Topiramate ER
TROKENDI XR
What it isExtended-release anticonvulsant with sodium-channel, glutamate, GABA-A, and carbonic-anhydrase actions; epilepsy and migraine prophylaxis.
Why this oneOne capsule replaces twice-daily dosing and smooths peaks that drive cognitive complaints.
What limits itMetabolic acidosis and kidney stones limit use; TROKENDI XR’s label specifically warns against alcohol near the dose because it can dump the extended release.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Epilepsy — initial monotherapy (partial-onset or primary generalized tonic-clonic seizures) | Adults & pediatric ≥10 y | 50 mg QD wk1, titrate weekly (100/150/200/300) to 400 mg QD by wk6 | 400 mg QD | 400 mg QD |
| Epilepsy — initial monotherapy | Pediatric 6–9 y | 25 mg QHS wk1; increase by 25–50 mg/day weekly (weight-based) | Weight-based maintenance | 250–400 mg/day by body weight |
| Epilepsy — adjunctive therapy (partial-onset, PGTC, or Lennox-Gastaut syndrome) | Adults ≥17 y | 25–50 mg QD; titrate weekly by 25–50 mg | 200–400 mg QD (PGTC: 400 mg) | 400 mg QD |
| Epilepsy — adjunctive therapy | Pediatric 6–16 y | 25 mg QHS wk1 (1–3 mg/kg/day); titrate q1–2 wk by 1–3 mg/kg/day | ~5–9 mg/kg QD | 400 mg/day |
| Migraine — preventive treatment | Aged 12 years and older | 25 mg QD wk1; 50/75; to 100 mg QD by wk4 | 100 mg QD | 100 mg QD |
Titration Increase at 1-week intervals (monotherapy and migraine); pediatric adjunctive at 1–2 week intervals
Renal CrCl <70 mL/min/1.73m²: one-half the usual adult dose
Hepatic Use with caution (clearance reduced ~26% in moderate–severe impairment)
Instructions
- Swallow capsule whole and intact; do not sprinkle on food, chew, or crush
- Can be taken without regard to meals
- Completely avoid alcohol within 6 h before and 6 h after dosing
- Withdraw gradually to minimize seizure risk
- Hemodialysis: supplemental dose may be required
Contraindications
- Recent alcohol use (within 6 hours before and 6 hours after TROKENDI XR use)
Cautions
- Acute myopia and secondary angle-closure glaucoma
- Visual field defects
- Oligohidrosis and hyperthermia (especially pediatric)
- Metabolic acidosis — monitor serum bicarbonate
- Suicidal behavior and ideation
- Cognitive/neuropsychiatric adverse reactions
- Fetal toxicity (oral clefts, small for gestational age)
- Withdraw antiepileptics gradually
- Decreased bone mineral density; negative effects on growth in children
- DRESS/multiorgan hypersensitivity, serious skin reactions, anaphylaxis and angioedema
- Hyperammonemia/encephalopathy (especially with valproic acid)
- Kidney stones
- Hypothermia with concomitant valproic acid
Adverse reactions
- Paresthesia
- Anorexia
- Weight loss
- Speech/language problems
- Fatigue
- Dizziness
- Somnolence
- Nervousness
- Psychomotor slowing
- Abnormal vision
- Difficulty with memory
- Fever (pediatric)
Pregnancy Can cause fetal harm — increased risk of oral clefts and small for gestational age
Lactation Topiramate excreted in human milk; diarrhea and somnolence reported in breastfed infants
NO BOXED WARNINGS
Principal riskCognitive slowing, kidney stones, and fetal oral clefts
Classes and tags
Clinical profile
Mechanism of action: Topiramate ER ballicule
Open Topiramate ER in the interactive console ↗
Memory aids: mascots and interaction avatars
long bone → long acting formulation
may decrease bone mineral density
alcohol can cause dose-dumping