients with severe liver impairment?

A: While use in patients with severe kidney impairment is strictly restricted, the official documentation does not stipulate a specific contraindication for severe hepatic impairment (severe liver issues). However, rare adverse effects of liver dysfunction have been reported in the available data.

Q: Is there information on whether Предуктал ОД is excreted in breast milk?

A: According to the official regulatory statement, it is unknown whether the active substance is excreted in human or animal breast milk. Because excretion and a risk to the suckling child cannot be excluded, use of the medicine during breastfeeding is officially advised against.

Q: Is a prescription required for Предуктал ОД?

A: Yes, this medicine is classified by regulatory authorities as a prescription-only medicine and requires a valid prescription from a licensed healthcare professional to be obtained.

Official Storage and Disposal Requirements

This section outlines the mandatory storage and disposal information for Предуктал ОД (Trimetazidine modified release) as stated in official regulatory documentation.

Requirement Area	Official Labeled Instruction
Storage Conditions	This medicinal product does not require any special storage conditions.
Child Safety	Keep this medicine out of the sight and reach of children.
Product Stability	Do not use the medicine after the expiry date (EXP) printed on the packaging.
Disposal Method	Do not dispose of this medicine via wastewater or household waste. Consult a pharmacist for instructions on proper disposal.

The regulatory profile ensures safety by requiring the product to be kept inaccessible to children and forbidding its use past the labeled expiration date. The official disposal instructions are designed to protect the environment by mandating that the product is returned to a pharmacist for appropriate pharmaceutical waste handling rather than being discarded in the regular trash or sewage system.