Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
The treatment of acute and chronic schizophrenia.
A starting dose of 400mg to 800mg daily, given as one or two tablets 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 sulpiride.
Patients with mixed positive and negative symptoms, with neither predominating, will normally respond to a dose of 400mg-600mg twice daily.
The same dose ranges are applicable in the elderly, but the dose should be reduced if there is evidence of renal impairment.
Clinical experience in children under 14 years of age is insufficient to permit specific recommendations.
For oral use.
Experience with sulpiride in overdosage is limited.
The range of single toxic doses is 1 to 16g but no deaths have occurred even at a dose of 16g.
Fatal outcomes have been reported mainly in combination with other psychotropic agents.
The clinical manifestations of poisoning vary depending upon the size of the dose taken. After single doses of 1g to 3g restlessness and clouding of consciousness have been reported and (rarely) extrapyramidal symptoms. Doses of 3g to 7g may produce a degree of agitation, confusion and extrapyramidal symptoms; more than 7g can cause, in addition, coma and low blood pressure.
The duration of intoxication is generally short, the symptoms disappearing within a few hours. Comas which have occurred after large doses have lasted up to four days.
No haematological or hepatic toxicity has been reported.
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 arrhythmias) is recommended until the patient recovers.
If severe extrapyramidal symptoms occur anticholinergics should be administrated.
Overdose may be treated with alkaline osmotic diuresis and, if necessary, anti-parkinsonian drugs. Emetic drugs are unlikely to be effective. Coma needs appropriate nursing, and cardiac monitoring is recommended until the patient recovers. Emetic drugs are unlikely to be effective in sulpiride overdosage.
3 years.
Do not store above 25°C.
Multiples of 10 or 14 tablets in strips of PVC/Aluminium foil.
Multiples of 10 or 14 tablets in polypropylene/polyethylene containers with tamper evident closures.
None.
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