Efudix

/ Megapharm

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.
Elderly: Many of the conditions for which Efudix is indicated are common in the elderly. No special precautions are necessary.
Children: In view of the lack of clinical data available, Efudix is not recommended for use in children.

Antineoplastic agent to treat actinic keratosis multiple and superfacial basal cell carcinoma.

Efudix is contraindicated in patients with known hypersensitivity to
fluorouracil or any of the excipients.
Coadministration of Efudix with antiviral nucleoside drugs (e.g. brivudine and analogues) may lead to a substantial increase in plasma levels of fluorouracil and associated toxicity and is contraindicated. Brivudine and analogues are potent inhibitors of DPD, a fluorouracil metabolising enzyme.
Use of Efudix during pregnancy and in breast-feeding mothers is contraindicated.

See prescribing information for full details.

Adverse reactions associated with exacerbations of normal pattern of response which are related to pharmacological activity of fluorouracil on the skin are the most frequently reported reactions. Allergic type skin reactions and reactions related to systemic drug toxicity are very rarely reported.
See prescribing information for full details.

Although no significant drug interactions with Efudix have been reported, potential drug interactions are possible as indicated below.
Brivudine, sorivudine and analogues are potent inhibitors of DPD, a fluorouracil metabolising enzyme. For this reason, concomitant administration of these drugs with Efudix is contraindicated.

Pregnancy: There are no adequate data from the use of topical fluorouracil in pregnant women. Studies in animals have shown that fluorouracil is teratogenic. The potential risk for humans is unknown, hence Efudix should not be used during pregnancy.
Women of childbearing potential should not become pregnant during topical fluorouracil therapy and should use effective method of contraception during treatment with fluorouracil therapy. If a pregnancy occurs during treatment the patient should be advised about the risk for the child of adverse effects associated with the treatment and genetic counselling is recommended. 
Breast-feeding: No information is available on the excretion of fluorouracil into breast milk. Studies in animals have shown the fluorouracil is teratogenic. A risk to the suckling child cannot be excluded, so Efudix should not be used in nursing mothers. If use during breastfeeding is absolutely necessary, breastfeeding must be discontinued.

If Efudix is accidentally ingested, signs of fluorouracil overdosage may include nausea, vomiting and diarrhoea. Stomatitis and blood dyscrasias may occur in severe cases. Appropriate measures should be taken for the prevention of systemic infection and daily white cell counts should be performed.