FLUTICASONE PROPIONATE

For topical administration. 4).

Duration of use:

Daily treatment should be continued until adequate control of the condition is achieved. Frequency of application should thereafter be reduced to the lowest effective dose. When fluticasone cream is used in the treatment of children, if there is no improvement within 7 – 14 days, treatment should be withdrawn and the child re-evaluated.

Once the condition has been controlled (usually within 7-14 days) frequency of application should be reduced to the lowest effective dose for the shortest possible time. Continuous daily treatment for longer than 4 weeks is not recommended.

An increase in the number of daily applications might aggravate side effects without improving the therapeutic effects.

Method of administration:

In adults and children, use the method of finger-tip unit to specify the quantity of cream applied to a given surface. The finger-tip unit corresponds to the amount of cream applied from the distal skin-crease to the tip of the index finger.

This quantity permits to treat a skin surface corresponding to 2 hands of an adult (approximately 250 to 300 cm2). A finger-tip unit corresponds to approx. 5g of product. A tube of 30 grams contains 60 finger-tip unities.

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 (≥ 1/1,000 and < 1/100), rare (≥ 1/10,000 and < 1/1,000) 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.

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.

The label will state strong steroid. 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.

• Rosacea. • Acne vulgaris. • Perioral dermatitis. : herpes simplex, chickenpox). 1. • Perianal and genital pruritus. • Ulceration of the skin • Atrophy of the skin • Fragile skin vessels • Ichthyosis • Juvenile dermatosis • Dermatoses in infants under 1 year of age, including dermatitis and napkin eruptions • Injuries ulcerated • The use of fluticasone cream is not indicated in the treatment of primary infected skin lesions caused by infection with fungi or bacteria.