OTOZOL 1% EAR DROPS 10ML

Indications

Approved Uses

Otomycosis (fungal otitis externa) due to susceptible fungi (e.g., Candida spp., Aspergillus spp.).

Dosage & Administration

Dosing by Condition

Otomycosis: Instill 4 drops (1 vial, 0.20 ml) into the affected ear(s) twice daily for 14 days.

Initial Dose

instill 1 vial (0.20 ml) in the affected ear canal twice daily.

Maintenance Dose

instill 1 vial (0.20 ml) in the affected ear canal twice daily for 14 consecutive days.

Maximum Dose

instill 1 vial (0.20 ml) in the affected ear canal twice daily for 14 consecutive days.

Children's Dosage

Not established for children; use under clinician supervision.

Dose Adjustment Notes

No dose adjustment required for renal or hepatic impairment due to negligible systemic absorption

How to Take

Wash hands. Warm the bottle in the hand. Tilt head with affected ear up. For adults pull pinna up and back (children: down and back) to straighten canal. Instill the prescribed number of drops without touching the dropper tip to the ear/skin. Gently press the tragus to help entry. Keep head tilted for 1-3 minutes; wipe excess. Replace cap tightly.

Side Effects

Common Side Effects

Local irritation (burning, stinging), itching, redness/erythema.

Side Effect Frequency

Primarily local application-site reactions: burning/stinging/irritation, pruritus, erythema (frequency not well quantified for otic use); hypersensitivity/contact dermatitis is uncommon/rare; systemic effects such as headache are not expected with auricular use.

Safety & Warnings

Contraindications

Hypersensitivity to clotrimazole or any component of the formulation

Warnings & Precautions

For ear use only; avoid eyes; do not use if tympanic membrane is perforated/suspected; keep ear dry; stop if significant irritation/hypersensitivity; seek medical review if not improving within ~7 days or if symptoms worsen.

Age Restriction

Adults (≥18 years); use in young children under clinician supervision.

Driving Warning

Safe

Drug Interactions

Drug Interactions

No clinically significant drug interactions are expected with auricular clotrimazole due to negligible systemic absorption.

Interaction Severity

No clinically significant drug interactions expected with auricular clotrimazole when used as directed.

Food Interaction

No restriction

Alcohol Interaction

Safe

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Safe

Children

Not established for children; use under clinician supervision.

Elderly

Standard adult dosing.

Kidney Impairment

No adjustment needed.

Liver Impairment

No hepatic dose adjustment is needed for auricular clotrimazole ear drops.

Storage & Patient Advice

Missed Dose

Use the missed dose as soon as remembered; if it is close to the next dose, skip the missed dose and continue the regular schedule-do not double dose.

Stopping the Medicine

Complete the prescribed course; do not stop early even if symptoms improve (do not add a fixed '14 days after symptoms clear' rule unless specifically directed).

Overdose

Overdose from auricular use is unlikely to cause systemic toxicity; if swallowed, seek medical advice/poison center and provide supportive care as needed.

Patient Counseling

Use exactly as directed and complete the course. Keep the dropper tip clean and do not touch the ear/skin. Keep the ear dry (avoid swimming/water entry) during treatment. Do not use in the eyes. Seek medical advice if severe irritation/allergy occurs, if pain/fever/discharge worsens, or if no improvement after ~7 days. Avoid use if you have (or suspect) a perforated eardrum or ear tubes unless a clinician has advised it.

Monitoring Requirements

No routine laboratory monitoring; reassess clinically if symptoms do not improve within ~7 days or if worsening occurs, and evaluate for complications (e.g., perforated tympanic membrane, bacterial co-infection).

Pharmacology

Mechanism of Action

Inhibits fungal ergosterol synthesis by inhibiting lanosterol 14-α-demethylase (CYP51), disrupting cell membrane integrity and function.

Onset of Action

Symptomatic improvement is often seen within a few days (about 3-7 days), though full resolution may take longer with completion of the course.

Duration of Effect

Effect is local and persists while drops are present; clinical cure generally requires a multi-day course (commonly 7-14 days, sometimes up to 21 days) with continued use as directed.

Half-Life

Not applicable for auricular administration due to negligible systemic absorption (systemic half-life is not clinically relevant).

Bioavailability

Systemic absorption is negligible with auricular use on intact external canal skin; systemic exposure is not expected to be clinically significant.

Metabolism

Negligible systemic absorption; if absorbed, clotrimazole is extensively metabolized in the liver (primarily via CYP3A4, with contribution from CYP2C9).

Excretion

Negligible systemic absorption after auricular use; if any is absorbed, clotrimazole is eliminated mainly via biliary/fecal excretion with minor renal excretion of metabolites.

Protein Binding

High plasma protein binding (~90% or higher) if systemically absorbed; not clinically relevant for auricular use due to negligible absorption.

Product Information

Available Dosage Forms

Ear drops (auricular solution) for this product (OTOZOL 1% EAR DROPS 10 mL).

Composition per Dose

Each 1 ml: 10 mg clotrimazole 1% in otic solution

Generic Availability

Yes

OTC Alternatives

No direct OTC antifungal ear-drop alternative is reliably recommended; refer for assessment/appropriate therapy if symptoms persist or diagnosis is uncertain.

Target Organ

Ear

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