Dermoban Ointment 20 mg Ointments.

DERMOBAN OINTMENT is indicated for the topical treatment of primary and secondary bacterial skin infections caused by Staphylococcus aureus and other susceptible organisms. Primary skin infections: Impetigo, folliculitis, furunculosis and ecthyma. Secondary infections: Infected dermatoses e.g., infected eczema. Infected traumatic lesions e.g., abrasions, insect bites, minor (not requiring hospitalisation) wounds and burns.

Prophylaxis: DERMOBAN OINTMENT may be used to avoid bacterial contamination of small wounds, incisions and other clean lesions, and to prevent infection of abrasions and small cuts and wounds.

For external use only (see section 4.4)

Posology

Adults and children older than 2 months: DERMOBAN is applied 2 - 3 times a day for up to 10 days, depending on the response. Hepatic impairment: As above. Renal impairment: See section 4.4. Paediatric population: The safety and efficacy of DERMOBAN OINTMENT in babies under 2 months have not yet been established.

Method of administration

Before applying, wash affected areas and dry thoroughly. A small quantity of DERMOBAN OINTMENT should be applied to cover the affected area. The treated area(s) may be covered with a gauze dressing if desired. Complete the full course of treatment. See section 6.3 for the product shelf-life after opening.

Do not mix with other preparations as there is a risk of dilution, resulting in a reduction in the antibacterial activity and potential loss of stability of the mupirocin in the ointment.

• Patients with known hypersensitivity to mupirocin or to any of the excipients used in the formulation of DERMOBAN OINTMENT (see section 6.1)
• DERMOBAN OINTMENT is not indicated for the treatment of skin lesions infected with Pseudomonas aeruginosa.

DERMOBAN OINTMENT is not suitable for:

• intranasal use.
• use in conjunction with cannulae.
• at the site of central venous cannulation.
• ophthalmic use.

Avoid contact with the eyes. If accidental contact occurs, the eyes should be thoroughly washed with water until all traces of the ointment have been removed. Treatment with DERMOBAN OINTMENT should be discontinued in the event of a sensitisation reaction or severe local irritation occurring. DERMOBAN OINTMENT should be rinsed off and alternative therapy for the infection should be prescribed. Irregular or prolonged use is not recommended as this may result in overgrowth of non-susceptible organisms.

Pseudomembranous colitis has been associated with antibiotic use and can vary in severity from mild to life-threatening. It is therefore important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic treatment. While the risk is lower with topically applied mupirocin, any instance of prolonged or severe diarrhoea, or abdominal cramps, should prompt immediate discontinuation of the treatment and further investigation for the patient.

Renal impairment: When DERMOBAN OINTMENT is applied to extensive open wounds, damaged skin or burns, the possibility of absorption of polyethylene glycol, resulting in serious renal toxicity, should be considered. Caution is advised in patients with moderate to severe renal impairment.

Do not mix with other preparations. Mixing may result in a decrease in antibacterial activity and a loss of stability of DERMOBAN OINTMENT.

Pregnancy
Safety in pregnancy has not been established.

Breastfeeding
It is not known whether DERMOBAN OINTMENT is excreted into breastmilk.

Fertility
There are no data on the effects of mupirocin on human fertility.

DERMOBAN OINTMENT has no or negligible influence on the ability to drive or operate machinery.

Tabulated summary of adverse reactions
The following adverse reactions have been classified according to the following categories, frequent, less frequent and frequency unknown.

MedDRA system organ Class

Frequency Side effects

Immune system disorders
Less frequent: Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema.

Skin and subcutaneous tissue disorders
Frequent: Burning localised to the area of application.
Less frequent: Itching, erythema, stinging and dryness localised to the area of application, cutaneous sensitisation reactions to mupirocin or the ointment base.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the Med Safety App (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website. Adverse reactions can also be reported to Unicorn Pharmaceuticals (Pty) Ltd to [email protected].

Symptoms
There is currently limited experience with overdosage of mupirocin.

Management
The toxicity of mupirocin is very low. In the event of accidental ingestion of the ointment, symptomatic treatment should be provided. In the case of erroneous oral ingestion of large quantities of the ointment, renal function should be closely monitored in patients with renal insufficiency due to the possible side effects of polyethylene glycol. There is no specific treatment for an overdose of mupirocin. In the event of an overdose, the patient should be treated supportively with appropriate monitoring as necessary. Further management should be as clinically indicated or as recommended by the national poisons centre, where available.