Indicated either alone or in combination with systemic therapy, in the treatment of primary
and secondary skin infections caused by sensitive strains of Staphylococcus aureus,
streptococcus spp and Corynebacterium minutissimum. Primary skin infections that
may be expected to respond to treatment with fusidic acid applied topically include:
impetigo contagiosa, superficial folliculitis, sycosis barbae, paronychia and erythrasma;
also such secondary skin infections as infected eczematoid dermatitis, infected contact
dermatitis and infected cuts /abrasions.

Adults and Children: Uncovered lesions - apply gently, three or four times daily.
Covered lesions - less frequent applications may be adequate.

Bacterial resistance among staphylococcus aureus has been reported to occur with the use
of topical Fusibact. As with all antibiotics, extended or recurrent use may increase the risk
of developing antibiotic resistance.
Extended or recurrent use may increase the risk of developing contact sensitisation.
When Fusibact ointment is used on the face; care should be taken to avoid the eyes as the
excipients in the ointment may cause conjunctival irritation.

No interaction studies have been performed. Interactions with systemically administered
medicinal products are considered minimal as the systemic absorption of topical Sodium
Fusidate ointment is negligible.

Fertility
There are no clinical studies with topical Sodium Fusidate ointment regarding fertility. No
effects in women of childbearing potential are anticipated, since systemic exposure
following topically applied Fusidic acid/sodium Fusidate is negligible.

Pregnancy
No effects during pregnancy are anticipated, since systemic exposure to topically applied
Fusidic acid/Sodium Fusidate is negligible. Topical Fusibact can be used during pregnancy.

Breast-feeding
No effects on the breastfed new-born/infant are anticipated since the systemic exposure of
topically applied Fusidic acid/Sodium Fusidate to the breast-feeding woman is negligible.
Topical Fusibact can be used during breast-feeding but it is recommended to avoid
applying topical Fusibact on the breast.

Fusibact administered topically has no or negligible influence on the ability to drive or to
use machines.

Based on pooled data from clinical studies including 4724 patients who received Fusidic Acid
cream or Sodium Fusidate 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 various 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 (incl. 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 (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.

To report any side effect(s):
• Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222,
Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

Other GCC States:
Please contact the relevant competent authority.

Overdose is unlikely to occur.
Unless hypersensitivity to Fusidic acid or any of the excipients exists, accidental ingestion of
Fusibact ointment is unlikely to cause any harm. The total quantity of Fusidic acid (30g
Fusibact ointment contains 576mg 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 ≤ 10kg. Although in this instance a child of this particular age group is unlikely to
ingest a whole tube of Fusibact ointment. The concentration of the excipients is too low to
constitute a safety risk.

Fusidic acid is a potent topical 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 microgram/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 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.

There are no pre-clinical data of relevance to the prescriber which are additional to that already
included in other sections of the SPC.

White Soft Paraffin (White Petroleum Jelly)

Not applicable

Do not store above 25°C. Discarded the tube after 3 months from opening

Aluminium collapsible tube of 15gm and 30gm with HDPE cap has piercing end

None