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GRALISE is indicated for the management of postherpetic neuralgia.
GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.
DOSAGE AND ADMINISTRATION
Do not use GRALISE interchangeably with other gabapentin products.
Titrate GRALISE 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).
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|
Patients with Renal Impairment
In patients with stable renal function, creatinine clearance (CCr) can be reasonably well estimated using the equation of Cockcroft and Gault:
For females CCr=(0.85)(140-age)(weight)/[(72)(SCr)]
For males CCr=(140-age)(weight)/[(72)(SCr)] where age is in years, weight is in kilograms and SCr is 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
|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|
Dosage Forms And Strengths
Tablets: 300 mg and 600 mg [see DESCRIPTION and Storage and Handling]
Storage And Handling
GRALISE (gabapentin) Tablets are supplied as follows:
300 mg tablets
GRALISE 300 mg tablets are white, oval shaped tablets debossed with “SLV” on one side and “300” on the other side.
NDC 13913-004-13 (Bottle of 30)
600 mg tablets
GRALISE 600 mg tablets are beige, oval shaped tablets debossed with “SLV” on one side and “600” on the other side.
NDC 13913-005-19 (Bottle of 90)
30-Day Starter Pack
NDC 13913-006-16 (Blister package containing 78 tablets: 9 x 300 mg tablets and 69 x 600 mg tablets)
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Keep out of reach of children.
Marketed by: Depomed, Inc. Menlo Park, CA 94025. Issued APR 2012
Last reviewed on RxList: 8/16/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Gralise Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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