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Uses
Side effects
Interactions
Precautions
TOPAMAX® is an antiepileptic (AED) agent indicated for:
- Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures
- Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS)
- Migraine: Treatment for adults for prophylaxis of migraine headache
- The most common (>5% more frequent than placebo or low-dose TOPAMAX® in monotherapy) adverse reactions in controlled, epilepsy clinical trials were paresthesia, anorexia, weight decrease, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, difficulty with memory, difficulty with concentration/attention, cognitive problems, confusion, mood problems, fever, infection, and flushing.
- The most common (>5% more frequent than placebo) adverse reactions in controlled, migraine clinical trials were paresthesia and taste perversion
- In vitro studies indicate that topiramate does not inhibit enzyme activity for CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1, and CYP3A4/5 isozymes. In vitro studies indicate that topiramate is a mild inhibitor of CYP2C19 and a mild inducer of CYP3A4.
- Drug interactions with some antiepileptic drugs, CNS depressants and oral contraceptives are described here. For other drug interactions, please refer to Clinical Pharmacology.
- Acute myopia and secondary angle closure glaucoma: Untreated elevated intraocular pressure can lead to permanent visual loss. The primary treatment to reverse symptoms is discontinuation of TOPAMAX® as rapidly as possible
- Oligohidrosis and hyperthermia: Monitor decreased sweating and increased body temperature, especially in pediatric patients
- Metabolic acidosis: Baseline and periodic measurement of serum bicarbonate is recommended. Consider dose reduction or discontinuation of TOPAMAX® if clinically appropriate
- Suicidal behavior and ideation: Antiepileptic drugs increase the risk of suicidal behavior or ideation
- Cognitive/neuropsychiatric: TOPAMAX® may cause cognitive dysfunction. Patients should use caution when operating machinery including automobiles. Depression and mood problems may occur in epilepsy and migraine populations
- Fetal Toxicity: TOPAMAX® use during pregnancy can cause cleft lip and/or palate
- Withdrawal of AEDs: Withdrawal of TOPAMAX® should be done gradually
- Hyperammonemia and encephalopathy associated with or without concomitant valproic acid use: Patients with inborn errors of metabolism or reduced mitochondrial activity may have an increased risk of hyperammonemia. Measure ammonia if encephalopathic symptoms occur
- Kidney stones: Use with other carbonic anhydrase inhibitors, other drugs causing metabolic acidosis, or in patients on a ketogenic diet should be avoided
- Hypothermia has been reported with and without hyperammonemia during topiramate treatment with concomitant valproic acid use
