Clioquinol + Flumetasone Pivalate

• Infected Eczematous Dermatitis: Treatment of inflammatory skin conditions complicated by superficial bacterial or fungal infections, where both antimicrobial and anti-inflammatory effects are required.
• Otitis Externa: Topical treatment of infected external ear canal inflammation caused by susceptible organisms.
• Other Superficial Dermatoses with Secondary Infection: As determined by clinical judgment, including seborrheic dermatitis with secondary infection.

• Adults and Adolescents (≥12 years):
• Topical Cream: Apply a thin layer to the affected skin twice daily (morning and evening). Duration should not exceed 7–10 days without reevaluation.
• Ear Drops: Instill 2–3 drops into the affected ear twice daily. Treatment duration usually 7–10 days.
• Pediatric Use:
  Use with caution in children above 2 years. Safety and efficacy not established in children under 2.
• Elderly:
  No specific dosage adjustments; monitor for skin thinning or steroid-related effects.
• Special Populations:
  No dose modification required in renal or hepatic impairment due to minimal systemic absorption.
• Administration Notes:
• Apply only to intact skin.
• Avoid contact with eyes and mucous membranes.
• Do not use occlusive dressings unless directed by a physician.

Clioquinol acts as a broad-spectrum antimicrobial agent by chelating metal ions essential for microbial enzyme function, disrupting DNA and protein synthesis in susceptible bacteria and fungi. Flumetasone pivalate is a potent topical corticosteroid that binds glucocorticoid receptors, modulating gene expression to suppress inflammatory cytokines and immune responses. The combination provides dual action: clioquinol controls infection, while flumetasone reduces inflammation, pruritus, and erythema.

• Absorption: Minimal systemic absorption under normal use. Increased absorption may occur with prolonged use, occlusion, or damaged skin.
• Distribution: Localized primarily within skin layers.
• Metabolism:
• Clioquinol metabolized hepatically if systemically absorbed.
• Flumetasone pivalate undergoes hepatic metabolism to inactive compounds.
• Excretion: Eliminated via urine and bile.
• Half-life: Not clinically significant due to topical administration.
• Onset: Clinical effects usually observed within days of application.

• Pregnancy: Use only if potential benefit justifies potential risk. Limited human data; animal studies do not show direct teratogenicity with topical use.
• Lactation: Minimal systemic absorption; unlikely to affect nursing infants. Avoid application on breast area to prevent infant exposure.
• Caution advised due to insufficient data.

• Primary Class: Topical Corticosteroid and Antimicrobial Combination
• Subclasses:
• Clioquinol: Antibacterial and Antifungal agent (hydroxyquinoline derivative)
• Flumetasone pivalate: Medium-potency fluorinated corticosteroid

• Hypersensitivity to clioquinol, flumetasone pivalate, or formulation excipients.
• Viral skin infections (e.g., herpes simplex, varicella).
• Tuberculous or syphilitic skin infections.
• Perforated tympanic membrane when used as ear drops.
• Rosacea or acne vulgaris involving facial skin.

• Limit duration of use to minimize risk of local corticosteroid adverse effects such as skin atrophy.
• Risk of hypothalamic-pituitary-adrenal (HPA) axis suppression with extensive or prolonged use.
• Avoid occlusive dressings unless prescribed.
• Discontinue if signs of secondary infections worsen.
• Avoid contact with eyes.
• Caution in patients with thyroid disorders due to potential interference with iodine metabolism.

• Local irritation: burning, itching, erythema.
• Skin thinning, striae, telangiectasia with prolonged use.
• Hypopigmentation or hyperpigmentation.
• Allergic contact dermatitis (rare).
• Possible systemic corticosteroid effects with long-term extensive use.
• Rare otic adverse effects: ear irritation or discomfort.

• May reduce response to live vaccines if used extensively.
• Potential additive effects with other topical corticosteroids.
• Clioquinol may interfere with thyroid function tests.
• No significant CYP450 enzyme interactions expected.

• Emphasis on limiting treatment duration to 7–10 days.
• Reinforcement of risks of prolonged topical corticosteroid use.
• Clinical guidelines recommend careful use in infected eczematous conditions with short treatment courses to minimize 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.
• Discard opened ear drops as per manufacturer’s instructions (usually within 4–8 weeks).
• Avoid contamination of the applicator or dropper.