Cutivate

Cutivate Manufacturers

• Pharmaderm, A Division Of Fougera Pharmaceuticals Inc.
  

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  Cutivate | Pharmaderm, A Division Of Fougera Pharmaceuticals Inc.

  

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  Apply a thin film of CUTIVATE® Ointment to the affected skin areas twice daily. Rub in gently.

  Avoid use with occulusive dressing.

  CUTIVATE® Ointment is for topical use only; it is not for ophthalmic, oral or intravaginal use.

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• Pharmaderm, A Division Of Nycomed Us Inc.
  

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  Cutivate | Pharmaderm, A Division Of Nycomed Us Inc.

  

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  CUTIVATE® Lotion may be used in adult and pediatric patients 1 year of age or older. The safety and efficacy of CUTIVATE® Lotion in pediatric patients below 1 year of age have not been established (see PRECAUTIONS: Pediatric Use).

  Atopic Dermatitis: Apply a thin film of CUTIVATE® Lotion to the affected skin areas once daily. Rub in gently.

  As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. The safety and efficacy of drug use for longer than 4 weeks have not been established.

  CUTIVATE® Lotion should not be used with occlusive dressings or applied in the diaper area unless directed by a physician.

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• Pharmaderm, A Division Of Fougera Pharmaceuticals Inc.
  

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  Cutivate | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

  

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  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution) and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 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 (14.1)], 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 twice daily). 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

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years to < 16 Years: Treatment should be initiated with a daily dose of 20 mg/kg in two divided doses (10 mg/kg twice daily). 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 twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 kg to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation for Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  2.3 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 twice daily). 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.

  2.4 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 twice daily). 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 two divided doses (10 mg/kg twice daily). 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 twice daily). 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 Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients with Impaired Renal Function

  Levetiracetam tablet dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

   Then CLcr is adjusted for body surface area (BSA) as follows:

  Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function

   

  Group

   

  Creatinine Clearance
  (mL/min/1.73m2)

   

  Dosage (mg)

   

  Frequency

   

  Normal

     > 80  500 to 1500  

  Every 12 hours

  Mild   50 to 80  500 to 1000  

  Every 12 hours

  Moderate  30 to 50  250 to 750  

  Every 12 hours

  Severe   < 30  250 to 500  

  Every 12 hours

  ESRD patients using dialysis   ---  500 to 10001  

  Every 24 hours1

  
  

  1Following dialysis, a 250 mg to 500 mg supplemental dose is recommended.

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• Pharmaderm A Division Of Fougera Pharmaceuticals Inc.
  

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  Cutivate | Pharmaderm A Division Of Fougera Pharmaceuticals Inc.

  

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  CUTIVATE® Cream may be used in adult and pediatric patients 3 months of age or older. Safety and efficacy of CUTIVATE® Cream in pediatric patients for more than 4 weeks of use have not been established (see PRECAUTIONS: Pediatric Use). The safety and efficacy of CUTIVATE® Cream in pediatric patients below 3 months of age have not been established.

  Atopic Dermatitis: Apply a thin film of CUTIVATE® Cream to the affected skin areas once or twice daily. Rub in gently.

  Other Corticosteroid-Responsive Dermatoses: Apply a thin film of CUTIVATE® Cream to the affected skin areas twice daily. Rub in gently.

  As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

  CUTIVATE® Cream should not be used with occlusive dressings. CUTIVATE® Cream should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressings.

  Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with CUTIVATE® Cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

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