QUDEXY XR 50 mg/1
Topiramate · CAPSULE, EXTENDED RELEASE · Upsher-Smith Laboratories, LLC
Qudexy XR is an extended-release oral capsule containing topiramate, used to treat epilepsy and prevent migraines. This medication works by inducing certain enzymes in your body that affect how other drugs are processed.
Key Facts
- Brand Name
- QUDEXY XR
- Generic Name
- Topiramate
- NDC Code (Product)
0245-1072- Manufacturer
- Upsher-Smith Laboratories, LLC
- Strength
- 50 mg/1
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA205122
- Drug Class
- Cytochrome P450 3A4 Inducers [MoA]; Cytochrome P450 2C19 Inhibitors [MoA]
- Marketing Start
- 04/11/2014
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 ) 1.1 Monotherapy Epilepsy QUDEXY XR is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.2 Adjunctive Therapy Epilepsy QUDEXY XR is indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older. 1.3 Migraine QUDEXY XR is indicated for the preventive treatment of migraine in patients 12 years of age and older.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 ) 2.1 Dosing in Monotherapy Epilepsy Adults and Pediatric Patients 10 Years of Age and Older The recommended dose for QUDEXY XR monotherapy in adults and pediatric patients 10 years of age and older is 400 mg orally once daily. Titrate QUDEXY XR according to the following schedule (see Table 1 ). Table 1: Monotherapy Titration Schedule for Adults and Pediatric Patients 10 Years of Age and Older QUDEXY XR Once Daily Dose Week 1 50 mg Week 2 100 mg Week 3 150 mg Week 4 200 mg Week 5 300 mg Week 6 400 mg Pediatric Patients 2 to 9 Years of Age Dosing in patients 2 to 9 years of age is based on weight. During the titration period, the initial dose of QUDEXY XR is 25 mg/day nightly for the first week. Based upon tolerability, the dosage can be increased to 50 mg…
Contraindications
4 CONTRAINDICATIONS QUDEXY XR is contraindicated in patients with a history of hypersensitivity reaction to topiramate, QUDEXY XR, or any of the inactive ingredients of QUDEXY XR. Anaphylaxis and angioedema have occurred with topiramate [see Warnings and Precautions (5.13) ]. History of hypersensitivity reaction to topiramate, QUDEXY XR, or any of the inactive ingredients of QUDEXY XR (4, 5.13)
Drug Interactions
7 DRUG INTERACTIONS Oral contraceptives: decreased contraceptive efficacy and increased breakthrough bleeding, especially at doses greater than 200 mg per day ( 7.4 ) Monitor lithium levels if lithium is used with high-dose QUDEXY XR ( 7.7 ) 7.1 Antiepileptic Drugs Concomitant administration of phenytoin or carbamazepine with topiramate resulted in a clinically significant decrease in plasma concentrations of topiramate when compared to topiramate given alone. A dosage adjustment may be needed [see Clinical Pharmacology (12.3) ] . Concomitant administration of valproic acid and topiramate has been associated with hypothermia and hyperammonemia with and without encephalopathy. Examine blood ammonia levels in patients in whom the onset of hypothermia has been reported [see Warnings and Precautions (5.12 , 5.14) , Clinical Pharmacology (12.3) ]. 7.2 Other Carbonic Anhydrase Inhibitors Concomitant use of topiramate, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e.g., zonisamide or acetazolamide) may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation. Patients should be monitored for the appearance or worse…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections of the labeling: Acute Myopia and Secondary Angle Closure Glaucoma [see Warnings and Precautions (5.1) ] Visual Field Defects [see Warnings and Precautions (5.2) ] Oligohydrosis and Hyperthermia [see Warnings and Precautions (5.3) ] Metabolic Acidosis [see Warnings and Precautions (5.4) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.5) ] Cognitive/Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5.6) ] Decrease in Bone Mineral Density [see Warnings and Precautions (5.9) ] Negative Effects on Growth (Height and Weight) [see Warnings and Precautions (5.10) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan • Hypersensitivity Reactions [see Warnings and Precautions (5.11) ] Serious Skin Reactions [see Warnings and Precautions (5.12) ] Anaphylaxis and Angioedema [see Warnings and Precautions (5.13) ] Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid Use [see Warnings and Precautions (5.14) ] Kidney Stones [see Warnings and Precautions (5.15) ] Hypothermia with Concomitant Valproic Acid Use [see…
Frequently Asked Questions
What is QUDEXY XR used for?
Qudexy XR is an extended-release oral capsule containing topiramate, used to treat epilepsy and prevent migraines. This medication works by inducing certain enzymes in your body that affect how other drugs are processed.
Is QUDEXY XR a controlled substance?
QUDEXY XR is not classified as a controlled substance by the DEA.
What is the generic name for QUDEXY XR?
The generic name for QUDEXY XR is Topiramate. There are 11 other brand versions of Topiramate.
What is the NDC code for QUDEXY XR 50 mg/1?
The NDC (National Drug Code) for QUDEXY XR 50 mg/1 is 0245-1072, listed by Upsher-Smith Laboratories, LLC.