Oxcarbazepine

Oxcarbazepine Manufacturers

• Remedyrepack Inc.
  

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  Oxcarbazepine | Remedyrepack Inc.

  

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  All dosing should be given in a twice-a-day regimen. Oxcarbazepine oral suspension and oxcarbazepine film-coated tablets may be interchanged at equal doses.
  
  Oxcarbazepine tablets should be kept out of the reach and sight of children.
  
  Oxcarbazepine tablets can be taken with or without food [see Clinical Pharmacology (12.3)].

   

  Treatment with oxcarbazepine 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 oxcarbazepine titration, as these plasma levels may be altered, especially at oxcarbazepine doses greater than 1200 mg/day [see Drug Interactions (7.1)].

   

  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with oxcarbazepine 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 The concomitant AEDs should be completely withdrawn over 3 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine 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 oxcarbazepine. Patients should be observed closely during this transition phase.

   

  Patients not currently being treated with AEDs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine 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 oxcarbazepine monotherapy (see above).

   

  In pediatric patients aged 4 to 16 years, treatment should be initiated at a daily dose of 8 to 10 mg/kg generally not to exceed 600 mg/day, given in a twice-a-day regimen. The target maintenance dose of oxcarbazepine should be achieved over two weeks, and is dependent upon patient weight, according to the following chart:
  20 to 29 kg - 900 mg/day
  29.1 to 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 to 51 mg/kg.
  
  In pediatric patients aged 2 to <4 years, treatment should also be initiated at a daily dose of 8 to 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 to 20 mg/kg may be considered [see Clinical Pharmacology (12.3)]. The maximum maintenance dose of oxcarbazepine should be achieved over 2 to ­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.

   

  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine at approximately 8 to 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 to 6 weeks while oxcarbazepine 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 oxcarbazepine is shown in the table below.

   

  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 8 to 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 Oxcarbazepine for Children by Weight During Monotherapy Weight in kg
  From
  To
  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
  

   

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

   

  In patients with impaired renal function (creatinine clearance <30 mL/min) oxcarbazepine 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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• Ncs Healthcare Of Ky, Inc Dba Vangard Labs
  

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  Oxcarbazepine | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

  

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  All dosing should be given in a twice-a-day regimen. Oxcarbazepine oral suspension and oxcarbazepine film-coated tablets may be interchanged at equal doses.
  
  Oxcarbazepine tablets should be kept out of the reach and sight of children.
  
  Oxcarbazepine tablets can be taken with or without food [see Clinical Pharmacology (12.3)].

  2.1 Adjunctive Therapy for Adults

  Treatment with oxcarbazepine 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 oxcarbazepine titration, as these plasma levels may be altered, especially at oxcarbazepine 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 oxcarbazepine 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 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine 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 oxcarbazepine. 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 oxcarbazepine. In these patients, oxcarbazepine 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 oxcarbazepine monotherapy (see above).

  2.4 Adjunctive Therapy for Pediatric Patients (Aged 2 to 16 Years)

  In pediatric patients aged 4 to 16 years, treatment should be initiated at a daily dose of 8 to 10 mg/kg generally not to exceed 600 mg/day, given in a twice-a-day regimen. The target maintenance dose of oxcarbazepine should be achieved over two weeks, and is dependent upon patient weight, according to the following chart:
  20 to 29 kg - 900 mg/day
  29.1 to 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 to 51 mg/kg.
  
  In pediatric patients aged 2 to <4 years, treatment should also be initiated at a daily dose of 8 to 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 to 20 mg/kg may be considered [see Clinical Pharmacology (12.3)]. The maximum maintenance dose of oxcarbazepine should be achieved over 2 to ­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 to 16 Years)

  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine at approximately 8 to 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 to 6 weeks while oxcarbazepine 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 oxcarbazepine is shown in the table below.

  2.6 Initiation of Monotherapy for Pediatric Patients (Aged 4 to 16 Years)

  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 8 to 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 Oxcarbazepine for Children by Weight During Monotherapy  Weight in kg
   From
   To
   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) oxcarbazepine 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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• Jubilant Cadista Pharmaceuticals, Inc.
  

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  Oxcarbazepine | Hyvee Inc

  

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  • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age

  age

  dose

  adults and children 12 years and over

  10 mL every 4 hours

  children under 12 years

  do not use

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• Cardinal Health
  

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  Oxcarbazepine | Northwind Pharmaceuticals, Llc

  

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  For Oral Administration

  The initial dosage varies from 0.75 to 9 mg a day depending on the disease being treated.

  It Should Be Emphasized That Dosage Requirements Are Variable And Must Be Individualized On The Basis Of The Disease Under Treatment And The Response Of The Patient.

  After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage that maintains an adequate clinical response is reached.

  Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

  In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of dexamethasone for a week followed by 4 to 12 mg every other day for one month have been shown to be effective (see PRECAUTIONS: Neuro-Psychiatric).

  In pediatric patients, the initial dose of dexamethasone may vary depending on the specific disease entity being treated. The range of initial doses is 0.02 to 0.3 mg/kg/day in three or four divided doses (0.6 to 9 mg/m2bsa/day).

  PLEASE REVIEW THE MANUFACTURER'S COMPLETE DRUG INFORMATION AT THIS FDA SITE:

  http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b15200fb-1826-472b-a907-e677a272513b

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• American Health Packaging
  

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  Oxcarbazepine | American Health Packaging

  

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  All dosing should be given in a twice-a-day regimen. Oxcarbazepine oral suspension and oxcarbazepine film-coated tablets may be interchanged at equal doses.

  Oxcarbazepine tablets should be kept out of the reach and sight of children.

  Oxcarbazepine tablets can be taken with or without food [see Clinical Pharmacology (12.3)].

  2.1 Adjunctive Therapy for Adults

  Treatment with oxcarbazepine tablets 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 oxcarbazepine tablets titration, as these plasma levels may be altered, especially at oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets should be reached in about 2-4 weeks. Oxcarbazepine tablets 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 oxcarbazepine tablets. 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 oxcarbazepine tablets. In these patients, oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets 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 to <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 oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets. In these patients, oxcarbazepine tablets 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 Oxcarbazepine Tablets 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) oxcarbazepine tablets 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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• Sun Pharmaceutical Industries Limited
  

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  Oxcarbazepine | Better Living Brands, Llc

  

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  this product does not contain directions or complete warnings for adult use find the right dose on chart below. If possible, use weight to dose; otherwise, use age. dissolve in mouth or chew before swallowing if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor  Weight (lb)  Age (yr)  Tablets  Under 48  Under 6  Ask a doctor  48-59  6-8  2  60-71  9-10  2 1/2  72-95  11  3  96 and over  12  4

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• American Health Packaging
  

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  Oxcarbazepine | Kmart Corporation

  

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  • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age

  age

  dose

  adults and children 12 years and over

  10 mL every 4 hours

  children under 12 years

  do not use

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• Remedyrepack Inc.
  

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  Oxcarbazepine | Remedyrepack Inc.

