Classes
DEA Class; Rx
Common Brand Names; Topamax, Trokendi XR, Qudexy XR, Eprontia
- Anticonvulsants,Others
- Antimigraine Agents
Description
Oral anticonvulsant; weak carbonic anhydrase inhibitor
Used for partial and generalized seizures, Lennox-Gastaut, refractory seizures, and migraine prophylaxis; off-label uses include binge-eating disorder and alcohol use disorder
Close monitoring for emerging or worsening suicidal thoughts/behavior or depression recommended
Indications
Indicated for the adjunctive treatment of partial seizures.
Indicated as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS)
Indicated for prophylaxis of migraine headache
Contraindications
Hypersensitivity
Extended release: Within 6 hr of alcohol intake; patients with metabolic acidosis that are taking metformin concomitantly
Adverse Effects
- Decrease in serum bicarbonate (7-67%)
- Dizziness (4-29%)
- Fatigue (9-16%)
- Ataxia (6-16%)
- Nervousness (9-18%)
- Paresthesia (1-11%)
- Psychomotor slowing (3-13%)
- Abnormal vision (2-13%)
- Anorexia (4-24%)
- Confusion (4-11%)
- Decreased memory (2-12%)
- Nausea (6-10%)
- Speech disorder (2-13%)
- Injury (14%)
- Abdominal pain (6-10%)
- Weight loss (4-9%)
- Diplopia (1-10%)
- Mood problems (<6%)
- Pharyngitis (6%)
- Tremor (3-9%)
- Abnormal gait (3-8%)
- Apathy (1%)
- Asthenia (1-5%)
- Dry mouth (2%)
- Menorrhagia (1-2%)
- Skin disorder (2-3%)
- Taste change (2%)
- Edema (2%)
- Hypertension (1-2%)
- Syncope (1%)
- Bradycardia (1%)
- Pallor (1%)
- Angina
- Erythema
- Hepatic failure
- Hyperthermia
- Hypokalemia
- Neuropathy
- Toxic epidermal necrolysis
Warnings
Kidneys stones reported with therapy; increased fluid intake increases urinary output, lowering the concentration of substances involved in stone formation; hydration is recommended to reduce new stone formation; increased ratio of urinary calcium/citrate increases risk of kidney stones and/or nephrocalcinosis
Use caution with alcohol use
Monitor closely for decreased sweating and increased body temperature; oligohydrosis reported with use; monitor during strenuous exercise
Concomitant use of drugs that predispose patients to heat-related disorders (such as carbonic anhydrase inhibitors and anticholinergics)
Coadministration with valproic acid increases risk of hyperammonemia (with or without encephalopathy)
Visual field defects reported independent of elevated IOP; reversible upon discontinuation
Rapid titration rate, dose, and higher initial dose associated with higher incidence of neuropsychiatric disorder in both epilepsy and migraine patients; also associated with higher incidences of cognitive-related dysfunction
Monitor serum bicarbonate at baseline and then periodically; may also monitor serum chloride, ammonia, and phosphorus
When discontinuing drug, gradually withdraw to decrease risk of seizure or increased seizure frequency
Increased risk in suicidal thoughts/behavior reported; monitor patients for notable changes in behavior and notify healthcare provider if symptoms occur
Use caution when operating heavy machinery
Hypothermia reported with and without hyperammonemia during topiramate treatment with concomitant valproic acid use; consideration should be given to stopping topiramate or valproate in patients who develop hypothermia
Pregnancy and Lactation
There is pregnancy exposure registry that monitors pregnancy outcomes in women exposed to drug during pregnancy
Topiramate is excreted in human milk; effects of topiramate exposure in breastfed infants or on milk production are unknownare unknown; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for extended release formulation and any potential adverse effects on the breastfed infant from extended release formulation or from the underlying maternal condition
Maximum Dosage
400 mg/day PO for epilepsy; 100 mg/day PO for migraine prophylaxis.
400 mg/day PO for epilepsy; 100 mg/day PO for migraine prophylaxis.
17 years: 400 mg/day PO for epilepsy; 100 mg/day PO for migraine prophylaxis.
13 to 16 years: 400 mg/day PO (monotherapy) or 9 mg/kg/day PO (adjunct therapy) for epilepsy; 100 mg/day PO for migraine prophylaxis.
12 years: 400 mg/day PO (monotherapy) or 9 mg/kg/day PO (adjunct therapy) for epilepsy; 100 mg/day PO for migraine prophylaxis.
10 to 11 years: 400 mg/day PO (monotherapy) or 9 mg/kg/day PO (adjunct therapy) for epilepsy.
2 to 9 years weighing more than 38 kg: 400 mg/day PO (monotherapy) or 9 mg/kg/day PO (adjunct therapy) for epilepsy.
2 to 9 years weighing 23 to 38 kg: 350 mg/day PO (monotherapy) or 9 mg/kg/day PO (adjunct therapy) for epilepsy.
2 to 9 years weighing 12 to 22 kg: 300 mg/day PO (monotherapy) or 9 mg/kg/day PO (adjunct therapy) for epilepsy.
2 to 9 years weighing 11 kg or less: 250 mg/day PO (monotherapy) or 9 mg/kg/day PO (adjunct therapy) for epilepsy.
Younger than 2 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Topiramate
tablet (Topamax)
- 25mg
- 50mg
- 100mg
- 200mg
capsule, sprinkle (Topamax Sprinkle)
- 15mg
- 25mg
capsule, extended-release
- 25mg (Trokendi XR, Qudexy XR)
- 50mg (Trokendi XR, Qudexy XR)
- 100mg (Trokendi XR, Qudexy XR)
- 150mg (Qudexy XR)
- 200mg (Trokendi XR, Qudexy XR)
oral solution
- 25mg/mL (Eprontia)