FUSIDIC ACID/BETAMETHASONE

Posology A single treatment course should not normally exceed 2 weeks. Method of administration For cutaneous use. A small quantity should be applied thinly to the affected area twice daily until a satisfactory response is obtained. In the more resistant lesions the effect of Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream can be enhanced by occlusion with polyethylene film.

Overnight occlusion is usually adequate. Hands should be washed before and after using this medicine to avoid cross-infection and ocular absorption. 4) and conjunctival irritation from fusidic acid Adults and children: In adults as in children, the method of fingertip unit can be used to better specify the quantity of cream applied to a given surface.

One fingertip unit is defined as a line from the tip of an adult index finger to the first crease. The usual number of fingertip units needed to cover different parts of the body is described hereafter. When using the cream in children, an adult finger should still be used to measure out the fingertip unit.

For an adult Site of application Usual number of finger tip units of cream Face and neck 2½ Back of the trunk 7 Front of the trunk 7 One arm (not including the hand) 3 One hand (both sides) 1 One leg (not including the foot)- 6 One foot 2 For a child from 1 to 10 years Usual number of finger tip units of cream Site of application For a child aged 1-2 years For a child aged 3-5 years For a child aged 6-10 years Face and neck 1½ 1½ 2 One arm and hand 1½ 2 2½ One leg and foot 2 3 4½ Front of the trunk 2 3 3½ Back of the trunk including the buttocks 3 3½ 5

The most frequently reported undesirable effects are various transient symptoms of application site irritation. Allergic reactions have been reported. Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.

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 Not known (cannot be estimated from the available data). Immune system disorders Not known Allergic reaction Skin and subcutaneous tissue disorders Uncommon Skin irritation Skin burning sensation Pruritus Eczema aggravated Skin stinging sensation Erythema Rare Urticaria Dry skin Not known (cannot be estimated from available data) Contact Dermatitis Rash Telangiectasia Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules.

4) Class effect Undesirable effects observed for corticosteroids include: Skin atrophy, telangiectasia, and skin striae, especially during prolonged application, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, glaucoma and adrenocortical suppression.

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 [To be completed nationally].

The label will state strong steroid. Depending on the application site, possible systemic absorption of betamethasone valerate should always be considered during treatment with this medicine. Due to the content of corticosteroid, this medicine should be used with care near the eyes.

8). Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur with or without occlusions following systemic absorption of topical corticosteroids. 8). Long-term continuous topical therapy should be avoided, particularly in children.

Adrenal suppression can occur even without occlusion. Cushing syndrome may occur as a potential risk in line with adrenal suppression. Atrophic changes may occur on the face and to a lesser degree in other parts of the body, after prolonged treatment with potent topical steroids.

Caution should be exercised if Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream is used near the eye. Glaucoma might result if the preparation enters the eye. Systemic chemotherapy is required if bacterial infection persists. Bacterial resistance has been reported to occur with the use of fusidic acid applied topically.

As with all topical antibiotics, extended or recurrent application may increase the risk of developing antibiotic resistance. Steroid-antibiotic combinations should not be continued for more than 7 days in the absence of any clinical improvement to avoid propagation of subclinical infection due to masking by the steroid.

Similarly, steroids may also mask hypersensitivity reactions. Due to the immunosuppressant effect of corticosteroids, this medicine may be associated with increased susceptibility to infection, aggravation of existing infection, and activation of latent infection.

3). This medicine contains a corticosteroid it is not recommended in the following conditions: atrophic skin, cutaneous ulcer, acne vulgaris, fragile skin veins and perianal and genital pruritus. Contact with open wounds and mucous membranes should be avoided.

As with all corticosteroids, prolonged use on the face should be avoided. 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 steroid withdrawal syndrome Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area.

It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected.

Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered. g. contact dermatitis) and chlorocresol which may cause allergic reactions. Applicable guidance on the appropriate use of antibacterial agents should be adhered to.

1. As with other topical corticosteroid preparations, Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream is contraindicated in infants under one year of age and in the following conditions: , skin lesions of viral, fungal or bacterial origin (such as herpes or varicella), skin manifestations in relation to tuberculosis or syphilis, acne vulgaris, perioral dermatitis and rosacea.