Fusidic Plus2%+1%

Fusidic Plus is a topical combination of an antibiotic (fusidic acid) and a corticosteroid (hydrocortisone), indicated for short-term treatment of inflammatory skin conditions that are infected, or likely to become infected, with fusidic-acid-sensitive bacteria (mainly Staphylococcus aureus).

Established/Approved Uses

• Infected atopic dermatitis (eczema)
• Infected contact dermatitis (irritant or allergic)
• Infected discoid (nummular) eczema
• Infected seborrhoeic dermatitis
• Infected intertrigo and other localized infected inflammatory dermatoses where both antibacterial and anti-inflammatory action are required

Important Note on Use

Fusidic Plus is intended only for skin lesions where infection is present or strongly suspected alongside inflammation. It is not appropriate as a first-line treatment for uncomplicated (non-infected) eczema or dermatitis, where a corticosteroid alone is usually preferred, and it is not a substitute for a plain antibiotic when infection is present without significant inflammation.

Each gram of Fusidic acid + Hydrocortisone topical cream/ointment typically contains fusidic acid (as fusidic acid or sodium fusidate) 20 mg (2% w/w) and hydrocortisone acetate 10 mg (1% w/w), in a suitable topical base.

Fusidic Plus is a fixed-dose topical combination product that pairs a bacteriostatic/bactericidal antibiotic active mainly against staphylococci with a mild-to-moderate potency corticosteroid. It is formulated as a cream or ointment for application to the skin, and is designed to treat inflamed skin conditions that are complicated by, or at significant risk of, bacterial infection — providing antibacterial cover while also reducing the itching, redness, and inflammation associated with the underlying dermatosis.

Topical Antibacterial and Corticosteroid Combination (Fusidic Plus)

Fusidic acid + Hydrocortisone combines two complementary mechanisms of action in a single topical preparation.

Fusidic acid component

Fusidic acid is a bacteriostatic antibiotic (bactericidal at higher local concentrations) that inhibits bacterial protein synthesis by binding to elongation factor G (EF-G) and blocking its release from the ribosome, thereby preventing translocation during translation. It is active mainly against Gram-positive organisms, particularly Staphylococcus aureus, including many strains resistant to other antibiotics.

Hydrocortisone component

Hydrocortisone acetate is a mild-to-moderate potency corticosteroid that binds intracellular glucocorticoid receptors, inducing anti-inflammatory proteins and suppressing pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines). This produces anti-inflammatory, antipruritic, and vasoconstrictive effects that reduce redness, swelling, and itching of the skin.

When applied topically, systemic absorption of both components through intact skin is generally low, but may increase with use on broken skin, large body surface areas, mucous membranes, or under occlusive dressings.

Fusidic Plus is for external (topical) use on the skin only. Wash and dry the affected area, then apply a thin film and rub in gently. Wash hands after application unless the hands themselves are being treated. Avoid contact with the eyes, mouth, nose, and mucous membranes; if accidental contact occurs, rinse thoroughly with water. Do not apply to broken skin, open wounds, or mucosal surfaces unless directed by a physician.

Clinically significant drug interactions with Fusidic Plus are unlikely when it is used topically on limited areas of skin at recommended doses, because systemic absorption of both fusidic acid and hydrocortisone is minimal under normal conditions of use.

Concurrent application of other topical products (including other corticosteroids or antibiotics) to the same skin area is not recommended, as it may alter local absorption or increase the risk of side effects. Use on large areas, broken skin, or under occlusive dressings can increase systemic absorption of the corticosteroid component, which could theoretically add to the effects of other systemic corticosteroids if these are being taken concurrently; inform the prescriber of all other medicines being used.

Most side effects of Fusidic Plus are local and mild, especially with short-term use as directed.

• Local burning, stinging, or itching at the application site
• Skin dryness or irritation
• Contact dermatitis or hypersensitivity reactions (uncommon)
• Skin thinning (atrophy), stretch marks (striae), visible blood vessels (telangiectasia), or delayed wound healing with prolonged or excessive use of the corticosteroid component
• Changes in skin pigmentation at the treated site
• Development of antibiotic-resistant bacteria with prolonged or inappropriate use of the fusidic acid component (see Precautions and Warnings)
• Rarely, signs of systemic corticosteroid absorption (e.g., in infants or with extensive/prolonged use) — see Use in Special Populations

Data on the use of Fusidic Plus in human pregnancy are limited. Fusidic Plus should be used during pregnancy only if clearly needed and if the potential benefit to the mother justifies the potential risk to the fetus; use should be limited to the smallest effective area and shortest possible duration, and a physician should be consulted before use.

