Drugs A - Z

Gabapentin Oral solution

It is used to control partial seizures in adults with epilepsy

Generic Name: gabapentin

Brand Names: Neurontin, Gralise, Gabarone

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[UPDATE 05/05/2009] FDA notified healthcare professionals that it approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (e.g., migraine and neuropathic pain syndromes). FDA also required development of a medication guide, to be issued to patients each time the product is dispensed. Since issuing safety alerts on December 16, 2008 and January 31, 2008, FDA has been working with the manufacturers of drugs in this class to better understand the suicidality risk. Eleven antiepileptic drugs were included in a pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication.

The drugs included in the analyses include (some of these drugs are also available in generic form):

  • Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
  • Felbamate (marketed as Felbatol)
  • Gabapentin (marketed as Neurontin)
  • Lamotrigine (marketed as Lamictal)
  • Levetiracetam (marketed as Keppra)
  • Oxcarbazepine (marketed as Trileptal)
  • Pregabalin (marketed as Lyrica)
  • Tiagabine (marketed as Gabitril)
  • Topiramate (marketed as Topamax)
  • Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
  • Zonisamide (marketed as Zonegran)

For more information visit the FDA website at: [Web] and [Web].

[UPDATE 12/16/2008] The FDA has completed its analysis of reports of suicidality (suicidal behavior or ideation [thoughts]) from placebo-controlled clinical trials of drugs used to treat epilepsy, psychiatric disorders, and other conditions. Based on the outcome of this review, FDA is requiring that all manufacturers of drugs in this class include a Warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions.

For more information visit the FDA website at: [Web] and [Web].

[Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA’s analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.

Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The drugs included in the analyses include (some of these drugs are also available in generic form):

  • Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
  • Felbamate (marketed as Felbatol)
  • Gabapentin (marketed as Neurontin)
  • Lamotrigine (marketed as Lamictal)
  • Levetiracetam (marketed as Keppra)
  • Oxcarbazepine (marketed as Trileptal)
  • Pregabalin (marketed as Lyrica)
  • Tiagabine (marketed as Gabitril)
  • Topiramate (marketed as Topamax)
  • Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
  • Zonisamide (marketed as Zonegran)

Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly. For more information visit the FDA website at: [Web] and [Web].

REMS:

FDA approved a REMS for gabapentin to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

GABAPENTIN (GA ba pen tin) is used to control partial seizures in adults with epilepsy. It is also used to treat certain types of nerve pain.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • kidney disease
  • suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
  • an unusual or allergic reaction to gabapentin, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth. Carefully measure the dose needed. Use a specially marked spoon or dropper to measure your medicine. Tell your pharmacist if you do not have one. Household spoons are not accurate. If this medicine upsets your stomach, take it with food or milk. Take your medicine at regular intervals. Do not take it more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • other gabapentin products (Gralise, Horizant)

This medicine may also interact with the following medications:

  • alcohol
  • antacids
  • antihistamines for allergy, cough and cold
  • certain medicines for anxiety or sleep
  • certain medicines for depression or psychotic disturbances
  • homatropine; hydrocodone
  • naproxen
  • narcotic medicines (opiates) for pain
  • phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You may want to keep a record at home of how you feel your condition is responding to treatment. You may want to share this information with your doctor or health care professional at each visit. You should contact your doctor or health care professional if your seizures get worse or if you have any new types of seizures. Do not stop taking this medicine or any of your seizure medicines unless instructed by your doctor or health care professional. Stopping your medicine suddenly can increase your seizures or their severity.

Wear a medical identification bracelet or chain if you are taking this medicine for seizures, and carry a card that lists all your medications.

You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness and dizziness. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.

Women who become pregnant while using this medicine may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic drug use during pregnancy.


Last Updated: January 09, 2013
Licensed from
The Healthline Site, its content, such as text, graphics, images, search results, HealthMaps, Trust Marks, and other material contained on the Healthline Site ("Content"), its services, and any information or material posted on the Healthline Site by third parties are provided for informational purposes only. None of the foregoing is a substitute for professional medical advice, examination, diagnosis, or treatment. Always seek the advice of a physician or other qualified healthcare provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on the Healthline Site. If you think you may have a medical emergency, call your doctor or 911 immediately. Please read the Terms of Service for more information regarding use of the Healthline Site.
Advertisement
Advertisement