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Pharmacologic classification: GABA transaminase inhibitor
Therapeutic classification: anticonvulsant
Pregnancy risk category: C
AVAILABLE FORMS
Tablets: 500 mg
INDICATIONS AND DOSAGES
Refractory complex partial seizures—
Adults: Initially, 500 mg b.i.d. May increase in 500-mg increments weekly, to maximum dose of 1,500 mg b.i.d. up to twice daily.
ADJUST-A-DOSE: For patients with creatinine clearance 51 to 80 ml/minute, reduce dose by 25%; for creatinine clearance 31 to 50 ml/minute, decrease dose by 50%; for creatinine clearance 11 to 30 ml/minute, decrease dose by 75%.
CONTRAINDICATIONS AND CAUTIONS
Use cautiously in patients with a history of vision problems, MRI abnormalities, neurotoxicity, depression, suicidal behavior or ideation, or anemia.
INTERACTIONS
Drug-drug.
Clonazepam: May increase clonazepam levels. Use together cautiously.
Phenytoin: May increase phenytoin levels. Monitor drug levels.
ADVERSE REACTIONS
CNS: abnormal behavior, abnormal coordination, abnormal dreams, abnormal thinking, anxiety, asthenia, attention disturbance, confusion, seizures, depression, dizziness, dysarthria, expressive language disorder, fatigue, fever, headache, hyperreflexia, hypoesthesia, hyporeflexia, insomnia, irritability, lethargy, malaise, memory impairment, nervousness, nystagmus, paresthesia, postictal state, sedation, sensory disturbance, sensory loss, sinus headache, somnolence, status epilepticus, tremor.
CV: chest pain, peripheral edema.
EENT: asthenopia, blurred vision, diplopia, eye pain, nasopharyngitis, pharyngolaryngeal pain, tinnitus, toothache, vertigo, visual field defect.
GI: abdominal distention, constipation, diarrhea, dyspepsia, nausea, stomach discomfort, upper abdominal pain, vomiting.
GU: dysmenorrhea, erectile dysfunction, UTI.
Metabolic: increased appetite, increased weight.
Musculoskeletal: arthralgia, back pain, contusion, extremity pain, gait disturbance, joint sprain, myalgia, muscle spasm, muscle twitching.
Respiratory: bronchitis, cough, influenza, pulmonary congestion, upper respiratory tract infection.
Skin: rash, wound secretion.
Reactions may be common, uncommon, life-threatening,
or COMMON AND LIFE-THREATENING.
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vigabatrin