Search The Medical Knowledge Base

Drug Details

EFUDIX Cream

• Drug Class Description
  Cytostatics.
• Generic Name
  Fluorouracil 5%
• Presentation
  White, opaque cream.
• Description
  Efudix cream contains 5% w/w fluorouracil.
• Indications
  Efudix is used for the topical treatment of superficial pre-malignant and malignant skin lesions; keratoses including senile, actinic and arsenical forms; keratoacanthoma; Bowen's disease; superficial basal-cell carcinoma. Deep, penetrating or nodular basal cell and squamous cell carcinomas do not usually respond to Efudix therapy. It should be used only as a palliative therapy in such cases where no other form of treatment is possible.
• Adult Dosage
  

  Efudix cream is for topical application.

  Pre-malignant conditions

  The cream should be applied thinly to the affected area once or twice daily; an occlusive dressing is not essential.

  Malignant conditions

  The cream should be applied once or twice daily under an occlusive dressing where this is practicable.

  The cream should not harm healthy skin. Treatment should be continued until there is marked inflammatory response from the treated area, preferably with some erosion in the case of pre-malignant conditions. Severe discomfort may be alleviated by the use of topical steroid cream. The usual duration of treatment for an initial course of therapy is three to four weeks, but this may be prolonged. Lesions on the face usually respond more quickly than those on the trunk or lower limbs whilst lesions on the hands and forearms respond more slowly. Healing may not be complete until one or two months after therapy is stopped.

• Child Dosage
  In view of the lack of clinical data available, Efudix is not recommended for use in children.
• Elderly Dosage
  

  Many of the conditions for which Efudix is indicated are common in the elderly. No special precautions are necessary.

• Contra Indications
  

  Efudix is contra-indicated in patients with known hypersensitivity to Efudix or parabens.

• Special Precautions
  

  The hands should be washed carefully after applying Efudix. Also care should be taken to avoid contact with mucous membranes or the eyes when applying the cream.

  The total area of skin being treated with Efudix at any one time should not exceed 500 cm² (approximately 23 x 23 cm). Larger areas should be treated a section at a time.

  The normal pattern of response includes: early and severe inflammatory phases (typically characterised by erythema, which may become intense and blotchy), a necrotic phase (characterised by skin erosion) and finally healing (when epithelialisation occurs). The clinical manifestation of response usually occurs in the second week of Efudix treatment. However these treatment effects sometimes be more severe and include pain, blistering and ulceration. Exposure to sunlight may increase the intensity of the reaction.

  Pre-existing subclinical lesions may become apparent following Efudix use.

  Any severe skin discomfort during treatment with Efudix may be alleviated by the use of an appropriate topical steroid cream.

  When used according to the approved prescribing information Efudix should have minimal effect on healthy skin.

  Significant systemic drug toxicity is unlikely via percutaneous absorption of fluorouracil when Efudix is administered as per the approved prescribing information. However the likelihood of this is increased if the product is used excessively, especially on skin areas in which the barrier function is impaired (e.g. cuts) and/or in individuals with deficiency in dihydropyrimidine dehydrogenase (DPD). DPD is a key enzyme involved in metabolising and eliminating fluorouracil. Determination of DPD activity may be considered where systemic drug toxicity is confirmed or suspected. There have been reports of increased toxicity in patients who have reduced activity/deficiency of the enzyme dihydropyrimidine dehydrogenase. In the event of suspected systemic drug toxicity, consideration should be given to stopping Efudix treatment.

  An interval of at least four weeks should elapse between treatment with brivudine, sorivudine or analogues and subsequent administration of Efudix.

  The excipients stearyl alcohol and propylene glycol may cause local skin irritations (e.g. contact dermatitis); the excipients methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

• Interactions
  

  No significant drug interactions with Efudix have been reported.

• Adverse Drug Reactions
  

  Efudix is well tolerated. Transient erythema may occur in healthy skin surrounding the area being treated. Pre-existing subclinical lesions may become apparent. Exposure to sunlight may increase the intensity of the reaction. Dermatitis, allergic skin reactions and, rarely, erythema multiforme have been reported.

  Percutaneous absorption of fluorouracil should not lead to clinically significant systemic toxicity when Efudix is administered as directed. However, this possibility should be borne in mind if the product is used excessively, especially on ulcerated or broken skin.