  

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  Oxcarbazepine is recommended as adjunctive treatment in the treatment of partial seizures in adults and children aged 2-16 years. Oxcarbazepine 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. Oxcarbazepine oral suspension and Oxcarbazepine filmcoated tablets may be interchanged at equal doses.
  Oxcarbazepine should be kept out of the reach and sight of children.
  Oxcarbazepine can be taken with or without food (see CLINICAL PHARMACOLOGY, Pharmacokineticssubsection).
  
  Adults
  
  Adjunctive Therapy
  PRECAUTIONS, Drug Interactionssubsection).
  
  Conversion to Monotherapy
  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with Oxcarbazepine 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 Oxcarbazepine should be reached in about 2-4 weeks. Oxcarbazepine 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 Oxcarbazepine. Patients should be observed closely during this transition phase.
  
  Initiation of Monotherapy
  
  
  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 Oxcarbazepine 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 Oxcarbazepine 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 to12 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine. In these patients, Oxcarbazepine 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.
  Table 8: Range of Maintenance Doses of Oxcarbazepine for Children by Weight During Monotherapy
  FromToWeight in kgDose (mg/day)Dose (mg/day)20600900259001200309001200359001500409001500451200150050120018005512001800601200210065120021007015002100
  Patients with Hepatic Impairment
  In general, dose adjustments are not required in patients with mild-to-moderate hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populationssubsection).
  
  Patients with Renal Impairment
  In patients with impaired renal function (creatinine clearance <30 mL/min) Oxcarbazepine 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 Populationssubsection).
  
  

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• Remedyrepack Inc.
  

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  Oxcarbazepine | Remedyrepack Inc.

  

  ---

  Oxcarbazepine is recommended as adjunctive treatment in the treatment of partial seizures in adults and children aged 2-16 years. Oxcarbazepine 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. Oxcarbazepine oral suspension and Oxcarbazepine filmcoated tablets may be interchanged at equal doses.
  Oxcarbazepine should be kept out of the reach and sight of children.
  Oxcarbazepine can be taken with or without food (see CLINICAL PHARMACOLOGY, Pharmacokineticssubsection).
  
  Adults
  
  Adjunctive Therapy
  PRECAUTIONS, Drug Interactionssubsection).
  
  Conversion to Monotherapy
  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with Oxcarbazepine 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 Oxcarbazepine should be reached in about 2-4 weeks. Oxcarbazepine 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 Oxcarbazepine. Patients should be observed closely during this transition phase.
  
  Initiation of Monotherapy
  
  
  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 Oxcarbazepine 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 Oxcarbazepine 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.
  
  Conversion to Monotherapy (Aged 4-16 years)
  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine. In these patients, Oxcarbazepine 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.
  Table 8: Range of Maintenance Doses of Oxcarbazepine for Children by Weight During Monotherapy
  FromToWeight in kgDose (mg/day)Dose (mg/day)20600900259001200309001200359001500409001500451200150050120018005512001800601200210065120021007015002100
  Patients with Hepatic Impairment
  In general, dose adjustments are not required in patients with mild-to-moderate hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populationssubsection).
  
  Patients with Renal Impairment
  In patients with impaired renal function (creatinine clearance <30 mL/min) Oxcarbazepine 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 Populationssubsection).
  
  

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  Oxcarbazepine tablets are recommended as adjunctive treatment in the treatment of partial seizures in adults and children aged 2 to 16 years. Oxcarbazepine tablets are also recommended as monotherapy in the treatment of partial seizures in adults and children aged 4 to 16 years. All dosing should be given in a twice-a-day (BID) regimen. Oxcarbazepine oral suspension and oxcarbazepine film-coated tablets may be interchanged at equal doses.
  Oxcarbazepine tablets should be kept out of the reach and sight of children.
  Oxcarbazepine can be taken with or without food (see CLINICAL PHARMACOLOGY, Pharmacokineticssubsection).
  
  Adults
  
  Adjunctive Therapy
  PRECAUTIONS, Drug Interactionssubsection).
  
  Conversion to Monotherapy
  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with oxcarbazepine 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 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine 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 oxcarbazepine. Patients should be observed closely during this transition phase.
  
  Initiation of Monotherapy
  
  
  Pediatric Patients
  
  Adjunctive Therapy (Aged 2 to 16 Years)
  In pediatric patients aged 4 to 16 years, treatment should be initiated at a daily dose of 8 to 10 mg/kg generally not to exceed 600 mg/day, given in a BID regimen. The target maintenance dose of oxcarbazepine should be achieved over two weeks, and is dependent upon patient weight, according to the following chart:
  20 to 29 kg - 900 mg/day
  29.1 to 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 to 51 mg/kg.
  In pediatric patients aged 2 to <4 years, treatment should also be initiated at a daily dose of 8 to 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 to 20 mg/kg may be considered (see CLINICAL PHARMACOLOGY). The maximum maintenance dose of oxcarbazepine should be achieved over 2 to 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.
  
  Conversion to Monotherapy (Aged 4 to 16 Years)
  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets at approximately 8 to 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 to 6 weeks while oxcarbazepine 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 oxcarbazepine is shown in the table below.
  
  Initiation of Monotherapy (Aged 4 to 16 Years)
  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 8 to 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.
  
  Table 8: Range of Maintenance Doses of Oxcarbazepine for Children by Weight During Monotherapy
  FromToWeightDoseDosein kg(mg/day)(mg/day)20600900259001200309001200359001500409001500451200150050120018005512001800601200210065120021007015002100
  Patients with Hepatic Impairment
  In general, dose adjustments are not required in patients with mild-to-moderate hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populationssubsection).
  
  Patients with Renal Impairment
  In patients with impaired renal function (creatinine clearance < 30 mL/min) oxcarbazepine 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 Populationssubsection).
  
  

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  Oxcarbazepine tablets are recommended as adjunctive treatment in the treatment of partial seizures in adults and children aged 2 to 16 years. Oxcarbazepine tablets are also recommended as monotherapy in the treatment of partial seizures in adults and children aged 4 to 16 years. All dosing should be given in a twice-a-day (BID) regimen. Oxcarbazepine oral suspension and oxcarbazepine film-coated tablets may be interchanged at equal doses.
  Oxcarbazepine tablets should be kept out of the reach and sight of children.
  Oxcarbazepine can be taken with or without food (see CLINICAL PHARMACOLOGY, Pharmacokineticssubsection).
  
  Adults
  
  Adjunctive Therapy
  PRECAUTIONS, Drug Interactionssubsection).
  
  Conversion to Monotherapy
  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with oxcarbazepine 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 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine 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 oxcarbazepine. Patients should be observed closely during this transition phase.
  
  Initiation of Monotherapy
  
  
  Pediatric Patients
  
  Adjunctive Therapy (Aged 2 to 16 Years)
  In pediatric patients aged 4 to 16 years, treatment should be initiated at a daily dose of 8 to 10 mg/kg generally not to exceed 600 mg/day, given in a BID regimen. The target maintenance dose of oxcarbazepine should be achieved over two weeks, and is dependent upon patient weight, according to the following chart:
  20 to 29 kg - 900 mg/day
  29.1 to 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 to 51 mg/kg.
  In pediatric patients aged 2 to <4 years, treatment should also be initiated at a daily dose of 8 to 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 to 20 mg/kg may be considered (see CLINICAL PHARMACOLOGY). The maximum maintenance dose of oxcarbazepine should be achieved over 2 to 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.
  
