Copnat-N

• Approved Indications:
• Treatment of moderate to severe inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, such as:
• Psoriasis vulgaris (especially plaque psoriasis)
• Atopic dermatitis
• Lichen planus
• Discoid lupus erythematosus
• Contact dermatitis
• Seborrheic dermatitis
• Management of lichen simplex chronicus and other chronic skin conditions unresponsive to less potent steroids.
• Treatment of oral mucosal inflammatory lesions (in suitable topical formulations).
• Clinically Accepted Off-Label Uses:
• Alopecia areata.
• Vitiligo (for reducing inflammation).
• Other resistant eczematous and inflammatory dermatoses.

• Adults:
• Apply a thin layer to the affected area once or twice daily.
• Duration typically limited to 2 weeks for continuous use to avoid adverse effects.
• Maximum dose usually not exceeding 50 grams per week.
• Pediatrics (≥12 years):
• Use with caution; apply thinly once daily.
• Duration and frequency should be limited due to increased risk of systemic absorption.
• Elderly:
• Use the lowest effective dose.
• Monitor closely for skin thinning and systemic effects.
• Special Populations:
• No specific dosage adjustment in renal or hepatic impairment due to minimal systemic absorption, but caution advised for extensive or prolonged use.
• Administration Notes:
• For topical use only.
• Avoid use on face, groin, or axilla unless directed.
• Avoid occlusive dressings unless prescribed.
• Do not apply on broken or infected skin.

Clobetasol propionate is a synthetic high-potency corticosteroid that binds to intracellular glucocorticoid receptors, modulating gene transcription to suppress pro-inflammatory cytokines and mediators such as prostaglandins and leukotrienes. This results in potent anti-inflammatory, immunosuppressive, antipruritic, and vasoconstrictive effects. The drug inhibits inflammatory cell infiltration, edema, capillary dilation, and fibroblast proliferation, thereby rapidly reducing skin inflammation and symptoms in corticosteroid-responsive dermatoses.

• Absorption:
  Minimal systemic absorption under normal topical use; increased with damaged skin or prolonged use.
• Distribution:
  Primarily localized within the epidermis and dermis.
• Metabolism:
  Extensively metabolized hepatically to inactive metabolites.
• Excretion:
  Eliminated via urine and feces.
• Half-life:
  Not clinically significant due to topical route.
• Onset of action:
  Anti-inflammatory effects often observed within hours to days of application.

• Pregnancy:
  Classified as FDA Category C. Use only if potential benefit justifies the risk to the fetus. Topical use leads to low systemic absorption.
• Lactation:
  Systemic absorption is minimal; however, caution is advised. Avoid applying to breast area to prevent infant exposure.
• Caution: Use during pregnancy and breastfeeding only under medical supervision.

• Primary Class: Topical Corticosteroid
• Subclass: High-potency (Class I) corticosteroid

• Hypersensitivity to clobetasol propionate or formulation excipients.
• Untreated bacterial, viral, or fungal skin infections.
• Rosacea, perioral dermatitis, acne vulgaris.
• Use on eyes or eyelids.
• Children under 12 years (unless under specialist supervision).

• Limit treatment duration to maximum 2 consecutive weeks to prevent skin atrophy, striae, and systemic corticosteroid effects.
• Avoid occlusive dressings unless specifically directed.
• Use caution in patients with diabetes, hypertension, or other conditions aggravated by corticosteroids.
• Monitor for hypothalamic-pituitary-adrenal (HPA) axis suppression in extensive or prolonged use.
• Avoid use on large areas or broken skin to reduce systemic absorption risk.
• Discontinue if skin irritation or hypersensitivity occurs.
• Avoid use in pediatrics without specialist guidance.

• Common: Burning, itching, irritation, dryness at application site.
• Less common: Skin atrophy, telangiectasia, hypopigmentation, striae, folliculitis.
• Rare: Allergic contact dermatitis, secondary infections.
• Severe (rare): HPA axis suppression, Cushing's syndrome with prolonged use.
• Side effects generally related to potency, duration, and area of use.

• Minimal systemic interactions due to topical use.
• Potential additive effects with other systemic corticosteroids if absorbed.
• Avoid concomitant use with other topical corticosteroids to reduce cumulative potency and risk of side effects.

• Emphasis on restricting duration of use to avoid skin and systemic adverse effects.
• Updated recommendations advise against use on face and intertriginous areas except under specialist care.
• Guidelines encourage patient education on correct application and monitoring for side effects.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from light and moisture.
• Do not freeze.
• Keep container tightly closed.
• Keep out of reach of children.