What it's for (Indications)
- Fusidic acid, topical + hydrocortisone is indicated for the treatment of inflammatory dermatoses where secondary bacterial infection is present or likely to occur.
- This combination therapy is particularly useful for conditions such as eczema, including atopic eczema, contact dermatitis, and seborrhoeic dermatitis, as well as psoriasis, which are complicated by infections with fusidic acid-sensitive organisms.
- These typically include Gram-positive bacteria, most commonly *Staphylococcus aureus*, and certain *Streptococcus spp.
- * The hydrocortisone component provides anti-inflammatory, antipruritic, and vasoconstrictive effects to reduce inflammation, redness, and itching, while fusidic acid acts as a topical antibiotic to combat the bacterial infection.
- The selection of this combination should be based on the clinical assessment of infection and inflammation, and ideally, on microbiological confirmation of bacterial susceptibility to fusidic acid, especially in cases of recurrent infection.
- This medication aims to address both the inflammatory and infectious components simultaneously, promoting a more effective resolution of the dermatological condition.
- It is not intended for prophylactic use against infection.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | This medication should be applied thinly and gently rubbed into the affected skin area two to three times daily, as directed by a healthcare professional. The duration of treatment should generally not exceed two weeks. Once clinical improvement is evident, the frequency of application may be reduced, or treatment with a corticosteroid-only preparation or an antibiotic-only preparation may be considered, based on the predominant remaining symptoms. The total daily dosage and duration of therapy should be kept to a minimum necessary to achieve therapeutic effect, especially in children, on the face, or in areas prone to occlusion. Patients should be advised to avoid applying the cream to large body surface areas and to refrain from using occlusive dressings, as these practices can increase systemic absorption of hydrocortisone. Any missed dose should be applied as soon as remembered, but double doses should be avoided. Discontinuation should be gradual after prolonged use to prevent rebound phenomena. |
Safety & Warnings
Common Side Effects
- Commonly reported side effects associated with topical fusidic acid and hydrocortisone combination therapy are primarily local and include application site reactions such as irritation, burning, stinging, itching, dryness, erythema (redness), and rash.
- Hypersensitivity reactions, including contact dermatitis, may occur due to either active ingredient or excipients.
- Prolonged and extensive use of the corticosteroid component, particularly under occlusive dressings or on delicate skin areas, can lead to local adverse effects such as skin atrophy, thinning of the skin, striae (stretch marks), telangiectasia (spider veins), purpura, hypertrichosis (excessive hair growth), folliculitis, acneiform eruptions, and hypopigmentation.
- Systemic absorption of hydrocortisone is generally low but can occur, especially with extensive use, prolonged duration, or in pediatric patients, potentially leading to hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria.
- Ocular effects like glaucoma and cataracts have been reported with topical corticosteroid use near the eyes.
- Resistance to fusidic acid can develop with prolonged or inappropriate use.
- Secondary infections, including fungal or viral infections, can be masked or exacerbated by the corticosteroid component.
- Patients should promptly report any persistent or worsening adverse reactions.
Serious Warnings
- Black Box Warning: While fusidic acid with hydrocortisone combination does not carry an FDA-mandated black box warning, clinicians and patients must be aware of significant potential risks, necessitating careful prescription and usage. Prolonged or extensive use of topical corticosteroids, even low-potency ones like hydrocortisone, can lead to systemic absorption, potentially resulting in hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria. This risk is amplified in pediatric patients, with occlusive dressings, or application to large body surface areas or damaged skin. Indiscriminate or prolonged use of the fusidic acid component can contribute to the development of bacterial resistance, diminishing the future efficacy of antibacterial treatments. Furthermore, the corticosteroid component can mask, exacerbate, or spread concurrent fungal, viral, or parasitic infections and may lead to irreversible local adverse effects such as skin atrophy, striae, telangiectasia, and pigmentary changes, particularly on delicate skin areas or with inappropriate duration of treatment. Ocular exposure must be meticulously avoided due to the potential for cataracts and glaucoma, especially with repeated or prolonged use near the eyes. Abrupt discontinuation after prolonged use can sometimes lead to a rebound phenomenon and worsening of the underlying skin condition, emphasizing the importance of gradual withdrawal or step-down therapy under medical guidance.
- This medication should be used with caution and under medical supervision.
- Avoid contact with the eyes, as it can cause irritation and potentially lead to glaucoma or cataracts with prolonged exposure, especially if applied near the eyelids.
- Prolonged and extensive use of topical corticosteroids, even low-potency ones like hydrocortisone, can lead to systemic absorption and potential systemic adverse effects, including HPA axis suppression, especially in children or when applied to large body surface areas, broken skin, or under occlusive dressings.
- The use of fusidic acid can lead to the emergence of resistant bacterial strains; therefore, prolonged or unnecessary use should be avoided, and treatment duration should be limited, typically to two weeks.
- If the infection does not improve within a few days or worsens, reassessment and culture-based therapy may be necessary.
- The corticosteroid component can mask signs of infection, potentially leading to the spread of untreated bacterial, fungal, or viral infections.
- If such an infection develops, the combination product should be discontinued, and appropriate antimicrobial therapy should be initiated.
- Patients should be advised against self-medication for conditions other than those for which it was prescribed.
- The medication contains corticosteroids, which should not be used on the face for prolonged periods without strict medical guidance due to the increased risk of atrophy, telangiectasias, and perioral dermatitis.
How it Works (Mechanism of Action)
The therapeutic efficacy of this combination product is derived from the distinct mechanisms of action of its two active components. Fusidic acid is a topical antibiotic that primarily inhibits bacterial protein synthesis by interfering with the translocation of elongation factor G (EF-G) on the bacterial ribosome. This disruption prevents the movement of the ribosome along the mRNA, thereby halting the synthesis of essential proteins required for bacterial growth and replication. Fusidic acid is particularly effective against Gram-positive bacteria, notably *Staphylococcus aureus*, including some methicillin-resistant strains, and *Streptococcus spp.* Hydrocortisone is a low-potency corticosteroid that exerts its therapeutic effects through potent anti-inflammatory, antipruritic, and vasoconstrictive actions. It achieves this by inducing the synthesis of phospholipase A2 inhibitory proteins, collectively known as lipocortins. Lipocortins, in turn, inhibit the release of arachidonic acid from phospholipid cell membranes. Arachidonic acid is a precursor to potent mediators of inflammation such as prostaglandins and leukotrienes. By suppressing the synthesis and release of these inflammatory mediators, hydrocortisone effectively reduces erythema, edema, heat, and pain associated with inflammatory skin conditions, providing symptomatic relief while the fusidic acid addresses the underlying bacterial infection.
Commercial Brands (Alternatives)
No other brands found for this formula.