Active Ingredient: Fusidic Acid 2% w/w.
Each 1 g Fuderm Cream contains 20 mg Fusidic Acid in cream base.
Excipients/Inactive Ingredients: Preservative: Chlorocresol 0.1% w/w.
Pharmacology: Pharmacodynamics: 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. Concentration of 0.03 - 0.12 mcg 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.
Pharmacokinetics: In vitro studies show that fusidic acid can penetrate intact human skin. The degree of penetration depends on factors such as the duration of exposure to fusidic acid and the condition of the skin. Fusidic acid is excreted mainly in the bile with little excreted in the urine.
Fuderm 2% w/w Cream is indicated for the treatment of skin infections caused by staphylococci, streptococci, Propionibacterium acnes, Corynebacterium minutissimum and other organisms sensitive to fusidic acid.
The most important indications: impetigo, infected wounds, folliculitis, boils, sycosis barbae, carbuncles, hidradenitis, paronychia, erythrasma.
Fuderm 2% w/w Cream is an invisible, non-staining topical preparation which is cosmetically acceptable for the treatment of face and scalp infections.
Directions of Use: For topical use only.
Apply a thin layer onto the affected area 2 to 3 times daily, generally for a period of 7 days, except in the treatment of acne where therapy should be extended for a longer period according to the nature of this disease.
For external use only. Avoid contact with eyes, nose and mouth. Not to be taken.
Overdose is unlikely to occur. Unless hypersensitivity to fusidic acid or any of the excipients exists, accidental ingestion of fusidic acid is unlikely to cause any harm.
Infections caused by non-susceptible organisms.
Patients with hypersensitivity to the active substance or to any of the ingredients.
Bacterial resistance among Staphylococcus aureus has been reported to occur with the use of topical Fusidic acid cream. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.
Extended or recurrent use may increase the risk of developing contact sensitisation.
Effects on ability to drive and use machines: Fuderm 2% w/w Cream administered topically has no or negligible influence on the ability to drive and use machines.
Pregnancy: No effects during pregnancy are anticipated since systemic exposure to topically-applied fusidic acid/sodium fusidate is negligible. Topical Fuderm 2% w/w Cream can be used during pregnancy.
Breast-feeding: No effects on the breastfed newborn/infant are anticipated since the systemic exposure of topically-applied fusidic acid/sodium fusidate to the breast-feeding woman is negligible. Topical Fuderm 2% w/w Cream can be used during breast-feeding but it is recommended to avoid applying topical Fuderm 2% w/w Cream on the breast.
Fertility: There are no clinical studies with topical Fuderm 2% w/w Cream regarding fertility. No effects in women of childbearing potential are anticipated since systemic exposure following topically-applied fusidic acid/sodium fusidate is negligible.
The most frequently reported adverse reactions during treatment are various skin reactions such as pruritus and rash, followed by application site conditions such as pain and irritation. Hypersensitivity and angioedema have been reported. (See table.)
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No interaction studies have been performed. Interactions with systemically administered medicinal products are considered minimal as the systemic absorption of topical Fuderm 2% w/w Cream is negligible.
Store below 30°C. Protect from light. Keep cap tightly closed.
Shelf Life: 3 years from the date of manufacture.
D06AX01 - fusidic acid ; Belongs to the class of other topical antibiotics used in the treatment of dermatological diseases.
Fuderm cream 2% w/w
15 g x 1's;5 g x 1's
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