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Qudexy XR

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Qudexy XR

Indications
Dosage
How Supplied

INDICATIONS

Partial Onset Seizures and Primary Generalized Tonic-Clonic Seizures

QUDEXY 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 2 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

QUDEXY XR (topiramate) extended-release capsules are indicated as adjunctive therapy in patients 2 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 QUDEXY 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 QUDEXY XR as adjunctive therapy in adults with partial onset seizures or Lennox-Gastaut Syndrome is 200 mg to 400 mg orally once daily. The recommended total dose for adults 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 50 mg 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 2 Years to 16 Years) -Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome

The recommended total daily dose of QUDEXY 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 2 week 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].

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 [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

Prior to dosing, obtain an estimated creatinine clearance (CrCl) in patients at high risk for renal insufficiency (e.g., older patients, or those with diabetes mellitus, hypertension, or autoimmune disease). CrCl can be estimated using the following equation (multiply by 0.85 for women):

CrCl: (weight in kg) x (140 – age)
(72) x serum creatinine (mg/100 mL)

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:

Laboratory Testing Prior To Treatment Initiation

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

Dosing Modifications In Patients Taking Phenytoin And/Or Carbamazepine

The co-administration of QUDEXY 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 QUDEXY XR may require adjustment of the dose of QUDEXY XR [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Monitoring For Therapeutic Blood Levels

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

Administration Instructions

QUDEXY XR capsules may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoon) of soft food. This drug/food mixture should be swallowed immediately and not chewed or crushed. Do not store drug/food mixture for further use. QUDEXY XR can be taken without regard to meals [see CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

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

QUDEXY XR Capsules

QUDEXY XR (topiramate) extended-release capsules contain beads of topiramate in a capsule and 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. 25 mg capsules are available in the following package configurations:

Bottle of 30 count with desiccant (NDC 0245-1071-30)
Bottle of 90 count with desiccant (NDC 0245-1071-90)
Bottle of 500 count with desiccant (NDC 0245-1071-15)

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. 50 mg capsules are available in the following package configurations:

Bottle of 30 count with desiccant (NDC 0245-1072-30)
Bottle of 90 count with desiccant (NDC 0245-1072-90)
Bottle of 500 count with desiccant (NDC 0245-1072-15)

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. 100 mg capsules are available in the following package configurations:

Bottle of 30 count with desiccant (NDC 0245-1074-30)
Bottle of 90 count with desiccant (NDC 0245-1074-90)
Bottle of 500 count with desiccant (NDC 0245-1074-15)

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. 150 mg capsules are available in the following package configurations:

Bottle of 30 count with desiccant (NDC 0245-1075-30)
Bottle of 90 count with desiccant (NDC 0245-1075-90)
Bottle of 500 count with desiccant (NDC 0245-1075-15)

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. 200 mg capsules are available in the following package configurations:

Bottle of 30 count with desiccant (NDC 0245-1073-30)
Bottle of 90 count with desiccant (NDC 0245-1073-90)
Bottle of 500 count with desiccant (NDC 0245-1073-15)

Storage And Handling

QUDEXY XR (topiramate) extended-release capsules should be stored in a tightly-closed container at 20 to 25°C (68 to 77°F). Excursions permitted 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Distributed by : Upsher-Smith Laboratories, Inc., Maple Grove, MN 55369. Revised: 3/2014

Last reviewed on RxList: 3/28/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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