Piban 20 mg Ointment

PIBAN 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: PIBAN 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, children, elderly PIBAN is applied two to three times daily for up to 10 days, depending on the response. Hepatic impairment As above. Renal impairment See section 4.4.

Method of administration

A small quantity of PIBAN should be applied to cover the affected area. The treated area may be covered by a dressing. Any product remaining at the end of treatment should be discarded. See section 6.3 for 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.

• Hypersensitivity to mupirocin or to any of the excipients of PIBAN listed in section 6.1.
• PIBAN is not indicated for the treatment of skin lesions infected with Pseudomonas aeruginosa.

PIBAN is not suitable for:

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

Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until all ointment residues have been removed. In the event of a sensitisation reaction or severe local irritation occurring with the use of PIBAN, treatment should be discontinued, the product should be rinsed off and appropriate alternative therapy for the infection should be instituted. Prolonged or irregular use of PIBAN may result in overgrowth of non-susceptible strains of S. aureus and other organisms. Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use, including PIBAN. Although this is less likely to occur with topically applied mupirocin as in PIBAN, if prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately, and the patient investigated further.

Special patient groups

Renal impairment No restrictions, unless the condition being treated could lead to absorption of polyethylene glycol and there is evidence of moderate to severe renal impairment. Polyethylene glycol can be absorbed from open wounds, burns and damaged skin and is excreted by the kidneys. PIBAN ointment should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment. The excretion of polyethylene glycol may be impaired and could lead to nephrotoxicity and severe metabolic disturbances.

No interactions have been reported.

Pregnancy Safety in pregnancy has not been established.

Lactation This in no information on the excretion of PIBAN in milk.

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

No adverse effects on the ability to drive or to operate machines have been reported.

Tabulated summary of adverse reactions

Immune system disorders

Less frequent: Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema (see section 4.4).

Infections and infestations

Frequency not known: Superinfection with non-susceptible strains of S. aureus and other organisms, pseudomembranous colitis.

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 sensitation reactions to mupirocin or the ointment base of PIBAN, (see section 4.4).

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. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Symptoms

In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8).

Treatment

There is no specific treatment for an overdose of mupirocin as in PIBAN. In the event of overdose, the patient should be treated supportively with appropriate monitoring, as necessary. Further management should be as clinically indicated.