Trileptal

Trileptal Manufacturers

• Pd-rx Pharmaceuticals, Inc.
  

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  Trileptal | Pd-rx Pharmaceuticals, Inc.

  

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  All dosing should be given in a twice-a-day 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 The prescribed amount of oral suspension should be withdrawn from the bottle using the oral dosing syringe supplied.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 (12.3)].

  2.1 Adjunctive Therapy for Adults

  Treatment with Trileptal should be initiated with a dose of 600 mg/day, given in a twice-a-day 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 Drug Interactions (7.1)].

  2.2 Conversion to Monotherapy for Adults

  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with Trileptal at 600 mg/day (given in a twice-a-day 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 The concomitant AEDs should be completely withdrawn over 3-6 weeks, while the maximum dose of Trileptal should be reached in about 2-4 weeks.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.

  2.3 Initiation of Monotherapy for Adults

  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 twice-a-day 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).

  2.4 Adjunctive Therapy for Pediatric Patients (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 twice-a-day 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 twice-a-day regimen. For patients under 20 kg, a starting dose of 16-20 mg/kg may be considered [see Clinical Pharmacology (12.3)].  The maximum maintenance dose of Trileptal should be achieved over 2-4 weeks and should not exceed 60 mg/kg/day in a twice-a-day 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.

  2.5 Conversion to Monotherapy for Pediatric Patients (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 twice-a-day 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.

  2.6 Initiation of Monotherapy for Pediatric Patients (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 twice-a-day regimen. The dose should be increased by 5 mg/kg/day every third day to the recommended daily dose shown in the table below.

  Table 1 Range of Maintenance Doses of Trileptal for Children by Weight During Monotherapy From To Weight in kg Dose (mg/day) Dose (mg/day)       20 600 900       25 900 1200       30 900 1200       35 900 1500       40 900 1500       45 1200 1500       50 1200 1800       55 1200 1800       60 1200 2100       65 1200 2100       70 1500 2100 2.7 Patients with Hepatic Impairment

  In general, dose adjustments are not required in patients with mild-to-moderate hepatic impairment [see Clinical Pharmacology (12.3).]

  2.8 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 (12.3)]

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• Physicians Total Care, Inc.
  

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  Trileptal | Physicians Total Care, Inc.

  

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  All dosing should be given in a twice-a-day 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 (12.3)].

  2.1 Adjunctive Therapy for Adults

  Treatment with Trileptal should be initiated with a dose of 600 mg/day, given in a twice-a-day 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 Drug Interactions (7.1)].

  2.2 Conversion to Monotherapy for Adults

  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with Trileptal at 600 mg/day (given in a twice-a-day 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.

  2.3 Initiation of Monotherapy for Adults

  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 twice-a-day 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).

  2.4 Adjunctive Therapy for Pediatric Patients (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 twice-a-day 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 twice-a-day regimen. For patients under 20 kg, a starting dose of 16-20 mg/kg may be considered [see Clinical Pharmacology (12.3)].  The maximum maintenance dose of Trileptal should be achieved over 2-4 weeks and should not exceed 60 mg/kg/day in a twice-a-day 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.

  2.5 Conversion to Monotherapy for Pediatric Patients (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 twice-a-day 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.

  2.6 Initiation of Monotherapy for Pediatric Patients (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 twice-a-day regimen. The dose should be increased by 5 mg/kg/day every third day to the recommended daily dose shown in the table below.

  Table 1 Range of Maintenance Doses of Trileptal for Children by Weight During Monotherapy From To Weight in kg Dose (mg/day) Dose (mg/day)       20 600 900       25 900 1200       30 900 1200       35 900 1500       40 900 1500       45 1200 1500       50 1200 1800       55 1200 1800       60 1200 2100       65 1200 2100       70 1500 2100 2.7 Patients with Hepatic Impairment

  In general, dose adjustments are not required in patients with mild-to-moderate hepatic impairment [see Clinical Pharmacology (12.3).]

  2.8 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 (12.3)]

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• Novartis Pharmaceuticals Corporation
  

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  Trileptal | Novartis Pharmaceuticals Corporation

  

  ---

  All dosing should be given in a twice-a-day 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 (12.3)].

  2.1     Adjunctive Therapy for Adults

  Treatment with Trileptal should be initiated with a dose of 600 mg/day, given in a twice-a-day 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 Drug Interactions (7.1)].

  2.2     Conversion to Monotherapy for Adults

  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with Trileptal at 600 mg/day (given in a twice-a-day 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.

  2.3     Initiation of Monotherapy for Adults

  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 twice-a-day 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).

  2.4     Adjunctive Therapy for Pediatric Patients (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 twice-a-day 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 twice-a-day regimen. For patients under 20 kg, a starting dose of 16-20 mg/kg may be considered [see Clinical Pharmacology (12.3)]. The maximum maintenance dose of Trileptal should be achieved over 2-4 weeks and should not exceed 60 mg/kg/day in a twice-a-day 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.

  2.5     Conversion to Monotherapy for Pediatric Patients (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 twice-a-day 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.

  2.6     Initiation of Monotherapy for Pediatric Patients (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 twice-a-day regimen. The dose should be increased by 5 mg/kg/day every third day to the recommended daily dose shown in the table below.

  Table 1 Range of Maintenance Doses of Trileptal for Children by Weight During Monotherapy From To Weight in kg Dose (mg/day) Dose (mg/day)       20 600 900       25 900 1200       30 900 1200       35 900 1500       40 900 1500       45 1200 1500       50 1200 1800       55 1200 1800       60 1200 2100       65 1200 2100       70 1500 2100 2.7     Patients with Hepatic Impairment

  In general, dose adjustments are not required in patients with mild-to-moderate hepatic impairment [see Clinical Pharmacology (12.3).]

  2.8     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 (12.3)]

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