IMPORTANT SAFETY INFORMATION
XR is contraindicated in patients with metabolic acidosis who are taking concomitant metformin (Glucophage®
WARNINGS & PRECAUTIONS
USE IN SPECIFIC POPULATIONS
- Acute Myopia and Secondary Angle Closure Glaucoma. A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate, with symptoms typically occurring within 1 month of therapy initiation. The primary treatment to reverse symptoms is discontinuation of Qudexy XR as rapidly as possible. If left untreated, elevated intraocular pressure can lead to serious sequelae, including permanent vision loss.
- Visual Field Defects. Visual field defects have been reported in patients receiving topiramate independent of elevated intraocular pressure. If visual problems occur at any time during topiramate treatment, consideration should be given to discontinuing the drug.
- Oligohydrosis and Hyperthermia. Oligohydrosis, resulting in hospitalization in some cases, has been reported in association with topiramate use. The majority of reports have been in pediatric patients, but all patients should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Caution should be used when Qudexy XR is prescribed with other drugs that predispose patients to heat-related disorders.
- Metabolic Acidosis. Hyperchloremic, non-anion gap metabolic acidosis has been reported in patients treated with topiramate, due to its inhibitory effect on carbonic anhydrase. Conditions that predispose patients to acidosis may be additive to the bicarbonate lowering effects of topiramate. Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering).
- Suicidal Behavior and Ideation. Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with Qudexy XR should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Patients, their caregivers, and families should be informed of these risks and behaviors of concern should be immediately reported to healthcare providers.
- Cognitive/Neuropsychiatric Adverse Reactions. Adverse reactions most often associated with use of topiramate were related to the central nervous system (CNS) and were observed in the epilepsy and migraine populations. In adults, the most frequent of these can be classified into three general categories: cognitive-related dysfunction, psychiatric/behavioral disturbances, and somnolence or fatigue. Additional nonspecific CNS events commonly observed with topiramate in the adjunctive epilepsy population include dizziness or ataxia. In migraine prophylaxis controlled trials, the most common cognitive adverse reaction was difficulty with concentration/attention. These adverse reactions typically occurred in isolation as a single type of cognitive adverse reaction. Patients should use caution when operating machinery including automobiles. Depression and mood problems may occur.
- Fetal Toxicity. Topiramate can cause fetal harm when administered to a pregnant woman. Use during pregnancy and data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk of cleft lip and/or cleft palate and of being small for gestational age. Qudexy XR should be used during pregnancy only if the potential benefit outweighs the potential risk. All women of childbearing potential should be informed of the potential hazard to the fetus and counseled to use effective contraception, as appropriate.
- Withdrawal of Antiepileptic Drugs. Antiepileptic drugs, including Qudexy XR, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency.
- Hyperammonemia and Encephalopathy. Hyperammonemia, with and without encephalopathy, has been observed in post-marketing reports in patients who were taking topiramate. Hyperammonemia appears more common when used concomitantly with valproic acid. Patients with inborn errors of metabolism or reduced mitochondrial activity may have an increased risk of hyperammonemia. Measure ammonia if encephalopathic symptoms occur.
- Kidney Stones. Topiramate is associated with the development of kidney stones. The concomitant use of Qudexy XR with other carbonic anhydrase inhibitors, any other drug producing metabolic acidosis, or potentially in patients on a ketogenic diet, may increase the risk of kidney stone formation, and should therefore be avoided. Hydration is recommended.
- Hypothermia with Concomitant Valproic Acid Use. Hypothermia has been reported in association with topiramate use with concomitant valproic acid, both in the presence and in the absence of hyperammonemia. Consideration should be given to stopping topiramate or valproate in patients who develop hypothermia.
- Paresthesia. Paresthesia, an effect associated with the use of other carbonic anhydrase inhibitors, appears to be a common effect of topiramate.
- Interaction with Other CNS Depressants. Topiramate is a CNS depressant. Concomitant administration of topiramate with other CNS depressant drugs or alcohol can result in significant CNS depression.
- Nursing Mothers: Topiramate is excreted in human milk. Caution should be exercised when administered to a nursing mother as the effects of topiramate exposure to infants are unknown.
- Females and Males of Reproductive Potential: Women of childbearing potential who are not planning a pregnancy should use effective contraception because of the risks to the fetus of oral clefts and of being small for gestational age.
- Pregnancy: Increased risk of cleft lip and/or palate.
- Patients with Renal Impairment: One-half of the usual adult dose is recommended.
- Patients Undergoing Hemodialysis: To avoid rapid drops in topiramate plasma concentration, a supplemental dose of topiramate may be required.
- Geriatric use: Dosage adjustment may be necessary for elderly with impaired renal function.
- Oral Contraceptives: The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with Qudexy XR, especially at doses >200 mg/day.
- Lithium: Monitor lithium levels when co-administered with high-dose topiramate.
- 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.
- Concomitant use of alcohol should be avoided.
- The most common (≥10% more frequent than placebo or low-dose topiramate in monotherapy) adverse reactions in adult and pediatric controlled, epilepsy 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.
- The most common (≥5% more frequent than placebo) adverse reactions at recommended dosing in adult and adolescent controlled, migraine clinical trials were paresthesia, anorexia, weight decrease, difficulty with memory, taste perversion, upper respiratory tract infection, abdominal pain, diarrhea, hypoesthesia, and nausea.
- Qudexy XR has been studied in a randomized, placebo-controlled phase 3 clinical study in 249 adult patients with a history of partial-onset seizures with or without secondary generalization. See the ADVERSE REACTIONS section of the Qudexy XR full prescribing information for adverse reaction rates from this clinical trial and other clinical trials conducted under widely varying conditions.
- The most serious adverse reactions are listed above in the WARNINGS AND PRECAUTIONS section.
Refer to the DOSAGE AND ADMINISTRATION section of the full Prescribing Information for recommended dosing guidelines for Qudexy XR, including specific populations.
XR (topiramate) Extended-Release Capsules are indicated for:
This safety information is not comprehensive. Please refer to the full Prescribing Information for Qudexy XR, WARNINGS AND PRECAUTIONS and Medication Guide. You can also visit www.upsher-smith.com or call 1-888-650-3789.
- Migraine: Prophylaxis of migraine headache in adults and adolescents 12 years of age and older.
- Partial-Onset Seizures and Primary Generalized Tonic-Clonic Seizures: Initial monotherapy in patients 2 years and older with partial-onset or primary generalized tonic-clonic seizures and adjunctive therapy in patients 2 years and older with partial-onset or primary generalized tonic-clonic seizures.
- Lennox-Gastaut Syndrome (LGS): Adjunctive therapy in patients 2 years and older with seizures associated with Lennox-Gastaut syndrome.
You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC. at 1-855-899-9180 or to the FDA by visiting www.fda.gov/medwatch
or calling 1-800-FDA-1088.
Qudexy is a registered trademark of Upsher-Smith Laboratories, LLC
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