GRALISE EXTENDED RELEASE TABLETS 600 MG [SIN17165P]

Product Info

GRALISE EXTENDED RELEASE TABLETS 600 MG

[SIN17165P]

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Postherpetic Neuralgia

Do not use GRALISE interchangeably with 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:

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_Cr 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.

4 CONTRAINDICATIONS

GRALISE is contraindicated in patients with demonstrated hypersensitivity to the drug or its ingredients.