Fusidic Acid/Betamethasone 20 mg/g + 1 mg/g Cream

Cream White to off white, smooth, homogeneous cream.

4.1 Therapeutic indications Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream is indicated for the treatment of eczematous dermatoses in adults and children over 1 year of age, including atopic eczema, discoid eczema, stasis eczema, contact eczema and seborrhoeic eczema when secondary bacterial infection is confirmed or suspected. Consideration should be given to official guidance on the appropriate use of antibacterial agents.4.2 Posology and method of administration **Posology** A single treatment course should not normally exceed 2 weeks. **Method of administration** For cutaneous use A small quantity should be applied to the affected area twice daily until a satisfactory response is obtained.4.3 Contraindications Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Due to the content of corticosteroid preparations, fusidic acid/betamethasone cream is contraindicated in the following conditions: | | | | --- | --- | | | • Infants under one year of age with infected dermatitis. | | | • Systemic fungal infections. | | | • Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate treatment (see section 4.4). | | | • Skin manifestations in relation to tuberculosis or syphilis, either untreated or uncontrolled by appropriate therapy. | | | • Acne vulgaris. | | | • Perioral dermatitis and acne rosacea. |4.4 Special warnings and precautions for use **Systemic absorption** Long-term continuous topical therapy should be avoided, particularly in infants and children. Depending on the application site, possible systemic absorption of betamethasone valerate should always be considered during treatment with fusidic acid/betamethasone. **Immunosuppressant effects** Reversible hypothalamic pituitary adrenal (HPA) axis suppression may occur following systemic absorption of topical corticosteroids. Fusidic acid/betamethasone should be used with care in children as paediatric patients may demonstrate greater susceptibility to topical corticosteroids induced HPA axis suppression and Cushing's syndrome than adult patients. Avoid large amounts, occlusion and prolonged treatment (see section 4.8). 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. **Bacterial resistance** Bacterial resistance has been reported to occur with the use of fusidic acid applied topically. As with all antibiotics, extended or recurrent application may increase the risk of developing antibiotic resistance. Limiting therapy with topical fusidic acid and betamethasone valerate to no more than 14 days at a time will minimise the risk of developing resistance. This also prevents the risk that the immunosuppressive action of corticosteroid might mask any potential symptoms of infections due to antibiotic resistant bacteria. Due to the content of corticosteroid having immunosuppressant effect, fusidic acid/ betamethasone may be associated with increased susceptibility to infection, aggravation of existing infection, and activation of latent infection. It is advised to switch to systemic treatment if infection cannot be controlled with topical treatment (see section 4.3). Steroid-antibiotic combinations should not be continued for more than 7 days in the absence of any clinical improvement since in this situation occult extension of the infection may occur due to the masking of the steroid. Similarly, steroids may also mask hypersensitivity reactions. **Eye effects/local effects** 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. Due to the content of corticosteroid, fusidic acid/betamethasone should be used with care near the eyes. Avoid getting fusidic acid/betamethasone into the eyes (see section 4.8). Glaucoma might result if the preparation enters the eye. Raised intra-ocular pressure and glaucoma may also occur after topical use of steroids near the eyes, particularly with prolonged use in patients predisposed to developing glaucoma. Long term continuous or inappropriate 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 advice is recommended in these cases or other treatment options should be considered. **Fire hazard** Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. **Excipients** Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) and chlorocresol which may cause allergic reactions.4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed.4.6 Fertility, pregnancy and lactation **Pregnancy** Fusidic acid: No effects during pregnancy are anticipated, since systemic exposure to fusidic acid is negligible Studies in animals have not shown teratogenic effects with fusidic acid. Limited studies in animals have shown negligible systemic absorption of topical fusidic acid. Betamethasone valerate: There are no or limited amount of data from the use of topical betamethasone valerate in pregnant women. Studies in animals have shown reproductive toxicity/foetal abnormalities (see section 5.3). Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream should not be used during pregnancy unless clearly necessary. **Breast-feeding** No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the topically applied fusidic acid and betamethasone valerate to a limited area of skin of the breast-feeding woman is negligible. Xemacort 20 mg/g + 1 mg/g cream can be used during breast-feeding but should not be applied on the breasts to avoid accidental ingestion by the infant **Fertility** **There are no clinical studies with fusidic acid/betamethasone regarding fertility.**4.7 Effects on ability to drive and use machines Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream has no or negligible influence on the ability to drive or to use machines.4.8 Undesirable effects The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical studies and spontaneous reporting. The most frequently reported adverse reaction during treatment is pruritis. Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 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** | | | Uncommon: (≥1/1,000 and <1/100) | Hypersensitivity | | **Eye disorders** | | | Not known: (cannot be estimated from the available data) | Blurred vision (see section 4.4) | | **Skin and subcutaneous tissue disorders** | | | Uncommon: (≥1/1,000 and <1/100) | Dermatitis contact Eczema (condition aggravated) Skin burning sensation Pruritus Dry skin | | Rare: (≥1/10,000 and <1/1,000) | Erythema Urticaria Rash (including rash erythematous and rash generalised) | | Not known: (cannot be estimated from the available data) | Withdrawal reactions (see section 4.4): - Redness of the skin which may extend to areas beyond the initial affected area - Burning or stinging sensation - Itch - Skin peeling - Oozing pustules | | **General disorders and administration site conditions** | | | Uncommon: (≥1/1,000 and <1/100) | Application site pain Application site irritation | | Rare: (≥1/10,000 and <1/1,000) | Application site swelling Application site vesicles | Systemic undesirable class effects of corticosteroids like betamethasone valerate include adrenal suppression especially during prolonged topical administration (see section 4.4). Raised intraocular pressure, glaucoma and cataract may also occur after topical use of corticosteroids near the eyes, particularly with prolonged use and in patients predisposed to developing glaucoma and cataract (see section 4.4). Dermatological undesirable class effects of potent corticosteroids include: Atrophy, dermatitis (including dermatitis contact and dermatitis acneiform), perioral dermatitis, skin striae, telangiectasia, rosacea, erythema, hypertrichosis, hyperhidrosis and depigmentation. Ecchymosis may also occur with prolonged use of topical corticosteroids. Class effects for corticosteroids have been uncommonly reported for fusidic acid/betamethasone cream described in the frequency table above. Paediatric population The observed safety profile is similar in children and adults (see section 4.4). **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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose For topically applied fusidic acid, no information concerning potential symptoms and signs due to overdose administration is available. Cushing's syndrome and adrenocortical insufficiency may develop following topical application of corticosteroids in large amounts and for more than 3 weeks. Systemic consequences of an overdose of the active substances after accidental oral intake are unlikely to occur. The amount of fusidic acid in one tube of Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream does not exceed the oral daily dose of systemic treatment. A single oral overdose of corticosteroids is rarely a clinical problem.

