SYCREST

Posology 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.

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. Special populations Elderly Sycrest should be used with care in the elderly.

Limited data on efficacy in patients 65 years of age and older are available. 2. Renal impairment 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.

Hepatic impairment 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. Paediatric population 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. 2 but no recommendation on a posology can be made. Method of administration 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.

Summary of safety profile The most frequently reported adverse drug reactions (ADRs) associated with the use of asenapine in clinical trials were somnolence and anxiety. Serious hypersensitivity reactions have been reported. 4. Tabulated list of adverse reactions The incidences of the ADRs associated with asenapine therapy are tabulated below.

The table is based on adverse reactions reported during clinical trials and/or post-marketing use. All ADRs are listed by system organ class and frequency; very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), and not known (cannot be estimated from the available data).

Within each frequency grouping, ADRs are presented in order of decreasing seriousness. 0 %). From the short-term (6 weeks) schizophrenia trials there appears to be a dose- response relationship for akathisia in patients treated with asenapine, and for parkinsonism there was an increasing trend with higher doses.

2). The incidence of dystonia in paediatric clinical trials using a gradual up-titration was similar to that seen in adult trials. 8 kg. 3 % for placebo. 6 % for placebo. 44 kg, respectively. 1 % for placebo. , ≥ 7 % increase in body weight at endpoint).

76) kg. 3 % in the combined phase 2/3 trial population. Falls Falls may occur as a result of one or more adverse events such as the following: Somnolence, Orthostatic hypotension, Dizziness, Extrapyramidal symptoms. Hepatic enzymes Transient, asymptomatic elevations of hepatic transaminases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment.

Other findings Cerebrovascular events have been reported in patients treated with asenapine but there is no evidence of any excess incidence over what is expected in adults between 18 and 65 years of age. Asenapine has anaesthetic properties.

Elderly patients with dementia-related psychosis Elderly patients with dementia-related psychosis treated with antipsychotic substances are at an increased risk of death. Sycrest is not approved for the treatment of patients with dementia-related psychosis and is not recommended for use in this particular group of patients.

Neuroleptic malignant syndrome Neuroleptic malignant syndrome (NMS), characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels, has been reported to occur with antipsychotics, including asenapine.

Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure. If a patient develops signs and symptoms indicative of NMS Sycrest must be discontinued. Seizures In clinical trials, cases of seizure were occasionally reported during treatment with asenapine.

Therefore, Sycrest should be used with caution in patients who have a history of seizure disorder or have conditions associated with seizures. Suicide The possibility of a suicide attempt is inherent in psychotic illnesses and bipolar disorder and close supervision of high-risk patients should accompany treatment.

Orthostatic hypotension Asenapine may induce orthostatic hypotension and syncope, especially early in treatment, probably reflecting its α1-adrenergic antagonist properties. 8). In clinical trials, cases of syncope were occasionally reported during treatment with Sycrest.

, dehydration and hypovolemia). Tardive dyskinesia Medicinal products with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical, involuntary movements, predominantly of the tongue and/or face.

In clinical trials, cases of tardive dyskinesia were occasionally reported during treatment with asenapine. The onset of extrapyramidal symptoms is a risk factor for tardive dyskinesia. If signs and symptoms of tardive dyskinesia appear in a patient on Sycrest, discontinuation of treatment should be considered.

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