Cetalkonium Chloride + Choline Salicylate

• Otitis Externa:
  Treatment of bacterial infections of the external auditory canal caused by susceptible organisms.
• Inflammatory Conditions of the Ear:
  Relief of pain and inflammation associated with otitis externa and other minor ear irritations.
• Cerumen Removal Adjunct:
  May be used to aid in softening and removal of ear wax in some formulations.
• Off-label Uses:
  Symptomatic relief of mild external ear infections or inflammations where topical antimicrobial and analgesic effects are needed.

• Route: Topical administration as ear drops.
• Adults and Children (>12 years):
  Instill 3-4 drops into the affected ear(s) 3-4 times daily.
• Children (<12 years):
  Use only under medical supervision; dose adjusted based on severity.
• Duration:
  Usually 7 to 14 days or as prescribed.
• Administration Instructions:
  Warm drops to room temperature before use.
  Patient should lie with affected ear upward during administration.
  Avoid contamination of dropper tip.
• Precautions:
  Do not use if tympanic membrane is perforated unless specifically directed by a physician.

Cetalkonium chloride is a quaternary ammonium compound that acts as a cationic surfactant with broad-spectrum antimicrobial properties. It disrupts bacterial cell membranes by interacting with phospholipids, leading to increased permeability and cell death. Choline salicylate is a salicylate derivative that provides local analgesic and anti-inflammatory effects by inhibiting cyclooxygenase enzymes, reducing prostaglandin synthesis at the site of inflammation, thereby alleviating pain and swelling.

• Absorption:
  Minimal systemic absorption due to topical application in the ear canal.
• Distribution:
  Primarily localized to the external auditory canal; negligible systemic distribution.
• Metabolism:
  Not significantly metabolized systemically.
• Elimination:
  Eliminated locally; any absorbed portion likely metabolized via standard salicylate pathways.
• Onset of Action:
  Rapid local antimicrobial and analgesic effects, generally within minutes to hours.

• Pregnancy:
  Limited data on use in pregnancy. Topical use is generally considered low risk due to minimal systemic absorption. Use only if clearly needed.
• Lactation:
  Safety during breastfeeding not well studied. Minimal systemic absorption suggests low risk, but caution advised.

• Combination topical antimicrobial and analgesic agent.
• Cetalkonium chloride: Antiseptic agent (quaternary ammonium compound).
• Choline salicylate: Topical analgesic and anti-inflammatory agent (salicylate derivative).

• Known hypersensitivity to cetalkonium chloride, choline salicylate, salicylates, or any excipients.
• Perforated tympanic membrane (unless specifically prescribed).
• Severe inflammation or infections requiring systemic antibiotic therapy.

• Avoid use in patients with tympanic membrane perforation unless directed by a healthcare professional.
• Discontinue if signs of hypersensitivity or local irritation occur.
• Use with caution in patients with known salicylate allergy.
• Avoid contamination of the dropper tip to prevent secondary infections.
• Monitor for signs of worsening infection or lack of improvement after 48-72 hours.

Common:

• Local irritation, burning sensation, or itching at application site.
• Mild ear discomfort or transient stinging.

Rare/Serious:

• Allergic reactions including rash, swelling, or anaphylaxis.
• Superinfection with prolonged use.

• No significant systemic drug interactions expected due to minimal systemic absorption.
• Caution with concurrent use of other topical ear medications to avoid additive irritation.
• Avoid simultaneous use with other salicylate-containing products to reduce risk of salicylate toxicity.

• No major recent changes in indications or safety warnings.
• Continued recommendation for topical management of mild to moderate otitis externa with combined antimicrobial and analgesic effect.
• Emphasis on avoiding use in patients with tympanic membrane perforation unless prescribed by a specialist.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from light and moisture.
• Keep bottle tightly closed when not in use.
• Avoid freezing.
• Keep out of reach of children.