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General: Although there is no evidence of rebound seizures with gabapentin, abrupt withdrawal of anticonvulsants in epileptic patients may precipitate status epilepticus.
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.
Concomitant use with opioids and other CNS depressants: Patients who require concomitant treatment with opioids may experience increases in gabapentin concentrations. Patients who require concomitant treatment with CNS (central nervous system) depressants, including opioids, should be carefully observed for signs of CNS depression, such as somnolence, sedation, and respiratory depression and the dose of gabapentin or concomitant treatment with CNS depressants, including opioids, should be reduced appropriately. Caution is advised when prescribing gabapentin concomitantly with opioids due to risk of CNS depression.
Respiratory depression: Gabapentin has been associated with severe respiratory depression. Patients with compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant use of CNS depressants and the elderly might be at higher risk of experiencing this severe adverse reaction. Dose adjustments might be necessary in these patients.
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/or psychiatric disorders and observe them for possible signs of gabapentin abuse. Potential for an increase in risk of suicidal thoughts or behaviours.
Withdrawal symptoms: After discontinuation of short-term and long-term treatment with gabapentin, withdrawal symptoms have been observed in some patients. Withdrawal symptoms may occur shortly after discontinuation, usually within 48 hours. Most frequently reported symptoms include anxiety, insomnia, nausea, pains, sweating, tremor, headache, depression, feeling abnormal, dizziness, and malaise.
Women of childbearing potential/Contraception: Gabapentin use in the first trimester of pregnancy may cause major birth defects in the unborn child. Gabapentin should not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the fetus. Women of childbearing potential must use effective contraception during treatment.
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.
