Overdose is unlikely to occur
Unless hypersensitivity to Fusidic acid or any of the excipients exists, accidental ingestion of Фуцидин cream is unlikely to cause any harm. The total quantity of fusidic acid (30 g Фуцидин cream contains 600 mg 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. Although in this instance a child of this particular age group is unlikely to ingest a whole tube of Фуцидин cream. The concentration of the excipients is too low to constitute a safety risk.
Not applicable.
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 Фуцидин cream or Фуцидин 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 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 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
| Immune system disorders | |
| Rare (>1/10,000 and <1/1,000) | Hypersensitivity |
| Eye disorders | |
| Rare (>1/10,000 and <1/1,000) | Conjunctivitis |
| Skin and subcutaneous tissue disorders | |
| Uncommon (>1/1,000 and <1/100) | Dermatitis (including dermatitis contact, eczema) Rash* Pruritus Erythema *Various types of rash reactions such as erythematous, pustular, vesicular, maculo-papular and papular have been reported. Rash generalised has also occurred. |
| Rare (>1/10,000 and <1/1,000) | Angioedema Urticaria Blister |
| General disorders and administration site conditions | |
| Uncommon (>1/1,000 and <1/100) | Application site pain (including skin burning sensation) Application site irritation |
Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Фуцидин 20 mg/g cream is 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.
Pharmacotherapeutic group: Other antibiotics for topical use, ATC code: D06AX01
Fusidic acid is a potent antibacterial agent. Fusidic 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 mcg fusidic acid per ml inhibit nearly all strains of Staphylococcus aureus. Topical application of fusidic acid is also effective against streptococci, corynebacteria, neisseria and certain clostridia.
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.
Bacterial resistance among staphylococcus aureus has been reported to occur with the use of topical Фуцидин. 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.
Фуцидин 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. Фуцидин cream should therefore be used with care when applied in the proximity of the eyes.
Фуцидин administered topically has no or negligible influence on the ability to drive and use machines.
Posology
Adults and Paediatric population
Uncovered lesions - apply gently three or four times daily.
Covered lesions - less frequent applications may be adequate.
Method of administration
Cutaneous use.
None.
