These highlights do not include all the information needed to use QUDEXY ® XR safely and effectively. See full prescribing information for QUDEXY ® XR.
QUDEXY ® XR (topiramate) extended-release capsules, for oral use
Initial U.S. Approval: 1996
RECENT MAJOR CHANGES
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Indications and Usage, Monotherapy (1.1) |
03/2015 |
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Dosage and Administration, Monotherapy Use (2.1) |
03/2015 |
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Warnings and Precautions, Metabolic Acidosis (5.4) |
03/2015 |
INDICATIONS AND USAGE
QUDEXY XR is indicated for:
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Partial Onset Seizures and Primary Generalized Tonic-Clonic Seizures - initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures and adjunctive therapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures (1.1)
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Lennox-Gastaut Syndrome (LGS) - adjunctive therapy in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome (1.2)
DOSAGE AND ADMINISTRATION
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Initial Dose |
Titration |
Recommended Dose |
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Monotherapy: Partial Onset or Primary Generalized Tonic-Clonic Seizures |
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Adults and pediatric patients 10 years and older (2.1) |
50 mg once daily |
Increase dose weekly by increments of 50 mg for the first 4 weeks then 100 mg for weeks 5 to 6 |
400 mg once daily |
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Pediatric patients 2 to less than 10 years (2.1) |
25 mg once daily at nighttime for the first week |
Titrate the dosage over 5 to 7 weeks |
Once daily doses based on weight
(Table 2) |
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Adjunctive Therapy |
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Adults with partial onset seizures or LGS (2.2) |
25 mg to 50 mg once daily |
Increase dose weekly by increments of 25 mg to 50 mg to achieve an effective dose |
200 mg to 400 mg once daily |
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Adults with primary generalized tonic-clonic seizures (2.2) |
25 mg to 50 mg once daily |
Increase dose weekly to an effective dose by increments of 25 mg to 50 mg |
400 mg once daily |
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Pediatric patients 2 years and older with partial onset seizures, primary generalized tonic-clonic seizures or LGS (2.2) |
25 mg once daily at nighttime for the first week |
Increase dosage at 1 or 2 week intervals by increments of 1 mg/kg to 3 mg/kg; dose titration should be guided by clinical outcome |
5 mg/kg to 9 mg/kg once daily |
Capsules may be swallowed whole or opened and sprinkled on a spoonful of soft food (2.8)
DOSAGE FORMS AND STRENGTHS
Extended-release capsules: 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg (3)
CONTRAINDICATIONS
In patients with metabolic acidosis taking concomitant metformin (4) (5.4)
WARNINGS AND PRECAUTIONS
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Acute myopia and secondary angle closure glaucoma: Untreated elevated intraocular pressure can lead to permanent visual loss. Discontinue QUDEXY XR if it occurs (5.1)
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Visual field defects: These have been reported independent of elevated intraocular pressure. Consider discontinuation of QUDEXY XR (5.2)
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Oligohydrosis and hyperthermia: Monitor decreased sweating and increased body temperature, especially in pediatric patients (5.3)
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Metabolic acidosis: Measure baseline and periodic measurement of serum bicarbonate. Consider dose reduction or discontinuation of QUDEXY XR if clinically appropriate (5.4)
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Suicidal behavior and ideation: Antiepileptic drugs increase the risk of suicidal behavior or ideation (5.5)
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Cognitive/neuropsychiatric: QUDEXY XR may cause cognitive dysfunction. Use caution when operating machinery including automobiles. Depression and mood problems may occur (5.6)
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Fetal toxicity: Topiramate use during pregnancy can cause cleft lip and/or palate (5.7)
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Withdrawal of AEDs: Withdrawal of QUDEXY XR should be done gradually (5.8)
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Hyperammonemia and encephalopathy: Patients with inborn errors of metabolism or reduced mitochondrial activity may have an increased risk of hyperammonemia. Measure ammonia if encephalopathic symptoms occur (5.9)
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Kidney stones: Avoid use with other carbonic anhydrase inhibitors, other drugs causing metabolic acidosis, or in patients on a ketogenic diet (5.10)
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Hypothermia: Reported with concomitant valproic acid use (5.11)
ADVERSE REACTIONS
The most common (≥ 10% more frequent than placebo or low-dose topiramate in monotherapy) adverse reactions in adult and pediatric controlled, clinical trials of immediate release topiramate were paresthesia, anorexia, weight decrease, speech disorders and related speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision, and fever (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, Inc. at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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Oral contraceptives: Decreased contraceptive efficacy and increased breakthrough bleeding, especially at doses greater than 200 mg per day (7.1)
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Phenytoin or carbamazepine: Concomitant administration with topiramate decreased plasma concentrations of topiramate (7.2)
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Other carbonic anhydrase inhibitors: Monitor for the appearance or worsening of metabolic acidosis (7.4)
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Lithium: Monitor lithium levels when co-administered with high-dose topiramate (7.6)
USE IN SPECIFIC POPULATIONS
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Renal Impairment: (creatinine clearance less than 70 mL/min/1.73m2), one-half of the adult dose is recommended (2.3) (8.7)
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Patients undergoing hemodialysis: Topiramate is cleared by hemodialysis. Dosage adjustment is necessary to avoid rapid drops in topiramate plasma concentration during hemodialysis (2.4) (8.8)
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Pregnancy: Increased risk of cleft lip and/or palate (8.1)
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Nursing mothers: Caution should be exercised when administered to a nursing mother (8.3)
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Geriatric use: Dosage adjustment may be necessary for elderly with impaired renal function (8.5)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 4/2015
