TRILEPTAL 300MG 50TAB; oxcarbazepine, anticonvulsants .
ACTIVE-INGREDIENT OF TRILEPTAL 300MG 50TAB
Each Trileptal film-coated contains 300 mg oxacarbazepine.
INDICATION OF TRILEPTAL 300MG 50TAB
Trileptal is indicated in adults and in children aged 1 month and above for the treatment of Partial seizures (which include the seizure subtypes of simple, complex and partial seizures evolving to secondarily generalized seizures) and Generalized tonic-clonic seizures. Trileptal is indicated as a first-line antiepileptic drug for use as monotherapy or adjunctive therapy. Trileptal can replace other antiepileptic drugs when current therapy provided insufficient seizure control.
DOSAGE OF TRILEPTAL 300MG 50TAB
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The recommended dose is : –
Dosage: Trileptal is suitable for use either as monotherapy or in combination with other antiepileptic drugs. In mono- and adjunctive therapy, treatment with Trileptal is initiated with a clinically effective dose given in two divided doses. The dose may be increased depending on the clinical response of the patient. When other antiepileptic drugs are replaced by Trileptal, the dose of the concomitant antiepileptic drug(s) should be reduced gradually on initiation of Trileptal therapy. In adjunctive therapy, as the total antiepileptic drug load of the patient is increased, the dose of concomitant antiepileptic drug(s) may need to be reduced and/or the Trileptal dose increased more slowly. Theraoeutic effect of oxcarbazepine is primarily exerted through the active metabolite 10-monohydroxy derivative (MHD) of oxcarbazepine. Plasma level monitoring of oxcarbazepine or MHD is not routinely warranted. However, plasma level monitoring of MHD may be considered during Trileptal therapy in order to rule out noncompliance, or in situations where an alteration in MHD clearance is to be expected, including: changes in renal function, pregnancy, concomitant use of liver enzyme-inducing drugs.If any of these situations apply, The dose of Trileptal may be adjusted (based on plasma levels measures 2-4 hours post dose) to maintain peak MHD plasma level OVER-DOSAGE OF TRILEPTAL 300MG 50TAB
Isolated cases of overdose have been reported. The maximum dose taken with approximately 48,000 mg. Signs and symptoms: Electrolyte and fluid balance conditions: hypontremia. Eye disorders: diplopia, miosis, blurred vision. Gastrointestinal disorders: nausea, vomiting, hyperkinesia. General disorders and administration site conditions: fatigue. Investigations: respiratory rate depression, QTc prolongation. Nervous system disorders: drowsiness and somnolence, dizziness, ataxia, nystagmus, tremor, disturbances in coordination (coordination abnormal), convulsion, headache, coma, loss of consciousness, dyskinesia. Psychiatric disorders: aggression, agitation, confusional state. Vascular disorders: hypotension. Respiratory, thoracic and mediastinal disorders: dyspnoea. 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 TRILEPTAL 300MG 50TAB
Known hypersensitivity to oxcarbazepine or eslicarbazepine or to any of the excipients of Trileptal.
STORAGE OF TRILEPTAL 300MG 50TAB
PACK OF TRILEPTAL 300MG 50TAB
TRILEPTAL 300MG 50TAB MANUFACTURED BY
Novartis Pharma S.A.E., Cairo, Egypt.