Dexcilo

Approved Indications:

• Acute Otitis Externa in Adults and Children ≥6 months: Treatment of inflammation and infection in the external auditory canal when caused by susceptible pathogens (e.g., Pseudomonas aeruginosa, Staphylococcus aureus).
• Otitis Media with Tympanostomy Tubes and Concomitant Otorrhea (Tympanostomy Tube–Otorrhea): For children and adults with tympanostomy tubes who develop otorrhea.

Off‑Label / Clinically Accepted Uses:

• Chronic Suppurative Otitis Media (with ear tubes): Short‑term use to control acute exacerbations.
• Post‑operative ear canal inflammation or infection (e.g., after mastoidectomy), in monitored settings.

Adults and Children ≥6 months:

• Standard Dose: 4 drops into affected ear(s) twice daily (every 12 hours) for 7 days.
• Administration:

1.        Lay on side with affected ear up.

2.        Warm bottle in hands to body temperature.

3.        Gently pull earlobe to open canal and instill drops.

4.        Keep ear upward for ~1 minute or use cotton plug.

5.        Clean external canal before next dose if necessary.

• Duration: Typically 7 days; extend only under medical supervision.

Special Populations:

• Elderly: Same dosing; monitor for ototoxicity or local irritation.
• Renal or Hepatic Impairment: No dose adjustment needed since systemic absorption is minimal.

• Ciprofloxacin is a broad‑spectrum fluoroquinolone antibiotic that inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, critical enzymes for DNA replication and repair—leading to rapid bactericidal activity.
• Dexamethasone is a potent synthetic glucocorticoid that modulates gene expression to suppress inflammatory cytokine production, reduce capillary permeability, and inhibit inflammatory cell infiltration—thereby relieving pain, swelling, and erythema. Together, the formulation eradicates infection while reducing inflammation and discomfort.

• Absorption: Minimal systemic absorption via intact tympanic membrane; systemic exposure negligible.
• Distribution: Concentrated locally in ear canal and middle ear drainage; not measurable systemically.
• Metabolism: Very limited systemic metabolism of tiny absorbed amounts; ciprofloxacin undergoes hepatic metabolism if absorbed; dexamethasone metabolized by CYP3A4.
• Elimination: Excreted unchanged in ear canal; minute systemic fractions eliminated renally or via bile.
• Onset of Action: Symptom relief often begins within 24–48 hours; bacterial eradication achieved within several days.

• Pregnancy:
• Ciprofloxacin is Pregnancy Category C (FDA)—animal studies show potential risk; limited human data. Topical otic use results in minimal systemic exposure, reducing risk.
• Dexamethasone similarly is Category C when systemic; otic use is unlikely to cause systemic effects.
• Use only if clearly needed and if benefits outweigh theoretical risks.
• Lactation:
• Minimal absorption into breast milk expected.
• Considered low risk during breastfeeding when used otically; systemic levels are virtually negligible.

• Primary Class: Otic antibiotic–steroid combination
• Subclass: Fluoroquinolone antibiotic + topical glucocorticoid

• Known hypersensitivity to ciprofloxacin, dexamethasone, or any component of the formulation
• Perforated tympanic membrane without medical advice (unless labeling specifically approved for perforated eardrum use)
• Viral or fungal infection of the ear (e.g., herpes simplex, mycotic otitis externa) without appropriate antifungal/antiviral therapy
• Prior history of fluoroquinolone-associated tendon disorders

• Ear Drum Status: Verify intact tympanic membrane before use unless product labeling supports use in perforated cases.
• Ototoxicity Potential: Though rare with otic administration, monitor for hearing changes—especially in patients with perforated membranes or prolonged use.
• Superinfection Risk: Use caution if fungal superinfection develops—discontinue if no improvement or signs of new infection.
• Allergic Reactions: Watch for rash, itching, or systemic reactions; discontinue if hypersensitivity occurs.
• Resistant Organisms: Use only when clinically indicated; avoid indiscriminate use to minimize resistance.

Common (≤5%):

• Ear discomfort or burning/stinging sensation
• Itching or irritation of ear canal
• Ear discharge (often due to underlying infection)

Less Common / Rare:

• Transient hearing impairment or tinnitus
• Vertigo
• Allergic contact dermatitis
• Secondary fungal infection (otitis externa)

Serious / Rare:

• Hypersensitivity reactions such as angioedema or severe rash (extremely rare)
• Ototoxicity (in patients with persistent perforation or prolonged use)

Onset & Dependency:
Local irritation may occur within initial doses; allergic or ototoxic effects emerge with prolonged or inappropriate use; most adverse effects are mild and reversible upon discontinuation.

• Systemic Interactions: Minimal due to negligible systemic absorption.
• CYP450 Considerations: Dexamethasone systemic metabolism is via CYP3A4, but systemic levels are minimal in otic use. Concomitant potent CYP3A4 inhibitors are unlikely to produce clinically meaningful interaction.
• Drug‑Device Interaction: Avoid using ear drops if cerumen obstructs canal—clean canal before instillation; avoid using with other otic preparations unless advised.

• FDA/EMA: Ongoing reaffirmation of safety profile for combined otic formulations; no new black‑box warnings.
• Pediatric Guidelines (2023): Strong endorsement for use in children ≥6 months with tympanostomy‑tube otorrhea.
• Antimicrobial Stewardship Recommendations: Advise limiting use to appropriately diagnosed bacterial otitis externa or otorrhea with tubes to avoid resistance.

• Store between 20 °C and 25 °C (room temperature).
• Protect from light; store in original container with cap tightly closed.
• Do not freeze.
• Shake gently before use to ensure uniform suspension.
• Discard within the expiry period; avoid using drops beyond the labeled duration after opening (commonly 28 days).
• Keep out of reach of children.