Vigabatrin 500 MG Oral Tablet

1 INDICATIONS AND USAGE Vigabatrin tablets are 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; Vigabatrin tablets are not indicated as a first line agent ( 1.1 ) 1.1 Refractory Complex Partial Seizures (CPS) Vigabatrin tablets are indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see Warnings and Precautions (5.1) ] . Vigabatrin tablets are not indicated as a first line agent for complex partial seizures.

actavis pharma, inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] adverse drug reaction` `[3] application site pruritus` `[4] off label use` `[5] drug hypersensitivity` `[6] headache` `[7] nausea` `[8] rash` `[9] fatigue` `[10] condition aggravated`

3 years ago

OVAL WHITE A314

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

VIGABATRIN Tablets, USP are available for oral administration and are supplied as follows: 500 mg — Each white to off-white, film-coated, oval biconvex tablet functionally-scored on one side and debossed with A314 on the other side contains 500 mg of

VIGABATRIN, USP. Tablets are supplied in bottles of 100 (NDC 0591-3851-01). 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Keep this and all drugs out of the reach of children.

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Vigabatrin 500 MG Oral Tablet

FDA Reported Adverse Reactions [1] drug ineffective [2] adverse drug reaction [3] application site pruritus [4] off label use [5] drug hypersensitivity [6] headache [7] nausea [8] rash [9] fatigue [10] condition aggravated

OVAL WHITE A314

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FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] adverse drug reaction` `[3] application site pruritus` `[4] off label use` `[5] drug hypersensitivity` `[6] headache` `[7] nausea` `[8] rash` `[9] fatigue` `[10] condition aggravated`