Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Xyloproct rectal ointment is indicated in adults and children of all ages for the relief of symptoms such as anal and peri-anal pruritus, pain and inflammation associated with haemorrhoids, anal fissure, fistulas and proctitis. Pruritus vulva.
Route of administration: Topical.
To be applied several times daily according to the severity of the condition. For intrarectal use, apply the ointment with the special applicator. Cleanse the applicator thoroughly after use.
A daily dose of 6 g ointment is well within safety limits. The duration of treatment may vary between ten days and three weeks. If the treatment is prolonged, a free interval can be recommended, especially if it is suspected that irritation due to lidocaine or hydrocortisone has occurred. If the local irritation disappears after the cessation of treatment, the possibility of sensitivity to lidocaine or hydrocortisone can be investigated, e.g. by a patch test.
Debilitated or elderly patients should be given doses commensurate with their age, weight and physical condition.
Children should be given doses commensurate with their age, weight and physical condition.
Systemic absorption of lidocaine may occur from the rectum. When using the special applicator care should be taken to avoid instillation of excessive amounts of Xyloproct Ointment into the rectum.
Lidocaine can cause acute toxic effects if high systemic levels occur due to rapid absorption or overdosage. With the recommended doses of Xyloproct, toxic effects have not been reported. On rare occasions convulsions have occurred in children following administration of overdose.
However, should systemic toxicity occur, the signs are anticipated to be similar in nature to those following the administration of local anaesthetics by other routes.
Local anaesthetic toxicity is manifested by symptoms of nervous system excitation and, in severe cases, central nervous and cardiovascular depression.
Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by respiratory support and the administration of anticonvulsive drugs.
2 years when stored between 2°C and 8°C.
2 months when stored below 25°C.
Store in a refrigerator (2°C-8°C). The patient may store the product at temperatures below 25°C for 2 months whilst in use. The remaining ointment should then be discarded.
Aluminium tube 20 g.
No special requirements.
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