FLUTICASONE PROPIONATE Cream Ref.[6857] Active ingredients: Fluticasone

Prolonged application of high doses to large areas of body surface, especially in infants and small children, might lead to adrenal suppression. Children and infants have a greater surface area to body weight ratio compared with adults. Therefore, in comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. This effect is more likely to occur in infants and children if occlusive dressings are used. In infants, the napkin may act as an occlusive dressing. Care should be taken when using fluticasone cream to ensure the amount applied is the minimum that provides therapeutic benefit.

The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema.

The prolonged use of corticosteroids on the face may cause steroid-induced dermatitis.

These incidents disappear at withdrawal of treatment, but a sudden withdrawal may be followed by an acute adrenal insufficiency.

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 20g per day.

Long-term continuous use should be avoided in children. The safety and efficacy of fluticasone propionate when used continuously for more than 4 weeks has not been established.

If signs of hypersensitivity appear, application should stop immediately.

The safety and efficacy in paediatric patients below 1 year of age have not been established.

If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye so as to avoid the risk of local irritation or glaucoma.

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.

Topical steroids may be hazardous in psoriasis for a number of reasons, including rebound relapses, development of tolerances, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important and referral to a dermatologist is required before using Fluticasone to treat psoriasis in children.

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 systemic administration of antimicrobial agents.

Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressing, and so the skin should be cleansed before a fresh dressing is applied.

Contains cetostearyl alcohol, which may cause skin reactions (e.g.: contact dermatitis).

Contains imidurea which releases traces of formaldehyde as a breakdown product. Formaldehyde may cause allergic sensitization or irritation upon contact with the skin.

Contains propylene glycol, which may cause skin irritation.

None reported.

Pregnancy

Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established; however, 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.

Lactation

The excretion of fluticasone propionate into human breast milk has not been investigated. When measurable plasma levels were obtained in lactating laboratory rats following subcutaneous administration there was evidence of fluticasone propionate in the milk. However, plasma levels in patients following dermal application of fluticasone propionate at recommended doses are likely to be low.

None reported.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10.000 and <1/1000) very rare (<1/10.000, including isolated reports) and not known (cannot be estimated from the available data). Very common, common and uncommon events were generally determined from clinical trial data. The background rates in placebo and comparator groups were not taken into account when assigning frequency categories to adverse events derived from clinical trial data, since these rates were generally comparable to those in the active treatment group. Rare and very rare events were generally derived from spontaneous data.

Infections and infestations

Very rare: secondary infections (particularly when occlusive dressings are used or when skin folds are involved) have been reported with corticosteroid use.

Immune system disorders

Very rare: hypersensitivity.

If signs of hypersensitivity appear, application should stop immediately.

Endocrine disorders

Very rare: features of hypercortisolism

Prolonged use of large amounts of corticosteroids, or treatment of extensive areas, can result in sufficient systemic absorption to produce the features of hypercortisolism. This effect is more likely to occur in infants and children, and if occlusive dressings are used. In infants, the napkin may act as an occlusive dressing (see Special Warnings and precautions for use).

Vascular disorders

Very rare: dilation of superficial blood vessels

Prolonged and intensive treatment with potent corticosteroid preparations may cause dilation of the superficial blood vessels.

Eye disorders

Not known: Vision, blurred (see section 4.4)

Skin and subcutaneous tissue disorders

Common: pruritus

Uncommon: local burning

Very rare: Thinning, striae, hypertrichosis, hypopigmentation, allergic contact dermatitis, exacerbation of dermatoses, pustular psoriasis.

Not known: Vascular purpura, skin fragility, peri-oral dermatitis, rosacea, scab, leg ulcer, acne, impaired healing.

Local burning and pruritus have been reported, however in clinical trials the incidence of these adverse reactions was generally comparable to placebo and comparator groups.

Prolonged and intensive treatment with potent corticosteroid preparations may cause local atrophic changes in the skin such as thinning, striae, hypertrichosis and hypopigmentation.

Exacerbation of the signs and symptoms of the dermatoses and allergic contact dermatitis have been reported with corticosteroid use.

Treatment of psoriasis with a corticosteroid (or its withdrawal) may provoke the pustular form of the disease.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store.

None reported.