Formulary
Cenobamate: Indications, Dosing, Side Effects and Interactions
Cenobamate clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Cenobamate: Indications, Dosing, Side Effects and Interactions
Cenobamate clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Adjunctive treatment of focal seizures with or without secondary generalisation**
- **Adult** (By Mouth): Initially 12.5 mg once daily for 2 weeks, followed by 25 mg once daily for a further 2 weeks, then 50 mg once daily for a further 2 weeks, then increased in steps of 50 mg every 2 weeks, according to response; 200 mg once daily is the usual target dose; increased if necessary up to 400 mg once daily.
Cautions
Elderly
Contraindications
Familial short QT syndrome
Side effects
Common or very common Confusion; constipation; diarrhoea; dizziness; drowsiness; dry mouth; fatigue; gait abnormal; headache; hepatic function abnormal; hypersomnia; irritability; memory impairment; movement disorders; nausea; nystagmus; skin reactions; speech impairment; vertigo; vision disorders; vomiting Uncommon Suicidal behaviours Rare or very rare Drug reaction with eosinophilia and systemic symptoms (DRESS)
Interactions
**Severe interactions:**
- No dose adjustments are required for both carbamazepine and cenobamate.
- No clinically relevant effect of valproic acid In a study in healthy subjects, concomitant administration of cenobamate 150 mg once daily and valproic acid 1,000 mg once daily showed no significant...
**Other interactions (20):**
- Cenobamate is extensively metabolized, primarily by glucuronidation, with oxidation contributing to a lesser degree.
- Cenobamate may reduce exposures of products primarily metabolized by CYP3A4 and 2B6.
- Cenobamate may increase exposures of products primarily metabolized by CYP2C19.
- When initiating or discontinuing treatment with cenobamate or changing the dose, it may take 2 weeks to reach the new level of enzyme activity.
- Pharmacodynamic interactions CNS depressants Concomitant use of cenobamate with other CNS depressants, including alcohol, barbiturates, and benzodiazepines may increase the risk of neurological...
- Therefore, based on individual response, doses of barbiturates and benzodiazepines may need to be reduced, as clinically appropriate, when used concomitantly with cenobamate.
Pregnancy
Important safety information For cenobamate 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
Avoid-present in milk in animal studies. M
Hepatic impairment
Caution in mild or moderate impairment (increased exposure in chronic hepatic disease); avoid in severe impairment (no information available). M Dose adjustments Consider up to 50% reduction in target dose; max. dose of 200 mg daily in mild or moderate impairment. M
Renal impairment
Caution; avoid in end-stage renal disease or haemodialysis patients (no information available). M Dose adjustments Consider reduction of target dose in mild or moderate (creatinine clearance 30 to less than 90 mL/minute) or severe (creatinine clearance less than 30 mL/minute) impairment; max. dose of 300 mg daily. M See Prescribing in renal impairment .
Medicinal forms
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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