is indicated for the treatment of eczematous dermatoses including atopic eczema,infantile eczema, discoid eczema, stasis eczema, contact eczema and seborrhoeic eczema when secondary bacterial infection is confirmed or suspected.

Posology
A small quantity should be applied to the affected area twice daily until a satisfactory response is obtained. A single treatment course should not normally exceed 2 weeks. In the more resistant lesions the effect of Uciderm B cream can be enhanced by occlusion with polythene film. Overnight occlusion is usually adequate.
Method of administration
Cutaneous use.

Hypersensitivity to Fusidic acid/sodium fusidate, betamethasone valearate or to any of the excipients listed. Due to the content of corticosteroid, Uciderm B Cream is contraindicated in the following conditions: Systemic fungal infections. Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate treatment. Skin manifestations in relation to tuberculosis or syphilis, either untreated or uncontrolled by appropriate therapy. Perioral dermatitis and rosacea.

Long-term continuous topical therapy with Uciderm B cream should be avoided.
Depending on the application site, possible systemic absorption of betamethasone valerate
should always be considered during treatment with Uciderm B cream.
Due to the content of corticosteroid, Uciderm B cream should be used with care near the eyes. Avoid getting Uciderm B cream into the eyes.
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur following systemic absorption of topical corticosteroids.
Uciderm B cream 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.
Due to the content of betamethasone valearate, prolonged topical use of Uciderm B cream may cause skin atrophy.
Bacterial resistance has been reported to occur with the topical use of fusidic acid. 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, Uciderm B cream 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.
Uciderm B cream contains Cetostearyl alcohol and chlorocresol as excipients. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and chlorocresol may cause allergic reactions

No interaction studies have been performed. Interactions with systemically administered medicinal products are considered minimal.

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 valearate: There are no or limited amount of data from the use of topical betamethasone valearate in pregnant women. Studies in animals have shown reproductive toxicity/foetal abnormalities. Uciderm B Cream should not be used during pregnancy unless clearly necessary.

Lactation

No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the topically applied fusidic acid and betamethasone valearate to a limited area of skin of the breast-feeding woman is negligible. Uciderm B cream can be used during breast-feeding but should not be applied on the breasts to avoid accidental ingestion by the infant.

 

 

Uciderm B Cream has no or negligible influence on the ability to drive or to use machines.

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 pruritus. 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.

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 Uciderm B cream does not exceed the oral daily dose of systemic treatment. A single oral overdose of corticosteroids is rarely a clinical problem.

ATC Code: D07CC01
Pharmacotherapeutic group: Betamethasone and antibiotics
Uciderm B cream combines the well-known anti-inflammatory and antipruritic effects of betamethasone with the potent topical antibacterial action of fusidic acid. Betamethasone valearate 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.

There are no data which define the pharmacokinetics of Uciderm B 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..

Studies of corticosteroids in animals have shown reproductive toxicity (e.g. Cleft palate, skeletal malformations, and low birth weight).

Cetostearyl Alcohol BP 1.500
White soft paraffin BP 1.500
Polyoxyl 40 stearate USP 0.555
Liquid paraffin BP 1.50
Isopropyl Myristate BP 0.30
Glycerol BP 3.0
Methyl hydroxybenzoate BP 0.027
Propyl Hydroxybenzoate BP 0.009
Water, Purified BP 6.282

NA

3 years

Store below 30˚ C.

15 gm aluminium tube.

NA