Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Glaxo Group Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
In the event of a sensitisation or severe local irritation from the use of retapamulin ointment, treatment should be discontinued, the ointment carefully wiped off, and appropriate alternative therapy for the infection instituted.
Retapamulin ointment must be kept away from the eyes and mucous membranes. Epistaxis has been reported with use of Altargo on nasal mucosa.
Care must be taken to avoid ingestion.
Alternative therapy should be considered if there is no improvement or a worsening in the infected area after 2-3 days of treatment.
Prolonged use of retapamulin may result in overgrowth of non-susceptible micro-organisms, including fungi. If super-infection with a non-susceptible organism is suspected, treatment should be guided by clinical and microbiological assessments.
Retapamulin should not be used to treat abscesses.
Retapamulin should not be used to treat infections known or thought likely to be due to MRSA (see section 5.1).
In clinical studies of secondarily infected open wounds, the efficacy of retapamulin was inadequate in patients with infections caused by MRSA. The reason for the reduced clinical efficacy observed in these patients is unknown.
Retapamulin ointment contains butylated hydroxytoluene, which may cause local skin reaction (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
The effect of concurrent application of retapamulin and other topical medicinal products to the same area of skin has not been studied, and is not recommended.
In human liver microsomes, retapamulin was shown to be a strong inhibitor of CYP3A4. However, since plasma concentrations of retapamulin during topical application have been low (see section 5.2), it is not expected that concurrent systemic administration of CYP3A4 substrates will result in clinically important inhibition of their metabolism by retapamulin.
Co-administration of oral ketoconazole 200mg twice daily increased mean retapamulin AUC and Cmax by 81% after topical application of retapamulin 10 mg/g ointment on the abraded skin of healthy adult males. Nevertheless, the highest plasma concentrations recorded were low (<10.5 ng/ml in the absence of ketoconazole and <17 ng/ml in the presence of ketoconazole.
Systemic exposure to retapamulin has been low following topical application of 10 mg/g ointment in adult and paediatric patients aged 2 years and older (maximum plasma concentration <20 ng/mL). Therefore it is not expected that clinically important increases in plasma concentrations of retapamulin will occur in patients aged 2 years and older who are also receiving CYP3A4 inhibitors.
In children aged from 9 months to 2 years it is possible that higher plasma concentrations may occasionally occur during treatment with retapamulin 10 mg/g ointment compared to older children and adults. Therefore caution is advised if retapamulin 10 mg/g ointment is administered to children in this age group who are also receiving CYP3A4 inhibitors, as further increase in systemic exposure to retapamulin may occur upon CYP3A4 inhibition.
See section 5.2 regarding plasma concentrations of retapamulin observed in patients in different age groups.
No clinical data on exposed pregnancies are available. Animal studies have shown reproductive toxicity after oral administration and are insufficient with respect to effects on parturition and fetal/postnatal development (see section 5.3).
Retapamulin ointment should only be used in pregnancy when topical antibacterial therapy is clearly indicated and the use of retapamulin is considered to be preferable to administration of a systemic antibacterial medicinal product.
It is unknown whether retapamulin is excreted in human breast milk. Minimal systemic exposure is observed in adults, therefore exposure of the breast-feeding infant is likely to be negligible. The excretion of retapamulin in milk has not been studied in animals. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Altargo should be made taking into account the benefit of breast-feeding to the child and the benefit of Altargo therapy to the woman.
There are no data on the effects of retapamulin on human fertility. No treatment-related effects on male or female fertility have been shown in animal studies (see section 5.3).
Altargo has no or negligible influence on the ability to drive and use machines.
In clinical studies in which 2150 patients with superficial skin infections applied Altargo, the most commonly reported adverse reaction was application site irritation, which affected approximately 1% of patients.
The following convention has been used for the classification of frequency: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Not known: Hypersensitivity, including angioedema
Uncommon: Contact dermatitis
Medicinal product no longer authorised
Common: Application site reactions: Irritation
Uncommon: Application site reactions: Pain, Pruritus, Erythema
Not known: Application site irritation (including burning sensation)
Frequency, type and severity of adverse reactions in the paediatric population are the same as in adults.
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 national reporting system listed in Appendix V.
Not applicable.
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