Recommended Topic Related To:

Trokendi XR

"About 1 out of 10 people has had a seizure. Do you know what to do if someone has a seizure near you? Read below to learn more.

About 1 out of 10 people has had a seizure. That means seizures are common, and one day you might need to help s"...

Trokendi XR

Indications
Dosage
How Supplied

INDICATIONS

Partial Onset Seizure and Primary Generalized Tonic-Clonic Seizures

Trokendi XR™ (topiramate) extended-release capsules are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures and adjunctive therapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures [see Clinical Studies]. 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 [see Clinical Studies].

Lennox-Gastaut Syndrome

Trokendi XR™ (topiramate) extended-release capsules are indicated as adjunctive therapy in patients 6 years of age and older with seizures associated with Lennox-Gastaut syndrome [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Monotherapy Use

Adults and Pediatric Patients 10 Years and Older with Partial Onset or Primary Generalized Tonic-Clonic Seizures

The recommended dose for topiramate monotherapy in adults and 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

Adjunctive Therapy Use

Adults (17 Years of Age and Older) -Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome

The recommended total daily dose of Trokendi XR™ as adjunctive therapy in adults with partial onset seizures or Lennox-Gaustaut Syndrome is 200 mg to 400 mg orally once daily with primary generalized tonic-clonic seizures is 400 mg orally once daily.

Initiate therapy at 25 mg to 50 mg once daily followed by titration to an effective dose in increments of 25 mg to 50mg every week. Daily topiramate doses above 1,600 mg have not been studied.

In the study of primary generalized tonic-clonic seizures using topiramate, the assigned dose was reached at the end of 8 weeks [see Clinical Studies].

Pediatric Patients (Ages 6 years to 16 Years) -Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome

The recommended total daily dose of Trokendi XR™ as adjunctive therapy for pediatric patients with partial onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 mg/kg to 9 mg/kg orally once daily. Begin titration at 25 mg once daily (based on a range of 1 mg/kg/day to 3 mg/kg/day) given nightly for the first week. Subsequently, increase the dosage at 1-or 2week intervals by increments of 1 mg/kg to 3 mg/kg to achieve optimal clinical response. Dose titration should be guided by clinical outcome. If required, longer intervals between dose adjustments can be used.

In the study of primary generalized tonic-clonic seizures, the assigned dose of 6 mg/kg once daily was reached at the end of 8 weeks [see Clinical Studies].

Administration with Alcohol

Alcohol use should be completely avoided within 6 hours prior to and 6 hours after Trokendi XR™ administration [see WARNINGS AND PRECAUTIONS].

Dose Modifications in Patients with Renal Impairment

In patients with renal impairment (creatinine clearance less than 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.

Prior to dosing, obtain an estimated GFR measurement in patients at high risk for renal insufficiency (e.g., older patients, or those with diabetes mellitus, hypertension, or autoimmune disease).

Dosage Modifications in Patients Undergoing Hemodialysis

Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than in patients with normal renal function. Accordingly, a prolonged period of dialysis may cause topiramate concentration to fall below that required to maintain an anti-seizure effect. To avoid rapid drops in topiramate plasma concentration during hemodialysis, 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
  • effective renal clearance of topiramate in the patient being dialyzed.

Laboratory Testing Prior to Treatment Initiation

Measurement of baseline and periodic serum bicarbonate during Trokendi XR™ treatment is recommended [see WARNINGS AND PRECAUTIONS].

Dosing Modifications in Patients Taking Phenytoin and/or Carbamazepine

The co-administration of Trokendi XR™ with phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy with Trokendi XR™ may require adjustment of the dose of Trokendi XR™.

Monitoring for Therapeutic Blood Levels

It is not necessary to monitor topiramate plasma concentrations to optimize Trokendi XR™ therapy.

Administration Instructions

Trokendi XR™ can be taken without regard to meals.

Swallow capsule whole and intact. Do not sprinkle on food, chew or crush.

HOW SUPPLIED

Dosage Forms And Strengths

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

25 mg: Size 2 capsules, light green opaque body/yellow opaque cap (printed “SPN” on the cap, “25” on the body)

50 mg: Size 0 capsules, light green opaque body/orange opaque cap (printed “SPN” on the cap, “50” on the body)

100 mg: Size 00 capsules, green opaque body/blue opaque cap (printed “SPN” on the cap, “100” on the body)

200 mg: Size 00 capsules, pink opaque body/blue opaque cap (printed “SPN” on the cap, “200” on the body)

Trokendi XR™ Capsules

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

Bottles

25 mg (light green opaque body/yellow opaque cap) topiramate extended-release capsules (black print “SPN” and “25”) -bottles of 100 count (NDC-17772-101-01)

50 mg (light green opaque body/orange opaque cap) topiramate extended-release capsules (black print “SPN” and “50”) -bottles of 100 count (NDC-17772-102-01)

100 mg (green opaque body/blue opaque cap) topiramate extended-release capsules (black print “SPN” and “100”) -bottles of 100 count (NDC-17772-103-01)

200 mg (pink opaque body/blue opaque cap) topiramate extended-release capsules (black print “SPN” and “200”) -bottles of 100 count (NDC-17772-104-01)

Blister package

25 mg (light green opaque body/yellow opaque cap) topiramate extended-release capsules (black print “SPN” and “25”) – blister packages of 30-count (NDC-17772-101-15)

50 mg (light green opaque body/orange opaque cap) topiramate extended-release capsules (black print “SPN” and “50”) – blister packages of 30-count (NDC-17772-102-15)

100 mg (green opaque body/blue opaque cap) topiramate extended-release capsules (black print “SPN” and “100”) – blister packages of 30-count (NDC-17772-103-15)

200 mg (pink opaque body/blue opaque cap) topiramate extended-release capsules (black print “SPN” and “200”) – blister packages of 30-count (NDC-17772-104-15)

Storage and Handling

Trokendi XR™ (topiramate) extended-release capsules should be stored in well closed containers at controlled room temperature [25°C (77°F); excursions 15°C-30°C (59°F-86°F)]. Protect from moisture and light.

Manufactured by: Catalent Pharma Solutions, Winchester, Kentucky 40391. Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, Maryland 20850. August 2013

Last reviewed on RxList: 9/9/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Epilepsy

Find tips and treatments to control seizures.