Indicated either alone or in combination with systemic therapy, in the treatment of primary and secondary skin infections caused by sensitive strains of Staphylococcus aureus, Streptococcus spp and Corynebacterium minutissimum. Primary skin infections that may be expected to respond to treatment with Fusidic acid applied topically include: impetigo contagiosa, superficial folliculitis, sycosis barbae, paronychia and erythrasma; also such secondary skin infections as infected eczematoid dermatitis, infected contact dermatitis and infected cuts/abrasions.

Adults and Children: Uncovered lesions - apply gently two to three times daily. Covered lesions - less frequent applications may be adequate

Bacterial resistance among staphylococcus aureus has been reported to occur with the use of topical Uciderm Gel, as with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance. Extended or recurrent use may increase the risk of developing contact sensitization.

No interaction studies have been performed. Interactions with systemically administered medicinal products are considered minimal as the systemic absorption of topical Uciderm Gel is negligible

Fertility

There are no clinical studies with topical Uciderm Gel regarding fertility. No effects in women of childbearing potential are anticipated, since systemic exposure following topically applied Fusidic acid/sodium fusidate is negligible.

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to topically applied Fusidic acid/sodium fusidate is negligible. Topical Uciderm Gel can be used during pregnancy.

Breast-feeding

No effects on the breastfed new-born/infant are anticipated since the systemic exposure of topically applied Fusidic acid/sodium fusidate to the breast-feeding woman is negligible. Topical Uciderm Gel can be used during breast-feeding but it is recommended to avoid applying topical Uciderm Gel on the breast.

Uciderm Gel administered topically has no or negligible influence on the ability to drive or to use machines.

The most frequently reported adverse reactions during treatment are various skin reactions such as pruritus and rash, followed by application site conditions such as pain and irritation, which all occurred in less than 1% of patients.

Overdose is unlikely to occur. Unless hypersensitivity to Fusidic acid or any of the excipients exists, accidental ingestion of Uciderm Gel is unlikely to cause any harm.

Fusidic acid is a potent antibacterial agent. Fusidic acid and its salts show fat and water solubility and strong surface activity and exhibit unusual ability to penetrate intact skin. Concentrations of 0.03 - 0.12 mcg Fusidic acid per ml inhibit nearly all strains of Staphylococcus aureus. Topical application of Fusidic acid is also effective against streptococci, Corynebacterium, Neisseria and certain clostridia

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.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Carbopol (Ultrez) 10 NF Ethanol Methyl Hydroxybenzoate Propyl Hydroxybenzoate Propylene glycol Sodium Hydroxide Purified Water

NA

Store below 30° C.

Aluminum tubes of 15 gm

NA