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Fusarpi, 2 % ointment

Drug formSoft

ATC categoryAntibacterials

ATC subcategoryOther antibiotics (for external use)

Brand nameFusarpi

Generic nameSodium fusidate

Composition

Each gram of Fusarpi 2% ointment contains:

active ingredient: sodium fusidate – 20 mg;

excipients: liquid paraffin, glycerol monostearate, white soft paraffin (vaseline).

Pharmacological group and ATC code
Antibacterial for topical use; D06AX01.

Pharmacology

Sodium fusidate is a steroidal antibacterial with a bacteriostatic or bactericidal activity, mainly against Gram-positive bacteria.

Antimicrobial Action

Fusidic acid is a steroidal antibacterial with a bacteriostatic or bactericidal activity, mainly against Gram-positive bacteria.

Mechanism of action. Fusidic acid inhibits bacterial protein synthesis although, in contrast to drugs such as the macrolides or tetracyclines, it does not bind to the bacterial ribosome, but inhibits a factor necessary for translocation of peptide subunits and elongation of the peptide chain. It is capable of inhibiting protein synthesis in mammalian cells but exerts a selective action against susceptible infecting organisms because of poor penetration into the host cell.

Spectrum of activity. Fusidic acid is very active against staphylococci, notably Staph. aureus and Staph. epidermidis (including meticillin-resistant strains). Nocardia asteroides and many clostridial strains are also highly susceptible. The streptococci and enterococci are less susceptible.

Most Gram-negative bacteria are intrinsically resistant but fusidic acid is active against Neisseria spp. and Bacteroides fragilis. It has some activity against strains of Mycobacterium tuberculosis and is highly active against M. leprae.

Fungi are resistant, but fusidic acid has some activity against a range of protozoa including Giardia lamblia and Plasmodium falciparum. High concentrations of fusidate are reported to inhibit viral growth in vitro, including that of HIV, although it is unclear whether this represents a surfactant effect, a general cytotoxic effect, or a genuine antiviral action.

Activity with other antimicrobials. No synergy has been demonstrated in vitro in most studies between fusidic acid and rifampicin or vancomycin, and antagonism of the effects of ciprofloxacin has been reported. Interactions with the penicillins are complex, with either antagonism of the effect of one or both drugs, or no interaction. However, use of an antistaphylococcal penicillin with fusidic acid may prevent the emergence of fusidic acid-resistant staphylococcal mutants, and such combinations may be clinically effective.

Resistance. Resistant strains of staphylococci are readily selected in vitro, and occasionally during therapy, but the number of clinical isolates that are initially resistant remains relatively low at about 1 to 2% overall, despite widespread topical use. Resistance may be chromosomally mediated, representing altered protein synthesis, or plasmid-mediated, which appears to be due to reduced penetration of active drug into the cell.

Pharmacokinetics
Only very small amounts of Sodium fusidate appear to be absorbed systemically following topical application to the skin.

Uses and administration
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.

Administration

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

Precautions

The sodium salt of fusidic acid has been shown to cause conjunctival irritation. The ointment should not be used in or near the eye. Bacterial resistance has been reported to occur with the use of sodium salt of fusidic acid applied topically. As with all topical antibiotics, extended or recurrent application may increase the risk of contact sensitisation and the development of antibiotic resistance.

Topical treatment for 7 days usually adequate; max. duration of topical treatment 10 days; seek local microbiology advice before using topical treatment in hospital.

Overdosage

Not applicable.

Contraindications
– Infection caused by non-susceptible organisms, in particular, Pseudomonas aeruginosa.
– Fusarpi ointment is contra-indicated in patients with hypersensitivity to fusidic acid and its salts.

Adverse effects
Hypersensitivity reactions in the form of rashes and irritation may occur after fusidates topically.

Pregnancy and Breast feeding

There is inadequate evidence of safety in human pregnancy. Animal studies and many years of clinical experience have suggested that fusidic acid is devoid of teratogenic effects.

There is evidence to suggest that when given systemically, fusidic acid can penetrate the placental barrier. The use of topical Fusarpi in pregnancy requires that the potential benefits be weighed against the possible hazards to the foetus.

Safety in nursing mothers has not been established. When fusidic acid (as the sodium salt) has been given systemically, levels have been detected in breast milk but with topical use the possible amount of drug present is unlikely to affect the infant.

Drug interactions

Not applicable.

Identification

A white, homogenous greasy ointment.

Presentation

15 g of ointment is filled into aluminum tubes (inside package).
The tubes are packed and inserted with the leaflet into cardboard boxes (outer package).

Expiry date

3 years. Do not use after the expiration date.

Prescription status

To be dispensed with prescription.

Storage conditions

Store at a room temperature (15-250C), in a dry place, out of the reach of children. Protect from light.