Explore the Difference With
Qudexy® XR

INDICATIONS

  • Qudexy® XR (topiramate) Extended-Release Capsules are indicated as 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. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.
  • Qudexy XR (topiramate) Extended-Release Capsules are indicated as adjunctive therapy in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.

Important Safety Information

Backed by PREVAIL Phase 3 Data

Demonstrated efficacy and
favorable tolerability profile1

100% Extended-Release Bead Formulation

Specifically engineered to deliver a smooth PK profile1,2

$0 Co-Pay Offer

Cost savings for your patients, time-saving support for you

Expand Collapse

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Qudexy® XR is contraindicated in patients with metabolic acidosis who are taking concomitant metformin.

WARNINGS & PRECAUTIONS

  • A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate. Symptoms can include acute onset of decreased visual acuity and/or ocular pain, myopia, anterior chamber shallowing, ocular hyperemia, and increased intraocular pressure. Symptoms typically occur within 1 month of initiating topiramate therapy. The primary treatment to reverse symptoms is discontinuation of Qudexy XR as rapidly as possible. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss.
  • 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 resulting in hospitalization has been reported in some cases in association with topiramate use. The majority of reports have been in pediatric patients. Patients, especially pediatric 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.
  • Hyperchloremic, non-anion gap metabolic acidosis has been reported in adults and pediatric patients treated with topiramate. This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of topiramate on carbonic anhydrase. Conditions that predispose patients to acidosis may be additive to the bicarbonate lowering effects of topiramate. Although Qudexy XR is not indicated for use in infants or toddlers less than 2 years of age, a study of topiramate as adjunctive treatment in patients under 2 produced metabolic acidosis of a notably greater magnitude than in older children and adults. 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.
  • Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED, including Qudexy XR for any indication, should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Anyone prescribing Qudexy XR must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which antiepileptic drugs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment with Qudexy XR, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.
  • Adverse reactions most often associated with use of topiramate, and therefore expected to be associated with the use of Qudexy XR, were related to the central nervous system (CNS) and were observed in the epilepsy population. 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 observed with topiramate in the adjunctive epilepsy population include dizziness or ataxia. In double-blind adjunctive and monotherapy epilepsy clinical studies conducted with topiramate, the incidence of cognitive/neuropsychiatric adverse reactions in pediatric patients was generally lower than observed in adults.
  • 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 can have increased risk of cleft lip and/or cleft palate. Qudexy XR should only be used during pregnancy if the potential benefit outweighs the potential risk. All women of childbearing potential should be informed of the potential hazard to the fetus.
  • Caution should be exercised when administered to a nursing mother.
  • 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.
  • Antiepileptic drugs, including Qudexy XR, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency.
  • Hyperammonemia with and without encephalopathy has been observed in post-marketing reports in patients who were taking topiramate with or without concomitant valproic acid (VPA); hyperammonemia appears more common when used concomitantly with VPA. Although Qudexy XR is not indicated for use in infants or toddlers less than 2 years of age, topiramate with concomitant VPA produced a dose-related increase in hyperammonemia in this population. Patients with inborn errors of metabolism or reduced mitochondrial activity may have an increased risk of hyperammonemia. Measure ammonia if encephalopathic symptoms occur.
  • 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.
  • Hypothermia has been reported in association with topiramate use with concomitant valproic acid (VPA) both in the presence and in the absence of hyperammonemia. Consideration should be given to stopping topiramate or valproate in patients who develop hypothermia; clinical management should include examination of blood ammonia levels.
  • Paresthesia, an effect associated with the use of other carbonic anhydrase inhibitors, appears to be a common effect of topiramate in adult and pediatric patients, and was more frequently reported in monotherapy epilepsy trials with topiramate than adjunctive therapy epilepsy trials.
  • Topiramate is a CNS depressant. Concomitant administration of topiramate with other CNS depressant drugs can result in significant CNS depression. Patients should be watched carefully when Qudexy XR is coadministered with other CNS depressant drugs.

DOSING GUIDELINES & CONSIDERATIONS

  • Refer to the Qudexy XR - DOSAGE AND ADMINISTRATION section of the full prescribing information for recommended dosing guidelines for Qudexy XR.
  • In patients with renal impairment (creatinine clearance <70 mL/min/1.73 m2), one-half of the usual adult dose is recommended. Such patients will require a longer time to reach steady-state at each dose.
  • In patients undergoing hemodialysis, to avoid rapid drops in topiramate plasma concentration, a supplemental dose of topiramate may be required. The actual adjustment should take into account the duration of dialysis period, clearance rate of the dialysis system being used, and the effective renal clearance of topiramate in the patient being dialyzed.
  • Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy with Qudexy XR may require adjustment of the dose of Qudexy XR.
  • Qudexy XR may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents on a small amount of soft food. Qudexy XR can be taken without regard to meals.
  • Patients should not drink alcohol while taking Qudexy XR.

ADVERSE REACTIONS

  • 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 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.

Please refer to the full Prescribing Information for Qudexy XR, including Medication Guide.

INDICATIONS

Qudexy® XR (topiramate) Extended-Release Capsules are indicated as 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. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials. Qudexy XR is also indicated as adjunctive therapy in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.

Qudexy is a registered trademark of Upsher-Smith Laboratories, Inc.

 

This site is intended for
US Healthcare Professionals only.

Are you a US Healthcare Professional?

YES NO

You are now leaving hcp.QudexyXR.com

OK Cancel

Full Prescribing
Information
Medication
Guide

Rotate Image   Rotate for Important Safety Information