Individual generic drug information

oxcarbazepine

Reference monograph

Part of registered formulation

OXCARBAZEPINE

Reference record: Oxcarbazepine
Source: BNF 80 (2020–2021)
Printed source pages: 359, 360
Age groups indexed: 2

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Oxcarbazepine only.

Indications And Dose

Monotherapy for the treatment of focal seizures with or without secondary generalised tonic-clonic seizures ▶BY MOUTH ▶Child 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: 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 for the treatment of focal seizures with or without secondary generalised tonic-clonic seizures ▶BY MOUTH ▶Child 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: 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 ▶BY MOUTH ▶Adult: 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

Source page 359

Dose Adjustments

DUE TO INTERACTIONS ▶In adjunctive therapy, the dose of concomitant antiepileptics may need to be reduced when using high doses of oxcarbazepine. l UNLICENSED USE Not licensed for the treatment of primary generalised tonic-clonic seizures.

Source page 359

Cautions

Avoid in Acute porphyrias p. 1120. cardiac conduction disorders. heart failure. hyponatraemia

Source page 359

Allergy And Cross Sensitivity

Caution in patients with hypersensitivity to carbamazepine. Antiepileptic hypersensitivity syndrome associated with oxcarbazepine. See under Epilepsy p. 321 for more information.

Source page 359

Pre Treatment Screening

Test for HLA-B*1502 allele in individuals of Han Chinese or Thai origin (avoid unless no alternative—risk of Stevens-Johnson syndrome in presence of HLA-B*1502 allele).

Source page 360

Prescribing And Dispensing Information

Patients may need to be maintained on a speciﬁc manufacturer’s branded or generic oxcarbazepine product. Switching between formulations Care should be taken when switching between oral formulations. The need for continued supply of a particular manufacturer’s product should be based on clinical judgement and consultation with the patient or their carer, taking into account factors such as seizure frequency and treatment history.

Source page 360

Safety

Extracted information for Oxcarbazepine only.

Interactions

→Appendix 1: antiepileptics

Source page 359

Side Effects

▶Common or very common Abdominal pain. agitation. alopecia. asthenia. ataxia. concentration impaired. constipation. depression. diarrhoea. dizziness. drowsiness. emotional lability. headache. hyponatraemia . nausea. nystagmus. skin reactions. vertigo. vision disorders. vomiting ▶Uncommon Leucopenia ▶Rare or very rare Angioedema. arrhythmia. atrioventricular block. hepatitis. hypothyroidism. pancreatitis. severe cutaneous adverse reactions (SCARs). systemic lupus erythematosus (SLE). thrombocytopenia ▶Frequency not known Agranulocytosis. bone disorders. bone marrow disorders. hypertension. inappropriate antidiuretic hormone secretion like-syndrome. neutropenia. speech impairment

Source page 359

Pregnancy

See also Pregnancy in Epilepsy p. 321. Monitoring The dose should be monitored carefully during pregnancy and after birth, and adjustments made on a clinical basis.

Source pages 359, 360

Breast Feeding

Amount probably too small to be harmful but manufacturer advises avoid.

Source page 360

Hepatic Impairment

Manufacturer advises caution in severe impairment (no information available). Nervous system

Source page 360

Renal Impairment

Dose adjustments ▶In adults Halve initial dose if eGFR less than 30 mL/minute/1.73 m2; increase according to response at intervals of at least 1 week. ▶In children Halve initial dose if estimated glomerular ﬁltration rate less than 30 mL/minute/1.73 m2, increase according to response at intervals of at least 1 week.

Source page 360

Monitoring Requirements

▶Monitor plasma-sodium concentration in patients at risk of hyponatraemia. ▶Monitor body-weight in patients with heart failure.

Source page 360

Dose and formulations

Extracted information for Oxcarbazepine only.

