Monotherapy and adjunctive treatment of partial seizures with or without secondarily generalized tonic- Clonic seizures, Trigeminal neuralgia
Adjunct anti-epileptic drugs
The pharmacological activity of Oxcarbazepine is primarily exerted through the metabolite derivative (the monohydroxy derivative, MHD) of Oxcarbazepine. The mechanism of action of Oxcarbazepine and MHD is thought to be mainly based on blockade of voltage-sensitive sodium channels, thus resulting in stabilization of hyper excited neural membranes, inhibition of repetitive neuronal firing and diminishment of propagation of synaptic impulses.
Initially 300 mg twice daily increased according to response in steps of up to 600 mg daily at weekly intervals; usual dose range 0.6-2.4 gm daily in divided doses;
Child over 6 years: 8-10 mg/kg daily in 2 divided doses increased according to response in steps of up to 10 mg/kg daily at weekly intervals (in adjunctive therapy, maintenance dose approximately 30 mg/kg daily); maximum 46 mg/kg daily in divided doses
Oxcarbazepine and its metabolite inhibit the enzyme CYP2C19 and therefore, interactions could arise when co-administering high doses of Oxazep with medicinal products that are metabolised by CYP2C19 (e.g. phenobarbital, phenytoin). Concurrent use of Oxazep with hormonal contraceptives may render few contraceptives ineffective (e.g. Ethinylestradiol and Levonorgestrel preparations). Co-administration of Oxazep lowers AUC of felodipine and Verapamil decreases bioavailability of MHD.
It is contraindicated to patients with hypersensitivity to the active substance or to any of the excipients.
The most commonly reported adverse reactions are somnolence, headache, dizziness, diplopia, nausea; vomiting and fatigue. Very rarely clinically significant hyponatraemia can develop during Oxazep use. Class I (immediate) hypersensitivity reactions including rash, pruritus, urticaria, angioedema and reports of anaphylaxis have been received.
Pregnancy: Data on a limited number of pregnancies indicate that Oxcarbazepine may cause serious birth defects (e.g. cleft palate) when administered during pregnancy. In the newborn child. Bleeding disorders in the newborn caused by antiepileptic agents have been reported. As a precaution, vitamin K1 should be administered as a preventive measure in the last few weeks of pregnancy and to the newborn. Oxcarbazepine and its active metabolite (MHD) cross the placenta. Neonatal and maternal plasma MHD concentrations were similar in one case.
Lactation: Oxcarbazepine and its active metabolite (MHD) are excreted in human breast milk. Therefore, Oxazep should not be used during breast-feeding.
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