Avoban is indicated for the topical treatment of secondarily infected traumatic lesions such as small lacerations,
sutured wounds or abrasions (up to 10 cm in length or 100 cm2 in area), due to susceptible strains
of Staphylococcus aureusand Streptococcus pyogenes.

Dosage
Adults/children ≥ 1 year/elderly
3 times a day for up to 10 days, depending on the response.
Patients not showing a clinical response within 3 to 5 days should be re-evaluated.
The duration of treatment should not exceed 10 days.
Children < 1 year
Avoban has not been studied in infants under 1 year old and therefore it should not be used in these patients
until further data become available.
Patients with hepatic impairment: No dosage adjustment is necessary.
Patients with renal impairment: No dosage adjustment is necessary.
Method of administration
A thin layer of cream should be applied to the affected area with a piece of clean cotton wool or gauze swab.

The treated area may be covered by a dressing.
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 cream.

Should a possible sensitisation reaction or severe local irritation occur with the use of Avoban, treatment should
be discontinued, the product should be washed off and appropriate therapy instituted.
As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible 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. Although this is less likely to occur with topically applied mupirocin, if prolonged or
significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued
immediately and the patient investigated further.
Avoban formulation is not suitable for ophthalmic use and intranasal use.
Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until the cream
residues have been removed.
Avoban contains cetyl alcohol and stearyl alcohol. These inactive ingredients may cause local skin reactions
(e.g. contact dermatitis)

No drug interactions have been identified.

Fertility:
There are no data on the effects of mupirocin on human fertility. Studies in rats showed no effects on fertility
(see section 5.3).
Pregnancy:
Reproduction studies on mupirocin in animals have revealed no evidence of harm to the foetus (see section
5.3). As there is no clinical experience on its use during pregnancy, mupirocin should only be used in
pregnancy when the potential benefits outweigh the possible risks of treatment.
Breast-feeding:
There is no information on the excretion of mupirocin in milk. If a cracked nipple is to be treated, it should be
thoroughly washed prior to breast feeding.

No adverse effects on the ability to drive or operate machinery have been identified.

Data from clinical trials was used to determine the frequency of very common to rare undesirable effects. Very
rare adverse reactions were primarily determined from post-marketing experience data and therefore refer to
reporting rate rather than true frequency.

Immune system disorders:
Very rare: Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and
angioedema
Skin and subcutaneous tissue disorders:
Common: Application site hypersensitivity reactions including urticaria, pruritus, erythema, burning
sensation, contact dermatitis, rash
Skin dryness and erythema have been reported in irritancy studies in volunteers.

Symptoms:
There is currently limited experience with overdosage of Avoban.
Management:
There is no specific treatment for an overdose of Avoban. In the event of 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.

Pharmacotherapeutic group: Dermatologicals ATC code: D06AX09, Antibiotics and chemotherapeutics for
dermatological use.
Mode of Action
Mupirocin is a novel antibiotic produced through fermentation by Pseudomonas fluorescens. Mupirocin inhibits
isoleucyl transfer-RNA synthetase, thereby arresting bacterial protein synthesis.

Mupirocin has bacteriostatic properties at minimum inhibitory concentrations and bactericidal properties at the
higher concentrations reached when applied locally.
Mechanism of Resistance
Low-level resistance in staphylococci is thought to result from point mutations within the usual staphylococcal
chromosomal gene (ileS) for the target isoleucyl tRNA synthetase enzyme. High-level resistance in
staphylococci has been shown to be due to a distinct, plasmid encoded isoleucyl tRNA synthetase enzyme.
Intrinsic resistance in Gram negative organisms such as the Enterobacteriaceae could be due to poor
penetration of the outer membrane of the Gram-negative bacterial cell wall.
Due to its particular mode of action, and its unique chemical structure, mupirocin does not show any crossresistance
with other clinically available antibiotics.
Microbiological Susceptibility
The prevalence of acquired resistance may vary geographically and with time for selected species, and local
information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice
should be sought when the local prevalence of resistance is such that the utility of the agent in at least some
types of infection is questionable.
 

Absorption
Systemic absorption of mupirocin through intact human skin is low although it may occur through
broken/diseased skin. However, clinical trials have shown that when given systemically, it is metabolised to the
microbiologically inactive metabolite monic acid and rapidly excreted.
Excretion
Mupirocin is rapidly eliminated from the body by metabolism to its inactive metabolite monic acid which is
rapidly excreted by the kidney.

Pre-clinical effects were seen only at exposures which are extremely unlikely to cause concern for humans
under normal conditions of clinical use. Mutagenicity studies revealed no risks to man.

- Xanthan gum
- Paraffin oil
- Cetomacrogol 1000
- Stearyl alcohol
- Cetyl alcohol
- Phenoxyethanol
- Benzyl alcohol
- Purified water

None known

Store below 25°C.

White Collapsible Aluminum internally golden lacquered tube and white HDPE screw cap.
Avoban is available in 30 g tube.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.