Topiramate ER (sprinkle)
QUDEXY XR
What it isTopiramate acting at sodium channels, GABA-A, glutamate receptors, and carbonic anhydrase; epilepsy and migraine prevention.
Why this oneIt is once-daily and may be opened onto soft food; mean effective half-life ~56 h per label, so levels ride out a missed dose better than IR.
What limits itCognitive slowing, acidosis, kidney stones, angle-closure glaucoma, and fetal oral clefts can end treatment; taper gradually.
FDA-approved for
- epilepsy (monotherapy / adjunct) (2014)
- migraine prophylaxis (2017)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Monotherapy epilepsy (partial-onset or primary generalized tonic-clonic seizures) | adults and pediatric ≥10 years | 50 mg QD, titrate weekly | 400 mg QD | 400 mg QD |
| Monotherapy epilepsy | pediatric 2–9 years | 25 mg QHS week 1, titrate weekly by 25–50 mg | weight-based (150–250 mg/day min to 250–400 mg/day max) | 400 mg/day |
| Adjunctive epilepsy (partial-onset, primary generalized tonic-clonic, Lennox-Gastaut) | adults ≥17 years | 25–50 mg QD, titrate weekly by 25–50 mg | 200–400 mg QD (400 mg for PGTC) | 400 mg QD |
| Adjunctive epilepsy | pediatric 2–16 years | 25 mg QD (titrate weekly) | ~5–9 mg/kg QD | ~9 mg/kg QD |
| Migraine prophylaxis | adults and pediatric ≥12 years | 25 mg QD, titrate weekly | 100 mg QD | 100 mg QD |
Titration Increase at weekly intervals (25–50 mg/week for epilepsy; per schedule for migraine).
Renal Moderate or severe impairment (CrCl <70 mL/min/1.73 m2): reduce dose (approximately half).
Hepatic Undefined
Instructions
- Capsules may be swallowed whole or opened and sprinkled on a spoonful of soft food.
- Withdraw gradually to minimize seizure risk.
- May be taken without regard to meals.
Cautions
- Acute myopia and secondary angle-closure glaucoma
- Visual field defects
- Oligohidrosis and hyperthermia
- Metabolic acidosis
- Suicidal behavior and ideation
- Cognitive/neuropsychiatric reactions
- Cardiac rhythm and conduction abnormalities
- Fetal toxicity (oral clefts, SGA)
- Withdrawal seizures if stopped abruptly
- Decreased bone mineral density (pediatric)
- Negative effects on growth
- DRESS/multiorgan hypersensitivity
- Hyperammonemia/encephalopathy
- Kidney stones
Adverse reactions
- Paresthesia
- Anorexia
- Weight loss
- Speech disorders
- Fatigue
- Dizziness
- Somnolence
- Nervousness
- Psychomotor slowing
- Abnormal vision
- Fever
Pregnancy Can cause fetal harm; increased risk of major congenital malformations including oral clefts and being 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 (sprinkle) ballicule
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