Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: N.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, The Netherlands
Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.
The recommended starting dose of Sycrest as monotherapy is 5 mg twice daily. One dose should be taken in the morning and one dose should be taken in the evening. The dose can be increased to 10 mg twice daily based on individual clinical response and tolerability. See section 5.1. For combination therapy a starting dose of 5 mg twice daily is recommended. Depending on the clinical response and tolerability in the individual patient, the dose can be increased to 10 mg twice daily.
Sycrest should be used with care in the elderly. Limited data on efficacy in patients 65 years of age and older are available. Available pharmacokinetic data are described in section 5.2.
No dose adjustment is required for patients with renal impairment. There is no experience with asenapine in patients with severe renal impairment who have a creatinine clearance less than 15 mL/min.
No dose adjustment is required for patients with mild hepatic impairment. The possibility of elevated asenapine plasma levels cannot be excluded in some patients with moderate hepatic impairment (Child-Pugh B) and caution is advised. In subjects with severe hepatic impairment (Child-Pugh C), a 7-fold increase in asenapine exposure was observed. Thus, Sycrest is not recommended in patients with severe hepatic impairment.
A pharmacokinetic study and a short term efficacy and safety study were performed in a paediatric population (ages 10-17 years) with manic or mixed episodes associated with bipolar I disorder. Long term safety in this population was explored in a 50-week, open-label, uncontrolled extension study. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
The tablet should not be removed from the blister until ready to take it. Dry hands should be used when touching the tablet. The tablet should not be pushed through the tablet pack. The tablet pack should not be cut or torn. The coloured tab should be peeled back and the tablet should be removed gently. The tablet should not be crushed.
To ensure optimal absorption, the Sycrest sublingual tablet should be placed under the tongue and allowed to dissolve completely. The tablet will dissolve in saliva within seconds. Sycrest sublingual tablets should not be chewed or swallowed. Eating and drinking should be avoided for 10 minutes after administration.
When used in combination with other medicinal products, Sycrest should be taken last.
Treatment with Sycrest is not advised in patients who are unable to comply with this method of administration, as the bioavailability of asenapine when swallowed is low (<2% with an oral tablet formulation).
Few cases of overdose were reported in the asenapine program. Reported estimated doses were between 15 and 400 mg. In most cases it was not clear if asenapine had been taken sublingually. Treatment-related adverse reactions included agitation and confusion, akathisia, orofacial dystonia, sedation, and asymptomatic ECG findings (bradycardia, supraventricular complexes, intraventricular conduction delay).
No specific information is available on the treatment of overdose with Sycrest. There is no specific antidote to Sycrest. The possibility of multiple medicinal product involvement should be considered. Cardiovascular monitoring is necessary to detect possible arrhythmias and management of overdose should concentrate on supportive therapy, maintaining an adequate airway oxygenation and ventilation, and management of symptoms. Hypotension and circulatory collapse should be treated with appropriate measures, such as intravenous fluids and/or sympathomimetic agents (epinephrine and dopamine should not be used, since beta stimulations may worsen hypotension in the setting of Sycrest-induced alpha blockade). In case of severe extrapyramidal symptoms, anticholinergic medicines should be administered. Close medical supervision and monitoring should continue until the patient recovers.
3 years.
Store in the original package in order to protect from light and moisture.
This medicinal product does not require any special temperature storage conditions.
Peelable aluminium/aluminium blisters in cartons of 20, 60 or 100 sublingual tablets per carton.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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