Fusidic Acid

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Skin infections caused by Gram-positive organisms, particularly Staphylococcus 

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Infection caused by non-susceptible organisms, in particular Pseudomonas aeruginosa

Cautions

• Renal impairment
• Hepatic impairment
• Prolonged use
  - Extended use
  - Recurrent use
• Smoking or close proximity with naked flames
• Contact with fabric
• Application to mucous membranes or proximity of the eyes (See additional prescribing points)

Forms avail. in SA and covered in this monograph: cre, oin

Dosages below include:

• International manufacturer recommendations
• South African manufacturer recommendations

Skin infections caused by: Nearly all strains of Staphylococcus aureus, Streptococci, Corynebacteria, Neisseria and certain Clostridia

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

International manufacturer recommendations

Treatment of primary skin infections caused by sensitive strains of Staphylococcus aureus, Streptococcus spp and Corynebacterium minutissimum (as monotherapy or in combination with additional agent)
- Impetigo contagiosa
- Superficial folliculitis
- Sycosis barbae
- Paronychia
- Erythrasma
Treatment of secondary skin infections caused by sensitive strains of Staphylococcus aureus, Streptococcus spp and Corynebacterium minutissimum (as monotherapy or in combination with additional agent)
- Eczematoid dermatitis
- Infected contact dermatitis
- Infected cuts/ abrasions

Uncovered lesions

• Topical (cre): Apply a small amount gently to affected area(s), 6-8hrly

Covered lesions

• Topical (cre): Apply a small amount gently to affected area(s); Less frequent applications may be adequate

South African manufacturer recommendations

Treatment of skin infections caused by Gram-positive organisms, particularly Staphylococcus (as monotherapy or in combination with additional agent)
- Abscesses
- Boils
- Carbuncles
- Impetigo
- Eczema
- Varicose ulcers
- Skin grafts
- Wounds
- Burns

Uncovered lesions

• Topical (cre, oin): Apply a small amount gently to affected area(s), 6-8hrly

Covered lesions

• Topical (cre, oin): Apply a small amount gently to affected area(s); Less frequent applications may be adequate

Paed. forms avail. in SA and covered in this monograph: cre, oin

Paed. dosages below include:

• International manufacturer recommendations
• South African manufacturer recommendations

Skin infections caused by: Nearly all strains of Staphylococcus aureus, Streptococci, Corynebacteria, Neisseria and certain Clostridia

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

International manufacturer recommendations

Treatment of primary skin infections caused by sensitive strains of Staphylococcus aureus, Streptococcus spp and Corynebacterium minutissimum (as monotherapy or in combination with additional agent)
- Impetigo contagiosa
- Superficial folliculitis
- Sycosis barbae
- Paronychia
- Erythrasma
Treatment of secondary skin infections caused by sensitive strains of Staphylococcus aureus, Streptococcus spp and Corynebacterium minutissimum (as monotherapy or in combination with additional agent)
- Eczematoid dermatitis
- Infected contact dermatitis
- Infected cuts/abrasions

• See adult dosage

South African manufacturer recommendations

Treatment of skin infections caused by Gram-positive organisms, particularly Staphylococcus (as monotherapy or in combination with additional agent)
- Abscesses
- Boils
- Carbuncles
- Impetigo
- Eczema
- Varicose ulcers
- Skin grafts
- Wounds
- Burns

• See adult dosage

Pregnancy

• Safe
• No effects during pregnancy are anticipated since systemic exposure to topically applied fusidic acid is negligible. Topical fusidic acid/ sodium fusidate can be used during pregnancy

Breastfeeding

• Compatible
• No effects on the breastfed infant are anticipated since the systemic exposure of topically applied fusidic acid/ sodium fusidate to the breastfeeding woman is negligible. Topical fusidic acid can be used during breastfeeding but it is recommended to avoid applying topical fusidic acid on the breast

Fertility

• There are no clinical studies with topical fusidic acid regarding fertility
• No effects in women of childbearing potential are anticipated since systemic exposure following topically applied fusidic acid/ sodium fusidate is negligible

Renal Impairment

• Caution, no information available

Hepatic Impairment

• Caution, no information available

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Skin and Subcutaneous Tissue Disorders

• Application site pain
  - Skin burning sensation
• Application site irritation
• Dermatitis
  - Contact dermatitis
  - Eczema
• Rash
• Pruritus
• Erythema
• Erythematous rash
• Pustular rash
• Vesicular rash
• Maculopapular rash
• Papular rash
• Generalised rash
• Urticaria
• Blisters

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Angioedema

Sensory Disorders

• Conjunctivitis

No information available

Interactions with systemically administered medicinal products are considered minimal as the systemic absorption of topical fusidic acid is negligible

None routine

Excipient precautions

Cream

• Fusidic acid cream formulations may contain butylhydroxyanisole, cetyl alcohol and potassium sorbate. These excipients may cause local skin reactions (e.g. contact dermatitis)
• Butylhydroxyanisole may also cause irritation to the eyes and mucous membranes
• Fusidic cream should therefore be used with care when applied in the proximity of the eyes

Ointment

• The sodium salt of fusidic acid has been shown to cause conjunctival irritation

Fusidic acid is a potent 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 0.03-0.12mcg fusidic acid per ml inhibit nearly all strains of Staphylococcus aureus.

Spectrum of activity: Nearly all strains of Staphylococcus aureus, Streptococci, Corynebacteria, Neisseria and certain Clostridia

Cream (per g) 20mg

• Fucidin (Adcock Ingram) originator

Ointment (per g) 20mg

• Fucidin (Adcock Ingram) originator

Also available in the following form: Eye drop, suspension, tablet and injection