Drugs List

Therapeutic Indications

Uses

Dermatitis
Eczema

Contraindications

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

Precautions and Warnings

Breastfeeding
Pregnancy

Careful supervision of patients with psoriasis required
Contains cetyl alcohol - may cause local skin reactions
Contains propylene glycol: may cause irritation
Application under occlusion should be restricted to limited areas
Avoid contact with eyes
Avoid occlusion in children or on face
May cause local and systemic toxicity especially in prolonged/extensive use
May cause local and systemic toxicity especially with polythene occlusion
Prolonged or high dose may lead to adrenal suppression
Corticosteroids may cause growth retardation in children under 18 years
Potential for withdrawal symptoms
Risk of generalised pustular psoriasis with use of topical corticosteroids
Discontinue therapy and use antimicrobials if secondary infection occurs
Avoid long term continuous therapy
Limit use in children to 5 days
Limit use on face to 5 days
Advise patient residue on clothing/bedding may cause fire hazard
Fire hazard: Keep away from naked flames and potential sources of ignition

Systemic absorption of fludroxycortide has resulted in reversible HPA axis suppression. If a large dose is being applied over a large area or an occlusive dressing is being used periodic urinary free cortisol and ACTH stimulation tests should be carried out. If HPA axis suppression is observed the treatment should either be withdrawn, possibly being replaced by a less potent steroid, or a reduction of the frequency of application.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, but some steroid withdrawal symptoms may occur requiring a supplemental systemic corticosteroid to be administered.

Children may absorb proportionally larger amounts of topical corticosteroids and thus may be more susceptible to systemic toxicity. Children may also demonstrate greater susceptibility to topical corticosteroid induced HPA axis suppression and Cushing's Syndrome because a larger skin surface to body weight ratio.

Antifungal or antibacterial agents should be co-administered in the presence of infection. If a favourable response does not occur promptly, the administration of fludroxycortide should be withdrawn until the infection has been adequately controlled.

The use of an occlusive dressing can enhance the effects of fludroxycortide. Fludroxycortide should not be used as a substitute for preparations used in the conventional management of skin lesions. It should be used as a supplement to lotions and wet dressings.

Rarely, severe skin reactions and adverse effects may occur on stopping treatment with topical corticosteroids. Consider the lowest potency required and counsel patient on safe and effective use.

Patients or carers should be advised on application of fludroxycortide cream.

Patients or carers should seek medical advice before using a topical corticosteroid on a new body area, as some areas of the body are more prone to side effects.

Pregnancy and Lactation

Pregnancy

Use fludroxycortide with caution during pregnancy.

The manufacturer recommends that fludroxycortide is only used during pregnancy when there is no safer alternative and when the disease itself carries risks for the mother and child.

At the time of writing there is limited published information regarding the topical use of fludroxycortide during pregnancy; however, animal studies have shown evidence of harmful effects. There may be a very small risk of cleft palate and intra-uterine growth retardation and suppression of the neonatal HPA axis.

Lactation

Use fludroxycortide with caution during breastfeeding.

The manufacturer recommends that caution should be exercised when fludroxycortide is administered to breastfeeding mothers.

At the time of writing there is limited published information regarding the topical use of fludroxycortide during breastfeeding. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into the breast milk, but in small quantities that are unlikely to cause harm to the infant.

Side Effects

Acne (at application site)
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
Mild depigmentation and vellus hair
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

Topical formulations of fludroxycortide.

Drugs List

Therapeutic Indications

Uses

Dermatitis
Eczema

Dosage

Adults

Children

Additional Dosage Information

Contraindications

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

Precautions and Warnings

Breastfeeding
Pregnancy

Careful supervision of patients with psoriasis required
Contains cetyl alcohol - may cause local skin reactions
Contains propylene glycol: may cause irritation
Application under occlusion should be restricted to limited areas
Avoid contact with eyes
Avoid occlusion in children or on face
May cause local and systemic toxicity especially in prolonged/extensive use
May cause local and systemic toxicity especially with polythene occlusion
Prolonged or high dose may lead to adrenal suppression
Corticosteroids may cause growth retardation in children under 18 years
Potential for withdrawal symptoms
Risk of generalised pustular psoriasis with use of topical corticosteroids
Discontinue therapy and use antimicrobials if secondary infection occurs
Avoid long term continuous therapy
Limit use in children to 5 days
Limit use on face to 5 days
Advise patient residue on clothing/bedding may cause fire hazard
Fire hazard: Keep away from naked flames and potential sources of ignition

Systemic absorption of fludroxycortide has resulted in reversible HPA axis suppression. If a large dose is being applied over a large area or an occlusive dressing is being used periodic urinary free cortisol and ACTH stimulation tests should be carried out. 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, but some steroid withdrawal symptoms may occur requiring a supplemental systemic corticosteroid to be administered.

Children may absorb proportionally larger amounts of topical corticosteroids and thus may be more susceptible to systemic toxicity. Children may also demonstrate greater susceptibility to topical corticosteroid induced HPA axis suppression and Cushing's Syndrome because a larger skin surface to body weight ratio.

Antifungal or antibacterial agents should be co-administered in the presence of infection. If a favourable response does not occur promptly, the administration of fludroxycortide should be withdrawn until the infection has been adequately controlled.

The use of an occlusive dressing can enhance the effects of fludroxycortide. Fludroxycortide should not be used as a substitute for preparations used in the conventional management of skin lesions. It should be used as a supplement to lotions and wet dressings.

Rarely, severe skin reactions and adverse effects may occur on stopping treatment with topical corticosteroids. Consider the lowest potency required and counsel patient on safe and effective use.

Patients or carers should be advised on application of fludroxycortide cream.

Patients or carers should seek medical advice before using a topical corticosteroid on a new body area, as some areas of the body are more prone to side effects.

Pregnancy and Lactation

Pregnancy

Use fludroxycortide with caution during pregnancy.

The manufacturer recommends that fludroxycortide is only used during pregnancy when there is no safer alternative and when the disease itself carries risks for the mother and child.

At the time of writing there is limited published information regarding the topical use of fludroxycortide during pregnancy; however, animal studies have shown evidence of harmful effects. There may be a very small risk of cleft palate and intra-uterine growth retardation and suppression of the neonatal HPA axis.

Lactation

Use fludroxycortide with caution during breastfeeding.

The manufacturer recommends that caution should be exercised when fludroxycortide is administered to breastfeeding mothers.

At the time of writing there is limited published information regarding the topical use of fludroxycortide during breastfeeding. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into the breast milk, but in small quantities that are unlikely to cause harm to the infant.

Side Effects

Acne (at application site)
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
Mild depigmentation and vellus hair
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: August 2022

Reference Sources

Summary of Product Characteristics: Fludroxycortide 0.0125% w/w Cream. Typharm Ltd. Revised August 2021.

MHRA Drug Safety Update September 2021 Available at: https://www.mhra.gov.uk
Last accessed: 10 August 2022

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 August 2022