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Trileptal (Oxcarbazepine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Trileptal® (oxcarbazepine) is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in children aged 4 years and above with epilepsy, and as adjunctive therapy in children aged 2 years and above with epilepsy.

DOSAGE AND ADMINISTRATION

Trileptal® (oxcarbazepine) is recommended as adjunctive treatment in the treatment of partial seizures in adults and children aged 2-16 years. Trileptal is also recommended as monotherapy in the treatment of partial seizures in adults and children aged 4-16 years. All dosing should be given in a twice-a-day (BID) regimen. Trileptal oral suspension and Trileptal film-coated tablets may be interchanged at equal doses.

Trileptal should be kept out of the reach and sight of children.

Before using Trileptal oral suspension, shake the bottle well and prepare the dose immediately afterwards. The prescribed amount of oral suspension should be withdrawn from the bottle using the oral dosing syringe supplied. Trileptal oral suspension can be mixed in a small glass of water just prior to administration or, alternatively, may be swallowed directly from the syringe. After each use, close the bottle and rinse the syringe with warm water and allow it to dry thoroughly.

Trileptal can be taken with or without food (see CLINICAL PHARMACOLOGY, Pharmacokinetics subsection).

Adults

Adjunctive Therapy

Treatment with Trileptal should be initiated with a dose of 600 mg/day, given in a BID regimen. If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals; the recommended daily dose is 1200 mg/day. Daily doses above 1200 mg/day show somewhat greater effectiveness in controlled trials, but most patients were not able to tolerate the 2400 mg/day dose, primarily because of CNS effects. It is recommended that the patient be observed closely and plasma levels of the concomitant AEDs be monitored during the period of Trileptal titration, as these plasma levels may be altered, especially at Trileptal doses greater than 1200 mg/day (see PRECAUTIONS, Drug Interactions subsection).

Conversion to Monotherapy

Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with Trileptal at 600 mg/day (given in a BID regimen) while simultaneously initiating the reduction of the dose of the concomitant AEDs. The concomitant AEDs should be completely withdrawn over 3-6 weeks, while the maximum dose of Trileptal should be reached in about 2-4 weeks. Trileptal may be increased as clinically indicated by a maximum increment of 600 mg/day at approximately weekly intervals to achieve the recommended daily dose of 2400 mg/day. A daily dose of 1200 mg/day has been shown in one study to be effective in patients in whom monotherapy has been initiated with Trileptal. Patients should be observed closely during this transition phase.

Initiation of Monotherapy

Patients not currently being treated with AEDs may have monotherapy initiated with Trileptal. In these patients, Trileptal should be initiated at a dose of 600 mg/day (given in a BID regimen); the dose should be increased by 300 mg/day every third day to a dose of 1200 mg/day. Controlled trials in these patients examined the effectiveness of a 1200 mg/day dose; a dose of 2400 mg/day has been shown to be effective in patients converted from other AEDs to Trileptal monotherapy (see above).

Pediatric Patients

Adjunctive Therapy (Aged 2-16 Years )

In pediatric patients aged 4-16 years, treatment should be initiated at a daily dose of 8-10 mg/kg generally not to exceed 600 mg/day, given in a BID regimen. The target maintenance dose of Trileptal should be achieved over two weeks, and is dependent upon patient weight, according to the following chart:

      20-29 kg - 900 mg/day

      29.1-39 kg - 1200 mg/day

     >39 kg - 1800 mg/day

In the clinical trial, in which the intention was to reach these target doses, the median daily dose was 31 mg/kg with a range of 6-51 mg/kg.

In pediatric patients aged 2-<4 years, treatment should also be initiated at a daily dose of 8-10 mg/kg generally not to exceed 600 mg/day, given in a BID regimen. For patients under 20 kg, a starting dose of 16-20 mg/kg may be considered (see CLINICAL PHARMACOLOGY). The maximum maintenance dose of Trileptal should be achieved over 2-4 weeks and should not exceed 60 mg/kg/day in a BID regimen.

In the clinical trial in pediatric patients (2 to 4 years of age) in which the intention was to reach the target dose of 60 mg/kg/day, 50% of patients reached a final dose of at least 55 mg/kg/day.

Under adjunctive therapy (with and without enzyme-inducing AEDs), when normalized by body weight, apparent clearance (L/hr/kg) decreased when age increased such that children 2 to <4 years of age may require up to twice the oxcarbazepine dose per body weight compared to adults; and children 4 to ≤12 years of age may require a 50% higher oxcarbazepine dose per body weight compared to adults.

Conversion to Monotherapy (Aged 4-16   Years )

Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with Trileptal at approximately 8-10 mg/kg/day given in a BID regimen, while simultaneously initiating the reduction of the dose of the concomitant antiepileptic drugs. The concomitant antiepileptic drugs can be completely withdrawn over 3-6 weeks while Trileptal may be increased as clinically indicated by a maximum increment of 10 mg/kg/day at approximately weekly intervals to achieve the recommended daily dose. Patients should be observed closely during this transition phase.

The recommended total daily dose of Trileptal is shown in the table below.

Initiation of Monotherapy (Aged 4-16 Years )

Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with Trileptal. In these patients, Trileptal should be initiated at a dose of 8-10 mg/kg/day given in a BID regimen. The dose should be increased by 5 mg/kg/day every third day to the recommended daily dose shown in the table below.

Table8: Range of Maintenance Doses of Trileptal® for Children by Weight During Monotherapy
From To
Weight
in kg
Dose
(mg/day)
Dose
(mg/day)
      20600900
      259001200
      309001200
      359001500
      409001500
      4512001500
      5012001800
      5512001800
      6012002100
      6512002100
      7015002100

Patients with Hepatic Impairment

In general, dose adjustments are not required in patients with mild-to-moderate hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations subsection).

Patients with Renal Impairment

In patients with impaired renal function (creatinine clearance <30 mL/min) Trileptal therapy should be initiated at one-half the usual starting dose (300 mg/day) and increased slowly to achieve the desired clinical response (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations subsection).

HOW SUPPLIED

Tablets

150 mg Film-Coated Tablets:   pale grey-green, ovaloid, slightly biconvex, scored on both sides. Imprinted with T/D on one side and C/G on the other side.

Bottle of 100………………………………………………………………..NDC 0078-0456-05

Unit Dose (blister pack)

      Box of 100 (strips of 10)…………………………………………...NDC 0078-0456-35

300 mg Film-Coated Tablets:    yellow, ovaloid, slightly biconvex, scored on both sides. Imprinted with TE/TE on one side and CG/CG on the other side.

Bottle of 100………………………………………………………………..NDC 0078-0337-05

Unit Dose (blister pack)

      Box of 100 (strips of 10).………………………………...………...NDC 0078-0337-06

600 mg Film-Coated Tablets:   light pink, ovaloid, slightly biconvex, scored on both sides. Imprinted with TF/TF on one side and CG/CG on the other side.

Bottle of 100………………………………………………………………..NDC 0078-0457-05

Unit Dose (blister pack)

      Box of 100 (strips of 10) …………………………………………..NDC 0078-0457-35

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).

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