Cutivate Special Precautions

Fluticasone propionate should be used with caution in patients with a history of local hypersensitivity to corticosteroids or to any of the excipients in the preparation (see Description). Local hypersensitivity reactions (see Adverse Reactions) may resemble symptoms of the condition under treatment.
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 of the previously mentioned are observed, withdraw the drug gradually by reducing the frequency of application, or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency (see Adverse Reactions). 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 (e.g. on intertriginous areas or under occlusive dressings (in infants the nappy may act as an occlusive dressing); Increasing hydration of the stratum corneum; Use on thin skin areas such as the face; Use on broken skin or other conditions where the skin barrier may be impaired; In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects. This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults.
Overt suppression of the HPA-axis (morning plasma cortisol less than 5 micrograms/dL) is very unlikely to result from therapeutic use of fluticasone propionate Cream unless treating more than 50% of an adult's body surface and applying more than 20 g per day.
Infection risk with occlusion: Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh dressing is applied.
Use in psoriasis: Topical steroids should be used with caution in psoriasis as rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin have been reported in some cases. If used in psoriasis, careful patient supervision is important.
Application to the face: Prolonged application to the face is undesirable as this area is more susceptible to atrophic changes.
Application to the eyelids: If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye as cataract and glaucoma might result from repeated exposure.
Concomitant infection: Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and administration of appropriate antimicrobial therapy.
Chronic leg ulcers: Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers. However, this use may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.
Visual disturbance: Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Excipients: CUTIVATE Cream contains the excipient propylene glycol as which may cause skin irritation. CUTIVATE Cream also contains cetostearyl alcohol and imidurea. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Imidurea releases formaldehyde as a breakdown product. Formaldehyde may cause allergic sensitisation or irritation upon contact with the skin.
Effect on ability to drive and use machines: There have been no studies to investigate the effect of fluticasone propionate on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated from the adverse reaction profile.
Use in Children: In infants and small children aged 3 months to 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression is more likely to occur.