Infira^® (Tablets, Granules) Instructions for Use

ATC Code

N03AG04 (Vigabatrin)

Active Substance

Vigabatrin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiepileptic drug

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 with or without food. The tablets should be swallowed whole with a glass of water; do not chew. For the granules, mix the entire contents of a sachet in a glass of water or soft food (e.g., yogurt, pudding) and consume immediately; do not store the mixture.

For adult patients with partial seizures, the initial total daily dose is 1 g (500 mg twice daily). Titrate the dose based on clinical response and tolerability. The maximum recommended total daily dose is 3 g (1.5 g twice daily).

For pediatric patients 10 years and older with partial seizures, the initial total daily dose is 40 mg/kg. The dose may be increased to a maximum of 80-100 mg/kg/day, not to exceed 3 g daily.

For infantile spasms (West syndrome) in pediatric patients, the recommended total daily dose is 50 mg/kg given as two divided doses. The dose may be titrated up to 150 mg/kg/day based on clinical efficacy.

For patients with renal impairment, adjust the dose. For a creatinine clearance of 30-60 mL/min, reduce the total daily dose by 25-50%. For a creatinine clearance of 10-30 mL/min, reduce the total daily dose by 50-75%.

When discontinuing therapy, gradually withdraw the medication over a period of 2 to 4 weeks to minimize the potential for rebound seizures. Monitor plasma levels of concomitant antiepileptic drugs (e.g., phenytoin) as vigabatrin may decrease their concentration.

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 dosage 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 illness, a history of psychosis 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.

Consultation with an ophthalmologist is required before starting and during treatment. If visual field defects are detected, the decision on further use of vigabatrin is made based on an assessment of the risk-benefit ratio of the therapy. In cases where 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 assessment of the risk-benefit ratio of treatment.

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

In experimental studies, Vigabatrin has been shown to cause reversible intramyelinic edema. Currently, there is no confirmation of the same phenomenon in humans.

Effect on 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 plasma concentrations of phenytoin, phenobarbital, and primidone is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.