What is VIGADRONE used for?

1 INDICATIONS AND USAGE VIGADRONE is indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; VIGADRONE is not indicated as a first line agent ( 1.1 ) Infantile Spasms – monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss ( 1.2 ) 1.1 Refractory Complex Partial Seizures (CP

How does VIGADRONE work?

11 DESCRIPTION VIGADRONE (vigabatrin, USP) is an oral antiepileptic drug and is available as a white, film- coated 500 mg tablet.

What pharmaceutical form is VIGADRONE available in?

VIGADRONE: Tabletki rozpuszczalne 100 mg (doustna, Podanie dożołądkowe)

Is VIGADRONE OTC or prescription only?

VIGADRONE requires a doctor's prescription.

What are the side effects of VIGADRONE?

6 ADVERSE REACTIONS The following serious and otherwise important adverse reactions are described elsewhere in labeling: Permanent Vision Loss [see BOXED WARNING , Warnings and Precautions (5.1) ] Magnetic Resonance Imaging (MRI) Abnormalities in Infants [see Warnings and Precautions (5.3) ] Neurotoxicity [see Warnings and Precautions (5.4) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.5) ] Withdrawal of Antiepileptic Drugs (AEDs) [see Warnings and Precautions (5.6) ] Anemia

Who should NOT take VIGADRONE?

4 CONTRAINDICATIONS None. None ( 4 )

Does VIGADRONE interact with other medications?

7 DRUG INTERACTIONS Decreased phenytoin plasma levels: dosage adjustment may be needed ( 7.1 ) 7.1 Antiepileptic Drugs Phenytoin Although phenytoin dose adjustments are not routinely required, dose adjustment of phenytoin should be considered if clinically indicated, since VIGADRONE may cause a moderate reduction in total phenytoin plasma levels [see Clinical Pharmacology (12.3) ]. Clonazepam VIGADRONE may moderately increase the C max of clonazepam resulting in an increase of

Can VIGADRONE be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 8.1 ) Lactation: VIGADRONE is excreted in human milk ( 8.2 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, including VIGADRONE, during pregnancy. Encourage women who are taking VIGADRONE during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by

What precautions should be taken with VIGADRONE?

WARNINGS: If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

What ATC class does VIGADRONE belong to?

VIGADRONE: ATC N03AG04. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

VIGADRONE

100 mg, Tabletki rozpuszczalne

INN: Vigabatrinum

Data updated: 2026-04-13

Available in:

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Form

Tabletki rozpuszczalne

Dosage

100 mg

Route

doustna, Podanie dożołądkowe

Storage

16.2 Storage and Handling Store a‍‍‍‍‍‍‍‍t 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature].

About This Product

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