Sulpistad 400

Rx

Indications: 

Sulpistad 400 is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.

Dosage:

Acute psychotic episodes: 400 – 800 mg/day, may be increased up to 1200 mg/day. Doses above 1200 mg/day should not be used. Doses should be adjusted according to individual response.

Mixed positive and negative symptoms: Doses should be adjusted to obtain optimal control of positive symptoms.

Maintenance treatment should be established individually with the minimally effective dose.

Predominant negative symptoms: 50 – 300 mg/day. Doses should be adjusted individually.

Amisulpride can be administered once daily at oral doses up to 300 mg, higher doses should be administered bid.

The minimum effective dose should be used.

Elderly: Amisulpride should be used with particular caution because of a possible risk of hypotension and sedation. Reduction in dosage may also be required because of renal insufficiency.

Children: The use of amisulpride from puberty to the age of 18 years is not recommended; in children up to puberty amisulpride is contraindicated.

Renal insufficiency:

• CrCl 30 – 60 ml/min: The dose should be reduced to half.
• CrCl 10 – 30 ml/min: The dose should be reduced to a third.
• CrCl < 10 ml/min: Particular care is recommended.

Hepatic insufficiency: A dosage reduction should not be necessary.

Duration of treatment: The duration of treatment should be determined by the treating physician. To avoid withdrawal symptoms treatment should be discontinued gradually.

Usage:

Sulpistad 400 is administered orally. Tablets should be swallowed whole or halved, with a sufficient amount of liquid. Sulpistad 400 can be administered independently from meals.

Hypersensitivity to the active ingredient or to other ingredients of the medicinal product.

Concomitant prolactin-dependent tumours (e.g. pituitary gland prolactinomas or breast cancer).

Phaeochromocytoma

Lactation

Combination with levodopa.

Children before the onset of puberty.

In combination with the following medicinal products which could induce torsade de pointes:

• Class Ia antiarrhythmics such as quinidine and disopyramide.
• Class III antiarrhythmics such as amiodarone and sotalol.
• Other medicinal products such as bepridil, cisapride, sultopride, thioridazine, methadone, erythromycin (intravenous application), vincamine (intravenous application

Very common (ADR ≥ 1/10): Extrapyramidal symptoms may occur: tremor, rigidity, hypokinesia, hypersalivation, akathisia, dyskinesia.

Common (1/100 ≤ ADR < 1/10): Amisulpride causes an increase in plasma prolactin levels which is reversible after drug discontinuation, may result in galactorrhoea, amenorrhoea, gynaecomastia, breast pain, and erectile dysfunction; insomnia, anxiety, agitation, orgasmic dysfunction; acute dystonia (spasm torticollis, oculogyric crisis, trismus) may appear, somnolence; blurred vision; qt interval prolongation; hypotension; constipation, nausea, vomiting, dry mouth; weight gain

Risk of neuroleptic malignant syndrome: In the event of hyperthermia, particularly with high daily doses, all antipsychotic drugs including amisulpride should be discontinued.

Risk of hyperglycaemia: Patients with an established diagnosis of diabetes mellitus or with risk factors for diabetes who are started on amisulpride, should get appropriate glycaemic monitoring.

Patient with renal insufficiency: The dose should be decreased or intermittent treatment could be considered.

Patients with a history of epilepsy: Need to closely monitor during amisulpride therapy.

Elderly patients: Caution because of a possible risk of hypotension or sedation. Reduction in dosage may also be required because of renal insufficiency.

Patients with Parkinson’s disease: Caution should be also exercised when prescribing amisulpride, amisulpride should be used only if neuroleptic treatment cannot be avoided.

Gradual withdrawal of amisulpride is advisable to avoid withdrawal symptoms.

Patients with stroke risk factors: Amisulpride should be used with caution.

Elderly patients with dementia: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.

Amisulpride is not licensed for the treatment of dementia-related behavioural disturbances.

Venous thromboembolism: All possible risk factors for VTE should be identified before and during treatment with amisulpride and preventive measures undertaken.

Breast cancer: Caution should be exercised and patients with a history or a family history of breast cancer should be closely monitored during amisulpride therapy.

Benign pituitary tumour: In case of very high levels of prolactin or clinical signs of pituitary tumour (such as visual field defect and headache), pituitary imaging should be performed. If the diagnosis of pituitary tumour is confirmed, the treatment with amisulpride must be stopped.

• Leukopenia, neutropenia and agranulocytosis have been reported. Unexplained infections or fever may be evidence of blood dyscrasia, and requires immediate haematological investigation.
• Prolongation of the QT interval:

Amisulpride induces a dose-dependent prolongation of the QT interval. This effect is known to potentiate the risk of serious ventricular arrhythmias such as torsade de pointes. Before any administration, and if possible according to the patient’s clinical status, it is recommended to exclude the following factors which could favour the occurrence of this rhythm disorder:

• Bradycardia less than 55 bpm.
• Cardiac disease or family history of sudden death or QT prolongation.
• Electrolyte imbalance, in particular hypokalaemia.
• Congenital prolongation of the QT interval.
• On-going treatment with a medicinal product likely to produce pronounced bradycardia (< 55 bpm), hypokalaemia, decreased intracardiac conduction, or prolongation of the QT interval.

Baseline ECG is recommended prior to treatment in all patients especially in the elderly and patients with a positive personal or family history of cardiac disease or abnormal findings on cardiac clinical examination. During therapy, the need for ECG monitoring (e.g. at dose escalation) should be assessed on an individual patient basis. The dose of amisulpride should be reduced if QT is prolonged and discontinued if QTc is > 500 ms.

Periodic electrolyte monitoring is recommended particularly if the patient is taking diuretics or during inter-current illness.

Concomitant use with antipsychotics should be avoided.

Severe liver toxicity: Patients should be instructed to report immediately signs such as asthenia, anorexia, nausea, vomiting, abdominal pain or icterus to a physician. Investigations including clinical examination and biological assessment of liver function should be undertaken immediately.

Sulpistad 400 contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Use of the drug is not recommended during pregnancy unless the benefits justify the potential risks. Breast-feeding is contraindicated.

Patients should be aware of how they react to drug before driving or operating machinery.