Epiven Special Precautions



Novell Pharma


Averroes Pharma
Full Prescribing Info
Special Precautions
Abrupt discontinuation; may increase seizure frequency or precipitate status epilepticus; discontinue gradually over a minimum of 1 week.
Gabapentin is not generally considered effective in the treatment of absence seizures.
Patients who require concomitant treatment with morphine may experience increases in gabapentin concentrations. Patients should be carefully observed for signs of CNS depression, such as somnolence, and the dose of gabapentin or morphine should be reduced appropriately.
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.
Drug Rash with Eosinophilia and Systemic Symptoms (DRESS)/multiorgan hypersensitivity, including fatal cases, has been reported; evaluate early signs/symptoms and discontinue gabapentin if confirmed.
Paediatric patients (age 3 to 12 years): neuropsychiatric adverse events, including emotional lability, hostility, thought disorder, and hyperkinesia, have been reported.
Renal impairment or hemodialysis; dose adjustment of Gabapentin is necessary.
Monitoring recommended for suicidality, worsening depression, and/or any unusual behavioral or mood changes (eg, anxiety, agitation, hostility, mania, and hypomania).
Effects on the ability to drive and use machines: Gabapentin may impair the ability to drive a car or operate potentially dangerous machinery. Patients are advised not to drive or operate potentially dangerous machinery, until it is known that this medication does not affect their ability to engage in these activities.
Potential for an increase in risk of suicidal thoughts or behaviors.
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