Fucidin

Fusidic acid.

Fusidic acid 20 mg/g in neutral cream base.
Excipients/Inactive Ingredients: butylhydroxyanisole (E320), cetyl alcohol, glycerol, liquid paraffin, polysorbate 60, potassium sorbate, purified water, white soft paraffin, all-rac-α-tocopherol, hydrochloric acid.

Fusidic acid is an antibiotic with powerful antibacterial activity against a number of gram-positive organisms. Staphylococci, including the strains resistant to penicillin or to other antibiotics, are particularly susceptible to fusidic acid.
Besides pronounced antibacterial activity against the majority of organisms responsible for skin infections, Fucidin cream also possesses unique ability for penetration to the focus of infection, even when applied to intact skin.

Fucidin cream is indicated for treatment of skin infections caused by Staphylococci, Streptococci, Propionibacterium acnes, Corynebacterium minutissimum, and other organisms sensitive to fusidic acid. The most important indications being: Impetigo, Infected wounds, Folliculitis, Boils, Sycosis barbae, Acne vulgaris, Carbuncles, Hidradenitis, Paronychia, Erythrasma.
Fucidin cream is an invisible, non-staining preparation, which is cosmetically acceptable for treatment of face and scalp infections.

Fucidin cream is applied to the affected area 2-3 times daily, generally for a period of 7 days, except in treatment of acne where therapy should be extended for a longer period according to the nature of this disease.

Overdose is unlikely to occur.

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

Bacterial resistance among Staphylococcus aureus has been reported to occur with the use of topical Fucidin. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance.
Fucidin 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. Fucidin cream should therefore be used with care when applied in the proximity of the eyes.
Effects On The Ability To Drive And Use Machines: Fucidin administered topically has no or negligible influence on the ability to drive or to use machines.

Fertility: There are no clinical studies with topical Fucidin 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 Fucidin 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 women is negligible.
Topical Fucidin can be used during breast-feeding but it is recommended to avoid applying topical Fucidin on the breast.

The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and from spontaneous reporting.
Based on pooled data from clinical studies including 4724 patients who received Fucidin cream or Fucidin ointment, the frequency of undesirable effects is 2.3%.
The most frequently reported adverse reactions during treatment are various skin reactions such as pruritus and rash, followed by various application site conditions such as pain and irritation, which all occurred in less than 1% of patients. Hypersensitivity and angioedema have been reported.
Undesirable effects are listed by MedDRA System Organ Class (SOC) and the individual undesirable effects are listed, starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1,000 and <1/100); Rare (≥1/10,000 and <1/1,000); Very rare (<1/10,000). (See table.)

Click on icon to see table/diagram/image

Paediatric population: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

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

Incompatibilities: Fucidin cream is a ready-for-use preparation and should, therefore, not be mixed with other ingredients or preparations.

Do not store above 30°C.

Topical Antibiotics

D06AX01 - fusidic acid ; Belongs to the class of other topical antibiotics used in the treatment of dermatological diseases.

A