Fucidin Ointment

/ Dexcel

Apply three to four times daily or as required. Less frequent application may be adequate for covered lesions.

Local treatment of skin infections due to sensitive strains of staphylococus aureus.

Known hypersensitivity to fusidic acid/sodium fusidate or to any of the excipients.

When this drug is used on the face; care should be taken to avoid the eyes as sodium fusidate may cause conjunctival irritation. It contains butylhydroxytoluene, cetyl alcohol and wool fat which may cause local skin reactions (e.g. contact dermatitis). Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.

Based on combined clinical data for Fucidin cream and this drug, approximately 5% of patients can be expected to experience an undesirable effect. The most frequently reported adverse drug reactions are various skin reactions and in particular application site reactions. Allergic reactions and contact dermatitis have been reported. Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.
Immune system disorders:  Rare (≥1/10,000 and <1/1,000):  Allergic reaction.
Eye Disorders: Rare (≥1/10,000 and <1/1,000): Conjunctival irritation.
Skin and subcutaneous tissue disorders: Uncommon (≥1/1,000 and <1/100): Rash* Irritation at site of application (incl. pain, stinging, burning and erythema) Pruritus Contact dermatitis.
* Various types of rash reactions such as erythematous, maculo-papular and pustular have been reported. Frequency unknown: Urticaria, Angioneurotic oedema, Eczema, Periorbital oedema.

None known.

Pregnancy: For fusidic acid/sodium fusidate no clinical data on exposed pregnancies are available. Animal studies do not indicate a direct or indirect harmful effect with respect to pregnancies, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.
Lactation: No effect on the suckling child are anticipated since the systemic exposure of the breastfeeding woman to fusidic acid is negligible. Fucidin cream and ointment can be used during breast-feeding.

Overdose is unlikely to occur.