Dosage/Direction for Use
Topical/Cutaneous Tinea cruris Adult: Available preparations: Betamethasone dipropionate 0.064% (equivalent to betamethasone 0.05%) and clotrimazole 1% cream Betamethasone dipropionate 0.064% (equivalent to betamethasone 0.05%) and clotrimazole 1% lotion Apply thinly onto affected area(s) bid, in the morning and evening, for up to 2 weeks. Max: 45 g per week (as cream); 45 mL per week (as lotion). Reassess the diagnosis if there is no clinical improvement after 1 week. Child: Available preparations: Betamethasone dipropionate 0.064% (equivalent to betamethasone 0.05%) and clotrimazole 1% cream Betamethasone dipropionate 0.064% (equivalent to betamethasone 0.05%) and clotrimazole 1% lotion ≥17 years Same as adult dose. Treatment guidelines may vary among individual products or between countries (refer to local product-specific recommendations). Topical/Cutaneous Tinea corporis Adult: Available preparations: Betamethasone dipropionate 0.064% (equivalent to betamethasone 0.05%) and clotrimazole 1% cream Betamethasone dipropionate 0.064% (equivalent to betamethasone 0.05%) and clotrimazole 1% lotion Apply thinly onto affected area(s) bid, in the morning and evening, for up to 2 weeks. Max: 45 g per week (as cream); 45 mL per week (as lotion). Reassess the diagnosis if there is no clinical improvement after 1 week. Child: Available preparations: Betamethasone dipropionate 0.064% (equivalent to betamethasone 0.05%) and clotrimazole 1% cream Betamethasone dipropionate 0.064% (equivalent to betamethasone 0.05%) and clotrimazole 1% lotion ≥17 years Same as adult dose. Treatment guidelines may vary among individual products or between countries (refer to local product-specific recommendations). Topical/Cutaneous Tinea pedis Adult: Available preparations: Betamethasone dipropionate 0.064% (equivalent to betamethasone 0.05%) and clotrimazole 1% cream Betamethasone dipropionate 0.064% (equivalent to betamethasone 0.05%) and clotrimazole 1% lotion Apply onto affected area(s) bid, in the morning and evening, for up to 4 weeks. Max: 45 g per week (as cream); 45 mL per week (as lotion). Reassess the diagnosis if there is no clinical improvement after 2 weeks. Child: Available preparations: Betamethasone dipropionate 0.064% (equivalent to betamethasone 0.05%) and clotrimazole 1% cream Betamethasone dipropionate 0.064% (equivalent to betamethasone 0.05%) and clotrimazole 1% lotion ≥17 years Same as adult dose. Treatment guidelines may vary among individual products or between countries (refer to local product-specific recommendations). |
Contraindications
Hypersensitivity. Bacterial or viral skin infections, acne vulgaris, facial rosacea, and perioral dermatitis.
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Special Precautions
Not recommended for the treatment of diaper dermatitis. Children. Pregnancy and lactation. Patient Counselling Do not use occlusive dressing. Avoid contact with eyes or mouth. Monitoring Parameters Monitor for signs and symptoms of HPA axis suppression or adrenal insufficiency, signs of skin infection or ocular changes.
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Adverse Reactions
Significant: Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, visual disturbances (e.g. blurred vision, glaucoma, posterior subcapsular cataract, central serous chorioretinopathy); intracranial hypertension, and systemic effects (e.g. manifestations of Cushing's syndrome, glycosuria, hyperglycaemia) particularly in children.
General disorders and administration site conditions: Oedema.
Infections and infestations: Secondary infection.
Nervous system disorders: Paraesthesia.
Skin and subcutaneous tissue disorders: Burning and stinging sensation, irritation, maculopapular rash, skin dryness, erythema, pruritus, skin peeling, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, skin atrophy, striae, miliaria.
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Lab Interference
Betamethasone: May suppress the flare and wheal reactions to skin test antigens.
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Action
Betamethasone is a corticosteroid that has anti-inflammatory, antipruritic, and vasoconstrictive actions. It induces the phospholipase A2 inhibitory proteins (lipocortins) and sequentially inhibits the release of arachidonic acid, thereby depressing the formation, release, and activity of endogenous chemical mediators of inflammation (e.g. prostaglandins, kinins, histamine, liposomal enzymes).
Clotrimazole is an imidazole antifungal agent. It alters cell wall permeability by binding to phospholipids in the fungal cell membrane which leads to loss of essential intracellular elements, thereby inhibiting fungal growth.
Absorption: Betamethasone: Absorbed percutaneously. Clotrimazole: Penetrates the epidermis. Distribution: Betamethasone: Crosses the placenta. Metabolism: Betamethasone: Metabolised in the liver. Clotrimazole: Metabolised in the liver to inactive compounds. Excretion: Betamethasone: Via urine and bile. Clotrimazole: Via faeces and urine. |
Storage
Topical/Cutaneous: Store between 20-25°C.
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CIMS Class
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ATC Classification
S01BA06 - betamethasone ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye.
D01AC01 - clotrimazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection. C05AA05 - betamethasone ; Belongs to the class of products containing corticosteroids for topical use. Used in the treatment of hemorrhoids and anal fissures. H02AB01 - betamethasone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations. S01CB04 - betamethasone ; Belongs to the class of corticosteroids/antiinfectives/mydriatics combinations. Used in the treatment of eye diseases. D07XC01 - betamethasone ; Belongs to the class of potent (group III) corticosteroids in other combinations. Used in the treatment of dermatological diseases. D07AC01 - betamethasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases. R03BA04 - betamethasone ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticoids. A01AB18 - clotrimazole ; Belongs to the class of local antiinfective and antiseptic preparations. Used in the treatment of diseases of the mouth. A07EA04 - betamethasone ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation. R01AD06 - betamethasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis. G01AF02 - clotrimazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections. S02BA07 - betamethasone ; Belongs to the class of corticosteroids used in the treatment of inflammation of the ear. S03BA03 - betamethasone ; Belongs to the class of corticosteroids used in ophthalmologic and otologic preparations. |