Maxgalin Special Precautions

As with all AEDs, pregabalin should be withdrawn gradually to minimize the potential of increased seizure frequency in patients with seizure disorders. Following abrupt or rapid discontinuation of pregabalin, some patients reported symptoms including insomnia, nausea, headache, diarrhea, flu syndrome, nervousness, depression, pain, sweating and dizziness. If pregabalin is discontinued this should be done gradually over a minimum of 1 week. Concerning discontinuation of long-term treatment of pregabalin there are no data of the incidence and severity of withdrawal symptoms in relation to duration of use and dosage of pregabalin.
There are insufficient data for the withdrawal of concomitant antiepileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached.
Pregabalin causes dizziness and somnolence. Patients should be informed that pregabalin-related dizziness and somnolence may impair their ability to perform tasks such as driving or operating machinery.
Pregabalin treatment caused weight gain and edema, primarily described as peripheral edema. As the thiazolidinedione class of antidiabetic drugs can cause weight gain and/or fluid retention, possible exacerbating or leading to heart failure, care should be taken when coadministering pregabalin and these agents. Therefore, dosage adjustment of these antidiabetics may be required.
Because there are limited data on congestive heart failure patients with New York Heart Association (NYHA) Class III or IV cardiac status, pregabalin should be used with caution in these patients.
Pregabalin treatment was associated with creatine kinase elevations. Prescribers should instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if these muscle symptoms are accompanied by malaise or fever. Pregabalin treatment should be discontinued if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur.
Pregabalin treatment was associated with decrease in platelet count and mild PR interval prolongation.
Patients should be counseled that pregabalin may cause visual disturbances. Patients should be informed that if changes in vision occur, they should notify their physician.
Patients who require concomitant treatment with central nervous system depressants such as opiates or benzodiazepines should be informed that they may experience additive CNS side effects, such as somnolence.
Patients should be told to avoid consuming alcohol while taking pregabalin, as pregabalin may potentiate the impairment of motor skills and sedation of alcohol.
Men being treated with pregabalin who plan to father a child should be informed of the potential risk of male-mediated teratogenicity.
Diabetic patients should be instructed to pay particular attention to skin integrity while being treated with pregabalin. Some animals treated with pregabalin developed skin ulcerations, although no increased incidence of skin lesions associated with pregabalin was observed in clinical trials.