Waxnil

Approved Indications:

• Cerumen Impaction (Earwax Removal):
  Sodium Bicarbonate ear preparations are indicated for the softening and dispersal of impacted or excessive earwax (cerumen) in the external auditory canal in adults and children.
• Facilitating Aural Toilet:
  Used as an adjunctive agent before ear irrigation or manual ear cleaning by healthcare professionals to ease wax removal.

Clinically Accepted Off-Label Uses:

• Preparation Prior to Otological Procedures:
  Occasionally used to prepare the ear canal before otoscopic examination or otologic surgeries requiring a clear view of the tympanic membrane.

Route of Administration: Otic (topical to the ear canal)

Adults and Elderly:

• Instill 3 to 5 drops of Sodium Bicarbonate ear drops into the affected ear once or twice daily.
• Keep the head tilted for 5 to 10 minutes to allow the solution to penetrate and soften wax.
• Continue for up to 7 days, or as directed by a physician.

Pediatric Use:

• Safe for use in children above 1 year under medical supervision.
• Use 2 to 3 drops once or twice daily for up to 3 to 5 days.
• Not typically recommended for infants <6 months unless prescribed.

Special Populations:

• Renal/Hepatic Impairment: Not systemically absorbed; no dosage adjustment required.
• Otic Surgery Patients: Use with caution if tympanic membrane integrity is compromised.

Administration Instructions:

• Warm the bottle to body temperature before use to avoid dizziness.
• Do not insert applicators or cotton buds deeply into the ear canal.
• Shake bottle gently before use if required.

Sodium Bicarbonate ear preparations exert their effect by releasing sodium and bicarbonate ions upon contact with cerumen. The bicarbonate ions raise the pH and break down keratin and lipids within the earwax, softening and dispersing the impacted material. This facilitates natural migration of wax or easier removal during ear irrigation. The mild alkaline environment also inhibits microbial growth, thereby reducing the risk of secondary infections.

Sodium Bicarbonate used in ear preparations is not systemically absorbed when applied topically to the intact external ear canal.

• Absorption: Minimal to none through the intact tympanic membrane.
• Distribution: Not applicable (localized action).
• Metabolism: Not metabolized locally.
• Excretion: Drained naturally from the ear canal; no renal or hepatic excretion involved.
• Onset of Action: Softening may begin within 15 to 30 minutes of instillation.
• Duration: Depends on cerumen composition; repeat use over several days may be required.

Pregnancy:

• FDA Category C (systemic form); however, topical otic use is considered low risk.
• Since absorption is negligible through the intact ear canal, Sodium Bicarbonate ear drops are generally considered safe for use during pregnancy when clearly needed.

Lactation:

• No data indicate excretion into breast milk.
• Topical otic use is not expected to pose a risk to a breastfed infant.

Caution:
Use only if the tympanic membrane is intact. Safety not established in perforated eardrums.

• Primary Class: Cerumenolytic Agent (Topical)
• Sub-class: Alkalinizing Agent (Otic Use)

• Known hypersensitivity to Sodium Bicarbonate or any excipients in the formulation.
• Perforated tympanic membrane or known/suspected tympanic membrane damage.
• Otitis media or external ear infections unless advised by a physician.
• Post-operative otologic surgery (e.g., mastoidectomy) without physician supervision.

• Avoid use if eardrum is perforated or if there is a history of ear surgery.
• Discontinue use immediately if pain, burning, or worsening symptoms occur.
• Not intended for prolonged use beyond 7 days unless under medical advice.
• Do not insert objects into the ear canal during treatment (e.g., cotton buds).
• Use with caution in children, especially under 3 years.

Common (Ear-related):

• Mild stinging or tingling at the site of application
• Transient dizziness (especially if the solution is cold)
• Ear discomfort or itching

Less Common:

• Local irritation or redness
• Ear discharge due to softened wax migration

Rare but Serious:

• Otitis externa (secondary infection)
• Ear canal inflammation if used with damaged tympanic membrane
• Allergic contact dermatitis

Most effects are mild and reversible. Discontinue if irritation persists.

• No systemic absorption, hence minimal risk of systemic drug-drug interactions.
• Topical interactions: Avoid concurrent use with other otic medications unless advised by a physician, as altered pH may affect drug activity.
• Enzyme systems: Not involved (no CYP450-related interactions).

• No recent changes in approved indications or dosing guidelines specific to Sodium Bicarbonate ear preparations.
• Guidelines continue to recommend cerumenolytics (like Sodium Bicarbonate) as first-line non-invasive therapy for impacted cerumen before attempting irrigation.
• No black box warnings or regulatory restrictions reported as of the latest updates from regulatory authorities (FDA, NICE, WHO).

• Store below 25°C (77°F) in a cool, dry place.
• Do not freeze.
• Protect from light and tightly close the cap after use.
• Use within 28 days of opening the bottle.
• Keep out of reach of children.
• Shake gently before use if separation is observed.