Clioquinol + Fluocinolone Acetonide

• Infected Eczematous Dermatitis: Treatment of inflammatory dermatoses complicated by superficial bacterial or fungal infections sensitive to clioquinol, requiring both antimicrobial and anti-inflammatory effects.
• Otitis Externa: Management of infected inflammation of the external auditory canal caused by susceptible organisms.
• Other Superficial Infections with Inflammation: Such as seborrheic dermatitis or psoriasis with secondary infection where topical corticosteroid and antimicrobial therapy is indicated.

• Adults and Adolescents (≥12 years):
• Topical Cream or Ointment: Apply a thin film to the affected skin areas twice daily (morning and evening). Treatment duration should generally not exceed 7–10 days without reevaluation.
• Ear Drops: If formulated for otic use, instill 2–3 drops into the affected ear twice daily for 7–10 days or as prescribed.
• Pediatrics (<12 years):
• Use only under medical supervision. Safety and efficacy in young children have not been firmly established.
• Elderly:
• No specific dosage adjustment necessary; monitor for corticosteroid-related skin effects.
• Special Populations:
• No dose modification required in renal or hepatic impairment due to minimal systemic absorption.
• Administration Notes:
• Avoid application to broken skin, eyes, and mucous membranes.
• Do not use occlusive dressings unless directed.

Clioquinol acts as a broad-spectrum antimicrobial by chelating essential metal ions, disrupting microbial enzymatic processes and inhibiting replication of bacteria and fungi involved in skin infections. Fluocinolone acetonide is a potent topical corticosteroid that binds to intracellular glucocorticoid receptors, inhibiting the expression of inflammatory mediators such as cytokines and prostaglandins. This combination results in reduction of microbial load and rapid control of inflammation, erythema, and pruritus associated with infected dermatoses.

• Absorption:
  Minimal systemic absorption under normal topical use; absorption increases with damaged skin or prolonged application.
• Distribution:
  Primarily localized within the epidermis and dermis.
• Metabolism:
• Fluocinolone acetonide is metabolized hepatically to inactive metabolites.
• Clioquinol undergoes hepatic metabolism if systemically absorbed.
• Excretion:
  Eliminated mainly via renal and biliary routes.
• Half-life:
  Not clinically relevant in topical formulations due to low systemic exposure.
• Onset of Action:
  Clinical improvement usually noted within days of therapy initiation.

• Pregnancy:
  Limited human data. Use only if clearly needed and when benefits outweigh risks. Topical use likely low risk with minimal systemic absorption.
• Lactation:
  Minimal excretion into breast milk expected. Avoid application to the breast area to prevent infant exposure.
• Caution:
  Use during pregnancy and lactation only under medical supervision.

• Primary Class: Topical Corticosteroid and Antimicrobial Combination
• Subclass:
• Clioquinol: Antibacterial and antifungal agent (hydroxyquinoline derivative)
• Fluocinolone acetonide: Medium-to-high potency fluorinated corticosteroid

• Hypersensitivity to clioquinol, fluocinolone acetonide, or any excipients.
• Skin infections caused by viruses (e.g., herpes simplex, varicella), tuberculosis, or syphilis.
• Perforated tympanic membrane when used as ear drops.
• Rosacea, acne vulgaris, or perioral dermatitis.

• Prolonged or extensive use may lead to systemic corticosteroid effects including hypothalamic-pituitary-adrenal (HPA) axis suppression.
• Risk of local adverse effects such as skin atrophy, telangiectasia, and striae with chronic use.
• Avoid use on large body surface areas or under occlusion unless directed.
• Discontinue if secondary infection worsens or hypersensitivity develops.
• Avoid contact with eyes; may increase intraocular pressure if exposure occurs.

• Common: Skin irritation, burning, dryness, itching, and redness at the application site.
• Less common: Skin thinning, striae, telangiectasia, hypopigmentation.
• Rare: Allergic contact dermatitis, secondary infections, systemic corticosteroid effects with long-term use.
• Otic use specific: Ear irritation or discomfort.

• Concomitant use with other topical corticosteroids may increase risk of adverse effects.
• May reduce efficacy of live vaccines if extensive systemic absorption occurs.
• Clioquinol can interfere with thyroid function tests.
• No significant CYP450 interactions are expected due to topical administration.

• Clinical guidelines emphasize limiting duration to 7–10 days to minimize steroid-related adverse effects.
• Updated labeling reinforces risk of skin atrophy and systemic absorption with prolonged use.
• Dermatology consensus supports combined antimicrobial-corticosteroid use for short-term treatment of infected dermatoses.

• Store at 20°C to 25°C (68°F to 77°F), protected from light and moisture.
• Do not freeze.
• Keep container tightly closed.
• Discard opened ear drops according to manufacturer instructions, typically within 4–8 weeks.
• Avoid contamination of applicator or dropper tip.