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension Oral suspension CAUTIONARY AND ADVISORY LABELS 3, 8 EXCIPIENTS: May contain Propylene glycol ▶Trileptal (Novartis Pharmaceuticals UK Ltd) Oxcarbazepine 60 mg per 1 ml Trileptal 60mg/ml oral suspension sugar-free | 250 ml P £48.96 DT = £48.96 Tablet CAUTIONARY AND ADVISORY LABELS 3, 8 ▶Oxcarbazepine (Non-proprietary) Oxcarbazepine 150 mg Oxcarbazepine 150mg tablets | 50 tablet P £11.14 DT = £8.37 Oxcarbazepine 300 mg Oxcarbazepine 300mg tablets | 50 tablet P £22.61 DT = £7.09 Oxcarbazepine 600 mg Oxcarbazepine 600mg tablets | 50 tablet P £45.19 DT = £38.71 ▶Trileptal (Novartis Pharmaceuticals UK Ltd) Oxcarbazepine 150 mg Trileptal 150mg tablets | 50 tablet P £12.24 DT = £8.37 Oxcarbazepine 300 mg Trileptal 300mg tablets | 50 tablet P £24.48 DT = £7.09 Oxcarbazepine 600 mg Trileptal 600mg tablets | 50 tablet P £48.96 DT = £38.71

Source page 360

Clinical care

Extracted information for Oxcarbazepine only.

Patient And Carer Advice

Blood, hepatic, or skin disorders Patients or their carers should be told how to recognise signs of blood, liver, or skin disorders, and advised to seek immediate medical attention if symptoms such as lethargy, confusion, muscular twitching, fever, rash, blistering, mouth ulcers, bruising, or bleeding develop. Medicines for Children: Oxcarbazepine for preventing seizures www.medicinesforchildren.org.uk/oxcarbazepine-preventing- seizures

Source page 360

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

Initially 300 mg twice daily, then increased in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 359

Adults

First line only; read the complete Indications and dose section above.

Initially 300 mg twice daily, then increased in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 359

Adults

First line only; read the complete Indications and dose section above.

Initially 300 mg twice daily, then increased in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 359

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

oxcarbazepine

Reference monograph

Part of registered formulation

OXCARBAZEPINE

Reference record: Oxcarbazepine
Source: BNF 80 (2020–2021)
Printed source pages: 359, 360
Age groups indexed: 2

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Oxcarbazepine only.

Indications And Dose

Source page 359

Dose Adjustments

Source page 359

Cautions

Avoid in Acute porphyrias p. 1120. cardiac conduction disorders. heart failure. hyponatraemia

Source page 359

Allergy And Cross Sensitivity

Caution in patients with hypersensitivity to carbamazepine. Antiepileptic hypersensitivity syndrome associated with oxcarbazepine. See under Epilepsy p. 321 for more information.

Source page 359

Pre Treatment Screening

Test for HLA-B*1502 allele in individuals of Han Chinese or Thai origin (avoid unless no alternative—risk of Stevens-Johnson syndrome in presence of HLA-B*1502 allele).

Source page 360

Prescribing And Dispensing Information

Source page 360

Safety

Extracted information for Oxcarbazepine only.

Interactions

→Appendix 1: antiepileptics

Source page 359

Side Effects

Source page 359

Pregnancy

See also Pregnancy in Epilepsy p. 321. Monitoring The dose should be monitored carefully during pregnancy and after birth, and adjustments made on a clinical basis.

Source pages 359, 360

Breast Feeding

Amount probably too small to be harmful but manufacturer advises avoid.

Source page 360

Hepatic Impairment

Manufacturer advises caution in severe impairment (no information available). Nervous system

Source page 360

Renal Impairment

Source page 360

Monitoring Requirements

▶Monitor plasma-sodium concentration in patients at risk of hyponatraemia. ▶Monitor body-weight in patients with heart failure.

Source page 360

Dose and formulations

Extracted information for Oxcarbazepine only.

Medicinal Forms

Source page 360

Clinical care

Extracted information for Oxcarbazepine only.

Patient And Carer Advice

Source page 360

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

Initially 300 mg twice daily, then increased in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 359

Adults

First line only; read the complete Indications and dose section above.

Initially 300 mg twice daily, then increased in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 359

Adults

First line only; read the complete Indications and dose section above.

Initially 300 mg twice daily, then increased in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 359

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.