Gralise
Generic Name: gabapentin
Date of Approval: January 28, 2011
Company: Abbott Laboratories
Treatment for: Post-Herpetic Neuralgia
Date of Approval: January 28, 2011
Company: Abbott Laboratories
Treatment for: Post-Herpetic Neuralgia
FDA Approves Gralise
The United States Food and Drug Administration has approved Gralise (gabapentin) Tablets for once-daily treatment of post-herpetic neuralgia (PHN), which is pain following healing of the rash associated with shingles.
Gralise Medication Guide
Read this Medication Guide before you start taking Gralise and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about Gralise, ask your healthcare provider or pharmacist.
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Important information
Do not stop taking Gralise without first talking with your healthcare provider. Stopping Gralise suddenly can cause serious problems.
Like other antiepileptic drugs, gabapentin, the active ingredient in Gralise, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. However, it is not known if Gralise is safe and effective in people with seizure problems (epilepsy). Therefore, Gralise should not be used in place of other gabapentin products.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
thoughts about suicide or dyingattempts to commit suicide
new or worse depression
new or worse anxiety
feeling agitated or restless
panic attacks
trouble sleeping (insomnia)
new or worse irritability
acting aggressive, being angry, or violent
acting on dangerous impulses
an extreme increase in activity and talking (mania)
other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Do not stop taking Gralise without first talking with your healthcare provider.
Stopping Gralise suddenly can cause serious problems.
What is Gralise?
Gralise is a prescription medicine used in adults, 18 years and older, to treat pain from damaged nerves (neuropathic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection).
It is not known if Gralise is safe and effective in people with seizure problems (epilepsy).
It is not known if Gralise is safe and effective in children under 18 years of age with postherpetic pain.
Gralise is not interchangeable with other gabapentin products.
Who should not take Gralise?
Do not take Gralise if you are allergic to gabapentin or any of the ingredients in Gralise.
See the end of this Medication Guide for a complete list of ingredients in Gralise.
Before taking this medicine
Before taking Gralise, tell your healthcare provider if you:
have or have had depression, mood problems or suicidal thoughts or behavior
have seizures
have kidney problems or get kidney dialysis
are pregnant or plan to become pregnant. It is not known if Gralise can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Gralise. You and your healthcare provider will decide if you should take Gralise while you are pregnant.
If you become pregnant while taking Gralise, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs, including gabapentin, the active ingredient in Gralise, during pregnancy. You can enroll in this registry by calling 1-888582-233-2334.
are breastfeeding or plan to breastfeed. Gralise can pass into your breast milk. You and your healthcare provider should decide how you will feed your baby while you take Gralise.
