Hydrocortisone/ Fusidic Acid

Registered South African indications:

Dermatitis with secondary bacterial infection caused by:

• Most gram positive aerobic organisms 
• Some gram negative aerobic organisms (including Neisseria spp)
• Some anaerobic organisms (including Clostridium difficile and Clostridium perfringens)

Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Primary skin infections caused by fungi, viruses or bacteria
• Tubercular skin manifestations
• Perioral dermatitis
• Rosacea

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Prolonged use
• Application near eyes, open wounds, or mucous membranes
• Children
• Atrophic skin
• Cutaneous ulcers
• Acne vulgaris
• Fragile skin veins
• Perianal and genital pruritus

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

Eczema - mild to moderate
Dermatitis
- with secondary bacterial infection

Hydrocortisone/ Fusidic Acid
10/20 (mg/g)

• Topical (cre): Apply to affected area, 8hrly; Max duration: 2 weeks

Less frequent applications may be adequate for covered lesions

See adult dosage

Pregnancy

• Caution
• Fusidic acid: No effects during pregnancy are anticipated since systemic exposure to fusidic acid is negligible
• Hydrocortisone acetate: A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicates no malformative nor feto/neonatal toxicity of corticosteroids
• Fusidic acid/hydrocortisone can be used during pregnancy if clinically needed. However, based on general knowledge about systemic corticosteroids, caution should be exercised when using topical fusidic acid/hydrocortisone during pregnancy

Breastfeeding

• Caution; not recommended
• No effects on the breastfed new-born/infant are anticipated since the systemic exposure of topically applied fusidic acid/hydrocortisone acetate to a limited area of skin of the breastfeeding woman is negligible.
• Fusidic acid/hydrocortisone can be used during breastfeeding but it is recommended to avoid applying fusidic acid/hydrocortisone on the breast

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• Caution; no information available

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Skin and Subcutaneous Tissue Disorders

• Application site reactions
• Contact dermatitis
• Eczema
• Rash

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity

No information available

None routine

Fusidic acid
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 0.03-0.12μg fusidic acid per ml inhibit nearly all strains of Staphylococcus aureus. Topical application of fusidic acid is also effective against streptococci, corynebacteria, neisseria and certain clostridia.

Hydrocortisone
Hydrocortisone inhibits the release of arachadonic acid from the cell membrane and thus interferes with the initiation of the inflammatory response. It may depress the formation, release and activity of endogenous chemical mediators of inflammation.  It has anti-inflammatory, antipruritic, antiallergic and vasoconstrictive effects.

COMBINATION PREPARATIONS

Hydrocortisone/ Fusidic acid

Cream (per g) 10mg/20mg

• Fucidin H (Adcock) originator