Indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in pediatric patients aged 4 years and above with epilepsy.
The pharmacological activity of Oxcarbazepine is primarily exerted through the 10-monohydroxy metabolite (MHD). The precise mechanism by which Oxcarbazepine and MHD exert their antiseizure effect is unknown; however, in vitro electrophysiological studies indicate that they produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. These actions are thought to be important in the prevention of seizure spread in the intact brain. In addition, increased potassium conductance and modulation of high voltage activated calcium channels may contribute to the anticonvulsant effects of the drug. No significant interactions of Oxcarbazepine or MHD with brain neurotransmitter or modulator receptor sites have been demonstrated.
ORAL Monotherapy or adjunctive therapy in the treatment of partial seizures w/ or w/o secondary generalised tonic-clonic seizures: Adult: Initially, 600 mg daily in 2 divided doses; increase at a max increments of 600 mg daily at wkly intervals depending on response. Maintenance: 600-1,200 mg daily. Adjunctive therapy/ refractory patients switched from other anticonvulsants: Up to 2,400 mg daily. Child: >6 yr: 8-10 mg/kg daily in 2 divided doses: increase as necessary to max increments of 10 mg/kg daily at about wkly intervals to a max of 46 mg/kg daily. Maintenance in adjunctive therapy: 30 mgI kg daily.
In vitro and in vivo studies showed little or no interaction of Oxcarbazepine with cytochrome P450 enzymes. Since Oxcarbazepine is used as adjunctive therapy, trials of Oxcarbazepine given concomitantly with other antiepileptics explored the effects of Oxcarbazepine on others antiepileptics. No drug interactions with cimetidine, dextropropoxyphene, erythromycin and warfarin.
Hypersensitivity. Lactation. Cross-sensitivity to carbamazepine may occur. Do not discontinue abruptly. Renal & hepatic impairment. Patients at risk of hyponatraemia. May impair ability to drive or operate machinery. Pregnancy.
Dizziness, somnolence, headache, ataxia, fatigue, vertigo, nervousness, amnesia, abnormal thinking, insomnia, speech disorder, agitation, confusion; vomiting, nausea, abdominal pain, diarrhoea, dyspepsia. constipation, gastritis, wt gain; abnormal gait, tremor, weakness, back pain, abnormal coordination, dysmetria, sprains/strains, muscle weakness; diplopia, nystagmus, abnormal vision & accommodation; hypotension, leg oedema; rash, acne; hyporiatraemia; rhinitis, chest infection, epistaxis, sinusitis. Stevens-Johnson syndrome, toxic epidermal necrolysis Anaphylaxis & angioedema.
it is frequently used during pregnancy, and the most recent studies indicate that its exposure during pregnancy has not been associated with an increased risk of malformations. Limited information indicates that oxcarbazepine would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. Monitor the infant for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of anticonvulsants.
Store at temperature not exceeding 30°C in a dry place. Protect from light and moisture.
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