Oxcarbazepine Suspension

Oxcarbazepine Suspension Manufacturers

• Roxane Laboratories, Inc
  

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  Oxcarbazepine Suspension | Mylan Institutional Llc

  

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  2.1 Recommended Dosage

  In Combination with Cisplatin 100 mg/m2   

  • The recommended dose of Vinorelbine Injection, USP is 25 mg/m 2 administered as an intravenous injection or infusion over 6 to 10 minutes on days 1, 8, 15 and 21 of a 28 day cycle in combination with cisplatin 100 mg/m 2 on day 1 only of each 28 day cycle.

  In Combination with Cisplatin 120 mg/m2

  • The recommended dose of Vinorelbine Injection, USP is 30 mg/m 2 administered as an intravenous injection or infusion over 6 to 10 minutes once a week in combination with cisplatin 120 mg/m 2 on days 1 and 29, then every 6 weeks.

  Single-Agent

  • The recommended dose of Vinorelbine Injection, USP is 30 mg/m 2 administered intravenously over 6 to 10 minutes once a week. 2.2 Dose Modifications

  Hematologic Toxicity

  [see  Warnings and Precautions (5.1)]

  Hold or decrease the dose of Vinorelbine Injection, USP in patients with decreased neutrophil counts using the following schema.

  Neutrophils on Day of Treatment (Cells/mm3) Percentage of Starting Dose of Vinorelbine Injection, USP

  ≥ 1,500

  100%

  1,000 to 1,499

  50%

  < 1,000

  Do not administer Vinorelbine Injection USP.

  Repeat neutrophil count in one week.

  If three consecutive weekly doses are held because Neutrophil count is < 1,000 cells/mm3, discontinue Vinorelbine Injection, USP

  Note : For patients who experience fever and/or sepsis while neutrophil count is < 1,500 or had 2 consecutive weekly doses held due to neutropenia, subsequent doses of Vinorelbine Injection, USP should be:

  > 1,500

  75%

  1,000 to 1,499

  37.5%

  < 1,000

  Do not administer Vinorelbine Injection, USP.

  Repeat neutrophil count in one week.

  Hepatic Impairment/Toxicity

  [see  Warnings and Precautions (5.2) and Use in Specific Populations (8.6)]

  Reduce Vinorelbine Injection, USP dose in patients with elevated serum total bilirubin concentration according to the following schema:

  Serum total bilirubin concentration (mg/dl)

  Percentage of Starting Dose of Vinorelbine Injection, USP

  ≤ 2.0

  100%

  2.1 to 3.0

  50%

  > 3.0

  25%

  Concurrent Hematologic Toxicity and Hepatic Impairment

  In patients with both hematologic toxicity and hepatic impairment, administer the lower of the doses based on the corresponding starting dose of Vinorelbine Injection, USP determined from the above schemas.

  Neurologic Toxicity

  [see  Warnings and Precautions (5.5) ]

  Discontinue  Vinorelbine Injection, USP  for  NCI  CTCAE  Grade  2  or  higher  peripheral  neuropathy  or autonomic neuropathy causing constipation.

  2.3 Preparation and Administration

  Preparation of Vinorelbine Injection, USP

  Dilute Vinorelbine Injection, USP in either a syringe or intravenous bag using one of the recommended solutions.

  Syringe

  Dilute to a concentration between 1.5 and 3 mg/mL. The following solutions may be used for dilution:

  •   5% Dextrose Injection, USP •   0.9% Sodium Chloride Injection, USP

  Intravenous Bag

  Dilute to a concentration between 0.5 and 2 mg/mL. The following solutions may be used for dilution:

  •   5% Dextrose Injection, USP •   0.9% Sodium Chloride Injection, USP •   0.45% Sodium Chloride Injection, USP •   5% Dextrose and 0.45% Sodium Chloride Injection, USP •   Ringer's Injection, USP •   Lactated Ringer's Injection, USP

  Stabiliy

  Diluted Vinorelbine Injection, USP may be used for up to 24 hours under normal room light when stored in polypropylene syringes or polyvinyl chloride bags at 5° to 30°C (41° to 86°F).

  Administration

  Administer diluted Vinorelbine Injection, USP over 6 to 10 minutes into the side port of a free-flowing intravenous line followed by flushing with at least 75 to 125 mL of one of the solutions.

  Vinorelbine Injection, USP must only be administered intravenously.  It is extremely important that the intravenous needle or catheter be properly positioned before any Vinorelbine Injection, USP is injected.

  Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. If particulate matter is seen, Vinorelbine Injection, USP should not be administered.

  Management of Suspected Extravasation

  •   If Vinorelbine Injection, USP leakage into surrounding tissue occurs or is suspected, immediately stop administration of Vinorelbine Injection, USP and initiate appropriate management measures in accordance with institutional policies. [see Warnings and Precautions (5.4).] 2.4 Procedures for Proper Handling and Disposal

  Handle and dispose Vinorelbine Injection, USP consistent with recommendations for the handling and disposal of hazardous drugs2.

  Exercise caution in handling and preparing the solution of Vinorelbine Injection, USP. The use of gloves is recommended. If the solution of Vinorelbine Injection, USP contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water.

  Avoid contamination of the eye with Vinorelbine Injection, USP. If exposure occurs, flush the eyes with water immediately and thoroughly.

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• Ranbaxy Pharmaceuticals Inc.
  

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  Oxcarbazepine Suspension | Ranbaxy Pharmaceuticals 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 oral suspension should be kept out of the reach and sight of children.

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

  Oxcarbazepine oral suspension 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 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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• Avkare, Inc.
  

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  Oxcarbazepine Suspension | Avkare, Inc.

  

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

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

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

  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 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 (12.4)]. 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 <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 Oxcarbazepinefor 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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• Amneal Pharmaceuticals Of New York, Llc
  

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  Oxcarbazepine Suspension | Amneal Pharmaceuticals Of New York, Llc

  

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

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

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

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

  2.1 Adjunctive Therapy for Adults

  Treatment with oxcarbazepine oral suspension, 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 oral suspension, USP titration, as these plasma levels may be altered, especially at oxcarbazepine oral suspension, 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 oral suspension, 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 to 6 weeks, while the maximum dose of oxcarbazepine oral suspension, USP should be reached in about 2 to 4 weeks. Oxcarbazepine oral suspension, 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 oral suspension, 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 oral suspension, USP. In these patients, oxcarbazepine oral suspension, 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 oral suspension, USP 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 oral suspension, USP 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 oral suspension, USP 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, USP dose per body weight compared to adults; and children 4 to ≤12 years of age may require a 50% higher oxcarbazepine, USP 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 oral suspension, USP 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 oral suspension, 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 oral suspension, USP 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 oral suspension, USP. In these patients, oxcarbazepine oral suspension, USP 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 Oral Suspension, 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 oral suspension, USP 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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