Fluticasone topical
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Topical formulations of fluticasone
Drugs List
Therapeutic Indications
Uses
Non-infected severe skin conditions responsive to corticosteroids
The relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as:-
atopic eczema, discoid eczema, prurigo nodularis, psoriasis (excluding widespread plaque psoriasis), neurodermatoses including lichen simplex, lichen planus, seborrhoeic dermatitis, contact sensitivity reactions, discoid lupus erythematosus, insect bite reactions, prickly heat and as an adjunct to systemic steroid therapy in generalised erythroderma.
Relief of inflammatory and pruritic manifestations of atopic dermatitis in children and infants aged three months and over when there has been no response to lower potency corticosteroids (under specialist supervision only).
Dosage
Adults
Apply thinly and gently rub in using only enough to cover affected area once or twice a day for up to 4 weeks until improvement occurs, then reduce frequency of application or change the treatment to a less potent preparation.
If the condition worsens or does not improve within 4 weeks, treatment and diagnosis should be re-evaluated.
Elderly
Apply thinly and gently rub in using only enough to cover affected area once or twice a day for up to 4 weeks until improvement occurs, then reduce frequency of application or change the treatment to a less potent preparation.
If the condition worsens or does not improve within 4 weeks, treatment and diagnosis should be re-evaluated.
The minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
Children
Expert opinion should be sought prior to the use of fluticasone cream or ointment for other corticosteroid responsive dermatoses in children. Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent agents than adults. Care should be taken when using fluticasone propionate to ensure the amount applied is the minimum that provides therapeutic benefit.
In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression is more likely to occur.
Children aged 3 months and older
Apply thinly and gently rub in using only enough to cover affected area once or twice a day for up to 4 weeks until improvement occurs, then reduce frequency of application or change the treatment to a less potent preparation.
If the condition worsens or does not improve within 4 weeks, treatment and diagnosis should be re-evaluated.
However if there is no improvement in the condition of the affected areas within 7 to 14 days, treatment should be withdrawn and the child re-evaluated.
Once the condition has been controlled within 7 to 14 days, frequency of application should be reduced to the lowest possible effective dose. Continuous daily treatment is not recommended for longer than 4 weeks.
Additional Dosage Information
Creams are especially appropriate for moist or weeping surfaces. Ointments are especially appropriate for dry, lichenified or scaly lesions.
Allow adequate time for absorption after each application before applying an emollient.
Therapy with topical corticosteroids should be gradually discontinued once control is achieved and an emollient continued as maintenance therapy.
Contraindications
Children under 3 months
Nappy rash
Acne vulgaris
Genital pruritus
Perianal pruritus
Perioral dermatitis
Rosacea
Skin infection
Precautions and Warnings
Children under 12 years
Breastfeeding
Pregnancy
Careful supervision of patients with psoriasis required
Use appropriate antimicrobial therapy in infected lesions
Contains propylene glycol: may cause irritation
Avoid contact with eyes
Avoid prolonged application to the face
Cleanse skin thoroughly before applying occlusive dressings
Long term use may cause adrenal suppression
Abrupt withdrawal may cause exacerbation or recurrence of condition
To discontinue, reduce dose gradually
Discontinue if hypersensitivity reactions occur
Not licensed for all indications in all age groups
Avoid prolonged use
Not recommended for use longer than 4 weeks
Advise patient residue on clothing/bedding may cause fire hazard
Fire hazard: Keep away from naked flames and potential sources of ignition
In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression is more likely to occur.
Manifestations of hypercortisolism (Cushing's Syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency, can occur in some individuals as a result of increased systemic absorption of topical steroids. If either are observed, withdraw the drug gradually by reducing the frequency of application, or by substituting a less potent corticosteroid. Abrupt withdrawal may result in glucocorticosteroid insufficiency.
Therapy with topical corticosteroids should be gradually discontinued once control is achieved and an emollient continued as maintenance therapy. Rebound of pre-existing dermatoses can occur with abrupt discontinuation of topical steroids especially with potent preparations.
Long term use of fluticasone may cause atrophic skin changes, particularly around the face. This should be taken into consideration when treating psoriasis, severe eczema and discoid lupus erythematosus.
When applying fluticasone to the eyelid, care should be taken to avoid contact with the eyes due to the risk of glaucoma and localised irritation.
Risk factors for increased systemic effects are; Potency and formulation of topical steroid, duration of exposure, application to a large surface area, use on occluded areas of skin, increasing hydration of the stratum corneum, use on thin skin areas such as the face and use on broken skin or other conditions where the skin barrier may be impaired.
Pregnancy and Lactation
Pregnancy
Use fluticasone with caution in pregnancy.
At the time of writing there are limited data on the use of fluticasone propionate in pregnant women.
Studies of topical administration of corticosteroids in pregnant animals have shown abnormalities in foetal development.
Administration of fluticasone propionate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus. The minimum quantity should be used for the minimum duration.
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 fluticasone with caution in breastfeeding.
At the time of writing it is not known whether the topical administration of corticosteroid could result in sufficient systemic absorption to produce detectable amounts in breast milk.
When measurable plasma levels were obtained in lactating laboratory rats following subcutaneous administration there was evidence of fluticasone in the milk.
Administration of fluticasone during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.
If used in breastfeeding, fluticasone should not be applied to the breasts to avoid accidental digestion by the infant.
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 (at application site)
Adrenal suppression
Allergic contact dermatitis
Burning sensation (local)
Cataracts
Cushingoid changes
Erythema
Exacerbation of infection
Exacerbation of symptoms
Glaucoma
Growth retardation (children)
Hyperglycaemia
Hypersensitivity reactions
Hypertension
Hypertrichosis
Mild depigmentation and vellus hair
Moon face
Opportunistic infections
Osteoporosis
Perioral dermatitis
Pruritus
Pustular psoriasis
Rash
Skin atrophy
Striae
Suppression of the hypothalamic-pituitary-adrenal axis
Telangiectasia
Thinning of skin
Urticaria
Weight gain
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 2016
Reference Sources
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 18 August 2016.
Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 18 August 2016.
Summary of Product Characteristics: Cutivate Cream 0.05%. GlaxoSmithKline UK. Revised February 2014.
Summary of Product Characteristics: Cutivate Ointment 0.005%. GlaxoSmithKline UK. Revised February 2014.
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
Fluticasone, Topical Last revised: 10 March, 2015
Last accessed: 18 March 2016
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