Topical/Cutaneous Corticosteroid-responsive dermatoses with secondary infection
Adult: Betamethasone valerate 0.1% and fusidic acid 2% cream Betamethasone dipropionate 0.064% (equivalent to betamethasone 0.05%) and fusidic acid 2% cream Betamethasone dipropionate 0.064% (equivalent to betamethasone 0.05%) and Na fusidate 2% ointment
Apply thinly onto the affected area bid until with adequate response. Treatment duration: Up to 2 weeks. Recommendations may vary among countries and between individual products (refer to specific product guidelines). Child: Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
What are the brands available for Betamethasone + Fusidic acid in Vietnam?
Hypersensitivity to betamethasone, fusidic acid and its salts. Systemic fungal infections; untreated primary bacterial, viral, or fungal skin infections; untreated skin manifestations in relation to TB or syphilis; perioral dermatitis; acne rosacea; ulcerative conditions.
Special Precautions
Avoid prolonged continuous use, especially on the face, flexures, and intertriginous areas. Avoid occlusion, application in large amounts, and long-term use (particularly in children) due to the greater risk of topical corticosteroids-induced HPA axis suppression and Cushing's syndrome. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Hypercortisolism or HPA axis suppression (particularly in younger children or at high doses for prolonged periods); increased susceptibility to infection, exacerbate existing infection, or activate latent infection (prolonged use); antibiotic resistance or superinfection, including fungal infections (prolonged use); visual disturbances, blurred vision, increased risk of posterior subcapsular cataracts and glaucoma; systemic effects (e.g. manifestations of Cushing's syndrome, hyperglycaemia, glycosuria); local skin reactions (e.g. skin atrophy, skin striae, contact dermatitis, dermatitis acneiform, perioral dermatitis, telangiectasia, rosacea, erythema, hypertrichosis, hyperhidrosis, depigmentation, ecchymosis) that may occur with prolonged use; topical steroid withdrawal reactions (after discontinuation of ≥6 months long-term use), may be manifested as severe redness which can spread beyond the initial affected area, itching, burning or stinging sensation, and skin peeling. General disorders and administration site conditions: Application site pain and irritation. Immune system disorders: Hypersensitivity. Skin and subcutaneous tissue disorders: Dry skin, pruritus, burning sensation of skin.
Patient Counseling Information
Avoid contact with the eyes. Do not use occlusive dressings unless directed by the doctor. Inform the doctor immediately if severe redness which can spread beyond the initial affected area, itching, burning or stinging sensation, and skin peeling occur after treatment discontinuation.
Monitoring Parameters
Observe response to treatment. Monitor for ocular symptoms, changes, or visual disturbances. Assess for signs and symptoms of adrenal suppression (particularly with prolonged or extensive use) or topical steroid withdrawal reactions (after discontinuation of ≥6 months long-term use).
Overdosage
Symptoms: Betamethasone: Cushing's syndrome, adrenocortical insufficiency. Management: Symptomatic treatment. Withdraw betamethasone gradually by decreasing the frequency of application or using less potent corticosteroids.
Lab Interference
Betamethasone: May suppress the flare and wheal reactions to skin tests antigens.
Action
Description: Mechanism of Action: Betamethasone is a synthetic corticosteroid that has anti-inflammatory, antipruritic, and vasoconstrictive properties. It induces phospholipase A2 inhibitory proteins (lipocortins) and sequentially inhibits arachidonic acid release, thereby suppressing the formation, release, and activity of endogenous inflammatory chemical mediators (e.g. kinins, histamine, liposomal enzymes, prostaglandins). Betamethasone has an intermediate to very high range of potency.
Fusidic acid is an antibiotic that inhibits bacterial protein synthesis by blocking the transfer of aminoacyl-transfer RNA (tRNA) to protein in susceptible bacteria. Pharmacokinetics: Absorption: Betamethasone: Absorbed percutaneously. Distribution: Crosses the placenta.
Fusidic acid: Widely distributed into the tissues and body fluids, including bone, synovial fluids, and pus; penetrates cerebral abscesses, but penetrates poorly to CSF; penetrates intact skin. Enters breast milk. Plasma protein binding: Approx 95%. Metabolism: Betamethasone: Metabolised in the liver. Excretion: Betamethasone: Via urine and bile.
Fusidic acid: Mainly via bile (as metabolites); faeces (2% as unchanged drug); urine (small amounts).
Chemical Structure
Betamethasone Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 9782, Betamethasone. https://pubchem.ncbi.nlm.nih.gov/compound/Betamethasone. Accessed Sept. 24, 2024.
Fusidic acid Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3000226, Fusidic Acid. https://pubchem.ncbi.nlm.nih.gov/compound/Fusidic-Acid. Accessed Apr. 28, 2024.
D07CC01 - betamethasone and antibiotics ; Belongs to the class of potent (group III) corticosteroids, in combination with antibiotics. Used in the treatment of dermatological diseases.
References
Anon. Betamethasone, Betamethasone Benzoate, Betamethasone Dipropionate, Betamethasone Valerate. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 26/06/2024.Betamethasone (Topical). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 26/06/2024.Brayfield A, Cadart C (eds). Betamethasone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 26/06/2024.Brayfield A, Cadart C (eds). Fusidic Acid. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 26/06/2024.Fobancort Cream and Ointment (HOE Pharmaceuticals). MIMS Singapore. http://www.mims.com/singapore. Accessed 27/06/2024.Fucibet Cream (LEO Laboratories Limited). MHRA. https://products.mhra.gov.uk. Accessed 26/06/2024.Fusidic Acid (Topical). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 26/06/2024.Fusidic Acid and Betamethasone. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 26/06/2024.Fusidic Acid-B Cream (New Formula) (Kotra Pharma [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 26/06/2024.Joint Formulary Committee. Betamethasone with Fusidic Acid. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 26/06/2024.LEO Pharma Ltd. Fucicort Cream data sheet 15 May 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 26/06/2024.Topical Corticosteroids: Information on the Risk of Topical Steroid Withdrawal Reactions. Medicines & Healthcare products Regulatory Agency. https://www.gov.uk/drug-safety-update. Accessed 12/08/2024.Topical Steroids: Introduction of New Labelling and a Reminder of the Possibility of Severe Side Effects, Including Topical Steroid Withdrawal Reactions. Medicines & Healthcare products Regulatory Agency. https://www.gov.uk/drug-safety-update. Accessed 12/08/2024.
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