Infloc 2 % Creme

Treatment of non-severe, superficial, non-extensive, primary skin infections caused by microorganisms that are sensitive to Infloc 2 % Creme, especially of infections caused by Staphylococcus.

Primary skin infections that may be expected to respond to treatment with Infloc 2 % Creme applied topically include: impetigo contagiosa, superficial folliculitis, sycosis barbae, paronychia and erythrasma.

Consideration should be given to official guidance on the appropriate use of antibacterial agents..

Infloc 2 % Creme 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.

Posology

Adults and children:

Uncovered lesions: apply gently three or four times daily.

Covered lesions: less frequent applications may be adequate.

Method of administration:

Cutaneous use

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.

Infloc 2 % Creme 20 mg/g cream is contraindicated in patients with known hypersensitivity to Infloc 2 % Creme or to any of the excipients used in the product.

Bacterial resistance has been reported to occur with the use of Infloc 2 % Creme.

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

When Infloc 2 % Creme 20 mg/g cream is used on the face, care should be taken to avoid the eyes, because Infloc 2 % Creme can cause irritation of the conjunctiva.

Infloc 2 % Creme 20 mg/g 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.

Bacterial resistance among staphylococcus aureus has been reported to occur with the use of topical Infloc 2 % Creme. 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.

Infloc 2 % Creme 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. Infloc 2 % Creme cream should therefore be used with care when applied in the proximity of the eyes.

Infloc 2 % Creme cream has no or negligible influence on the ability to drive and use machines.

Infloc 2 % Creme administered topically has no or negligible influence on the ability to drive and use machines.

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 4754 patients who received Infloc 2 % Creme 20mg/g cream or Infloc 2 % Creme 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 MeDRA (SOC) and the individual undesirable effects are listed starting with the most frequently reported.

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

Not known (cannot be estimated from the available data).

Side effects are classified according to organ system, and within each organ, grouped by frequency.

- Immune system disorders

Rare

Hypersensitivity

- Eye disorders

Rare

Conjunctivitis

- Skin and subcutaneous tissue disorders

Uncommon:

Dermatitis (incl. dermatitis contact, eczema) Rash*

Pruritus

Erythema

*Various types of rash reactions such as erythematous, pustular, vesicular, macula-papular and popular have been reported. Rash generalised has also occurred.

Rare

Angioedema

Urticaria

Blister

- General disorders and administration site conditions

Uncommon

Application site pain (incl. 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 reaction 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 Website: www.mhra.gov.uk/yellowcard.

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 Infloc 2 % Creme cream or Infloc 2 % Creme 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

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.

Overdose is unlikely.

Unless hypersensitivity to Infloc 2 % Creme or any of the excipients exist, accidental ingestion of Infloc 2 % Creme 20mg/g cream is unlikely to cause any harm. The total quantity of Infloc 2 % Creme (30g Infloc 2 % Creme 20mg/g cream contains 600mg Infloc 2 % Creme) will usually not exceed the approved total daily oral dose of Infloc 2 % Creme containing products except in children aged less than 1 year and weighing ≤10kg.

Although in this instance a child of this particular age group is unlikely to ingest a whole tube of Infloc 2 % Creme 20mg/g cream. The concentration of the excipients is too low to constitute a safety risk.

Overdose is unlikely to occur

Unless hypersensitivity to Fusidic acid or any of the excipients exists, accidental ingestion of Infloc 2 % Creme cream is unlikely to cause any harm. The total quantity of fusidic acid (30 g Infloc 2 % Creme 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 Infloc 2 % Creme cream. The concentration of the excipients is too low to constitute a safety risk.

Pharmacotherapeutic group: other antibiotics for topical use, ATC code: D06AX01

Active mechanism:

Infloc 2 % Creme belongs to a unique group of antibiotics, the fusidanes, which act to inhibit bacterial protein synthesis by blocking the lengthening of factor G. This is to prevent it from associating with ribosomes and GTP, thus preventing energy supply to the synthesis process.

As it is the only type of drug available in this family of drugs, there have been no reports of cross resistance to Infloc 2 % Creme.

Resistance mechanism(s):

Resistance for Infloc 2 % Creme can vary geographically and information about local resistance patterns should be obtained through a local microbiology laboratory. In general, resistance occurs in 1-10 % of Staphylococcus aureus and 10-20 % of coagulase negative staphylococcus. Cross-resistance between Infloc 2 % Creme hydrophilic cream 20 mg/g and other antibiotics has not been reported.

Breakpoints:

The following MIC values are recommended to distinguish sensitive and non-sensitive germs: S ≤ 1 µg/ml and R > 1 µg/ml. This breakpoint should be used for the systemic use of Infloc 2 % Creme. In general, no breakpoints are established for the topical use of antibiotics.

Sensitivity:

The sensitivity of organisms to Infloc 2 % Creme is based on the in vitro sensitivity and plasma concentrations that are achieved after systemic therapy. Local treatment causes higher peak concentrations as compared to plasma. However, it is not known how the kinetics of the cream after local application may change the effectiveness of the cream.

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 Infloc 2 % Creme can penetrate intact human skin. The degree of penetration depends on factors such as the duration of exposure to Infloc 2 % Creme and the condition of the skin. Infloc 2 % Creme is excreted mainly in the bile with little excreted in the urine.

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.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Not applicable.

None.