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Neurontin (gabapentin) oral solution

Company: Parke-Davis
Approval Status: Approved March 2000
Treatment for: Adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults w/ epilepsy
Areas: Neurology & Nervous System
Possible similar drugs: Neurontin; Neurontin

| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |


General Information

Neurontin is an anticonvulsant indicated for use as an adjunctive therapy in the treatment of partial seizures in adults with epilepsy. This newly approved oral solution form of the drug has bioequivalence to the capsule form of the Neurontin, which was approved in January 1999. The two dosage forms have the same indications.

Neurontin may be taken with or without food.

If you take antacids (such as Maalox or Mylanta), you should wait at least two hours after antacid use before taking gabapentin.


Clinical Results

705 adults with partial seizures were patients in clinical studies. Previous to clinical trials, all of these patients had at least 4 partial seizures a month, despite the use of one or more antiepileptic drugs. In three multicenter, placebo-controlled clinical trials, Neurontin was administered concurrently with the existing therapy. Reduction of frequency of partial seizures was significantly reduced in patients taking Neurontin 1200 mg/day, compared to placebo.

In a second study, patients taking 1200 mg/day Neurontin had greater reduction in seizure frequency than did those taking the placebo, however the difference was not statistically significant. The same was the case for 600 mg/day of Neurontin. On the other hand, 1800 mg/day yielded significantly greater reduction in seizure frequency than placebo.

Several studies also indicated that Neurontin was significantly more effective than placebo in preventing secondarily generalized tonic-clonic seizures.

In general, higher doses of Neurontin yielded greater reduction in frequency of seizures.


Side Effects

In clinical studies the most common side effects associated with Neurontin were:

  • Drowsiness (19.3% vs 8.7% for patients taking placebo
  • Fatigue (11% vs 5% with placebo)
  • Dizziness (17.1% vs 6.9% with placebo)
  • Involuntary rhythmic eye movement (8.3% vs 4.0% with placebo)
  • Problems with muscular coordination (12.5% vs 5.6% with placebo)

The above side effects reportedly lasted approximately 2 weeks within clinical trials.

During postmarketing development of Neurontin, 8 sudden and unexplained deaths were recorded among 2203 patients.


Mechanism of Action

The mechanism by which gabapentin exerts its anticonvulsant action is unknown, but in animal test systems designed to detect anticonvulsant activity, gabapentin prevents seizures as do other marketed anticonvulsants. Gabapentin exhibits antiseizure activity in mice and rats in both the maximal electroshock and pentylenetetrazole seizure models and other preclinical models (e.g., strains with genetic epilepsy, etc.). The relevance of these models to human epilepsy is not known.

Gabapentin is structurally related to the neurotransmitter GABA (gamma aminobutyric acid) but it does not interact with GABA receptors, it is not metabolically into GABA or a GABA agonist, and it is not an inhibitor of GABA uptake or degradation… (From FDA Label)


Literature References

Visit the Parke-Davis Pharmaceuticals web site, www.parke-davis.com, to learn more about Neurontin and about other products, research, and services provided by the company that developed this drug.

For more information about epilepsy, visit the official web site of the Epilepsy Foundation, a non-profit volunteer agency devoted to research, education, advocacy, and services in the community for people with epilepsy and their families: www.efa.org


Additional Information

This is what the Epilepsy Foundation says to do and not to do if you encounter a person having an epileptic seizure:

What To Do:

  • Look for medical identification.
  • Protect from nearby hazards.
  • Loosen ties or shirt collars.
  • Protect head from injury.
  • Turn on side to keep airway clear unless injury exists.
  • Reassure as consciousness returns.
  • If a single seizure lasted less than 5 minutes, ask if hospital evaluation wanted.
  • If there are multiple seizures, or if one seizure lasts longer than 5 minutes, call an ambulance.
  • If person is pregnant, injured, or diabetic, call for aid at once.

What Not To Do:

  • Don't put any hard implement in the mouth.
  • Don't try to hold tongue. It can't be swallowed.
  • Don't try to give liquids during or just after seizure,
  • Don't use artificial respiration unless breathing is absent after muscle jerks subside, or unless water has been inhaled.
  • Don't restrain.



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Neurontin Drug Information

The Neurontin drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.





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