Sulpiride STELLA 50 mg

Rx

Indications:

• Short-term symptomatic treatment of anxiety in adults when the usual therapeutic measures have failed.
• Acute and chronic schizophrenia.

Dosage:

Short-term symptomatic treatment of anxiety in adults when the usual therapeutic measures have failed: 50 – 150 mg daily for a maximum period of 4 weeks.

Schizophrenia:

• Patients with negative symptoms: Initial doses of 200 to 400 mg twice daily, if necessary increased up to a total of 800 mg daily.
• Patients with positive symptoms: 400 mg of sulpiride twice daily, if necessary increased up to a maximum of 1.2 g twice daily.
• Patients with mixed positive and negative symptoms: 400 to 600 mg twice daily.

Elderly patients: Lower initial doses of 50 – 100 mg twice daily, subsequently adjusted as required.

Children over 14 years: A daily dose of 3 to 5 mg/kg.

Patients with renal impairment:

• Clcr = 30 – 60 ml/min: two-thirds of the normal amount or dosage interval can be prolonged by a factor of 1.5.
• Clcr = 10 – 30 ml/min: half of the normal amount or dosage interval can be prolonged by a factor of 2.
• Clcr < 10 ml/min: one-third of the normal amount or dosage interval can be prolonged by a factor of 3.

Usage:

Sulpiride STELLA 50 mg is taken orally.

• Patients with known hypersensitivity to any ingredients of the drug.
• Adrenal marrow tumours.
• Acute porphyria.
• CNS depression states, coma, alcoholic poisoning, and CNS depressants.
• Concomitant prolactin-dependent tumours (e.g. breast cancer, pituitary gland prolactinomas).
• Pregnancy (especially during the first 16 weeks of pregnancy) and breastfeeding women.

Common:

Insomnia or drowsiness; hyperprolactinaemia, galactorrhoea, menstrual disturbances or amenorrhea.

Uncommon:

Excitement, extrapyramidal symptoms (restlessness, spasmodic torticollis, oculogyric crises); Parkinsonian symptoms; QT interval prolongation (arrhythmias, torsade de pointes

• In the event of renal impairment, reduce the dosage and increase patient monitoring. In the event of severe renal impairment, prescription of intermittent treatment courses is recommended.
• Monitoring of sulpiride treatment must be increased in epileptic patients, manic or hypomanic patients and the elderly people with dementia.
• All possible risk factors for venous thromboembolism (VTE) should be identified before and during treatment with antipsychotics and preventative measures undertaken.
• Gradual withdrawal is advisable because acute withdrawal symptoms (including nausea, vomiting, sweating and insomnia), recurrence of psychotic symptoms and and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) may occur after abrupt cessation of drug.
• Alcohol consumption and use of medicinal products containing alcohol are strongly inadvisable throughout the duration of treatment.
• Sulpiride STELLA 50 mg must absolutely be discontinued in the event of unexplained hyperthermia.
• Sulpiride STELLA 50 mg contains lactose and wheat starch. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption and patients with wheat allergy (different from coeliac disease) shouldnot take this medicine.
• Sulpiride STELLA 50 mg may cause drowsiness which may affect performance of skilled tasks (e.g. driving or operating machinery), especially at start of treatment.