Overdose is unlikely.
Unless hypersensitivity to Fucithalmic or any of the excipients exist, accidental ingestion of Fucithalmic 20mg/g cream is unlikely to cause any harm. The total quantity of Fucithalmic (30g Fucithalmic 20mg/g cream contains 600mg Fucithalmic) will usually not exceed the approved total daily oral dose of Fucithalmic 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 Fucithalmic 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 Fucithalmic cream is unlikely to cause any harm. The total quantity of fusidic acid (30 g Fucithalmic 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 Fucithalmic 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 4754 patients who received Fucithalmic 20mg/g cream or Fucithalmic 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 Fucithalmic cream or Fucithalmic 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 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.
Pharmacotherapeutic group: other antibiotics for topical use, ATC code: D06AX01
Active mechanism:
Fucithalmic 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 Fucithalmic.
Resistance mechanism(s):
Resistance for Fucithalmic 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 Fucithalmic 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 Fucithalmic. In general, no breakpoints are established for the topical use of antibiotics.
Sensitivity:
The sensitivity of organisms to Fucithalmic 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.
| Commonly susceptible species | Staphylococcus aureus and Staphylococcus epidermis (including methycillin resistant and beta lactamase producing strains); Corynebacterium minutissimum; Clostridium spp.; Peptococcus spp.; Peptostreptococcus spp.; Neiseria spp.; Bacteroides fragilis. |
| Inherently resistant organisms | Streptococcus pyogenes; Streptococcus pneumoniae; Streptococci viridans; most gram negative bacilli including Haemophilus influenza; Enterobactericeae; Pseudomonas spp.; Escherichia coli and Klebsiella pneumoniae. |
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 Fucithalmic can penetrate intact human skin. The degree of penetration depends on factors such as the duration of exposure to Fucithalmic and the condition of the skin. Fucithalmic 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.
Not applicable.
None.
