Topiramate Extended-Release Capsules (Qudexy XR) (online only)
Med Lett Drugs Ther. 2014 Dec 8;56(1457):e126
The FDA has approved a new extended-release capsule formulation of topiramate (Qudexy XR – Upsher Smith), which can be opened and sprinkled on food for patients who have difficulty swallowing tablets or capsules, for treatment of epilepsy. Qudexy XR was marketed as a branded drug in March 2014 and as a generic drug four months later. An earlier extended-release formulation (Trokendi XR) must be swallowed whole.
Trokendi XR is approved for initial monotherapy in patients ≥10 years old with partial-onset seizures or primary generalized tonic-clonic seizures and for adjunctive therapy in patients ≥6 years old with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. Qudexy XR has been approved for the same indications, but the indication for adjunctive therapy has been extended to children ≥2 years old. Topiramate has been available for many years in immediate-release formulations (Topamax, and others) for the same indications for patients ≥2 years old. Trokendi XR and Qudexy XR both appear to be bioequivalent to immediate-release formulations of topiramate; whether they are bioequivalent to one another has not been established.
Table 1. Oral Formulations of Topiramate for Epilepsy Immediate-reiease — Topamax Topamax Sprinkle (J an' gen) Extended- release — Trokendi XR Oudexy XR (upsher Smith) Fornudations 25.50, 100. 200 mg tabs; 25 mg sprinkle Capa 25.50, 100. 200 mg tabs 15.25 mg caps Dosage' Costa $10.10 day in 2 div ded doses 25.50, 100, 100-200 mg 200 mg caps once/d 2550. 200 mg caps 475.70 545.00 445.20 365.00 186_80 1. rnonother»y to a maximtn of may be needed use, 2 WAC 30 days• dosaqe WAC • Btbolesaler acqu.s•tm costor manufacturers *.bhshd wx:e to whdesakrs; WAC represents a pubhshed catabque ist and mt reøesent actual transrt.mal Source Analy• Soua Mmth November S. 2014 Rem nt«d p« by First Oat±aü. Irr I 02014
Med Lett Drugs Ther. 2014 Dec 8;56(1457):e126
The FDA has approved a new extended-release capsule formulation of topiramate (Qudexy XR – Upsher Smith), which can be opened and sprinkled on food for patients who have difficulty swallowing tablets or capsules, for treatment of epilepsy. Qudexy XR was marketed as a branded drug in March 2014 and as a generic drug four months later. An earlier extended-release formulation (Trokendi XR) must be swallowed whole.
Trokendi XR is approved for initial monotherapy in patients ≥10 years old with partial-onset seizures or primary generalized tonic-clonic seizures and for adjunctive therapy in patients ≥6 years old with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. Qudexy XR has been approved for the same indications, but the indication for adjunctive therapy has been extended to children ≥2 years old. Topiramate has been available for many years in immediate-release formulations (Topamax, and others) for the same indications for patients ≥2 years old. Trokendi XR and Qudexy XR both appear to be bioequivalent to immediate-release formulations of topiramate; whether they are bioequivalent to one another has not been established.
Table 1. Oral Formulations of Topiramate for Epilepsy Immediate-reiease — Topamax Topamax Sprinkle (J an' gen) Extended- release — Trokendi XR Oudexy XR (upsher Smith) Fornudations 25.50, 100. 200 mg tabs; 25 mg sprinkle Capa 25.50, 100. 200 mg tabs 15.25 mg caps Dosage' Costa $10.10 day in 2 div ded doses 25.50, 100, 100-200 mg 200 mg caps once/d 2550. 200 mg caps 475.70 545.00 445.20 365.00 186_80 1. rnonother»y to a maximtn of may be needed use, 2 WAC 30 days• dosaqe WAC • Btbolesaler acqu.s•tm costor manufacturers *.bhshd wx:e to whdesakrs; WAC represents a pubhshed catabque ist and mt reøesent actual transrt.mal Source Analy• Soua Mmth November S. 2014 Rem nt«d p« by First Oat±aü. Irr I 02014
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