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Drug Details

Xyloproct 5%/0.275% Ointment

• Drug Class Description
  Local anaesthetic / corticosteroids (steroids) - ATC code: C05A A01
• Generic Name
  Lidocaine [lignocaine], hydrocortisone acetate
• Presentation
  Ointment
• Description
  Composition for: 100 g: Lidocaine 5 g Hydrocortisone Acetate micro Ph. Eur. 0.275 g
• Indications
  

  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.

• Adult Dosage
  

  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 and children should be given doses commensurate with their age, weight and physical condition.

• Child Dosage
  

  Debilitated or elderly patients and children should be given doses commensurate with their age, weight and physical condition.

• Elderly Dosage
  

  Debilitated or elderly patients and children should be given doses commensurate with their age, weight and physical condition.

• Contra Indications
  

  Known hypersensitivity to local anaesthetics of the amide type or any of the other ingredients. Use on atrophic skin. Xyloproct Ointment should not be used in patients with untreated infections of bacterial, viral, pathogenic fungal or parasitic origin. Xyloproct should not be used by patients being treated with a class III anti-arrhythmic drug outside of hospital.

• Special Precautions
  

  Xyloproct is intended for use for limited periods. Excessive dosage of lidocaine or short intervals between doses, may result in high plasma levels of lidocaine and serious adverse effects. Patients should be instructed to strictly adhere to recommended dosage.

  Hospitalised patients treated with anti-arrhythmic drugs class III (e.g. amiodarone or sotalol) should be kept under close surveillance and ECG monitoring considered, since cardiac effects may be additive.

  Appropriate antibacterial, antiviral or antifungal therapy should be given with Xyloproct if infection is present at the site of application.

  The possibility of malignancy should be excluded before use.

  If irritation or rectal bleeding develops treatment should be discontinued.

  When using the special applicator, care should be taken to avoid instillation of excessive amounts of Xyloproct Ointment into the rectum. This is of particular importance in infants and children.

  Systemic absorption of lidocaine may occur from the rectum, and large doses may result in CNS side-effects. On rare occasions convulsions have occurred in children.

  Prolonged and excessive use of hydrocortisone use may produce systemic corticosteroid effects or local effects such as skin atrophy. With the recommended dosage systemic effects of hydrocortisone are unlikely.

  Xyloproct ointment is possibly porphyrinogenic and should only be prescribed to patients with acute porphyria when no safer alternative is available. Appropriate precautions should be taken for vulnerable patients.

• Interactions
  

  Lidocaine should be used with caution in patients receiving anti-arrhythmic drugs, local anaesthetics or agents structurally related to local anaesthetics, since the toxic effects of these compounds are additive

• Adverse Drug Reactions
  

  Contact sensitivity to lidocaine has been reported after perianal use. Contact sensitivity may also occur after the use of topical hydrocortisone.

  In extremely rare cases amide-type local anaesthetic preparations have been associated with allergic reactions (in the most severe instances anaphylactic shock).