Eslicarbazepine acetate is indicated as an add-on therapy for partial seizure with or without secondary generalization.
Adjunct anti-epileptic drugs
Adult: Eslicarbazepine acetate must be added to existing anticonvulsant therapy. The recommended starting dose is 400 mg once daily which should be increased to 800 mg once daily after one or two weeks. Based on individual response the dose may be increased to 1200 mg once daily Elderly (over 65 years of age): Caution should be exercised in the treatment of elderly patients as there is limited safety information on the use of Eslicarbazepine acetate in these patients. Paediatric: The safety and efficacy of Eslicarbazepine acetate below 18 years has not yet been established. No data are available.
Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) or to any of the excipients. Eslicarbazepine acetate has been associated with some central nervous system adverse reactions, such as dizziness and somnolence, which could increase the occurrence of accidental injury. Eslicarbazepine acetate may decrease the effectiveness of hormonal contraceptives. Additional non-hormonal forms of contraception are recommended when using Eslicarbazepine acetate. As with other anti-epileptic medicinal products, if Eslicarbazepine acetate is to be discontinued it is recommended to withdraw it gradually to minimize the potential of increased seizure frequency. Concomitant use of Eslicarbazepine acetate with oxcarbazepine is not recommended because this may cause overexposure to the active metabolites. Rash developed as an adverse reaction in 1.1% of total population treated with Eslicarbazepine acetate in placebo-controlled add-on studies in epileptic patients. If signs or symptoms of hypersensitivity develop, Eslicarbazepine acetate must be discontinued. Hyponatraemia has been reported as an adverse reaction in less than 1% of patients treated with Eslicarbazepine acetate.
The use of Eslicarbazepine acetate is associated with increase in the PR interval. Adverse reactions associated with PR interval prolongation (e.g. AV block, syncope, bradycardia) may occur.
There are no data from the use of Eslicarbazepine acetate in pregnant women. Studies in animals have shown reproductive toxicity. If women receiving Eslicarbazepine acetate become pregnant or plan to become pregnant, the use of Exalief should be carefully re-evaluated. It is unknown whether Eslicarbazepine acetate is excreted in human breast milk.
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