Qudexy Xr

QUDEXY XR is indicated for:

• Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (
  
  1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older (
  
  1.2)
  
• Preventive treatment of migraine in patients 12 years of age and older (
  
  1.3)
  

• QUDEXY XR initial dose, titration, and recommended maintenance dose varies by indication and age group. See Full Prescribing Information for recommended dosage, and dosing considerations in patients with renal impairment, geriatric patients, and patients undergoing hemodialysis (
  
  2.1,
  
  2.2,
  
  2.3,
  
  2.4,
  
  2.5,
  
  2.6)
  
• Capsules may be swallowed whole or opened and sprinkled on a spoonful of soft food (
  
  2.6)
  

QUDEXY XR (topiramate) extended-release capsules are available in the following strengths and colors:

• 25 mg: light pink and grey capsules, printed with "UPSHER-SMITH" on the cap in black ink and "25 mg" on the body in black ink
• 50 mg: golden yellow and grey capsules, printed with "UPSHER-SMITH" on the cap in black ink and "50 mg" on the body in black ink
• 100 mg: reddish brown and grey capsules, printed with "UPSHER-SMITH" on the cap in black ink and "100 mg" on the body in black ink
• 150 mg: pale yellow and grey capsules, printed with "UPSHER-SMITH" on the cap in black ink and "150 mg" on the body in black ink
• 200 mg: brown and grey capsules, printed with "UPSHER-SMITH" on the cap in white ink and "200 mg" on the body in black ink

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as QUDEXY XR, during pregnancy. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334. Information about the North American Drug Pregnancy Registry can be found at http://www.aedpregnancyregistry.org/.

• Acute myopia and secondary angle closure glaucoma: can lead to permanent visual loss; discontinue QUDEXY XR as soon as possible (
  
  5.1)
  
• Visual field defects: consider discontinuation of QUDEXY XR (
  
  5.2)
  
• Oligohydrosis and hyperthermia: monitor decreased sweating and increased body temperature, especially in pediatric patients (
  
  5.3)
  
• Metabolic acidosis: baseline and periodic measurement of serum bicarbonate is recommended; consider dose reduction or discontinuation of QUDEXY XR if clinically appropriate (
  
  5.4)
  
• Suicidal behavior and ideation: antiepileptic drugs increase the risk of suicidal behavior or ideation (
  
  5.5)
  
• Cognitive/neuropsychiatric adverse reactions: use caution when operating machinery including cars; depression and mood problems may occur (
  
  5.6)
  
• Fetal Toxicity: use during pregnancy can cause major congenital malformations, including but not limited to cleft lip and/or palate and being small for gestational age (
  
  5.7)
  
• Withdrawal of AEDs: withdraw QUDEXY XR gradually (
  
  5.8)
  
• Decrease in Bone Mineral Density: has been shown to decrease bone mineral density and bone mineral content in pediatric patients (
  
  5.9)
  
• Negative effects on growth (height and weight): may slow height increase and weight gain; carefully monitor children receiving prolonged therapy (
  
  5.10)
  
• Serious skin reactions: If SJS or TEN is suspected, discontinue QUDEXY XR (
  
  5.11)
  
• Hyperammonemia/encephalopathy: measure ammonia if encephalopathic symptoms occur (
  
  5.12)
  
• Kidney stones: avoid use with other carbonic anhydrase inhibitors, drugs causing metabolic acidosis, or in patients on a ketogenic diet (
  
  5.13)
  
• Hypothermia has been reported with and without hyperammonemia during topiramate treatment with concomitant valproic acid use (
  
  5.14)