ear Healthcare Professional,
Trokendi XR
TM
(topiramate) extended-release capsules
Company: Supernus Pharmaceuticals, Inc.
Pharmacological Class: Sulfamate.
Active Ingredient: Topiramate; 25 mg, 50 mg, 100 mg,
200 mg extended-release capsules.
Indications: Partial Onset Seizure and Primary Generalized
Tonic-Clonic Seizures: initial monotherapy in patients 10 years of
age and older with partial onset or primary generalized
tonic-clonic seizures and adjunctive therapy in patients 6 years
of age and older with partial onset or primary generalized
tonic-clonic seizures. Lennox-Gastaut Syndrome (LGS):
adjunctive therapy in patients 6 years of age and older with
seizures associated with Lennox-Gastaut syndrome.
Adults: Swallow capsule whole and intact. Do not sprinkle on
food, chew, or crush. Monotherapy: initially 50 mg once daily.
Increase dose weekly by increments of 50 mg for the first
4 weeks, then 100 mg for weeks 5–6 to recommended dose of
400 mg once daily. Adjunctive therapy: initially 25–50 mg once
daily. Increase dose weekly by increments of 25–50 mg to achieve
effective dose; recommended dose of 200–400 mg once daily
(partial onset seizures or LGS) or 400 mg once daily (primary
generalized tonic-clonic seizures).
Pediatrics: Swallow capsule whole and intact. Do not sprinkle
on food, chew, or crush. Monotherapy: (?10 years of age): initially
50 mg once daily. Increase dose weekly by increments of 50 mg
for the first 4 weeks, then 100 mg for weeks 5–6 to recommended
dose of 400 mg once daily. Adjunctive therapy: (?6 years of age):
initially 1–3 mg/kg (max 25 mg) once in the PM for first week.
Increase at 1– or 2–week intervals by increments of 1–3 mg/kg to
recommended dose of 5–9 mg/kg once daily. Dose titration
should be guided by clinical outcome.
Contraindications: With recent alcohol use (ie, within
6 hours prior to and 6 hours after Trokendi XR use; in patients
with metabolic acidosis taking concomitant metformin.
Warnings/Precautions: Acute myopia and secondary angle
closure glaucoma: Untreated elevated intraocular pressure can
lead to permanent visual loss. Discontinue Trokendi XR if it
occurs. Oligohydrosis and hyperthermia: Monitor decreased
sweating and increased body temperature, especially in
pediatric patients. Metabolic acidosis: Measure baseline and
periodic measurement of serum bicarbonate. Consider dose
reduction or discontinuation of Trokendi XR if clinically
appropriate. Suicidal behavior and ideation: Antiepileptic drugs
increase the risk of suicidal behavior or ideation. Cognitive/
neuropsychiatric: Trokendi XR may cause cognitive dysfunction.
Use caution when operating machinery including automobiles.
Depression and mood problems may occur. Fetal toxicity:
Topiramate use during pregnancy can cause cleft lip and/or
palate. Withdrawal of AEDs: Withdrawal of Trokendi XR
should be done gradually. Hyperammonemia and
encephalopathy: Patients with inborn errors of metabolism or
reduced mitochondrial activity may have an increased risk of
hyper-ammonemia. Measure ammonia if encephalopathic
symptoms occur. Kidney stones: Avoid use with other carbonic
anhydrase inhibitors, other drugs causing metabolic acidosis,
or in patients on a ketogenic diet. Hypothermia: Reported with
concomitant valproic acid use.
Adverse Reactions: Most common (>5% more frequent
than placebo or low-dose topiramate in monotherapy):
paresthesia, anorexia, weight decrease, fatigue, dizziness,
somnolence, nervousness, psychomotor slowing, difficulty
with memory, difficulty with concentration/attention,
cognitive problem, confusion, mood problems, fever, infection,
and flushing.
Drug Interactions: Oral contraceptives: Decreased
contraceptive efficacy and increased breakthrough bleeding,
especially at doses greater than 200 mg per day. Phenytoin or
carbamazepine: Concomitant administration with topiramate
decreased plasma concentrations of topiramate. Other carbonic
anhydrase inhibitors: Monitor for the appearance or worsening
of metabolic acidosis. Lithium: Monitor lithium levels when
co-administered with high-dose topiramate.
Specific Populations: Renal Impairment: (creatinine
clearance less than 70 mL/min/1.73m2
), one-half of the adult
dose is recommended. Patients undergoing hemodialysis:
Topiramate is cleared by hemodialysis. Dosage adjustment is
necessary to avoid rapid drops in topiramate plasma
concentration during hemodialysis. Pregnancy: Increased risk of
cleft lip and/or palate. Pregnancy registry available. Nursing
mothers: Caution should be exercised when administered to a
nursing mother. Pediatric Use: Because the capsule must be
swallowed whole, and may not be sprinkled on food, crushed
or chewed, Trokendi XR is recommended only for children
ages 6 years and older.
How Supplied: XR caps–30