  Conversion to Monotherapy (Aged 4 to 16 Years)
  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets at approximately 8 to 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 to 6 weeks while oxcarbazepine 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 oxcarbazepine is shown in the table below.
  
  Initiation of Monotherapy (Aged 4 to 16 Years)
  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 8 to 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.
  
  Table 8: Range of Maintenance Doses of Oxcarbazepine for Children by Weight During Monotherapy
  FromToWeight in kgDose (mg/day)Dose (mg/day)20600900259001200309001200359001500409001500451200150050120018005512001800601200210065120021007015002100
  Patients with Hepatic Impairment
  In general, dose adjustments are not required in patients with mild-to-moderate hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populationssubsection).
  
  Patients with Renal Impairment
  In patients with impaired renal function (creatinine clearance < 30 mL/min) oxcarbazepine 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 Populationssubsection).
  
  

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  Oxcarbazepine is recommended as adjunctive treatment in the treatment of partial seizures in adults and children aged 4-16 years. Oxcarbazepine 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. Oxcarbazepine oral suspension and Oxcarbazepine film-coated tablets may be interchanged at equal doses.

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

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

  Adults Adjunctive Therapy

  Treatment with Oxcarbazepine 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 Oxcarbazepine titration, as these plasma levels may be altered, especially at Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine should be reached in about 2-4 weeks. Oxcarbazepine 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 Oxcarbazepine. Patients should be observed closely during this transition phase.

  Initiation of Monotherapy

  Patients not currently being treated with AEDs may have monotherapy initiated with Oxcarbazepine. In these patients, Oxcarbazepine 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 Oxcarbazepine monotherapy (see above).

  Pediatric Patients Adjunctive Therapy (Aged 4-16 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 Oxcarbazepine 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 less then 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.

  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 4 to greater then 12 years of age may require a 50% higher oxcarbazepine dose per body weight compared to adults.

  Pediatric dosing and drug clearance information for pediatric patients ages 2 to greater then 4 years is approved for Novartis Pharmaceuticals corporation's tablets and oral suspension. However due to Novartis' marketing exclusivity rights, this drug product is not labeled for this age group.

  Conversion to Monotherapy (Aged 4-16 years)

  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine. In these patients, Oxcarbazepine 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.

  Table 8: Range of Maintenance Doses of Oxcarbazepine 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 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 greater then 30 mL/min) Oxcarbazepine 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).

  
  

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  Oxcarbazepine is recommended as adjunctive treatment in the treatment of partial seizures in adults and children aged 2-16 years. Oxcarbazepine 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. Oxcarbazepine oral suspension and Oxcarbazepine film-coated tablets may be interchanged at equal doses.
       Oxcarbazepine should be kept out of the reach and sight of children.
       Oxcarbazepine can be taken with or without food (see CLINICAL PHARMACOLOGY, Pharmacokineticssubsection).
  
  Adults
  
  Adjunctive Therapy
  PRECAUTIONS, Drug Interactionssubsection).
  
  Conversion to Monotherapy
  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with Oxcarbazepine 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 Oxcarbazepine should be reached in about 2-4 weeks. Oxcarbazepine 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 Oxcarbazepine. Patients should be observed closely during this transition phase.
  
  Initiation of Monotherapy
  
  
  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 Oxcarbazepine 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 Oxcarbazepine 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 to12 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine. In these patients, Oxcarbazepine 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.
  Table 8: Range of Maintenance Doses of Oxcarbazepine for Children by Weight During Monotherapy
  FromToWeight in kgDose (mg/day)Dose (mg/day)20600900259001200309001200359001500409001500451200150050120018005512001800601200210065120021007015002100
  Patients with Hepatic Impairment
  In general, dose adjustments are not required in patients with mild-to-moderate hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populationssubsection).
  
  Patients with Renal Impairment
  In patients with impaired renal function (creatinine clearance <30 mL/min) Oxcarbazepine 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 Populationssubsection).
  
  

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  Oxcarbazepine tablets are recommended as adjunctive treatment in the treatment of partial seizures in adults and children aged 2 to 16 years. Oxcarbazepine tablets are also recommended as monotherapy in the treatment of partial seizures in adults and children aged 4 to 16 years. All dosing should be given in a twice-a-day (BID) regimen. Oxcarbazepine oral suspension and oxcarbazepine film-coated tablets may be interchanged at equal doses.
  Oxcarbazepine tablets should be kept out of the reach and sight of children.
  Oxcarbazepine can be taken with or without food (see CLINICAL PHARMACOLOGY, Pharmacokineticssubsection).
  
  Adults
  
  Adjunctive Therapy
  PRECAUTIONS, Drug Interactionssubsection).
  
  Conversion to Monotherapy
  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with oxcarbazepine 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 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine 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 oxcarbazepine. Patients should be observed closely during this transition phase.
  
  Initiation of Monotherapy
  Patients not currently being treated with AEDs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine 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 1200mg/day dose; a dose of 2400 mg/day has been shown to be effective in patients converted from other AEDs to oxcarbazepine monotherapy (see above).
  
  Pediatric Patients
  
  Adjunctive Therapy (Aged 2 to 16 Years)
  In pediatric patients aged 4 to 16 years, treatment should be initiated at a daily dose of 8 to 10 mg/kg generally not to exceed 600 mg/day, given in a BID regimen. The target maintenance dose of oxcarbazepine should be achieved over two weeks, and is dependent upon patient weight, according to the following chart:
  20 to 29 kg - 900 mg/day
  29.1 to 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 to 51 mg/kg.
  In pediatric patients aged 2 to <4 years, treatment should also be initiated at a daily dose of 8 to 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 to 20 mg/kg may be considered (see CLINICAL PHARMACOLOGY). The maximum maintenance dose of oxcarbazepine should be achieved over 2 to 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 to12 years of age may require a 50% higher oxcarbazepine dose per body weight compared to adults.
  
  Conversion to Monotherapy (Aged 4 to 16 Years)
  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets at approximately 8 to 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 to 6 weeks while oxcarbazepine 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 oxcarbazepine is shown in the table below.
  
  Initiation of Monotherapy (Aged 4 to 16 Years)
  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 8 to 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.
  
  Table 8: Range of Maintenance Doses of Oxcarbazepine for Children by Weight During Monotherapy
  FromToWeight in kgDose (mg/day)Dose (mg/day)20600900259001200309001200359001500409001500451200150050120018005512001800601200210065120021007015002100
  Patients with Hepatic Impairment
  In general, dose adjustments are not required in patients with mild-to-moderate hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populationssubsection).
  
  Patients with Renal Impairment
  In patients with impaired renal function (creatinine clearance < 30 mL/min) oxcarbazepine 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 Populationssubsection).
  
