Gralise

Gabapentin is a prescription medication used to treat adults with nerve pain caused by shingles. Shingles is a painful rash that is caused by the varicella-zoster virus, the virus that also causes chickenpox. Gabapentin is also used in combination with other medications to treat partial seizures. Gabapentin belongs to a group of drugs called anticonvulsants, which help treat seizures by decreasing abnormal excitement in the brain. It also works by altering the way the body senses pain.

This medication comes in tablet, capsule, and oral (by mouth) solution forms and is taken up to 3 times a day, with or without food. The capsules are taken with a full glass of water.

Common side effects of gabapentin include lack of coordination, dizziness, and drowsiness. Do not drive a car or operate heavy machinery until you know how this medication affects you.

Gabapentin is a prescription medicine used to treat:

• Pain from damaged nerves (postherpetic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) in adults.
• Partial seizures when taken together with other medicines in adults and children 3 years of age and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Depomed, Inc.

Serious side effects have been reported with gabapentin. See “Drug Precautions” section.

The most common side effects of gabapentin include:

• dizziness
• lack of coordination
• viral infection
• feeling drowsy
• feeling tired
• fever
• jerky movements
• difficulty with speaking
• temporary loss of memory 
  (amnesia)
• tremor
• difficulty with coordination
• double vision
• unusual eye movement

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of gabapentin. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• hydrocodone (found in medications such as Vicodin, Norco, and Lorcet)
• morphine (found in medications such as Kadian, MS Contin, and RMS Suppository)
• Maalox

This is not a complete list of gabapentin drug interactions. Ask your doctor or pharmacist for more information.

Do not stop taking gabapentin without first talking to your healthcare provider.

Stopping gabapentin suddenly can cause serious problems.

Gabapentin can cause serious side effects including:

1.  Like other antiepileptic drugs, gabapentin may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

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 dying
• attempts 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 you can 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 gabapentin without first talking to a healthcare provider.

• Stopping gabapentin suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

2.  Changes in behavior and thinking - Using gabapentin in children 3 to 12 years of age can cause emotional changes, aggressive behavior, problems with concentration, restlessness, changes in school performance, and hyperactivity.

 

3.  Gabapentin may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have a rash when you get this type of reaction. It may cause you to be hospitalized or to stop gabapentin. Call a healthcare provider right away if you have any of the following symptoms:

• skin rash
• hives
• fever
• swollen glands that do not go away
• swelling of your lip and tongue
• yellowing of your skin or of the whites of the eyes
• unusual bruising or bleeding
• severe fatigue or weakness
• unexpected muscle pain
• frequent infections

These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking gabapentin.

Do not take gabapentin if you are allergic to gabapentin or any of the other ingredients in gabapentin.

Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin without first talking with your healthcare provider. Taking gabapentin with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how gabapentin affects you. Gabapentin can slow your thinking and motor skills.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of gabapentin there are no specific foods that you must exclude from your diet when receiving gabapentin.

Before taking gabapentin, tell your healthcare provider if you:

• have or have had kidney problems or are on hemodialysis
• have or have had depression, mood problems, or suicidal thoughts or behavior
• are pregnant or plan to become pregnant. 
• are breastfeeding or plan to breastfeed. 

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Taking gabapentin with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if gabapentin can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking gabapentin. You and your healthcare provider will decide if you should take gabapentin while you are pregnant.

• If you become pregnant while taking gabapentin, 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 during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Gabapentin can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take gabapentin.

• Take gabapentin exactly as prescribed. Your healthcare provider will tell you how much Gabapentin to take.
  • Do not change your dose of gabapentin without talking to your healthcare provider. If you break a tablet in half, the unused half of the tablet should be taken at your next scheduled dose. Half tablets not used within several days of breaking should be thrown away. If taking capsules, always swallow them whole with plenty of water.
• Gabapentin can be taken with or without food. If you take an antacid containing aluminum and magnesium, such as Maalox, Mylanta, Gelusil, Gaviscon, or Di-Gel, you should wait at least 2 hours before taking your next dose of gabapentin.
• If you take too much gabapentin, call your healthcare provider or your local Poison Control Center right away.

• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin without first talking with your healthcare provider. Taking gabapentin with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how gabapentin affects you. Gabapentin can slow your thinking and motor skills.

Postherpetic Neuralgia:

In adults with postherpetic neuralgia, gabapentin therapy may be started as a single 300-mg dose on Day 1, 600 mg/day on Day 2 (divided twice daily), and 900 mg/day on Day 3 (divided three times daily). The dose can be increased as needed for pain relief to a daily dose of 1800 mg (divided three times daily). Additional benefit of using doses greater than 1800 mg/day was not shown.

Epilepsy:

If you take too much gabapentin, call your healthcare provider or your local Poison Control Center right away.

• Store gabapentin capsules between 59°F to 86°F (15°C to 30°C).
• Store gabapentin tablets between 59°F to 86°F (15°C to 30°C).
• Store gabapentin oral solution in the refrigerator between 36°F to 46°F (2°C to 8°C).

Keep gabapentin and all medicines out of the reach of children.