Indicated either alone or in combination with systemic therapy, in thetreatment of primary and secondary skin infections caused by sensitivestrains o f Staphylococcus aureus, streptococcus spp and Corynebacteriumminutissimum. Primary skin infections that may be expected to respond totreatment with fusidic acid applied topically include: impetigo contagiosa,superficial folliculitis, sycosis barbae, paronychia and erythrasma; also suchsecondary skin infections as infected eczematoid dermatitis, infected contactdermatitis and infected cuts /abrasions

Adults and children:
Uncovered lesions - apply gently, three or four times daily.
Covered lesions - less frequent applications may be adequate.

Bacterial resistance among staphylococcus aureus has been reported tooccur with the use of topical uciderm®. As with all antibiotics, extended orrecurrent use may increase the risk of developing antibiotic resistance.
Extended or recurrent use may increase the risk of developing contactsensitisation. When Uciderm® ointment is used on the face; care should betaken to avoid the eyes as the excipients in the ointment may causeconjunctival irritation.

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

Fertility
There are no clinical studies with topical uciderm® regarding fertility. Noeffects in women of childbearing potential are anticipated, since systemicexposure following topically applied fusidic acid/sodium fusidate isnegligible.
Pregnancy
No effects during pregnancy are anticipated, since systemic exposure totopically applied fusidic acid/sodium fusidate is negligible. TopicalUciderm® can be used during pregnancy.

USE IN LACTATION

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

Uciderm® administered topically has no or negligible influence on theability to drive or to use machines.

The most frequently reported adverse reactions during treatment are various skinreactions such as pruritus and rash, followed by various application site conditionssuch as pain and irritation, which all occurred in less than 1% of patients.
Hypersensitivity and angio edema have been reported.

Overdose is unlikely to occur.

ATC Code: D06AX01
Pharmacotherapeutic group: Fusidic acid is a potent topical antibacterial agentFusidic 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 microgram/ml inhibit nearly all strains of Staphylococcus aureus. Topical application of fusidic acid is also effective against streptococci, corynebacteria, neisseria and certain clostridia. 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.

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 additionalto that already included in other sections of the SPC.

Wool Fat BP 1.500 gm/tube ( 15 gm )
Beeswax BP 1.500 gm/tube ( 15 gm )
White soft Parrafin BP 11.664 gm/tube (15 gm )
Cetostearyl Alcohol BP 0.75 gm/tube ( 15 gm )

None known

Store below 30˚ C.

15 gm aluminums tube.

none