May be taken with or without food.
Administration
May be taken with or without food.
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Contraindications
Lactation.
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Special Precautions
Patient with hypersensitivity reaction to carbamazepine, pre-existing renal conditions associated with low Na levels (e.g. inappropriate antidiuretic hormone secretion like syndrome), pre-existing conduction disturbances (e.g. atrioventricular block, arrhythmia), cardiac insufficiency, secondary heart failure. HLA-B*15:02 positive patients. Avoid abrupt withdrawal. Extended-release tab and conventional preparations are not bioequivalent, higher dosages may be needed when switching from conventional form to extended-release tab. Severe renal (CrCl <30 mL/min) and hepatic impairment. Children and elderly. Pregnancy. Patient Counselling This drug may cause dizziness, somnolence, lack of concentration, abnormal coordination, or visual disturbances; if affected, do not drive or operate machinery. Women of childbearing potential must use highly effective birth control methods during treatment. Consider using additional or other reliable contraceptive methods recommended by the doctor as hormonal contraceptives may be ineffective. Monitoring Parameters Consider screening for the presence of HLA-B*15:02 allele in patients at increased risk of developing oxcarbazepine-associated SJS/TEN before treatment initiation. Monitor serum Na levels for the 1st 3 months during therapy or based on clinical needs; seizure frequency; mental alertness and symptoms of CNS depression; signs and symptoms of skin or hypersensitivity reactions and suicidality. Obtain periodic thyroid function tests (particularly in children) and CBC.
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Adverse Reactions
Significant: Immediate hypersensitivity reactions (e.g. rash, pruritus, urticaria, angioedema, anaphylaxis); seizure aggravation (particularly in children), hyponatraemia, hypothyroidism; agranulocytosis, leucopenia, pancytopenia, aplastic anaemia, thrombocytopenia, suicidal ideation and behaviour. Very rarely, impaired cardiac conduction, hepatitis.
Ear and labyrinth disorders: Vertigo.
Eye disorders: Nystagmus, visual disturbance, blurred vision, diplopia.
Gastrointestinal disorders: Nausea, vomiting, constipation, abdominal pain, diarrhoea.
General disorders and administration site conditions: Asthenia, fatigue.
Investigations: Weight increased.
Nervous system disorders: Headache, dizziness, somnolence, disturbance in attention, amnesia, speech disorders (including dysarthria), ataxia, tremor.
Psychiatric disorders: Apathy, depression, agitation, affect lability, confusional state.
Skin and subcutaneous tissue disorders: Alopecia, acne.
Potentially Fatal: Very rarely, serious dermatological reactions including SJS, TEN (Lyell's syndrome), erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS). |
Drug Interactions
May increase the risk of hyponatraemia with Na-lowering drugs (e.g. diuretics, desmopressin). May decrease the plasma concentrations and efficacy of hormonal contraceptives containing ethinylestradiol or levonorgestrel. May increase the plasma concentration of phenytoin. Strong CYP3A4 and/or uridine diphosphate glucuronosyltransferase (UGT) inducers (e.g. carbamazepine, phenytoin, phenobarbital, rifampicin) may decrease the plasma levels of the active metabolite of oxcarbazepine. May cause enhanced neurotoxicity with lithium.
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CIMS Class
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ATC Classification
N03AF02 - oxcarbazepine ; Belongs to the class of carboxamide derivatives antiepileptic.
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