Indication 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.

Important Safety Information
GRALISE is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
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.
Gabapentin should be withdrawn gradually. If GRALISE is discontinued, this should be done gradually over a minimum of 1 week or longer (at the discretion
of the prescriber).
The safety and efficacy of GRALISE in patients with epilepsy has not been studied.
The most common adverse reaction to GRALISE (≥5% and twice placebo) is dizziness.
Across all GRALISE clinical trials the other most common adverse reactions (≥2%) are somnolence, headache, peripheral edema, diarrhea, dry
mouth, and nasopharyngitis. 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 should be used during pregnancy or in women who are nursing only if the benefits clearly outweigh the risks.
The safety and effectiveness of GRALISE in the management of postherpetic neuralgia in patients less than 18 years of age has not been studied.
An increase in gabapentin AUC values has been reported when administered with hydrocodone or morphine.
It is recommended that GRALISE be taken at least 2 hours following antacid administration.
Because gabapentin is not metabolized, studies have not been conducted in patients with hepatic impairment.
Dosage adjustment of GRALISE is necessary in patients with impaired renal function. GRALISE should not be administered in patients with creatinine clearance <30 mL/min or in patients undergoing hemodialysis. Reductions in GRALISE dose should be made in patients with age-related compromised renal function.
The abuse and dependence potential of GRALISE has not been evaluated in human studies.

References: 1. GRALISE [prescribing information]. Menlo Park, CA: Depomed Inc.; October 2012. 2. Data on file. Depomed Inc.


Please see full Prescribing Information and Medication Guide.