Gabapentin

Gabapentin tablets are indicated for the management of postherpetic neuralgia.

Once-daily gabapentin tablets are not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.

• •Gabapentin tablets should be titrated to an 1,800 mg dose taken orally, once-daily, with the evening meal. Gabapentin tablets should be swallowed whole. Do not crush, split, or chew the tablets. (
  2.1 Postherpetic Neuralgia

  Do not use once-daily gabapentin tablets interchangeably with other gabapentin products.

  Titrate gabapentin tablets to an 1,800 mg dose taken orally once daily with the evening meal. Gabapentin tablets should be swallowed whole. Do not split, crush, or chew the tablets.

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

  In adults with postherpetic neuralgia, gabapentin tablets therapy should be initiated and titrated as follows:

  Table 1: Gabapentin Tablets Recommended Titration Schedule

  	Day 1	Day 2	Days 3 to 6	Days 7 to 10	Days 11 to 14	Day 15
  Daily Dose	300 mg	600 mg	900 mg	1,200 mg	1,500 mg	1,800 mg
  )
• •If gabapentin tablets dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week or longer (at the discretion of the prescriber). (
  2.1 Postherpetic Neuralgia

  Do not use once-daily gabapentin tablets interchangeably with other gabapentin products.

  Titrate gabapentin tablets to an 1,800 mg dose taken orally once daily with the evening meal. Gabapentin tablets should be swallowed whole. Do not split, crush, or chew the tablets.

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

  In adults with postherpetic neuralgia, gabapentin tablets therapy should be initiated and titrated as follows:

  Table 1: Gabapentin Tablets Recommended Titration Schedule

  	Day 1	Day 2	Days 3 to 6	Days 7 to 10	Days 11 to 14	Day 15
  Daily Dose	300 mg	600 mg	900 mg	1,200 mg	1,500 mg	1,800 mg
  )
• •Renal impairment: Dose should be adjusted in patients with reduced renal function. Gabapentin tablets should not be used in patients with CrCl less than 30 or in patients on hemodialysis. (
  2.2 Patients with Renal Impairment

  In patients with stable renal function, creatinine clearance (C_Cr) can be reasonably well estimated using the equation of Cockcroft and Gault:

  • For females C_Cr=(0.85)(140-age)(weight)/[(72)(S_Cr)]
  • For males C_Cr=(140-age)(weight)/[(72)(S_Cr)]

  where age is in years, weight is in kilograms and S_Cris serum creatinine in mg/dL.

  The dose of gabapentin tablets should be adjusted in patients with reduced renal function, according to Table 2. Patients with reduced renal function must initiate gabapentin tablets at a daily dose of 300 mg. Gabapentin tablets should be titrated following the schedule outlined in Table 1. Daily dosing in patients with reduced renal function must be individualized based on tolerability and desired clinical benefit.

  Table 2: Gabapentin Tablets Dosage Based on Renal Function

  Once-daily dosing
  Creatinine Clearance (mL/min)	Gabapentin Tablets Dose (once daily with evening meal)
  ≥ 60	1,800 mg
  30 to 60	600 mg to 1,800 mg
  < 30	Gabapentin tablets should not be administered
  patients receiving hemodialysis	Gabapentin tablets should not be administered
  )

Tablets:

300 mg: white, oval-shaped, film-coated tablets debossed with “300” above “ ” on one side and plain on the other side.

600 mg: orange, oval-shaped, film-coated tablets debossed with “600” above “ ” on one side and plain on the other side.

• •Elderly: Reductions in gabapentin tablets dose should be made in patients with age-related compromised renal function. (
  8.5 Geriatric Use

  The total number of patients treated with gabapentin tablets in controlled clinical trials in patients with postherpetic neuralgia was 359, of which 63% were 65 years of age or older. The types and incidence of adverse events were similar across age groups except for peripheral edema, which tended to increase in incidence with age.

  Gabapentin tablets are known to be substantially excreted by the kidney. Reductions in gabapentin tablets dose should be made in patients with age-related compromised renal function

  [see Dosage and Administration (2.2)].
  )
• •Renal impairment: Dosage adjustment is necessary for patients with impaired renal function. (
  8.7 Renal Impairment

  Gabapentin tablets are known to be substantially excreted by the kidney. Dosage adjustment is necessary in patients with impaired renal function. Gabapentin tablets should not be administered in patients with CrCL between 15 and 30 or in patients undergoing hemodialysis

  [see Dosage and Administration (2.2)].
  )

Once-daily gabapentin tablets are not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.

The safety and effectiveness of gabapentin tablets in patients with epilepsy has not been studied.