Topical/Cutaneous Corticosteroid-responsive dermatoses with secondary infection
Adult: Available preparation:
Each cream or ointment contains fluocinolone 0.025% and neomycin base 0.35%
Apply thinly onto affected area bid-tid up to 7 days.
Hypersensitivity to neomycin. Perforated eardrum. Infections caused by bacteria, fungi, or viruses and in rosacea, acne, perioral dermatitis and napkin eruptions.
Patient with hypersensitivity to gentamicin, kanamycin, paromomycin, streptomycin; minor or major skin damages. Application on intertriginous or flexor areas; use of occlusive dressings. Children. Pregnancy and lactation. Not intended for ophthalmic use. Avoid prolonged use.
Significant: Local irritation, hypersensitivity reactions, steroid withdrawal. Rarely, atrophy of the skin and the subcutaneous tissues due to prolonged application; ototoxicity, nephrotoxicity, hypothalamic-pituitary-adrenal axis suppression, Cushing’s syndrome, hyperglycaemia, glucosuria. Infections and infestations: Folliculitis. Rarely, secondary or opportunistic infections. Skin and subcutaneous tissue disorders: Pruritus, dryness, burning sensation, dermatitis, new or worsening acne, hypopigmentation, maceration, striae, miliaria, hypertrichosis.
Monitor signs of bacterial or fungal infection.
May increase risk of adverse reactions associated to systemic absorption with other corticosteroids.
Description: Fluocinolone is a topical corticosteroid that has immunosuppressant, anti-inflammatory, antipruritic and vasoconstrictive properties. It induces phospholipase A2 inhibitory proteins (lipocortin) and sequentially inhibits the release of arachidonic acid, thereby depressing the formation, release, and activity of endogenous chemical mediators of inflammation (e.g. histamine, kinins).
Neomycin, an aminoglycoside antibacterial, is bactericidal against a variety of gram-positive and gram-negative organisms. It inhibits bacterial protein synthesis by irreversibly binding to 30S ribosomal ribonucleic acid subunits. Pharmacokinetics: Absorption: Fluocinolone: Absorbed from intact skin; increased if inflamed.
Neomycin: Poorly absorbed from intact skin; increased if inflamed. Metabolism: Fluocinolone: Metabolised in the liver. Excretion: Fluocinolone: Mainly via urine; bile.
Neomycin: Via urine (30-50% as unchanged drug).