Drugs List

Therapeutic Indications

Uses

Non-infected severe skin conditions responsive to corticosteroids
Skin disorder - dry or scaly

Contraindications

Children under 1 year
Varicella
Acne vulgaris
Genital pruritus
Perianal pruritus
Perioral dermatitis
Rosacea
Skin manifestation of tuberculosis

Precautions and Warnings

Breastfeeding
Pregnancy

Application under occlusion should be restricted to limited areas
Avoid occlusion in children or on face
Cleanse skin thoroughly before applying occlusive dressings
Do not apply to weeping dermatoses
May cause local and systemic toxicity especially in prolonged/extensive use
May cause local and systemic toxicity especially with polythene occlusion
Corticosteroids may cause growth retardation in children under 18 years
Avoid long term use
Limit use in children to 5 days
Limit use on face to 5 days

Systemic absorption of fludroxycortide has resulted in reversible hypothalamic pituitary adrenal (HPA) axis suppression. If a large dose is being given over a large area or an occlusive dressing is being used periodic urinary free cortisol and ACTH stimulation tests should be taken. If HPA axis suppression is observed the treatment should either be withdrawn, possibly being replaced by a less potent steroid, or a reduction of the frequency of application. On discontinuation recovery is fast and complete, some steroid withdrawal symptoms may occur requiring a supplemental systemic corticosteroid to be administered.

Antifungal or antibacterial agents should be co-administered in the presence of infection. The administration of fludroxycortide should be withdrawn until the infection has been adequately controlled.

Pregnancy and Lactation

Pregnancy

Use fludroxycortide tape with caution in pregnancy.

At the time of writing there is limited published information regarding the use of fludroxycortide tape during pregnancy. Animal studies on topical corticosteroids have shown teratogenic effects such as interference with brain growth, suppression of the HPA axis, a risk of cleft palate and intra-uterine growth retardation. Briggs (2015) also states corticosteroids have been found to cause harm to the foetus during pregnancy. The manufacturer suggests to only use fludroxycortide tape in pregnancy if there is no safer alternative and the potential benefit to the mother outweighs the potential risk to the foetus.

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

Use fludroxycortide tape with caution in breastfeeding.

At the time of writing there is limited published information on the use of topical corticosteroids during breastfeeding. Schaefer (2015) states systemic corticosteroids are secreted into breast milk in small quantities not likely to cause harm to the infant. However it is not known whether topical corticosteroids are systemically absorbed and excreted in breast milk. It is unlikely short-term application of topical corticosteroids will be excreted into breast milk and will cause harm to the infant (LactMed). The manufacturer suggests caution should be exercised when administrating topical corticosteroids.

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

Acne-like eruptions
Allergic contact dermatitis
Bulging fontanelles in infants
Cushing's syndrome
Dry skin
Folliculitis
Glycosuria
Growth retardation (children)
Headache
Hyperglycaemia
Hypersensitivity reactions
Hypertrichosis
Hypopigmentation
Intracranial hypertension
Irritation (localised)
Itching
Local burning
Maceration of skin
Miliaria
Papilloedema
Perioral dermatitis
Reduction in serum cortisol levels
Secondary infections
Skin atrophy
Striae
Suppression of the hypothalamic-pituitary-adrenal axis
Systemic steroid effects
Telangiectasia
Weight gain
Wound healing retarded

Presentation

Tape impregnated with fludroxycortide

Drugs List

Therapeutic Indications

Uses

Non-infected severe skin conditions responsive to corticosteroids
Skin disorder - dry or scaly

Dosage

Adults

Elderly

Children

Contraindications

Children under 1 year
Varicella
Acne vulgaris
Genital pruritus
Perianal pruritus
Perioral dermatitis
Rosacea
Skin manifestation of tuberculosis

Precautions and Warnings

Breastfeeding
Pregnancy

Application under occlusion should be restricted to limited areas
Avoid occlusion in children or on face
Cleanse skin thoroughly before applying occlusive dressings
Do not apply to weeping dermatoses
May cause local and systemic toxicity especially in prolonged/extensive use
May cause local and systemic toxicity especially with polythene occlusion
Corticosteroids may cause growth retardation in children under 18 years
Avoid long term use
Limit use in children to 5 days
Limit use on face to 5 days

Systemic absorption of fludroxycortide has resulted in reversible hypothalamic pituitary adrenal (HPA) axis suppression. If a large dose is being given over a large area or an occlusive dressing is being used periodic urinary free cortisol and ACTH stimulation tests should be taken. If HPA axis suppression is observed the treatment should either be withdrawn, possibly being replaced by a less potent steroid, or a reduction of the frequency of application. On discontinuation recovery is fast and complete, some steroid withdrawal symptoms may occur requiring a supplemental systemic corticosteroid to be administered.

Antifungal or antibacterial agents should be co-administered in the presence of infection. The administration of fludroxycortide should be withdrawn until the infection has been adequately controlled.

Pregnancy and Lactation

Pregnancy

Use fludroxycortide tape with caution in pregnancy.

At the time of writing there is limited published information regarding the use of fludroxycortide tape during pregnancy. Animal studies on topical corticosteroids have shown teratogenic effects such as interference with brain growth, suppression of the HPA axis, a risk of cleft palate and intra-uterine growth retardation. Briggs (2015) also states corticosteroids have been found to cause harm to the foetus during pregnancy. The manufacturer suggests to only use fludroxycortide tape in pregnancy if there is no safer alternative and the potential benefit to the mother outweighs the potential risk to the foetus.

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

Use fludroxycortide tape with caution in breastfeeding.

At the time of writing there is limited published information on the use of topical corticosteroids during breastfeeding. Schaefer (2015) states systemic corticosteroids are secreted into breast milk in small quantities not likely to cause harm to the infant. However it is not known whether topical corticosteroids are systemically absorbed and excreted in breast milk. It is unlikely short-term application of topical corticosteroids will be excreted into breast milk and will cause harm to the infant (LactMed). The manufacturer suggests caution should be exercised when administrating topical corticosteroids.

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

Acne-like eruptions
Allergic contact dermatitis
Bulging fontanelles in infants
Cushing's syndrome
Dry skin
Folliculitis
Glycosuria
Growth retardation (children)
Headache
Hyperglycaemia
Hypersensitivity reactions
Hypertrichosis
Hypopigmentation
Intracranial hypertension
Irritation (localised)
Itching
Local burning
Maceration of skin
Miliaria
Papilloedema
Perioral dermatitis
Reduction in serum cortisol levels
Secondary infections
Skin atrophy
Striae
Suppression of the hypothalamic-pituitary-adrenal axis
Systemic steroid effects
Telangiectasia
Weight gain
Wound healing retarded

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: November 2016

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 16 November 2016.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications. Accessed on 16 November 2016.

Summary of Product Characteristics: Fludroxycortide 4 micrograms per square centimetre Tape. TypharmLtd. Revised June 2016.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Last revised: 10 March 2015
Last accessed: 16 November 2016