  

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  Oxcarbazepine is recommended as adjunctive treatment in the treatment of partial seizures in adults and children aged 2-16 years. Oxcarbazepine 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. Oxcarbazepine oral suspension and Oxcarbazepine filmcoated tablets may be interchanged at equal doses.
  Oxcarbazepine should be kept out of the reach and sight of children.
  Oxcarbazepine can be taken with or without food (see CLINICAL PHARMACOLOGY, Pharmacokineticssubsection).
  
  Adults
  
  Adjunctive Therapy
  PRECAUTIONS, Drug Interactionssubsection).
  
  Conversion to Monotherapy
  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with Oxcarbazepine 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 Oxcarbazepine should be reached in about 2-4 weeks. Oxcarbazepine 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 Oxcarbazepine. Patients should be observed closely during this transition phase.
  
  Initiation of Monotherapy
  
  
  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 Oxcarbazepine 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 Oxcarbazepine 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 to12 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine. In these patients, Oxcarbazepine 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.
  Table 8: Range of Maintenance Doses of Oxcarbazepine for Children by Weight During Monotherapy
  FromToWeight in kgDose (mg/day)Dose (mg/day)20600900259001200309001200359001500409001500451200150050120018005512001800601200210065120021007015002100
  Patients with Hepatic Impairment
  In general, dose adjustments are not required in patients with mild-to-moderate hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populationssubsection).
  
  Patients with Renal Impairment
  In patients with impaired renal function (creatinine clearance <30 mL/min) Oxcarbazepine 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 Populationssubsection).
  
  

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  Oxcarbazepine | Rebel Distributors Corp

  

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  Oxcarbazepine is recommended as adjunctive treatment in the treatment of partial seizures in adults and children aged 2-16 years. Oxcarbazepine 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. Oxcarbazepine oral suspension and oxcarbazepine film-coated tablets may be interchanged at equal doses.

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

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

  Adults Adjunctive Therapy

  Treatment with oxcarbazepine 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 oxcarbazepine titration, as these plasma levels may be altered, especially at oxcarbazepine 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 oxcarbazepine 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 oxcarbazepine should be reached in about 2-4 weeks. Oxcarbazepine 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 oxcarbazepine. Patients should be observed closely during this transition phase.

  Initiation of Monotherapy

  Patients not currently being treated with AEDs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine 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 oxcarbazepine 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 oxcarbazepine 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 to <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 oxcarbazepine 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 oxcarbazepine 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 oxcarbazepine 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 oxcarbazepine 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 oxcarbazepine. In these patients, oxcarbazepine 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.

  Table 8: Range of Maintenance Doses of Oxcarbazepine for Children by Weight During Monotherapy

  Patients with Hepatic Impairment

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

  Patients with Renal Impairment

  In patients with impaired renal function (creatine clearance <30 mL/min) oxcarbazepine 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).

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• Remedyrepack Inc.
  

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  Oxcarbazepine | Remedyrepack Inc.

  

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  Oxcarbazepine is recommended as adjunctive treatment in the treatment of partial seizures in adults and children aged 2 to 16 years. Oxcarbazepine is also recommended as monotherapy in the treatment of partial seizures in adults and children aged 4 to 16 years. All dosing should be given in a twice-a-day (BID) regimen. Oxcarbazepine oral suspension and oxcarbazepine film-coated tablets may be interchanged at equal doses.
  Oxcarbazepine tablets should be kept out of the reach and sight of children.
  Oxcarbazepine can be taken with or without food (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
  
  Adults
  
  Adjunctive Therapy
  
  
  Conversion to Monotherapy
  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets 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 to 6 weeks, while the maximum dose of oxcarbazepine tablets should be reached in about 2 to 4 weeks. Oxcarbazepine tablets 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 oxcarbazepine. Patients should be observed closely during this transition phase.
  
  Initiation of Monotherapy
  
  
  Pediatric Patients
  
  Adjunctive Therapy (Aged 2 to 16 Years)
  In pediatric patients aged 4 to 16 years, treatment should be initiated at a daily dose of 8 to 10 mg/kg generally not to exceed 600 mg/day, given in a BID regimen. The target maintenance dose of oxcarbazepine tablets should be achieved over two weeks, and is dependent upon patient weight, according to the following chart:
  20 to 29 kg - 900 mg/day
  29.1 to 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 to 51 mg/kg.
  In pediatric patients aged 2 to < 4 years, treatment should also be initiated at a daily dose of 8 to 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 to 20 mg/kg may be considered (see CLINICAL PHARMACOLOGY). The maximum maintenance dose of oxcarbazepine should be achieved over 2 to 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 to12 years of age may require a 50% higher oxcarbazepine dose per body weight compared to adults.
  
  Conversion to Monotherapy (Aged 4 to 16 Years)
  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets at approximately 8 to 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 to 6 weeks while oxcarbazepine tablets 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 oxcarbazepine tablets is shown in the table below.
  
  Initiation of Monotherapy (Aged 4 to 16 Years)
  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine tablets. In these patients, oxcarbazepine tablets should be initiated at a dose of 8 to 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.
  
  Table 8: Range of Maintenance Doses of Oxcarbazepine Tablets for Children by Weight During Monotherapy
  FromToWeightDoseDosein kg(mg/day)(mg/day)20600900259001200309001200359001500409001500451200150050120018005512001800601200210065120021007015002100
  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).
  
  Patients With Renal Impairment
  In patients with impaired renal function (creatinine clearance < 30 mL/min) oxcarbazepine tablet 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).
  
  

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• Physicians Total Care, Inc.
  

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  Oxcarbazepine | Physicians Total Care, Inc.

  

  ---

  All dosing should be given in a twice-a-day regimen.

  Oxcarbazepine tablets should be kept out of the reach and sight of children.

  Oxcarbazepine tablets can be taken with or without food [see Clinical Pharmacology (12.3)].

  2.1 Adjunctive Therapy for Adults

  Treatment with oxcarbazepine tablets 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 oxcarbazepine tablets titration, as these plasma levels may be altered, especially at oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets should be reached in about 2-4 weeks. Oxcarbazepine tablets 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 oxcarbazepine. 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 oxcarbazepine tablets. In these patients, oxcarbazepine tablets 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 oxcarbazepine 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 oxcarbazepine tablets 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 oxcarbazepine tablets should be achieved over 24 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 oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets. In these patients, oxcarbazepine tablets 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 Oxcarbazepine Tablets 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) oxcarbazepine tablets 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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• Remedyrepack Inc.
  

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  Oxcarbazepine | Remedyrepack Inc.

  

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  Oxcarbazepine is recommended as adjunctive treatment in the treatment of partial seizures in adults and children aged 2-16 years. Oxcarbazepine 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. Oxcarbazepine oral suspension and Oxcarbazepine filmcoated tablets may be interchanged at equal doses.
  Oxcarbazepine should be kept out of the reach and sight of children.
  Oxcarbazepine can be taken with or without food (see CLINICAL PHARMACOLOGY, Pharmacokineticssubsection).
  
  Adults
  
  Adjunctive Therapy
  PRECAUTIONS, Drug Interactionssubsection).
  
  Conversion to Monotherapy
  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with Oxcarbazepine 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 Oxcarbazepine should be reached in about 2-4 weeks. Oxcarbazepine 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 Oxcarbazepine. Patients should be observed closely during this transition phase.
  
