OXALEPTAL 300 MG 30 TAB; oxcarbazepine, anticonvulsants .
ACTIVE-INGREDIENT OF OXALEPTAL 300 MG 30 TAB
oxcarbazepine 300 mg .
INDICATION OF OXALEPTAL 300 MG 30 TAB
oxaleptal (oxcarbazepine ) is 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 children aged 4 years and above with epilepsy . And as adjuctive therapy in children aged 2 years and above with epilepsy .
DOSAGE OF OXALEPTAL 300 MG 30 TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
OXALEPTAL (oxcabazepine) is recommended as adjunctive treatment in the treatment of partial seizures in adults and children aged 2 – 16 years. OXALEPTAL is also recommended as monotherapy in the treatment of partial seizures in adults and children aged 4 – 16 years. All dosing should be given in a twice-a-day (BID) regimen. OXALEPTAL oral suspension and OXALEPTAL film-coated tablets may be interchanged at equal doses. Before using OXALEPTAL oral suspension, Shake the bottle well and prepare the dose immediately afterwards. The prescribed amount of oral ssuspension should be withdrawn from the bottle using the oral dosing syringe supplied. OXALEPTAL oral suspension can be mixed in a small glass of water just prior to administration or, alternatively, may be swallowed directly from the syringe. After each use, close the bottle and rinse the syringe with warm water and allow it to dry throughly. OXALEPTAL can be taken with or without food. Adults : adjunctive therapy : treatment with oxaleptal should be initiated with a dose at 600 mg/day, Given in a BID regimen . If clinically indicated . The dose may be increased by a maximum o 600 mg / day at approximately weekly intervals . The recommended daily dose is 1200 mg / day . daily dose above 1200 mg / day show somewhat greater effectiveness in controlled trails , but most patients were not able to tolerate the 2400 mg / day dose , primarily because of CNS effects . it bis recommended that the patient be observed closely and plasma levels at the concomitant AEDs be monitored during the period of oxaleptal doses greater than 1200 mg/day . – conversion to monotherapy : patients recieving concomotant AEDs may be converted to monotherapy by initiating treatment with oxaleptal at 600 mg/day ( given in a BID regimen ) while simultaneously iniating the reduction of the dose of the concomitant AEDs . the concomitant AEDs shoild be completly withdrawn over 3-6 weeks . while the maximum dose of oxaleptal should be reached in about 2-4 weeks . oxaleptal may be increased as clinically indicated by a maximum increment of 600 mg/day at approximately weekly intervals to achive the recommended daily dose of 2400 mg/day . a daily dose of 1200 mg/day has been shown in one study to be effective in patients in whom monotherapy has been initiated with oxaleptal . patients should be observed closely during this transition phase . pediatric patients: adjunctive therapy ( aged 2-16 years ) in pediatric patients aged 4-16 years . treatment should be initiated at a daily dose of 8 – 10 mg/kg generally not to exceed 600 mg/day , given in a BID regimen , the target maintance dose of oxaleptal should be achieved over two weeks , and is dependent upon patient weight , according to the following chart : 20-29 kg – 900 mg /day . – 29-39 kg – 1200 mg /day . – >39 – 1800 mg/day . In the clinical trial, in which the intention was to reach thses target doses, the median daily dose was 31 mg/kg with a range of 6 – 51 mg/kg. In pediatric patients aged 2 – OVER-DOSAGE OF OXALEPTAL 300 MG 30 TAB
Human overdose experience: Isolated cases of overdose with Oxaleptal (oxcarbezepine) have been reported. The maximum dose taken was approximately 24,000 mg. All patients recovered with symptomatic treatment. Treatment and Management: There is no specific antidote. Symptomatic and supportive treatment should be administered as appropriate. Removal of the drug by gastric lavage and/or inactivation by administering activated charcoal should be considered.
CONTRA-INDICATION OF OXALEPTAL 300 MG 30 TAB
oxaleptal (oxcarbazepine ) should not be used in patients with a known hypersensitivity to oxcarbazepine or to any of its components .
STORAGE OF OXALEPTAL 300 MG 30 TAB
store at temperature not exceeding 30° C .
PACK OF OXALEPTAL 300 MG 30 TAB
carton box containing 1 ,2, or 3 (AL/PVC) strips , each of 10 tablets and inner leaflet .
OXALEPTAL 300 MG 30 TAB MANUFACTURED BY
MASH FOR PHARMACEUTICAL INDUSTRIES & COSMETICS ( MASH PREMIEREe ) – Badr City – Egypt