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Fucidin Cream overview

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.

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Related DrugsDrug Details
Fucidin Cream
Drug Class Description :

Antibacterial agent

Generic Name :

fusidic acid

Drug description :

Fucidin® Cream contains fusidic acid Ph.Eur. 2%. Excipient: butylhydroxyanisole Excipient: cetyl alcohol Excipient: potassium sorbate

Presentation :

Cream for topical administration

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.

Adult Dosage :

Adults and Children:

Uncovered lesions – 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.

Covered lesions - less frequent applications may be adequate.

Contra Indications :

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

Infection caused by non-susceptible organisms, in particular, Pseudomonas aeruginosa.

Special Precautions :

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.

Extended or recurrent use may increase the risk of developing contact sensitisation.

Fusidic acid does not appear to cause conjunctival irritation in experimental animals. Caution should still be exercised, however, when Fucidin Cream is used near the eyes.

Fucidin® Cream contains butylhydroxyanisole, cetyl alcohol and potassium sorbate which may cause local skin reactions (e.g. contact dermatitis). Butylhydroxyanisole may also cause irritation to the eyes and mucous membranes.

Interactions :

None known

Adverse Reactions :

Based on combined clinical data for Fucidin® cream and Fucidin® ointment, less than 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.

Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.

Very common GREATER-THAN OR EQUAL TO (8805)1/10

Common GREATER-THAN OR EQUAL TO (8805)1/100 and <1/10

Uncommon GREATER-THAN OR EQUAL TO (8805)1/1,000 and <1/100

Rare GREATER-THAN OR EQUAL TO (8805)1/10,000 and <1/1,000

Very rare <1/10,000

Not known (cannot be estimated from the available data)

Immune system disorders

Rare

Hypersensitivity

Eye disorders

Rare

Conjunctivitis

Skin and subcutaneous tissue disorders

Uncommon

Pruritus

Rash including erythematous, maculo-papular and pustular reactions

Contact Dermatitis

Irritation at site of application (including pain, stinging, burning and erythema)

Not known

Urticaria

Angioedema

Eczema

Periorbital oedema

Manufacturer :

Leo Laboratories Limited

Drug Availability :

(POM)

Drug Updated :

29 March 2012

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