  Initiation of Monotherapy
  
  
  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 Oxcarbazepine 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 Oxcarbazepine 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 to12 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine. In these patients, Oxcarbazepine 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.
  Table 8: Range of Maintenance Doses of Oxcarbazepine for Children by Weight During Monotherapy
  FromToWeight in kgDose (mg/day)Dose (mg/day)20600900259001200309001200359001500409001500451200150050120018005512001800601200210065120021007015002100
  Patients with Hepatic Impairment
  In general, dose adjustments are not required in patients with mild-to-moderate hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populationssubsection).
  
  Patients with Renal Impairment
  In patients with impaired renal function (creatinine clearance <30 mL/min) Oxcarbazepine 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 Populationssubsection).
  
  

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• Golden State Medical Supply, Inc.
  

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  Oxcarbazepine | Golden State Medical Supply, Inc.

  

  ---

  All dosing should be given in a twice-a-day regimen. Oxcarbazepine oral suspension and oxcarbazepine film-coated tablets may be interchanged at equal doses.

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

  Oxcarbazepine can be taken with or without food [see Clinical Pharmacology (12.3)].

  2.1 Adjunctive Therapy for Adults

  Treatment with oxcarbazepine 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 oxcarbazepine titration, as these plasma levels may be altered, especially at oxcarbazepine 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 oxcarbazepine 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 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine 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 oxcarbazepine. 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 oxcarbazepine. In these patients, oxcarbazepine 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 oxcarbazepine monotherapy (see above).

  2.4 Adjunctive Therapy for Pediatric Patients (Aged 2 to 16 Years)

  In pediatric patients aged 4 to 16 years, treatment should be initiated at a daily dose of 8 to 10 mg/kg generally not to exceed 600 mg/day, given in a twice-a-day regimen. The target maintenance dose of oxcarbazepine 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 to 51 mg/kg.

  In pediatric patients aged 2 to <4 years, treatment should also be initiated at a daily dose of 8 to 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 to 20 mg/kg may be considered [see Clinical Pharmacology (12.4)]. The maximum maintenance dose of oxcarbazepine should be achieved over 2 to 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 ≤12 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 to 16 Years)

  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine at approximately 8 to 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 to 6 weeks while oxcarbazepine 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 oxcarbazepine is shown in the table below.

  2.6 Initiation of Monotherapy for Pediatric Patients (Aged 4 to 16 Years)

  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 8 to 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 Oxcarbazepine 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) oxcarbazepine 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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  Oxcarbazepine | Roxane Laboratories, Inc

  

  ---

  All dosing should be given in a twice-a-day regimen. Oxcarbazepine oral suspension and oxcarbazepine tablets may be interchanged at equal doses.

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

  Oxcarbazepine can be taken with or without food [see Clinical Pharmacology (12.3)].

  2.1 Adjunctive Therapy for Adults

  Treatment with oxcarbazepine 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 oxcarbazepine titration, as these plasma levels may be altered, especially at oxcarbazepine doses greater than 1200 mg/day [see Drug Interacctions (7.1)].

  2.2 Conversion to Monotherapy for Adults

  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with oxcarbazepine 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 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine 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 oxcarbazepine. 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 oxcarbazepine. In these patients, oxcarbazepine 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 oxcarbazepine monotherapy (see above).

  2.4 Adjunctive Therapy for Pediatric Patients (Aged 2 to 16 Years)

  In pediatric patients aged 4 to 16 years, treatment should be initiated at a daily dose of 8 to 10 mg/kg generally not to exceed 600 mg/day, given in a twice-a-day regimen. The target maintenance dose of oxcarbazepine should be achieved over 2 weeks, and is dependent upon patient weight, according to the following chart:

  20 to 29 kg to 900 mg/day

  29.1 to 39 kg to 1200 mg/day

  >39 kg to 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 to 51 mg/kg.

  In pediatric patients aged 2 to <4 years, treatment should be initiated at a daily dose of 8 to 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 to 20 mg/kg may be considered [see Clinical Pharmacology (12.3)]. The maximum maintenance dose of oxcarbazepine should be achieved over 2 to 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 to 16 Years)

  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine at approximately 8 to 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 to 6 weeks while oxcarbazepine 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 oxcarbazepine is shown in the table below.

  2.6 Initiation of Monotherapy for Pediatric Patients (Aged 4 to 16 Years)

  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 8 to 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 Oxcarbazepine for Children by Weight During Monotherapy

  Weight in kg

  From Dose (mg/day)

  To 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 (creatine clearance <30 mL/min) oxcarbazepine 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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  Oxcarbazepine | Bryant Ranch Prepack

  

  ---

  Oxcarbazepine is recommended as adjunctive treatment in the treatment of partial seizures in adults and children aged 2-16 years. Oxcarbazepine 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. Oxcarbazepine oral suspension and Oxcarbazepine film–coated tablets may be interchanged at equal doses.

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

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

  Adults Adjunctive Therapy

  Treatment with Oxcarbazepine 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 Oxcarbazepine titration, as these plasma levels may be altered, especially at Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine should be reached in about 2-4 weeks. Oxcarbazepine 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 Oxcarbazepine. Patients should be observed closely during this transition phase.

  Initiation of Monotherapy

  Patients not currently being treated with AEDs may have monotherapy initiated with Oxcarbazepine. In these patients, Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine. In these patients, Oxcarbazepine 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.

  Table 8: Range of Maintenance Doses of Oxcarbazepine 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 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) Oxcarbazepine 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).

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• Remedyrepack Inc.
  

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  Oxcarbazepine | Remedyrepack Inc.

  

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  All dosing should be given in a twice-a-day regimen. Oxcarbazepine Oral suspension and Oxcarbazepine film-coated tablets may be interchanged at equal doses.

  Oxcarbazepine Tablets should be kept out of the reach and sight of children.

  Oxcarbazepine Tablets can be taken with or without food [see Clinical Pharmacology (12.3)].

   

  Treatment with Oxcarbazepine 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 Oxcarbazepine titration, as these plasma levels may be altered, especially at Oxcarbazepine doses greater than 1200 mg/day [see Drug Interactions (7.1)].

   

  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with Oxcarbazepine 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 Oxcarbazepine should be reached in about 2-4 weeks. Oxcarbazepine 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 Oxcarbazepine. Patients should be observed closely during this transition phase.

   

  Patients not currently being treated with AEDs may have monotherapy initiated with Oxcarbazepine. In these patients, Oxcarbazepine 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 Oxcarbazepine monotherapy (see above).

   

  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 Oxcarbazepine 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 Oxcarbazepine 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.

   

  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine is shown in the table below.

   

  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with Oxcarbazepine. In these patients, Oxcarbazepine 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 Oxcarbazepine for Children by Weight During Monotherapy

  Weight in kg

  From
  Dose (mg/day)

  To
  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

   

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

   

  In patients with impaired renal function (creatinine clearance <30 mL/min) Oxcarbazepine 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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  Oxcarbazepine | Cardinal Health

  

  ---

  All dosing should be given in a twice-a-day regimen. Oxcarbazepine oral suspension and oxcarbazepine tablets may be interchanged at equal doses.

