General: Although there is no evidence of rebound seizures with gabapentin, abrupt withdrawal of anticonvulsants in epileptic patients may precipitate status epilepticus (see General under Dosage & Administration).
Gabapentin is generally not considered effective in the treatment of absence seizures.
Gabapentin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall). There have also been post-marketing reports of confusion, loss of consciousness and mental impairment. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medication.
Patients who require concomitant treatment with opioids may experience increases in gabapentin concentrations. Patients should be carefully observed for signs of central nervous system (CNS) depression, such as somnolence, sedation and respiratory depression and the dose of gabapentin or opioid should be reduced appropriately (see Interactions).
Drug rash with eosinophilia and systemic symptoms: Severe, life-threatening, systemic hypersensitivity reactions such as drug rash with eosinophilia and systemic symptoms (DRESS) have been reported in patients taking antiepileptic drugs, including gabapentin.
It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Gabapentin should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
Anaphylaxis: Gabapentin can cause anaphylaxis. Signs and symptoms in reported cases have included difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment. Patients should be instructed to discontinue gabapentin and seek immediate medical care should they experience signs or symptoms of anaphylaxis.
Abuse and dependence: Cases of abuse and dependence have been reported in the post-marketing database. As with any CNS active drug, carefully evaluate patients for a history of drug abuse and observe them for possible signs of gabapentin abuse.
Effects on ability to drive and use machines: Patients should be advised not to drive a car or operate potentially dangerous machinery until it is known that this medication does not affect their ability to engage in these activities.
Fertility: There is no effect on fertility in animal studies (see Pharmacology: Toxicology: Preclinical safety data: Impairment of fertility under Actions).