Trokendi XR 50 mg/1
topiramate · CAPSULE, EXTENDED RELEASE · Supernus Pharmaceuticals, Inc.
Trokendi XR is a capsule, extended release containing topiramate at 50 mg/1, taken oral. Manufactured by Supernus Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Trokendi XR
- Generic Name
- topiramate
- NDC Code (Product)
17772-102- Manufacturer
- Supernus Pharmaceuticals, Inc.
- Strength
- 50 mg/1
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA201635
- Drug Class
- Cytochrome P450 3A4 Inducers [MoA]; Cytochrome P450 2C19 Inhibitors [MoA]
- Marketing Start
- 08/16/2013
Recall History
Supernus Pharmaceuticals, Inc.
Superpotent Drug: Failure of assay specifications in the capsule.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE TROKENDI XR is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 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 TROKENDI XR is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older [see Clinical Studies (14.2) ] . 1.2 Adjunctive Therapy Epilepsy TROKENDI 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 6 years of age and older [see Clinical Studies (14.3) ] . 1.3 Migraine TROKENDI XR is indicated for the preventive treatment of migraine in patients 12 years of age and older [see Clinical Studies (14.4) ] .
Dosage & Administration
2 DOSAGE AND ADMINISTRATION TROKENDI 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 ) Swallow capsule whole and intact. Do not sprinkle on food, chew, or crush ( 2.7 ) 2.1 Dosing in Monotherapy Epilepsy Adults and Pediatric Patients 10 Years of Age and Older with Partial Onset or Primary Generalized Tonic-Clonic Seizures The recommended dose for TROKENDI XR monotherapy in adults and in pediatric patients 10 years of age and older is 400 mg orally once daily. Titrate TROKENDI XR according to the following schedule: Week 1: 50 mg once daily Week 2: 100 mg once daily Week 3: 150 mg once daily Week 4: 200 mg once daily Week 5: 300 mg once daily Week 6: 400 mg once daily Pediatric Patients Ages 6 to 9 Years of Age Dosing in patients 6 to 9 years of age is based on weight. During the titration period, the initial dose of TROKENDI XR is 25 mg/day nightly for the first week. Based upon tolerability, the dosage can be increased to 50 …
Contraindications
4 CONTRAINDICATIONS TROKENDI XR is contraindicated in patients with: recent alcohol use (i.e., within 6 hours prior to and 6 hours after TROKENDI XR use) [see Warnings and Precautions (5.5) ]. a history of hypersensitivity reaction to topiramate, TROKENDI XR, or any of the inactive ingredients of TROKENDI XR. Anaphylaxis and angioedema have occurred [see Warnings and Precautions (5.14) ]. With recent alcohol use, i.e., within 6 hours prior to and 6 hours after TROKENDI XR use ( 4 , 5.5 ) History of hypersensitivity reaction to topiramate. TROKENDI XR, or any of the inactive ingredients of TROKENDI XR ( 4 , 5.14 )
Drug Interactions
7 DRUG INTERACTIONS Contraceptives: Decreased contraceptive efficacy and increased breakthrough bleeding, especially at doses greater than 200 mg per day ( 7.5 ) Monitor lithium levels if lithium is used with high-dose TROKENDI XR ( 7.8 ) 7.1 Alcohol Alcohol use is contraindicated within 6 hours prior to and 6 hours after TROKENDI XR administration [see Contraindications (4) and Warnings and Precautions (5.5) ]. 7.2 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 Dosage and Administration (2.1) , 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 (5.15 , 5.17) and Clinical Pharmacology (12.3) ] . 7.3 Other Carbonic Anhydrase Inhibitors Concomitant use of topiramate, a carbonic anhydrase inhibitor, with any other carbonic anhydras…
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) ] Interaction With Alcohol [see Warnings and Precautions (5.5) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.6) ] Cognitive/Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5.7) ] Fetal Toxicity [see Warnings and Precautions (5.8) ] Withdrawal of Antiepileptic Drugs [see Warnings and Precautions (5.9) ] Decrease of Bone Mineral Density [see Warnings and Precautions (5.10) ] Negative Effects on Growth (Height and Weight) [see Warnings and Precautions (5.11) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions [see Warnings and Precautions (5.12) ] Serious Skin Reactions [see Warnings and Precautions (5.13) ] Anaphylaxis and Angioedema [see Warnings and Precautions (5.14) ] Hyperammonemia and Encephalopathy (Witho…
Frequently Asked Questions
What is Trokendi XR used for?
Trokendi XR contains topiramate. It is a capsule, extended release taken oral. Consult your doctor for specific uses.
Is Trokendi XR a controlled substance?
Trokendi XR is not classified as a controlled substance by the DEA.
What is the generic name for Trokendi XR?
The generic name for Trokendi XR is topiramate. There are 12 other brand versions of topiramate.
What is the NDC code for Trokendi XR 50 mg/1?
The NDC (National Drug Code) for Trokendi XR 50 mg/1 is 17772-102, listed by Supernus Pharmaceuticals, Inc..