Mirobatrin (Tablets) Instructions for Use

Marketing Authorization Holder

Salyutfarma, LLC (Russia)

Manufactured By

OHFK, JSC (Russia)

ATC Code

N03AG04 (Vigabatrin)

Active Substance

Vigabatrin (Rec.INN registered by WHO)

Dosage Form

Mirobatrin

Film-coated tablets 500 mg

Dosage Form, Packaging, and Composition

Film-coated tablets

100 pcs. – jars – cardboard packs (100 pcs.) – By prescription
50 pcs. – jars – cardboard packs (50 pcs.) – By prescription
60 pcs. – jars – cardboard packs (60 pcs.) – By prescription

Pharmacotherapeutic Group

Antiepileptic agents; fatty acid derivatives

Pharmacological Action

Antiepileptic agent. An irreversible selective inhibitor of GABA aminotransferase. It increases the concentration of GABA in the synapses, thereby enhancing inhibitory effects.

It suppresses the increased excitability of neurons, which underlies the occurrence and spread of epileptic seizures.

Indications

Partial seizures, West syndrome.

ICD codes

Dosage Regimen

Administer orally.

For adults, initiate therapy at 500 mg twice daily.

Increase the total daily dose to a maximum of 1.5 g if clinically required for seizure control.

For pediatric patients, calculate the initial dose based on body weight at 40 mg/kg/day.

Divide the total daily dose into two administrations.

Titrate the pediatric dose upward to a maximum of 80-100 mg/kg/day based on therapeutic response and tolerability.

For all patients with renal impairment (creatinine clearance less than 60 ml/min), adjust the dosage downward.

In elderly patients, particularly those with reduced renal function, a dose reduction is mandatory.

When discontinuing therapy, gradually reduce the dose over a period of 2 to 4 weeks to avoid rebound seizures.

Do not abruptly stop treatment.

Adverse Reactions

From the central and peripheral nervous system: anxiety, irritability, aggressiveness, psychotic disorders; rarely – headaches, nystagmus, tremor, paresthesia, impaired concentration, increased fatigue, visual field defects; in isolated cases – increased frequency of epileptic seizures, including status epilepticus.

Other: rarely – mild dyspeptic symptoms, weight gain; in isolated cases – edema.

Contraindications

Pregnancy, lactation (breastfeeding), hypersensitivity to vigabatrin.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Renal Impairment

In elderly patients, especially with impaired renal function (creatinine clearance less than 60 ml/min), dose adjustment is required.

Pediatric Use

Use is possible according to the dosing regimen.

Geriatric Use

In elderly patients and especially with impaired renal function (creatinine clearance less than 60 ml/min), dose adjustment is required.

Special Precautions

Use with caution in patients with mental illnesses, a history of psychoses, and behavioral disorders.

During treatment, careful medical supervision is required to identify possible adverse reactions from the nervous system.

If it is necessary to discontinue treatment, it is recommended to gradually reduce the dose over 2-4 weeks. Sudden withdrawal of treatment may lead to the recurrence of seizures.

Before starting and during treatment, periodic consultations with an ophthalmologist are required. If visual field defects are detected, the decision on further use of vigabatrin is made based on the risk-benefit ratio of the therapy. In cases where the detection of visual field defects cannot be performed appropriately (for example, in young children), the decision on vigabatrin therapy should be based on an analysis of clinical indicators that allow assessing the risk-benefit ratio of the treatment.

In elderly patients and especially with impaired renal function (creatinine clearance less than 60 ml/min), dose adjustment is required.

In experimental studies, it has been shown that Vigabatrin causes reversible edema of the myelin sheaths. Currently, there is no confirmation of the same phenomenon in humans.

Effect on the ability to drive vehicles and operate machinery

Use with caution in patients whose activities require high concentration and rapid psychomotor reactions.

Drug Interactions

With simultaneous use, a decrease in the plasma concentrations of phenytoin, phenobarbital, and primidone is possible.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.