SULPIREN Tablet Ref.[28259] Active ingredients: Sulpiride

Source: Υπουργείο Υγείας (CY)  Revision Year: 2015  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

Acute and chronic schizophrenia.

4.2. Posology and method of administration

Posology

Adults

A starting dose of 400mg to 800mg daily, given twice daily (morning and early evening) is recommended.

Predominantly positive symptoms (formal thought disorder, hallucinations, delusions, incongruity of affect) respond to higher doses, and a starting dose of at least 400mg twice daily is recommended, increasing if necessary up to a suggested maximum of 1200mg twice daily. Increasing the dose beyond this level has not been shown to produce further improvement.

Predominantly negative symptoms (flattening of affect, poverty of speech, anergia, apathy, as well as depression) respond to doses below 800mg daily; therefore, a starting dose of 400mg twice daily is recommended. Reducing this dose towards 200mg twice daily will normally increase the alerting effect of Sulpiren.

Patients with mixed positive and negative symptoms, with neither predominating, will normally respond to dosage of 400-600mg twice daily.

Paediatric population

Clinical experience in children under 14 years of age is insufficient to permit specific recommendations.

Elderly

The same dose ranges are applicable in the elderly, but the dose should be reduced if there is evidence of renal impairment.

Method of administration

Oral administration.

4.9. Overdose

Symptoms

Experience with sulpiride in overdosage is limited. In the event of an overdose, dyskinetic manifestations with spasmodic torticollis, protrusion of the tongue, and trismus may occur. Some patients may develop life-threatening parkinsonian manifestations and coma.

Management

Sulpiride is partly removed by haemodialysis.

There is no specific antidote to sulpiride. Treatment is only symptomatic. Appropriate supportive measures should therefore be instituted, close supervision of vital functions and cardiac monitoring (risk of QT interval prolongation and subsequent ventricular arrythmias) is recommended until the patient recovers.

If severe extrapyramidal symptoms occur, anticholinergics should be administrated.

6.3. Shelf life

60 months.

6.4. Special precautions for storage

Store below 25°C, the original package.

6.5. Nature and contents of container

PVC-Al blister of 10 in carton boxes of 20, 100 & 1000 tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.