Drugs List

Therapeutic Indications

Uses

Deep skin carcinomas: palliative treatment
Superficial pre-malignant/malignant skin lesions:treatment

Topical treatment of, superficial pre-malignant and malignant skin lesions, keratoses (senile, actinic and arsenical forms), keratoacanthoma, bowen's disease and superficial basal cell carcinoma.

Deep penetrating or nodular basal and squamous cell carcinomas do not usually respond curatively to fluorouracil topical treatment. Therefore should only be used in palliative therapy where no other treatment is possible.

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

Dihydropyrimidine dehydrogenase deficiency

Contains parabens
Contains polysorbate
Contains propylene glycol: may cause irritation
Advise patient to wash hands after use
Avoid contact with eyes
Avoid contact with mucous membranes
Do not apply to broken or denuded skin
If accidental contact with eyes or mucous membranes - rinse with cool water
Limit total area treated at any one time to 500 sq cm
Advise patient to report any lesions developing within treatment area
Possible systemic effects if applied to broken or ulcerated skin
Advise patient residue on clothing/bedding may cause fire hazard
Advise patient to avoid exposure to sunlight and UV rays during treatment
Fire hazard: Keep away from naked flames and potential sources of ignition

Systemic drug toxicity may occur in patients with a dihydropyrimidine dehydrogenase (DPD) deficiency and/or if the product is used excessively, especially when used on skin areas in which the barrier function is impaired.

There have been reports of increased toxicity in patients who have DPD deficiency, determination of DPD activity may be considered where systematic drug toxicity is confirmed or suspected.

Pregnancy and Lactation

Pregnancy

Contraindicated in pregnancy.

No adequate data, at the time of writing, on the use of fluorouracil in pregnant women.

Fluorouracil has been shown to be teratogenic in animals.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Contraindicated in breastfeeding.

No adequate data, at the time of writing, on the use of fluorouracil during breastfeeding.

The low molecular weight suggests fluorouracil would be excreted into breast milk. Women should not breastfeed during treatment due to the potential of severe adverse reactions in nursing infants.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Allergic skin reactions
Alopecia
Application site reaction
Blisters (application site)
Burning sensation (local)
Chills
Conjunctival irritation
Contact dermatitis
Dermatitis
Diarrhoea
Dizziness
Dysgeusia
Eczema
Erythema
Erythema multiforme
Haematological disorders
Headache
Hypersensitivity reactions
Increased lacrimation
Keratitis
Mucosal inflammation
Photosensitivity
Pruritus
Psychotic symptoms
Pyrexia
Rash
Skin exfoliation
Skin irritation
Skin pain
Swelling(localised)
Systemic effects (large quantities and/or prolonged use)
Ulceration
Urticaria
Vomiting

Presentation

Cream containing fluorouracil.

Drugs List

Therapeutic Indications

Uses

Deep skin carcinomas: palliative treatment
Superficial pre-malignant/malignant skin lesions:treatment

Topical treatment of, superficial pre-malignant and malignant skin lesions, keratoses (senile, actinic and arsenical forms), keratoacanthoma, bowen's disease and superficial basal cell carcinoma.

Deep penetrating or nodular basal and squamous cell carcinomas do not usually respond curatively to fluorouracil topical treatment. Therefore should only be used in palliative therapy where no other treatment is possible.

Dosage

Treatment should be continued until marked inflammatory response occurs. The pattern of response usually follows the sequence: early and severe inflammatory phases (characterised by erythema), necrotic phase (characterised by skin erosion) and healing (epithelisation occurs).

The cream should not harm healthy skin.

Adults

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

Dihydropyrimidine dehydrogenase deficiency

Contains parabens
Contains polysorbate
Contains propylene glycol: may cause irritation
Advise patient to wash hands after use
Avoid contact with eyes
Avoid contact with mucous membranes
Do not apply to broken or denuded skin
If accidental contact with eyes or mucous membranes - rinse with cool water
Limit total area treated at any one time to 500 sq cm
Advise patient to report any lesions developing within treatment area
Possible systemic effects if applied to broken or ulcerated skin
Advise patient residue on clothing/bedding may cause fire hazard
Advise patient to avoid exposure to sunlight and UV rays during treatment
Fire hazard: Keep away from naked flames and potential sources of ignition

Systemic drug toxicity may occur in patients with a dihydropyrimidine dehydrogenase (DPD) deficiency and/or if the product is used excessively, especially when used on skin areas in which the barrier function is impaired.

There have been reports of increased toxicity in patients who have DPD deficiency, determination of DPD activity may be considered where systematic drug toxicity is confirmed or suspected.

Pregnancy and Lactation

Pregnancy

Contraindicated in pregnancy.

No adequate data, at the time of writing, on the use of fluorouracil in pregnant women.

Fluorouracil has been shown to be teratogenic in animals.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Contraindicated in breastfeeding.

No adequate data, at the time of writing, on the use of fluorouracil during breastfeeding.

The low molecular weight suggests fluorouracil would be excreted into breast milk. Women should not breastfeed during treatment due to the potential of severe adverse reactions in nursing infants.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Allergic skin reactions
Alopecia
Application site reaction
Blisters (application site)
Burning sensation (local)
Chills
Conjunctival irritation
Contact dermatitis
Dermatitis
Diarrhoea
Dizziness
Dysgeusia
Eczema
Erythema
Erythema multiforme
Haematological disorders
Headache
Hypersensitivity reactions
Increased lacrimation
Keratitis
Mucosal inflammation
Photosensitivity
Pruritus
Psychotic symptoms
Pyrexia
Rash
Skin exfoliation
Skin irritation
Skin pain
Swelling(localised)
Systemic effects (large quantities and/or prolonged use)
Ulceration
Urticaria
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: December 2017.

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Efudix Cream. Meda Pharmaceuticals. Revised November 2016.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: November 2017.