Cliomet

 1%+0.02% Ear Drop
Incepta Pharmaceuticals Ltd.

5 ml drop: ৳ 100.00

Indications
  • 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.
Dosage & Administration
  • 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.
Mechanism of Action (MOA)

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.

Pharmacokinetics
  • 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 Category & Lactation
  • 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.
Therapeutic Class
  • Primary Class: Topical Corticosteroid and Antimicrobial Combination
  • Subclasses:
    • Clioquinol: Antibacterial and Antifungal agent (hydroxyquinoline derivative)
    • Flumetasone pivalate: Medium-potency fluorinated corticosteroid
Contraindications
  • 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.
Warnings & Precautions
  • 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.
Side Effects
  • 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.
Drug Interactions
  • 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.
Recent Updates or Guidelines
  • 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.
Storage Conditions
  • 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.
Available Brand Names