Ucb Farchim S.a.

Ucb Farchim S.a. Drugs

• Xyzal
  

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  Xyzal

  

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  XYZAL is available as 2.5 mg/5 mL (0.5 mg/mL) oral solution and as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. XYZAL can be taken without regard to food consumption.

  2.1 Adults and Children 12 Years of Age and Older

  The recommended dose of XYZAL is 5 mg (1 tablet or 2 teaspoons [10 mL] oral solution) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening.

  2.2 Children 6 to 11 Years of Age

  The recommended dose of XYZAL is 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].

  2.3 Children 6 months to 5 Years of Age

  The recommended initial dose of XYZAL is 1.25 mg (1/2 teaspoon oral solution) [2.5mL] once daily in the evening. The 1.25 mg once daily dose should not be exceeded based on comparable exposure to adults receiving 5 mg [see Clinical Pharmacology (12.3)].

  2.4 Dose Adjustment for Renal and Hepatic Impairment

  In adults and children 12 years of age and older with:

  Mild renal impairment (creatinine clearance [CLCR] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CLCR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CLCR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended; End-stage renal disease patients (CLCR < 10 mL/min) and patients undergoing hemodialysis should not receive XYZAL.

  No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

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• Keppra
  

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  Keppra

  

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  KEPPRA is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  KEPPRA is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

  KEPPRA is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

  Partial Onset Seizures

  Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  KEPPRA is given orally with or without food.

  Table 15: KEPPRA Tablet Weight-Based Dosing Guide For Children Daily Dose  Patient Weight 20 mg/kg/day (BID dosing) 40 mg/kg/day (BID dosing) 60 mg/kg/day (BID dosing) 20.1-40 kg 500 mg/day (1 x 250 mg tablet BID) 1000 mg/day (1 x 500 mg tablet BID) 1500 mg/day (1 x 750 mg tablet BID) >40 kg 1000 mg/day (1 x 500 mg tablet BID) 2000 mg/day (2 x 500 mg tablets BID) 3000 mg/day (2 x 750 mg tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

  Total daily dose (mL/day) =   Daily dose (mg/kg/day) x patient weight (kg) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years And Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 14 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients With Impaired Renal Function

  KEPPRA dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  CLcr =   [140-age (years)] x weight (kg)   (x 0.85 for female patients) - - - - - - - - - - - - - - - - - - - - - - 72 x serum creatinine (mg/dL) Table 16: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance(mL/min) Dosage(mg) Frequency 1 Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal > 80 500 to 1,500 Every 12 h Mild 50 – 80 500 to 1,000 Every 12 h Moderate 30 – 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis ---- 500 to 1,000 1Every 24 h

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• Keppra
  

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  Keppra

  

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  KEPPRA is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  KEPPRA is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

  KEPPRA is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

  Partial Onset Seizures

  Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  KEPPRA is given orally with or without food.

  Table 15: KEPPRA Tablet Weight-Based Dosing Guide For Children Daily Dose  Patient Weight 20 mg/kg/day (BID dosing) 40 mg/kg/day (BID dosing) 60 mg/kg/day (BID dosing) 20.1-40 kg 500 mg/day (1 x 250 mg tablet BID) 1000 mg/day (1 x 500 mg tablet BID) 1500 mg/day (1 x 750 mg tablet BID) >40 kg 1000 mg/day (1 x 500 mg tablet BID) 2000 mg/day (2 x 500 mg tablets BID) 3000 mg/day (2 x 750 mg tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

  Total daily dose (mL/day) =   Daily dose (mg/kg/day) x patient weight (kg) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years And Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 14 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients With Impaired Renal Function

  KEPPRA dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 16. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

  CLcr =   [140-age (years)] x weight (kg)   (x 0.85 for female patients) - - - - - - - - - - - - - - - - - - - - - - 72 x serum creatinine (mg/dL) Table 16: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance(mL/min) Dosage(mg) Frequency 1 Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal > 80 500 to 1,500 Every 12 h Mild 50 – 80 500 to 1,000 Every 12 h Moderate 30 – 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis ---- 500 to 1,000 1Every 24 h

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