5.1 Pharmacodynamic properties Pharmacotherapeutic group: Corticosteroids, potent, combinations with antibiotic, ATC code: D07CC01. Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream combines the well-known anti-inflammatory and antipruritic effects of betamethasone with the potent topical antibacterial action of fusidic acid. Betamethasone is a topical steroid rapidly effective in those inflammatory dermatoses which normally respond to this form of therapy. More refractory conditions can often be treated successfully. When applied topically, fusidic acid is effective against *Staphyloccus aureus, Streptococci, Corynebacteria*, Neisseria and certain Clostridia and Bacteroides. Concentrations of 0.03 to 0.12 microgram per ml inhibit nearly all strains of *S. aureus*. The antibacterial activity of fusidic acid is not diminished in the presence of betamethasone.5.2 Pharmacokinetic properties There are no data which define the pharmacokinetics of fusidic acid/betamethasone cream, following topical administration in man. However, *in vitro* studies show that fusidic acid can penetrate intact human skin. The degree of penetration depends on factors such as the duration of exposure to fusidic acid and the condition of the skin. Fusidic acid is excreted mainly in the bile with little excreted in the urine. Betamethasone is absorbed following topical administration. The degree of absorption is dependent on various factors including skin condition and site of application. Betamethasone is metabolised largely in the liver but also to a limited extent in the kidneys, and the inactive metabolites are excreted with the urine.5.3 Preclinical safety data Studies of corticosteroids in animals have shown reproductive toxicity (e.g. cleft palate, skeletal malformations, low birth weight).

6.1 List of excipients Macrogol cetostearyl ether Cetostearyl alcohol Chlorocresol Liquid paraffin Sodium dihydrogen phosphate dihydrate White soft paraffin All-rac-α-tocopherol Purified water Sodium hydroxide6.2 Incompatibilities Not applicable.6.3 Shelf life Unopened container: 36 months After first opening: 6 months.6.4 Special precautions for storage Do not store above 30°C.6.5 Nature and contents of container Aluminium tubes with a white conical polyethylene cap of 5 gram, 15 gram, 30 gram, and 60 grams. Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.