Oxazep (Oxcarbazepine)

Therapeutic Group: Drugs of Nervous System Anti Epileptic

Oxazep 300: Each film-coated tablet contains 300 mg Oxcarbazepine INN. Oxazep 600: Each film-coated tablet contains 600 mg Oxcarbazepine INN. Oxazep Suspension: Each 5ml suspension contains 300 mg of Oxcarbazepine INN.

The pharmacological activity of Oxazep (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.

Monotherapy and adjunctive treatment of partial seizures with or without secondarily generalized tonic- clonic seizures Trigeminal neuralgia

Initially 300mg twice daily increased according to response in steps of up to 600mg daily at weekly intervals; usual dose range 0.6-2.4g daily in divided doses; CHILD over 6 years, 8-10mg/kg daily in 2 divided doses increased according to response in steps of up to 10mg/kg daily at weekly intervals (in adjunctive therapy, maintenance dose approximately 30mg/kg daily); maximum 46mg/kg daily in divided doses

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.

Alcohol Caution should be exercised if alcohol is taken in combination with Oxazep therapy, due to a possible additive sedative effect. Withdrawal As with all antiepileptic medicinal products, Oxazep should be withdrawn gradually to minimise the potential of increased seizure frequency.

It is contraindicated to patients with hypersensitivity to the active substance or to any of the excipients.

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.

Oxazep 300: Each commercial box contains 3 blister strips of 10 tablets Oxazep 600: Each commercial box contains 2 blister strips of 10 tablets Oxazep suspension: Each box contains 1 bottle of Oxcarbazepine 100ml suspension