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

  Oxcarbazepine can be taken with or without food [see Clinical Pharmacology (12.3)].

  2.1 Adjunctive Therapy for Adults

  Treatment with oxcarbazepine 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 oxcarbazepine titration, as these plasma levels may be altered, especially at oxcarbazepine doses greater than 1200 mg/day [see Drug Interacctions (7.1)].

  2.2 Conversion to Monotherapy for Adults

  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with oxcarbazepine 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 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine 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 oxcarbazepine. 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 oxcarbazepine. In these patients, oxcarbazepine 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 oxcarbazepine monotherapy (see above).

  2.4 Adjunctive Therapy for Pediatric Patients (Aged 2 to 16 Years)

  In pediatric patients aged 4 to 16 years, treatment should be initiated at a daily dose of 8 to 10 mg/kg generally not to exceed 600 mg/day, given in a twice-a-day regimen. The target maintenance dose of oxcarbazepine should be achieved over 2 weeks, and is dependent upon patient weight, according to the following chart:

  20 to 29 kg to 900 mg/day

  29.1 to 39 kg to 1200 mg/day

  >39 kg to 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 to 51 mg/kg.

  In pediatric patients aged 2 to <4 years, treatment should be initiated at a daily dose of 8 to 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 to 20 mg/kg may be considered [see Clinical Pharmacology (12.3)]. The maximum maintenance dose of oxcarbazepine should be achieved over 2 to 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 to 16 Years)

  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine at approximately 8 to 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 to 6 weeks while oxcarbazepine 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 oxcarbazepine is shown in the table below.

  2.6 Initiation of Monotherapy for Pediatric Patients (Aged 4 to 16 Years)

  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 8 to 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 Oxcarbazepine for Children by Weight During Monotherapy

  Weight in kg

  From Dose (mg/day)

  To 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 (creatine clearance <30 mL/min) oxcarbazepine 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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  Oxcarbazepine | Glenmark Generics Inc., Usa

  

  ---

  All dosing should be given in a twice-a-day regimen.

  Oxcarbazepine tablets should be kept out of the reach and sight of children.

  Oxcarbazepine tablets can be taken with or without food [see Clinical Pharmacology (12.3)].

  2.1 Adjunctive Therapy for Adults

  Treatment with oxcarbazepine tablets 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 oxcarbazepine tablets titration, as these plasma levels may be altered, especially at oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets should be reached in about 2-4 weeks. Oxcarbazepine tablets 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 oxcarbazepine. 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 oxcarbazepine tablets. In these patients, oxcarbazepine tablets 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 oxcarbazepine 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 oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets. In these patients, oxcarbazepine tablets 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 Oxcarbazepine Tablets 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) oxcarbazepine tablets 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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• Ncs Healthcare Of Ky, Inc Dba Vangard Labs
  

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  Oxcarbazepine | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

  

  ---

  All dosing should be given in a twice-a-day regimen. Oxcarbazepine oral suspension and oxcarbazepine film-coated tablets may be interchanged at equal doses.

  Oxcarbazepine tablets should be kept out of the reach and sight of children.

  Oxcarbazepine tablets can be taken with or without food [see Clinical Pharmacology (12.3)]. 

  2.1 Adjunctive Therapy for Adults

  Treatment with oxcarbazepine 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 2,400 mg/day dose, primarily because of CNS effects. lt is recommended that the patient be observed closely and plasma levels of the concomitant AEDs be monitored during the period of oxcarbazepine titration, as these  plasma levels may be altered, especially at oxcarbazepine doses greater than 1200mg/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 oxcarbazepine 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 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine 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 oxcarbazepine. 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 oxcarbazepine. ln these patients, oxcarbazepine 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 oxcarbazepine monotherapy (see above).

  2.4 Adjunctive Therapy for Pediatric Patients (Aged 2 to 16 Years)

  In pediatric patients aged 4 to16 years, treatment should be initiated at a daily dose of 8 to10 mg/kg generally not to exceed 600 mg/day, given in a twice-a-day regimen. The target maintenance dose of oxcarbazepine should be achieved over two weeks, and is dependent upon patient weight, according to the following chart:

  20 to 29 kg to 900 mg/day 29.1 to 39 kg to 1200 mg/day >39 kg to 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 to 51 mg/kg.

  In pediatric patients aged 2 to <4 years, treatment should also be initiated at a daily dose of 8 to 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 to 20 mg/kg may be considered [see Clinical Pharmacology (12.3)]. The maximum maintenance dose of oxcarbazepine should be achieved over 2 to 4 weeks and should not exceed 60mg/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 to 16 Years)

  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine at approximately 8 to10mg/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 to 6 weeks while oxcarbazepine 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 oxcarbazepine is shown in the table below.

  2.6 Initiation of Monotherapy for Pediatric Patients (Aged 4 to 16 Years)

  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. ln these patients, oxcarbazepine should be initiated at a dose of 8 to10mg/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 Oxcarbazepine for Children by Weight During Monotherapy

  Weight in kg

  From Dose (mg/day)

  To 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 ClinicalPharmacology (12.3).]

  2.8 Patients with Renal Impairment

  In patients with impaired renal function (creatinine clearance <30 mL/min) oxcarbazepine therapy should he 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)]

  2.1 Adjunctive Therapy for Adults

  Treatment with oxcarbazepine 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 2,400 mg/day dose, primarily because of CNS effects. lt is recommended that the patient be observed closely and plasma levels of the concomitant AEDs be monitored during the period of oxcarbazepine titration, as these  plasma levels may be altered, especially at oxcarbazepine doses greater than 1200mg/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 oxcarbazepine 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 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine 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 oxcarbazepine. 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 oxcarbazepine. ln these patients, oxcarbazepine 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 oxcarbazepine monotherapy (see above).

  2.4 Adjunctive Therapy for Pediatric Patients (Aged 2 to 16 Years)

  In pediatric patients aged 4 to16 years, treatment should be initiated at a daily dose of 8 to10 mg/kg generally not to exceed 600 mg/day, given in a twice-a-day regimen. The target maintenance dose of oxcarbazepine should be achieved over two weeks, and is dependent upon patient weight, according to the following chart:

  20 to 29 kg to 900 mg/day 29.1 to 39 kg to 1200 mg/day >39 kg to 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 to 51 mg/kg.

  In pediatric patients aged 2 to <4 years, treatment should also be initiated at a daily dose of 8 to 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 to 20 mg/kg may be considered [see Clinical Pharmacology (12.3)]. The maximum maintenance dose of oxcarbazepine should be achieved over 2 to 4 weeks and should not exceed 60mg/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 to 16 Years)

  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine at approximately 8 to10mg/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 to 6 weeks while oxcarbazepine 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 oxcarbazepine is shown in the table below.

  2.6 Initiation of Monotherapy for Pediatric Patients (Aged 4 to 16 Years)

  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. ln these patients, oxcarbazepine should be initiated at a dose of 8 to10mg/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 Oxcarbazepine for Children by Weight During Monotherapy

  Weight in kg

  From Dose (mg/day)

  To 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 ClinicalPharmacology (12.3).]

