Betamethasone + Fusidic acid

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.

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.

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.

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.

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).

Symptoms: Betamethasone: Cushing's syndrome, adrenocortical insufficiency. Management: Symptomatic treatment. Withdraw betamethasone gradually by decreasing the frequency of application or using less potent corticosteroids.

Betamethasone: May suppress the flare and wheal reactions to skin tests antigens.

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).

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.

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.

Store below 30°C. Protect from light.

Thuốc kháng khuẩn có corticoid dùng tại chỗ

D07CC01 - betamethasone and antibiotics ; Belongs to the class of potent (group III) corticosteroids, in combination with antibiotics. Used in the treatment of dermatological diseases.

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