Gralise

GRALISE is indicated for the management of postherpetic neuralgia.

GRALISE is not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.

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

  Do not use GRALISE as a substitute for other gabapentin products.

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

  If GRALISE 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, GRALISE therapy should be initiated and titrated as follows:

  Table 1: GRALISE Recommended Titration Schedule

  	Day 1	Day 2	Days 3-6	Days 7-10	Days 11-14	Day 15
  Daily Dose	300 mg	600 mg	900 mg	1,200 mg	1,500 mg	1,800 mg
  )
• If GRALISE 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 GRALISE as a substitute for other gabapentin products.

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

  If GRALISE 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, GRALISE therapy should be initiated and titrated as follows:

  Table 1: GRALISE Recommended Titration Schedule

  	Day 1	Day 2	Days 3-6	Days 7-10	Days 11-14	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. GRALISE 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 GRALISE should be adjusted in patients with reduced renal function, according to Table 2. Patients with reduced renal function must initiate GRALISE at a daily dose of 300 mg. GRALISE 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: GRALISE Dosage Based on Renal Function

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

Tablets:

• 300 mg, white, oval, debossed with “SLV” on one side and “300” on the other side.
• 450 mg, red, oval, debossed with “ALM” on one side and “450” on the other side.
• 600 mg, beige, oval, debossed with “SLV” on one side and “600” on the other side.
• 750 mg,
  yellow, oval, debossed with “ALM” on one side and “750” on the other side.
• 900 mg, pink, oval, debossed with “ALM” on one side and “900” on the other side.

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

  The total number of patients treated with GRALISE 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.

  GRALISE is known to be substantially excreted by the kidney. Reductions in GRALISE dose should be made in patients with age-related compromised renal function

  [see Dosage and Administration ]

  .
  )
• Renal impairment: Dosage adjustment is necessary for patients with impaired renal function. (
  8.7 Renal Impairment

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

  [see Dosage and Administration ].
  )