GRALISE® (gabapentin) tablets
BRIEF SUMMARY: For full prescribing information, see package insert.
INDICATIONS AND USAGE
GRALISE is indicated for the management of Postherpetic Neuralgia (PHN). GRALISE is not interchangeable
with other gabapentin products because of differing pharmacokinetic profiles that affect the
frequency of administration.
DOSAGE AND ADMINISTRATION
Postherpetic neuralgia
• GRALISE should be titrated to an 1800 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 dose 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).
• 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.
• 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
1200 mg
1500 mg
1800 mg
CONTRAINDICATIONS
GRALISE is contraindicated in patients with demonstrated hypersensitivity to the drug or its ingredients.
Table 2 GRALISE Dosage Based on Renal Function
Once-daily dosing
Creatinine clearance (mL/min)
GRALISE dose (once daily with evening meal)
≥ 60
1800 mg
30-60
600 mg to 1800 mg
< 30
GRALISE should not be administered
Patients receiving hemodialysis
GRALISE should not be administered
WARNINGS AND PRECAUTIONS
GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles
that affect the frequency of administration. The safety and effectiveness of GRALISE in patients with epilepsy has
not been studied. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including gabapentin, the active
ingredient in GRALISE, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any
indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening
of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Table 3 Risk by Indication for Antiepileptic Drugs (including gabapentin, the active ingredient
in Gralise) in the Pooled Analysis
Indication
Epilepsy
Psychiatric Other
Total
Placebo patients with events per 1000 patients
1.0
5.7
1.0
2.4
Drug patients with events per 1000 patients
3. @