Ezex

• Approved Indications:
• Treatment of inflammatory skin conditions including:
• Eczema (atopic dermatitis)
• Dermatitis (contact, seborrheic, nummular)
• Psoriasis (mild to moderate, excluding widespread or severe cases)
• Pruritic dermatoses with inflammatory component
• Relief of itching, redness, and swelling associated with these dermatologic conditions.
• Clinically Accepted Off-Label Uses:
• Treatment of other steroid-responsive dermatoses with inflammation and pruritus.
• Use in conditions where lower potency corticosteroids have proven insufficient but high-potency corticosteroids are not indicated.

• Adults and Children (≥12 years):
• Apply a thin layer of clobetasone butyrate cream, ointment, or lotion to the affected area once to twice daily.
• Duration usually limited to up to 2 weeks; extension only under medical supervision.
• Pediatrics (<12 years):
• Use cautiously; generally recommended only for short-term use and under specialist guidance.
• Elderly:
• Use standard dosing with careful monitoring for side effects due to potentially thinner skin.
• Special Populations:
• No specific dosage adjustment for renal or hepatic impairment due to topical route.
• Avoid use on large surface areas or prolonged use to minimize systemic absorption.
• Administration Notes:
• Topical application only.
• Avoid use on face, groin, or axilla unless prescribed.
• Do not cover treated skin with occlusive dressings unless directed.

Clobetasone butyrate is a medium-potency corticosteroid that binds to intracellular glucocorticoid receptors, modulating transcription of anti-inflammatory proteins and repressing pro-inflammatory genes. This action results in decreased release of inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines), reduction in capillary permeability, suppression of leukocyte migration, and inhibition of edema, erythema, and pruritus. The net effect is a decrease in inflammation, immune response, and associated symptoms in the skin.

• Absorption:
  Minimal systemic absorption when applied topically to intact skin; absorption may increase with broken skin or occlusion.
• Distribution:
  Primarily localized to skin layers at application site.
• Metabolism:
  Any absorbed drug is metabolized hepatically via reduction and conjugation.
• Elimination:
  Metabolites are excreted mainly via urine.
• Half-life:
  Not clinically significant due to topical use.
• Onset of Action:
  Clinical effects typically observed within days of starting treatment.

• Pregnancy:
  Classified as Category C by FDA; limited human data available. Use only if clearly needed and under medical supervision. Avoid extensive or prolonged use during pregnancy.
• Lactation:
  Limited data; topical application leads to minimal systemic exposure. Use with caution and avoid application to breast area during breastfeeding.

• Primary Therapeutic Class: Topical corticosteroid
• Subclass: Medium-potency glucocorticoid

• Known hypersensitivity to clobetasone butyrate or formulation excipients.
• Untreated bacterial, fungal, or viral skin infections at the treatment site.
• Rosacea, perioral dermatitis, acne vulgaris, or skin ulcers.
• Use on eyes or mucous membranes.
• Application to thin or atrophic skin areas without specialist advice.

• Prolonged use may cause skin atrophy, striae, telangiectasia, or hypothalamic-pituitary-adrenal (HPA) axis suppression.
• Avoid use under occlusive dressings unless prescribed.
• Monitor for secondary infections; discontinue if infection develops.
• Use cautiously in children, elderly, and those with impaired skin barrier.
• Discontinue if local irritation or hypersensitivity occurs.

• Common: Burning, itching, irritation, dryness at application site.
• Less common: Skin thinning, telangiectasia, folliculitis.
• Rare: Allergic contact dermatitis, secondary infections, HPA axis suppression with extensive or prolonged use.

• Minimal systemic drug interactions due to topical use.
• Avoid concurrent use with other topical corticosteroids unless directed.
• Use caution when combining with skin irritants or other topical agents.

• Current guidelines emphasize limiting medium-potency corticosteroids like clobetasone butyrate to short-term use (≤2 weeks) for inflammatory dermatoses to minimize side effects.
• Avoid use on face or thin skin areas except under specialist supervision.
• Increased caution advised in children and elderly populations.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from excessive heat and moisture.
• Keep container tightly closed.
• Keep out of reach of children.