  2.8 Patients with Renal Impairment

  In patients with impaired renal function (creatinine clearance <30 mL/min) oxcarbazepine therapy should he 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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• Golden State Medical Supply
  

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  Oxcarbazepine | Golden State Medical Supply

  

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  Oxcarbazepine is recommended as adjunctive treatment in the treatment of partial seizures in adults and children aged 2-16 years. Oxcarbazepine 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. Oxcarbazepine oral suspension and Oxcarbazepine film–coated tablets may be interchanged at equal doses.

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

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

  Adults Adjunctive Therapy

  Treatment with Oxcarbazepine 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 Oxcarbazepine titration, as these plasma levels may be altered, especially at Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine should be reached in about 2-4 weeks. Oxcarbazepine 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 Oxcarbazepine. Patients should be observed closely during this transition phase.

  Initiation of Monotherapy

  Patients not currently being treated with AEDs may have monotherapy initiated with Oxcarbazepine. In these patients, Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine. In these patients, Oxcarbazepine 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.

  Table 8: Range of Maintenance Doses of Oxcarbazepine 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 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) Oxcarbazepine 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).

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• Breckenridge Pharmaceutical, Inc.
  

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  Oxcarbazepine | Breckenridge Pharmaceutical, Inc.

  

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  All dosing should be given in a twice-a-day regimen. Oxcarbazepine oral suspension and oxcarbazepine film-coated tablets may be interchanged at equal doses.

  Oxcarbazepine tablets, USP should be kept out of the reach and sight of children.

  Oxcarbazepine tablets, USP can be taken with or without food [see Clinical Pharmacology (12.3)].

  2.1 Adjunctive Therapy for Adults

  Treatment with oxcarbazepine tablets, USP 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 oxcarbazepine tablets, USP titration, as these plasma levels may be altered, especially at oxcarbazepine tablets, USP 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 oxcarbazepine tablets, USP 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 oxcarbazepine tablets, USP should be reached in about 2-4 weeks. Oxcarbazepine tablets, USP 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 oxcarbazepine tablets, USP. 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 oxcarbazepine tablets, USP. In these patients, oxcarbazepine tablets, USP 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 oxcarbazepine tablets, USP 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 oxcarbazepine tablets, USP 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 to <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 oxcarbazepine tablets, USP 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 oxcarbazepine tablets, USP 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 oxcarbazepine tablets, USP 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 oxcarbazepine tablets, USP 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 oxcarbazepine tablets, USP. In these patients, oxcarbazepine tablets, USP 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 Oxcarbazepine Tablets, USP 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) oxcarbazepine 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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• Remedyrepack Inc.
  

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  Oxcarbazepine | Remedyrepack Inc.

  

  ---

  All dosing should be given in a twice-a-day regimen. Oxcarbazepine oral suspension and oxcarbazepine film-coated tablets may be interchanged at equal doses.

  Oxcarbazepine tablets should be kept out of the reach and sight of children.

  Oxcarbazepine tablets can be taken with or without food [see Clinical Pharmacology (12.3)].

   

  Treatment with oxcarbazepine tablets 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 oxcarbazepine tablets titration, as these plasma levels may be altered, especially at oxcarbazepine tablets doses greater than 1200 mg/day [see Drug Interactions (7.1)].

   

  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets 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 oxcarbazepine tablets should be reached in about 2-4 weeks. Oxcarbazepine tablets 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 oxcarbazepine tablets. Patients should be observed closely during this transition phase.

   

  Patients not currently being treated with AEDs may have monotherapy initiated with oxcarbazepine tablets. In these patients, oxcarbazepine tablets 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 oxcarbazepine tablets monotherapy (see above).

   

  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 oxcarbazepine tablets 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 to <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 oxcarbazepine tablets 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.

   

  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets is shown in the table below.

   

  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine tablets. In these patients, oxcarbazepine tablets 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 Oxcarbazepine Tablets 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

   

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

   

  In patients with impaired renal function (creatinine clearance <30 mL/min) oxcarbazepine tablets 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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• Aidarex Pharmaceuticals Llc
  

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  Oxcarbazepine | Aidarex Pharmaceuticals Llc

  

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

  Oxcarbazepine tablets should be kept out of the reach and sight of children.

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

  Adults Adjunctive Therapy

  Treatment with oxcarbazepine 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 oxcarbazepine titration, as these plasma levels may be altered, especially at oxcarbazepine 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 oxcarbazepine 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 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine 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 oxcarbazepine. Patients should be observed closely during this transition phase.

  Initiation of Monotherapy

  Patients not currently being treated with AEDs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine 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 oxcarbazepine monotherapy (see above).

  Pediatric Patients Adjunctive Therapy (Aged 2 to 16 Years)

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

             20 to 29 kg - 900 mg/day

             29.1 to 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 to 51 mg/kg.

  In pediatric patients aged 2 to <4 years, treatment should also be initiated at a daily dose of 8 to 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 to 20 mg/kg may be considered (see CLINICAL PHARMACOLOGY). The maximum maintenance dose of oxcarbazepine should be achieved over 2 to 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 to 16 Years)

  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets at approximately 8 to 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 to 6 weeks while oxcarbazepine 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 oxcarbazepine is shown in the table below.

  Initiation of Monotherapy (Aged 4 to 16 Years)

  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 8 to 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.

  Table 8: Range of Maintenance Doses of Oxcarbazepine 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 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) oxcarbazepine 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).

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• Remedyrepack Inc.
  

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  Oxcarbazepine | Remedyrepack Inc.

  

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

  Oxcarbazepine tablets should be kept out of the reach and sight of children.

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

   

   

  Treatment with oxcarbazepine 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 oxcarbazepine titration, as these plasma levels may be altered, especially at oxcarbazepine doses greater than 1200 mg/day (see PRECAUTIONS, Drug Interactions subsection).

   

  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with oxcarbazepine 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 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine 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 oxcarbazepine. Patients should be observed closely during this transition phase.

   

  Patients not currently being treated with AEDs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine 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 oxcarbazepine monotherapy (see above).

   

   

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

             20 to 29 kg - 900 mg/day

             29.1 to 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 to 51 mg/kg.

  In pediatric patients aged 2 to <4 years, treatment should also be initiated at a daily dose of 8 to 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 to 20 mg/kg may be considered (see CLINICAL PHARMACOLOGY). The maximum maintenance dose of oxcarbazepine should be achieved over 2 to 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.

   

  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets at approximately 8 to 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 to 6 weeks while oxcarbazepine 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 oxcarbazepine is shown in the table below.

   

  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 8 to 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.

  Table 8: Range of Maintenance Doses of Oxcarbazepine 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

   

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

   

  In patients with impaired renal function (creatinine clearance < 30 mL/min) oxcarbazepine 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).

   

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• Bryant Ranch Prepack
  

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  Oxcarbazepine | Bryant Ranch Prepack

  

  ---

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

  Oxcarbazepine tablets should be kept out of the reach and sight of children.

