Composition and excipients: 

Each 1g Fucine ointment contains:

• active ingredients: Soduim fusidate 20mg.
• inactive ingredients: Vaseline, B.H.T.

Each 1g Fucine cream contains:

• active ingredients: Fusidic acid 20mg.
• inactive ingredients: Vaseline, potassium sorbate, B.H.A, Cetanol, Paraffin oil, Glycerin, polysorbate 80, purified water.

Indications:

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.

Dosage and administration:

Adults and Children:

Uncovered lesions: apply gently three or four times daily.

Covered lesions:  less frequent applications may be adequate

Contraindications:

Hypersensitivity to the active substance or to any of the excipients.

Warnings and precautions:

• Bacterial resistance among staphylococcus aureus has been reported to occur with the use of topical Fusidic acid 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 sensitisation.
• Fusidic acid ointment contains buthylhydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membrance.
• When fusidic acid is used on the face; care should be taken to avoid the eyes as the excipients in the ointment may cause conjunctival irritation.
• Fusidic acid Cream contains butylhydroxyanisole, cetyl alcohol and potassium sorbate. These excipients may cause local skin reactions (e.g. contact dermatitis). Butylhydroxyanisole may also cause irritation to the eyes and mucous membranes, fusidic acid cream should therefore be used with care when applied in the proximity of the eyes.

Drug interactions:

Interactions with systemically administered medicinal products are considered minimal as the systemic absorption of topical fusidic acid is negligible.

Pregnancy:

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

Breast-feeding:

No effects on the breast-feeding babies are anticipated since the systemic exposure of topically applied fusidic acid/sodium fusidate to the breast-feeding woman is negligible. Topical fusidic acid can be used during breast-feeding but it is recommended to avoid applying it on the breast.

Undesirable effects

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, Hypersensitivity and angioedema have been reported

Other effects:

Skin and subcutaneous tissue disorders: Uncommon: Dermatitis (contact dermatitis, eczema) Rash (such as erythematous, pustular, vesicular, maculopapular , papular and rash generalized), Pruritus, Erythema.

General disorders and administration site conditions: Uncommon: Application site pain (skin burning sensation), application site irritation.

Overdose:

Overdose is unlikely to occur unless hypersensitivity to Fusidic acid or any of the excipients exists, accidental ingestion of the cream or the ointment is unlikely to cause any harm. The total quantity of fusidic acid will usually not exceed the approved total daily oral dose of fusidic acid containing products except in children aged less than 1 year and weighing ≤ 10 kg. The concentration of the excipients is too low to constitute a safety risk.

Storage conditions: Store between 15° and 25°C.

How supplied :

Fucine ointment: Tube containing (20-40) grams ointment.

Fucine Cream: Tube containing 20 grams Cream.