Lenzapatch

Lenzapatch Manufacturers

• Pharmaceutica North America, Inc.
  

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  Lenzapatch | Mylan Pharmaceuticals Inc.

  

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  2.1 Administration Information

  Administer gabapentin tablets orally with or without food.

  Inform patients that, should they break the scored 600 mg or 800 mg gabapentin tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within 28 days of breaking the scored tablet should be discarded.

  If the gabapentin tablets dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).

  2.2 Dosage for Postherpetic Neuralgia

  In adults with postherpetic neuralgia, gabapentin tablets may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated.

  2.3 Dosage for Epilepsy with Partial Onset Seizures Patients 12 Years of Age and Above

  The starting dose is 300 mg three times a day. The recommended maintenance dose of gabapentin tablets is 300 mg to 600 mg three times a day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. Administer gabapentin tablets three times a day using 600 mg or 800 mg tablets. The maximum time between doses should not exceed 12 hours.

  Pediatric Patients Age 3 to 11 Years

  The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the recommended maintenance dose reached by upward titration over a period of approximately 3 days. The recommended maintenance dose of gabapentin tablets in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of gabapentin tablets in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. Gabapentin may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.

  2.4 Dosage Adjustment in Patients with Renal Impairment

  Dosage adjustment in patients 12 years of age and older with renal impairment or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication):

  Table 1. Gabapentin Tablets Dosage Based on Renal Function TID = Three times a day; BID = Two times a day; QD = Single daily dose * For patients with creatinine clearance < 15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive). † Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.

  Renal Function

  Creatinine Clearance

  (mL/min)

  Total Daily

  Dose Range

  (mg/day)

  Dose Regimen

  (mg)

  ≥ 60

  900 to 3600

  300 TID

  400 TID

  600 TID

  800 TID

  1200 TID

  > 30 to 59

  400 to 1400

  200 BID

  300 BID

  400 BID

  500 BID

  700 BID

  > 15 to 29

  200 to 700

  200 QD

  300 QD

  400 QD

  500 QD

  700 QD

  15*

  100 to 300

  100 QD

  125 QD

  150 QD

  200 QD

  300 QD

  Post-Hemodialysis Supplemental Dose (mg)†

  Hemodialysis

  125†

  150†

  200†

  250†

  350†

  Creatinine clearance (CLCr) is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault:

  The use of gabapentin tablets in patients less than 12 years of age with compromised renal function has not been studied.

  2.5 Dosage in Elderly

  Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.

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• Proficient Rx Lp
  

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  Lenzapatch | Proficient Rx Lp

  

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  • Clean and dry affected area. • Remove patch from backing and apply to affected area. • Use only one patch at a time, and maximum of four patches/day. • Leave patch on affected area for up to 8-hours. • Do not use patches for longer than five consecutive days. • Children under 12 should consult physician prior to use.
  

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