Indications
This ointment is used to relieve inflammation in hyperkeratotic and dry dermatoses that respond to corticosteroids. These conditions include psoriasis, chronic atopic dermatitis, neurodermatitis (lichen simplex chronicus), lichen planus, eczema (such as nummular eczema, hand eczema, and eczematous dermatitis), seborrheic dermatitis of the scalp, ichthyosis vulgaris, and other ichthyotic disorders. For use under the guidance of a registered physician.
Pharmacology
Clobetasol Propionate is a potent corticosteroid that helps reduce inflammation by stabilizing leukocyte lysosomal membranes, preventing the release of destructive enzymes from leukocytes, inhibiting macrophage accumulation in inflamed areas, decreasing capillary permeability and edema, and reducing scar formation through decreased fibroblast activity and collagen deposition.
Salicylic acid, a strong keratolytic, promotes skin exfoliation and provides mild antiseptic effects. By increasing skin hydration, it softens the stratum corneum, causing the outer layer to swell, soften, and slough off. High concentrations can have a caustic effect and offer weak antifungal and antibacterial properties.
Dosage & Administration
Adults: Apply a thin layer of the ointment to the affected areas twice daily, rubbing it in gently until absorbed. Maintenance therapy may require less frequent application. Discontinue when control is achieved; if no improvement is observed within two weeks, reevaluate the diagnosis. Avoid use with occlusive dressings. Do not exceed 50 grams per week or two consecutive weeks of use due to potential suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
Children: Not recommended for those under 12 years of age.
For use under the guidance of a registered physician.
Drug Interactions
No known interactions exist with Clobetasol Propionate when used as recommended. Salicylic Acid may increase absorption of other topical medications if applied concurrently on the same area, so avoid combining it with other topicals in the same location.
Contraindications
Clobetasol Propionate is contraindicated in patients with known hypersensitivity to it. It should not be used for untreated bacterial or fungal infections, primary viral skin infections (like herpes simplex, vaccinia, varicella), tuberculous skin lesions, or dermatoses in children under one year, including diaper dermatitis. Salicylic Acid is contraindicated in patients sensitive to salicylates or any ointment ingredient.
Side Effects
Extended use of large amounts of Clobetasol Propionate over extensive areas may cause systemic absorption, leading to hypercortisolism, especially in infants and children, or with occlusive dressings. Rarely, psoriasis treated with corticosteroids (or following their withdrawal) may develop into pustular forms. Clobetasol Propionate is generally well-tolerated; if hypersensitivity arises, discontinue use. Salicylic Acid may occasionally cause skin drying or irritation.
Pregnancy & Lactation
Topical corticosteroids may cause fetal developmental issues in animals, though human relevance is uncertain. Clobetasol Propionate should only be used during pregnancy if the potential benefit justifies the risk. The safe use of Salicylic Acid during pregnancy and lactation hasn’t been established, so it should be used with caution.
Precautions & Warnings
Exercise caution using Clobetasol Propionate near the eyes. Extended use over large areas may lead to adrenal suppression, particularly in children due to their higher skin-to-body mass ratio. Corticosteroid use in psoriasis requires careful monitoring to prevent risks such as relapse, tolerance, toxicity, or pustular psoriasis. In case of infection, stop corticosteroid use and begin antimicrobial therapy as needed. Avoid use on broken or inflamed skin, as salicylate toxicity could result from application over large areas, particularly in neonates.
Overdose Effects
Acute overdose is rare; however, prolonged misuse could result in symptoms of hypercortisolism, requiring gradual withdrawal under medical supervision. Large quantities of Salicylic Acid applied topically for extended periods may lead to symptoms of systemic salicylate toxicity, like tinnitus and dizziness. Accidental ingestion of large quantities could also cause salicylate poisoning.
Therapeutic Class
Clobetasol/Clobetasone & Combination Preparations
Storage Conditions
Store in a cool, dry place away from light.
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