It is not known whether topically applied fusidic acid or hydrocortisone are excreted in human breast milk in clinically significant amounts. As a precaution, breastfeeding mothers using Fusidic Plus should avoid application to the breast/nipple area and should consult a physician before use, particularly for prolonged treatment or use over large areas.

Duration of use: Fusidic Plus should not be used continuously for prolonged periods. Extended or repeated courses increase the risk of skin atrophy from the corticosteroid component and, importantly, are a well-documented risk factor for the emergence of fusidic-acid-resistant bacteria (particularly Staphylococcus aureus). Treatment should generally be limited to 1–2 weeks, and use should be reassessed by a physician if longer treatment appears necessary.

Antibiotic stewardship: Use Fusidic Plus exactly as prescribed by your physician for the full recommended duration; do not stop, extend, skip applications, or share this medicine with others without medical advice, in order to reduce the risk of bacterial resistance.

Site of application: Avoid use near the eyes and on mucous membranes. Do not use on infected lesions caused by organisms not sensitive to fusidic acid, or on untreated fungal or viral skin infections, as the corticosteroid may mask or worsen the underlying infection.

Extent of use: Avoid application to large areas of the body, broken or denuded skin, or use under occlusive dressings unless specifically directed, as these increase systemic absorption of the corticosteroid and the risk of local and systemic side effects.

Children: see Use in Special Populations.

Topical overdose with Fusidic Plus is unlikely with correct use, but application of excessive amounts, over large areas, for prolonged periods, or accidental ingestion may increase the risk of local skin damage (atrophy) or, rarely, systemic corticosteroid effects. If excessive application, accidental ingestion, or an allergic reaction (e.g., swelling, difficulty breathing, severe rash) occurs, seek immediate medical attention or contact a poison control center/emergency services. Do not attempt to manage a suspected overdose or serious reaction at home without medical guidance.

Store at room temperature (below 30°C), away from light and moisture. Do not freeze. Keep the tube tightly closed and out of the reach and sight of children.

Pediatric Use

Fusidic Plus can be used in children under medical supervision, but treatment should be limited to the shortest effective duration and smallest effective area, as children (especially infants) have a higher skin surface-area-to-body-weight ratio and are more susceptible to systemic corticosteroid absorption and adrenal suppression with prolonged or extensive use. Safety and efficacy of long-term use in young infants have not been well established; use in this group only as directed by a physician.

Elderly

No specific dose adjustment is generally required in elderly patients, but skin is often thinner and more fragile in this population, so the lowest effective duration should be used and the skin monitored for atrophy or irritation.

Renal and Hepatic Impairment

Because systemic absorption from topical use is normally minimal, specific dose adjustment for renal or hepatic impairment is not established as necessary; however, caution and medical advice are recommended if used over large areas or for prolonged periods in patients with significant hepatic or renal disease.

Pregnancy and Lactation

See Pregnancy and Lactation section above.

Fusidic Plus is generally used for short courses of 7–14 days and should not be used continuously for more than about 2 weeks unless specifically directed by a physician, due to the combined risks of corticosteroid-related skin atrophy and antibiotic resistance with prolonged fusidic acid use. If symptoms do not improve or worsen within this period, medical review is required.

Topical Antibacterial (Fusidane class) + Topical Corticosteroid (mild-to-moderate potency) combination

Fusidic acid + Hydrocortisone works through two combined mechanisms: fusidic acid inhibits bacterial protein synthesis by blocking elongation factor G (EF-G)-mediated ribosomal translocation, producing an antibacterial effect mainly against Staphylococcus aureus, while hydrocortisone acetate binds glucocorticoid receptors to suppress local inflammatory mediators, reducing redness, swelling, and itching.

Fusidic Plus may be used in children under medical supervision for short-term treatment of infected inflammatory skin conditions, using the same application technique as in adults but restricted to the smallest affected area and shortest effective duration. Because infants and young children have a proportionally larger skin surface area relative to body weight, they are at greater risk of systemic corticosteroid absorption, adrenal suppression, and growth effects with prolonged or extensive use, so treatment must be closely supervised by a physician. Safety and efficacy of long-term or extensive use in neonates and young infants have not been well established, and use in this age group should be avoided unless specifically directed by a pediatrician.