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Vigasep®

Patient Details

Vigasep®

Generic name: Vigabatrin
Dosage form: 500 mg tablet
Pharmacologic class: Anticonvulsant
Indication: This medicine is used to control treatment-resistant seizures.


Vigasep®

Vigasep® (vigabatrin) is an antiepileptic that irreversibly inhibits the enzyme GABA transaminase (GABA-T), thereby increasing the level of the inhibitory neurotransmitter GABA in the brain.


Indications of Vigasep®

• Drug-resistant complex partial (focal impaired-awareness) seizures
Infantile spasms


Dosage form of Vigasep®

500 mg tablet


How to take Vigasep®

• Take Vigasep® exactly as prescribed, with or without food.
• Do not stop taking the medicine—even if you feel better—without consulting your doctor.


Missed dose

• If you miss a dose, it is best to inform your doctor.
• Take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Do not take two doses at once or extra doses.


Overdose

If you take more than the prescribed amount, contact your doctor immediately.


Monitoring during Vigasep® therapy

Ophthalmic monitoring: Assessment of visual acuity and visual fields by an eye specialist, with interpretation of field testing and indirect ophthalmoscopy of the retina, should be performed no later than 4 weeks after starting therapy, every 3 months during treatment, and 3–6 months after discontinuation.
• Monitor patients for excessive sedation, especially at initiation or after dose increases.
• Monitor hemoglobin and hematocrit.
• Monitor for weight gain or edema.
• Monitor for depression, suicidal thoughts, or unusual behavioral changes.


Contraindications to Vigasep®

Avoid use if you have a history of hypersensitivity to vigabatrin. Avoid during pregnancy or breastfeeding.


Warnings and precautions

• If there is no meaningful clinical response after initiation (within 2–4 weeks for infantile spasms; within <3 months for drug-resistant complex partial seizures), treatment should not be continued.
• There is a risk of vision loss or visual field defects, which increases with higher cumulative dose. Avoid use in patients at risk of vision loss or in combination with medicines that can cause significant ocular adverse effects (e.g., glaucoma). Report any visual problems to your doctor immediately.
• Vigabatrin may cause drowsiness; avoid driving or activities requiring high alertness if affected.
• Consult your doctor if you experience numbness/tingling in the toes or loss of reflexes.


Use of Vigasep® in pregnancy and lactation

• Consult your doctor or pharmacist before use during pregnancy or breastfeeding.
• Use during pregnancy may cause congenital malformations, including cardiac, limb, renal, and ear anomalies.
• Use during breastfeeding is not recommended.


Possible side effects of Vigasep®

As with all medicines, adverse effects may occur (not everyone is affected), including:
Dizziness, drowsiness, fatigue, weakness
Gastrointestinal problems
Urinary tract infection
Weight gain
Headache
Joint and muscle pain


Drug interactions

Consult your doctor or pharmacist before using vigabatrin with any other medicines or supplements.


Packaging

Each pack contains 30 film-coated tablets.


Storage

• Keep out of the reach of children and pets.
• Store in a dry place at room temperature.
• Usable until the end of the month shown on the expiry date. Do not keep or use expired medicines.


References

  1. Vigabatrin: Drug information, UpToDate 2025

  2. https://www.drugs.com/monograph/vigabatrin.html