DEWAX EAR DROPS 10ML

Indications

Approved Uses

Softening and aiding removal of excessive/impacted earwax (cerumen); off-label use.

Off-Label Uses

Docusate sodium is sometimes used as a cerumenolytic agent, even though it is not officially approved.

Dosage & Administration

Dosing by Condition

Cerumen impaction/excessive wax: instill enough drops to fill the affected ear canal once or twice daily (often at bedtime if once daily) for up to 3-4 days, then wax may be removed/irrigated if needed as directed by a clinician.

Children's Dosage

May be used in children under medical supervision; same dose as adults (1 mL per affected ear). Use with caution in young children - confirm intact tympanic membrane before use

Dose Adjustment Notes

No dose adjustment is required; for auricular use only and do not use for more than 3-4 days without medical review.

How to Take

For auricular use only: warm the bottle in the hand, tilt head/lie with affected ear upward, instill enough drops to fill the ear canal (avoid touching the dropper tip to the ear), gently press the tragus to help entry, and keep the ear upward for several minutes; a loose cotton plug may be placed at the ear opening if needed to prevent leakage (do not pack deeply).

Side Effects

Common Side Effects

Transient local irritation/stinging or discomfort, sensation of fullness, and temporary reduced hearing immediately after instillation.

Side Effect Frequency

Uncommon: local irritation/stinging/burning, pruritus, transient discomfort or fullness; Rare: hypersensitivity/contact dermatitis.

Safety & Warnings

Contraindications

Perforated (or suspected perforated) tympanic membrane; hypersensitivity to docusate sodium/excipients; do not use when ear pain, discharge, or active ear infection/inflammation is present unless assessed by a clinician.

Warnings & Precautions

For auricular use only; do not use with known/suspected tympanic membrane perforation or when ear pain, discharge, or infection is present without clinician assessment; stop if irritation/pain/dizziness occurs; avoid inserting cotton buds/objects into the ear; if symptoms persist beyond 2-3 days, seek medical evaluation.

Age Restriction

No fixed minimum age in labeling; use in infants/young children only under clinician supervision (practically avoid routine self-use in <1 year).

Driving Warning

Safe

Drug Interactions

Drug Interactions

No clinically significant systemic drug interactions expected; if other ear drops are needed, separate administration times to avoid dilution/washout.

Interaction Severity

No clinically significant drug interactions expected; if using other ear drops, separate administration by at least 10-15 minutes to avoid dilution/washout.

Food Interaction

No food interactions (not applicable for otic administration).

Special Populations

Breastfeeding

Safe

Children

May be used in children under medical supervision; same dose as adults (1 mL per affected ear). Use with caution in young children - confirm intact tympanic membrane before use

Elderly

Standard adult dosing.

Kidney Impairment

No adjustment needed

Liver Impairment

No adjustment needed

Storage & Patient Advice

Stopping the Medicine

Stop at any time; stop immediately and seek medical advice if pain, irritation, dizziness, discharge, or hearing worsening occurs, or if not improved after 2-3 days of use.

Patient Counseling

For auricular use only (do not swallow). Use only if the tympanic membrane is intact-do not use with suspected perforation, grommets, ear infection, significant ear pain, or discharge unless a clinician advises. Warm the bottle in the hand, tilt head/lie with affected ear up, instill the prescribed number of drops without touching the dropper tip to the ear, and keep the ear up for a few minutes; a loose cotton plug may be used if needed. Use for a short course (typically 1-3 days) and seek medical advice if not improving or if pain, rash, dizziness/vertigo, or worsening symptoms occur.

Monitoring Requirements

No routine monitoring; otoscopic examination to confirm cerumen removal if needed

Pharmacology

Mechanism of Action

An anionic surfactant that lowers surface tension, allowing water/lipids to penetrate and soften/disperse cerumen, facilitating its removal.

Onset of Action

Softening can begin within minutes to hours after instillation, but meaningful clinical softening/removal typically occurs over 1-3 days of repeated use (up to 3-4 days).

Duration of Effect

Local effect lasts while the solution remains in contact with cerumen; clinically, softening accumulates over repeated applications across 1-3(-4) days.

Half-Life

Not clinically applicable/unknown for otic use due to negligible systemic absorption.

Bioavailability

Minimal to negligible systemic absorption is expected with auricular use when the tympanic membrane is intact.

Metabolism

Not clinically applicable for otic use; if absorbed, docusate undergoes metabolism (including hydrolysis) with subsequent elimination mainly in feces.

Excretion

Not clinically applicable for otic use; if any small amount is systemically absorbed, docusate and metabolites are primarily eliminated via bile/feces with minor urinary excretion.

Product Information

Available Dosage Forms

Ear drops (otic/auricular solution).

Composition per Dose

Each 1 mL: 50 mg docusate sodium (5%)

Generic Availability

Yes

OTC Alternatives

Olive oil (or other mineral/almond oil) drops, sodium bicarbonate drops, and carbamide peroxide ear drops (where available OTC).

Target Organ

Ear

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