Neurontin Special Precautions

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 postmarketing 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 (see Interactions).
Caution is advised when prescribing gabapentin concomitantly with opioids due to risk of CNS depression. In a population-based, observational, nested case-control study of opioid users, co-prescription of opioids and gabapentin was associated with an increased risk for opioid-related death compared to opioid prescription use alone (adjusted odds ratio [aOR], 1.49 [95% CI, 1.18 to 1.88, p<0.001]).
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.
Potential for an increase in risk of suicidal thoughts or behaviors.
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.
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 the discontinuation, usually within 48 hours. Most frequently reported symptoms include anxiety, insomnia, nausea, pains, sweating, tremor, headache, depression, feeling abnormal, dizziness and malaise.
Information for patients: To assure safe and effective use of gabapentin, the following information and instructions should be given to patients: The patient should inform a physician about any prescription or non-prescription medications, alcohol, or drugs that the patient are now taking or are planning to take during the treatment with gabapentin.
The patient should inform a physician if the patient is pregnant, or if planning to become pregnant, or if the patient becomes pregnant while taking gabapentin.
Gabapentin is excreted in human milk, and the effect on the nursing infant is unknown. The patient should inform a physician if the patient is breast-feeding an infant (see Lactation under Use in Pregnancy & Lactation).
Gabapentin may impair the patient's ability to drive a car or operate potentially dangerous machinery. Until it is known that this medication does not affect the ability to engage in these activities, do not drive a car or operate potentially dangerous machinery.
The patient should not allow more than 12 hours between gabapentin doses to prevent breakthrough convulsions.
Prior to initiation of treatment with gabapentin, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity, such as fever or lymphadenopathy may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.
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.
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 (see Use in Pregnancy & Lactation).