Gralise
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Questions & Answers
Question
Gabapentin
Question
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Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
Gabapentin is 1-(aminomethyl)cyclohexaneacetic acid; γ-amino-2-cyclohexyl-butyric acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24.
The structural formula is:
Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and acidic and basic solutions. The log of the partition coefficient (n-octanol/ 0.05 M phosphate buffer) at pH 7.4 is -1.25.
GRALISE is supplied as tablets containing 300 mg or 600 mg of gabapentin. GRALISE tablets swell in gastric fluid and gradually release gabapentin. Each 300 mg tablet contains the inactive ingredients copovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, and Opadry® II white. Opadry® II white contains polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol 3350, and lecithin (soya). Each 600 mg tablet contains the inactive ingredients copovidone, hypromellose, magnesium stearate, polyethylene oxide, and Opadry® II beige. Opadry® II beige contains polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol 3350, iron oxide yellow, and iron oxide red.
Sources
Gralise Manufacturers
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Bryant Ranch Prepack
![Gralise (Gabapentin) Tablet, Film Coated [Bryant Ranch Prepack]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Gralise | Bryant Ranch Prepack
2.1 Postherpetic NeuralgiaDo 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 2.2 Patients with Renal ImpairmentIn 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 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 -
Depomed, Inc.
Gralise | Depomed, Inc.
2.1 Postherpetic NeuralgiaDo 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 2.2 Patients with Renal ImpairmentIn 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 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
![Gralise (Gabapentin) Tablet, Film Coated Gralise Starter Pack (Gabapentin) Kit [Depomed, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7d12b4e9-ed44-43c0-9e46-f6c195300f03&name=gralise-figure-3.jpg)
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