Formulary
Oxcarbazepine: Indications, Dosing, Side Effects and Interactions
Oxcarbazepine clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 5 min read
Oxcarbazepine: Indications, Dosing, Side Effects and Interactions
Oxcarbazepine clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Monotherapy**
- **Child** (By Mouth): for the treatment of focal seizures with or without secondary generalised tonic-clonic seizures 6-17 years Initially 4-5 mg/kg twice daily (max. per dose 300 mg), then increased in steps of up to 5 mg/kg twice daily, adjusted according to response, dose to be adjusted at weekly intervals; maximum 46 mg/kg per day.
- **Adult** (By Mouth): Initially 300 mg twice daily, then increased in steps of up to 600 mg daily, adjusted according to response, dose to be adjusted at weekly intervals; usual dose 0.6-2.4 g daily in divided doses.
**Adjunctive therapy**
- **Child** (By Mouth): for the treatment of focal seizures with or without secondary generalised tonic-clonic seizures 6-17 years Initially 4-5 mg/kg twice daily (max. per dose 300 mg), then increased in steps of up to 5 mg/kg twice daily, adjusted according to response, dose to be adjusted at weekly intervals; maintenance 15 mg/kg twice daily; maximum 46 mg/kg per day.
- **Adult** (By Mouth): Initially 300 mg twice daily, then increased in steps of up to 600 mg daily, adjusted according to response, dose to be adjusted at weekly intervals; usual dose 0.6-2.4 g daily in divided doses.
**Treatment of primary generalised tonic-clonic seizures**
- **Adult** (By Mouth): Initially 300 mg twice daily, then increased in steps of up to 600 mg daily, adjusted according to response, dose to be increased at weekly intervals; usual dose 0.6-2.4 g daily in divided doses.
**Monotherapy for the treatment of focal seizures with or without secondary generalised tonic-clonic seizures for oxcarbazepine**
- **Child 6-17 years** (By mouth): Initially 4-5 mg/kg twice daily (max. per dose 300 mg), then increased in steps of up to 5 mg/kg twice daily, adjusted according to response, dose to be adjusted at weekly intervals; maximum 46 mg/kg per day.
**Adjunctive therapy for the treatment of focal seizures with or without secondary generalised tonic-clonic seizures for oxcarbazepine**
- **Child 6-17 years** (By mouth): Initially 4-5 mg/kg twice daily (max. per dose 300 mg), then increased in steps of up to 5 mg/kg twice daily, adjusted according to response, dose to be adjusted at weekly intervals; maintenance 15 mg/kg twice daily; maximum 46 mg/kg per day.
Cautions
Avoid in Acute porphyrias ; cardiac conduction disorders; heart failure; hyponatraemia; presence of HLA-B*1502 or HLA-A*3101 allele; seizures (may be exacerbated) Cautions, further information HLA allele The presence of HLA-B*1502 allele, particularly in individuals of Han Chinese or Thai origin, is strongly associated with an increased risk of carbamazepine-induced Stevens-Johnson syndrome; this may also occur with oxcarbazepine, a structurally-related antiepileptic-see also Pre-treatment screening . M The presence of HLA-A*3101 allele, particularly in individuals of European or Japanese origin, is associated with an increased risk of carbamazepine-induced cutaneous adverse reactions. This may also occur with oxcarbazepine, a structurally-related antiepileptic, but there are insufficient data to support pre-treatment screening. Consider use if potential benefit outweighs risk. M Seizure exacerbation Oxcarbazepine may exacerbate seizures in patients with absence or myoclonic seizures (including juvenile myoclonic epilepsy), tonic or atonic seizures, Dravet syndrome, Lennox-Gastaut syndrome, and myoclonic-atonic seizures. A
Side effects
Common or very common Abdominal pain; agitation; alopecia; asthenia; ataxia; concentration impaired; confusion; constipation; depression; diarrhoea; dizziness; drowsiness; emotional lability; headache; hyponatraemia; memory loss; nausea; nystagmus; skin reactions; speech impairment; tremor; vertigo; vision disorders; vomiting; weight increased Uncommon Hypertension; hypothyroidism; leucopenia Rare or very rare Agranulocytosis; angioedema; arrhythmia; atrioventricular block; bone disorders; bone fracture; bone marrow disorders; hepatitis; inappropriate antidiuretic hormone secretion like-syndrome; neutropenia; pancreatitis; severe cutaneous adverse reactions (SCARs); systemic lupus erythematosus (SLE); thrombocytopenia Frequency not known Suicidal behaviours
Interactions
**Other interactions (18):**
- Enzyme induction Oxcarbazepine and its pharmacologically active metabolite (the monohydroxy derivative, MHD) are weak inducers in vitro and in vivo of the cytochrome P450 enzymes CYP3A4 and CYP3A5...
- In vitro , oxcarbazepine and MHD are weak inducers of UDP-glucuronyl transferases (effects on specific enzymes in this family are not known).
- Therefore, in vivo oxcarbazepine and MHD may have a small inducing effect on the metabolism of medicinal products which are mainly eliminated by conjugation through the UDP-glucuronyl transferases.
- When initiating treatment with oxcarbazepine or changing the dose, it may take 2 to 3 weeks to reach the new level of induction.
- In case of discontinuation of oxcarbazepine therapy, a dose reduction of the concomitant medications may be necessary and should be decided upon by clinical and/or plasma level monitoring.
- Hormonal contraceptives: oxcarbazepine was shown to have an influence on the two components, ethinylestradiol (EE) and levonorgestrel (LNG), of an oral contraceptive.
Pregnancy
Important safety information For oxcarbazepine MHRA/CHM advice: Antiepileptics: risk of suicidal thoughts and behaviour (August 2008) See Epilepsy . MHRA/CHM advice: Antiepileptic drugs: updated advice on switching between different manufacturers' products (November 2017) See Epilepsy and see also Prescribing and dispensing information . MHRA/CHM advice: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review (January 2021) See Epilepsy .
Breast feeding
Amount probably too small to be harmful but manufacturer advises avoid.
Hepatic impairment
Manufacturer advises caution in severe impairment (no information available).
Renal impairment
Dose adjustments Halve initial dose if creatinine clearance less than 30 mL/minute; increase according to response at intervals of at least 1 week. M See Prescribing in renal impairment .
Medicinal forms
Suspension,Tablet,Suspension
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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