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

  Adults Adjunctive Therapy

  Treatment with oxcarbazepine 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 oxcarbazepine titration, as these plasma levels may be altered, especially at oxcarbazepine 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 oxcarbazepine 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 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine 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 oxcarbazepine. Patients should be observed closely during this transition phase.

  Initiation of Monotherapy

  Patients not currently being treated with AEDs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine 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 oxcarbazepine monotherapy (see above).

  Pediatric Patients Adjunctive Therapy (Aged 2 to 16 Years)

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

             20 to 29 kg - 900 mg/day

             29.1 to 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 to 51 mg/kg.

  In pediatric patients aged 2 to <4 years, treatment should also be initiated at a daily dose of 8 to 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 to 20 mg/kg may be considered (see CLINICAL PHARMACOLOGY). The maximum maintenance dose of oxcarbazepine should be achieved over 2 to 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 to 16 Years)

  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets at approximately 8 to 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 to 6 weeks while oxcarbazepine 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 oxcarbazepine is shown in the table below.

  Initiation of Monotherapy (Aged 4 to 16 Years)

  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 8 to 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.

  Table 8: Range of Maintenance Doses of Oxcarbazepine 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 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) oxcarbazepine 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).

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• Jubilant Cadista Pharmaceuticals, Inc.
  

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  Oxcarbazepine | Jubilant Cadista Pharmaceuticals, Inc.

  

  ---

  All dosing should be given in a twice-a-day regimen. Oxcarbazepine Oral suspension and Oxcarbazepine film-coated tablets may be interchanged at equal doses.

  Oxcarbazepine Tablets should be kept out of the reach and sight of children.

  Oxcarbazepine Tablets can be taken with or without food [see Clinical Pharmacology (12.3)].

  2.1 Adjunctive Therapy for Adults

  Treatment with Oxcarbazepine 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 Oxcarbazepine titration, as these plasma levels may be altered, especially at Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine should be reached in about 2-4 weeks. Oxcarbazepine 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 Oxcarbazepine. 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 Oxcarbazepine. In these patients, Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine. In these patients, Oxcarbazepine 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 Oxcarbazepine for Children by Weight During Monotherapy

  Weight in kg

  From
  Dose (mg/day)

  To
  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) Oxcarbazepine 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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• Taro Pharmaceuticals U.s.a., Inc.
  

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  Oxcarbazepine | Taro Pharmaceuticals U.s.a., Inc.

  

  ---

  All dosing should be given in a twice-a-day regimen.

  Oxcarbazepine tablets should be kept out of the reach and sight of children.

  Oxcarbazepine tablets can be taken with or without food [see Clinical Pharmacology (12.3)].

  2.1 Adjunctive Therapy for Adults

  Treatment with oxcarbazepine 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 oxcarbazepine titration, as these plasma levels may be altered, especially at oxcarbazepine 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 oxcarbazepine 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 oxcarbazepine should be reached in about 2-4 weeks. Oxcarbazepine 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 oxcarbazepine. 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 oxcarbazepine. In these patients, oxcarbazepine 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 oxcarbazepine 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 oxcarbazepine 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 oxcarbazepine 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 oxcarbazepine 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 oxcarbazepine 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 oxcarbazepine 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 oxcarbazepine. In these patients, oxcarbazepine 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 Oxcarbazepine Tablets 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) oxcarbazepine 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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  Oxcarbazepine | Tya Pharmaceuticals

  

  ---

  All dosing should be given in a twice-a-day regimen.

  Oxcarbazepine tablets should be kept out of the reach and sight of children.

  Oxcarbazepine tablets can be taken with or without food [ ]. see ( ) Clinical Pharmacology12.3

  2.1 Adjunctive Therapy for Adults

  Treatment with oxcarbazepine tablets 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 oxcarbazepine tablets titration, as these plasma levels may be altered, especially at oxcarbazepine tablets doses greater than 1200 mg/day [ ]. see ( ) Drug Interactions7.1

  2.2 Conversion to Monotherapy for Adults

  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets 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 oxcarbazepine tablets should be reached in about 2-4 weeks. Oxcarbazepine tablets 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 oxcarbazepine. 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 oxcarbazepine tablets. In these patients, oxcarbazepine tablets 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 oxcarbazepine 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 oxcarbazepine tablets 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 [ ]. The maximum maintenance dose of oxcarbazepine tablets should be achieved over 24 weeks and should not exceed 60 mg/kg/day in a twice-a-day regimen. see ( ) Clinical Pharmacology12.3

  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 oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets. In these patients, oxcarbazepine tablets 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 Oxcarbazepine Tablets 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 Pharmacology12.3

  2.8 Patients with Renal Impairment

  In patients with impaired renal function (creatinine clearance <30 mL/min) oxcarbazepine tablets 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 Pharmacology12.3

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• Apotex Corp.
  

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  Oxcarbazepine | Apotex Corp.

  

  ---

  All dosing should be given in a twice-a-day regimen. Oxcarbazepine oral suspension and oxcarbazepine film-coated tablets may be interchanged at equal doses.

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

  Oxcarbazepine can be taken with or without food [see Clinical Pharmacology (12.3)].

  2.1 Adjunctive Therapy for Adults

  Treatment with oxcarbazepine 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 oxcarbazepine titration, as these plasma levels may be altered, especially at oxcarbazepine 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 oxcarbazepine 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 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine 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 oxcarbazepine. 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 oxcarbazepine. In these patients, oxcarbazepine 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 oxcarbazepine monotherapy (see above).

  2.4 Adjunctive Therapy for Pediatric Patients (Aged 2 to 16 Years)

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

  20-29 kg to 900 mg/day 29.1-39 kg to 1200 mg/day >39 kg to 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 to 51 mg/kg.

  In pediatric patients aged 2 to <4 years, treatment should also be initiated at a daily dose of 8 to 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 to 20 mg/kg may be considered [see Clinical Pharmacology (12.3)]. The maximum maintenance dose of oxcarbazepine should be achieved over 2 to 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 to 16 Years)

  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine at approximately 8 to 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 to 6 weeks while oxcarbazepine 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 oxcarbazepine is shown in the table below.

  2.6 Initiation of Monotherapy for Pediatric Patients (Aged 4 to 16 Years)

  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 8 to 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 Oxcarbazepine 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) oxcarbazepine 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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• Medsource Pharmaceuticals
  

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  Oxcarbazepine | Medsource Pharmaceuticals

  

  ---

  All dosing should be given in a twice-a-day regimen.

  Oxcarbazepine tablets should be kept out of the reach and sight of children.

  Oxcarbazepine tablets can be taken with or without food [ see Clinical Pharmacology ( 12.3) ].

  2.1 Adjunctive Therapy for Adults

  Treatment with oxcarbazepine tablets 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 oxcarbazepine tablets titration, as these plasma levels may be altered, especially at oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets should be reached in about 2-4 weeks. Oxcarbazepine tablets 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 oxcarbazepine. 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 oxcarbazepine tablets. In these patients, oxcarbazepine tablets 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 oxcarbazepine 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 oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets 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 oxcarbazepine tablets. In these patients, oxcarbazepine tablets 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 Oxcarbazepine Tablets 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) oxcarbazepine tablets 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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