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Drug Details

Calcipotriol Scalp Solution

• Drug Class Description
  Other antipsoriatics for topical use - ATC code: D05AX02
• Generic Name
  calcipotriol
• Presentation
  Cutaneous solution
  
  Clear, colourless solution with an odour of menthol.
• Description
  One ml of calcipotriol cutaneous solution contains 50 micrograms of calcipotriol.
  
  Excipient: Propylene glycol 30 mg/ml.
• Indications
  Calcipotriol 50 micrograms/ml Scalp Solution is indicated for the topical treatment of mild to moderate scalp psoriasis.
• Adult Dosage
  

  Adults

  Calcipotriol 50 micrograms/ml Scalp Solution should be applied to the affected areas twice daily (morning and evening).

  The maximum weekly dose should not exceed 60 ml.

  If this solution is used together with cream or ointment containing calcipotriol, the total weekly dose of calcipotriol should not exceed 5 mg (for example 60 ml of Calcipotriol 50 micrograms/ml Scalp Solution plus 30 g of cream or ointment, or 30 ml of Calcipotriol 50 micrograms/ml Scalp Solution plus 60 g of cream or ointment.

  Duration of treatment should be decided by the physician, but should normally not be for longer than 22 weeks.

  Renal/hepatic impairment

  Patients with known severe renal or liver impairment should not be treated with calcipotriol.

  Children and adolescents (under 18 years of age)

  Calcipotriol 50 micrograms/ml Scalp Solution is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.

• Contra Indications
  

  - Hypersensitivity to the active substance calcipotriol or to any of the excipients

  - Patients with severe renal or liver impairment

  - Known disorders of calcium metabolism or treatment with other medicinal products which increase serum calcium level.

  - Hypercalcaemia.

• Special Precautions
  

  Application of Calcipotriol 50 micrograms/ml Scalp Solution to the face may cause local irritation. Calcipotriol 50 micrograms/ml Scalp Solution should therefore not be applied directly to the face. Patients should be advised to wash their hands after applying the solution in order to prevent inadvertent transfer to the face.

  The efficacy and long-term safety of this solution in children has not been established. Therefore its use in this population cannot be recommended.

  Patients should be advised to use no more than the maximum weekly dose since hypercalcaemia, which rapidly reverses on cessation of treatment, may occur.

  During calcipotriol treatment physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Topical calcipotriol should be used with UV radiation only if the physician and patient consider that the potential benefits outweigh the potential risks.

  Calcipotriol 50 micrograms/ml Scalp Solution contains propylene glycol. It may cause skin irritation.

• Interactions
  

  No interaction studies have been performed .

  There is no experience of concomitant therapy with other antipsoriatic products applied to the same area.

• Adverse Drug Reactions
  

  Based on the clinical data undesirable effects occurred in approximately 25% of the patients.

  The most frequently reported undesirable effects are various transient skin reactions and in particular application site reactions.

  The undesirable effects are listed by MedDra SOC and the individual undesirable effects are listed starting with the most frequently reported. The following convention has been used for the classification of frequency of undesirable effects:

  Very common 1/10

  Common 1/100 and <1/10

  Uncommon 1/1,000 and<1/100

  Rare 1/10,000 and <1/1,000

  Very rare <1/10,000, not known (cannot be estimated from the available data)

  Skin and subcutaneous disorders

  Very common	Skin burning sensation and skin stinging sensation
  Common	Pruritus, skin irritation, dry skin, erythema, rash*
  Uncommon	Eczema, contact dermatitis, aggravation of psoriasis
  Rare)	Perioral dermatitis

  *various types of rash reaction such as scaly, erythematous, maculo-papular and pustular have been reported.

  Metabolism and nutrition disorders

  Very rare

  Hypercalcaemia, hypercalciuria

  The following undesirable effects have been reported on other products containing calcipotriol (cream, ointment, scalp solution) during post-marketing experience:

  Transient changes in skin pigmentation, transient photosensitivity reactions and hypersensitivity reactions including urticaria, angioedema, periorbital or facial oedema (very rarely), perioral dermatitis (rarely).

  Based on post-marketing data the total 'reporting rate' of undesirable effects is very rare being approximately 1:10,000 treatment courses.