Neomed 325

Neomed 325 Manufacturers

• Bimeda, Inc. Division Of Cross Vetpharm Group
  

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  Neomed 325 | Zydus Pharmaceuticals (usa) Inc.

  

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  2.1 Dosage for Postherpetic Neuralgia

  In adults with postherpetic neuralgia, gabapentin 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.

  2.2 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 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 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 in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of gabapentin in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. 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.

  2.3 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 1Gabapentin Dosage Based on Renal Function

  TID = Three times a day; BID = Two times a day; QD = Single daily dose
  

  aFor 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).
  

  bPatients 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
  15a 
  100 to 300
  100 QD
  125 QD
  150 QD
  200 QD
  300 QD
  
  
  Post-Hemodialysis Supplemental Dose (mg)b
  
  
  
  Hemodialysis 
  
  125b
  150b
  200b
  250b
  350b
  

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

  2.4 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.

  2.5 Administration Information

  Administer gabapentin tablets orally with or without food.

  Inform patients that, should they divide the scored 600 mg or 800 mg gabapentin tablets 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 dividing the scored tablet should be discarded.

  If gabapentin 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).

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