Bactin HC

Approved Indications:

• Acute Otitis Externa (Swimmer’s Ear) in adults and children ≥1 year caused by susceptible strains of Pseudomonas aeruginosa, Proteus mirabilis, Staphylococcus aureus, and other gram-negative or gram-positive organisms.
• Otitis Externa with Inflammatory Symptoms: Beneficial where inflammation and infection coexist.

Clinically Accepted Off-label Uses:

• Postoperative Ear Inflammation or Minor Trauma-induced Canal Inflammation: Limited use under medical supervision.
• External Otitis in Immunocompromised Patients (e.g., diabetics): Short-term use with monitoring.

Adults and Children ≥1 year

• Dose: Instill 3 drops into the affected ear twice daily (every 12 hours).
• Duration: Continue treatment for 7 days, or as directed by physician.
• Administration Guidelines:
• Warm bottle in hand before use.
• Tilt the patient’s head or lie down with affected ear upward.
• Gently pull earlobe to straighten the canal (downward in children, upward in adults).
• Instill drops and maintain position for at least 1 minute.
• Repeat for opposite ear if required.

Elderly:

• No dosage adjustment necessary. Use with standard precautions.

Renal/Hepatic Impairment:

• No adjustment required due to minimal systemic absorption.

• Ciprofloxacin is a second-generation fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV—essential for DNA replication, transcription, and repair. This action disrupts bacterial cell division and leads to rapid cell death.
• Hydrocortisone Acetate is a corticosteroid that acts by inducing lipocortin production, which inhibits phospholipase A2. This suppression reduces prostaglandin and leukotriene synthesis, alleviating inflammation, itching, and swelling. Together, this combination addresses both infection and the inflammatory component of otitis externa.

• Absorption: Minimal systemic absorption through the intact tympanic membrane. Increased systemic absorption possible if the tympanic membrane is perforated.
• Distribution: Concentrated in the external auditory canal and local tissue; negligible systemic distribution.
• Metabolism:
• Ciprofloxacin: Hepatic metabolism via CYP1A2 pathway (negligible due to low systemic levels).
• Hydrocortisone Acetate: Undergoes enzymatic conversion to hydrocortisone; metabolized by hepatic enzymes.
• Excretion: Trace systemic amounts (if absorbed) are excreted renally for ciprofloxacin; hydrocortisone is excreted renally and in bile.
• Onset of Action: Within 24 to 48 hours for symptomatic relief.

• Pregnancy:
• Ciprofloxacin and corticosteroids fall under FDA Category C (use only if benefits outweigh risks).
• Animal studies show potential fetal risk, but no adequate human data exists for otic use.
• Given minimal systemic absorption, risk is low for topical otic application.
• Lactation:
• Systemic absorption is negligible; unlikely to be excreted in significant amounts in breast milk.
• Can be used with caution during breastfeeding.

• Primary Class: Topical otic antibiotic and corticosteroid combination
• Subclasses:
• Ciprofloxacin: Fluoroquinolone antibiotic
• Hydrocortisone Acetate: Low-potency corticosteroid

• Hypersensitivity to ciprofloxacin, hydrocortisone, or other quinolones/steroids
• Viral infections of the external ear canal (e.g., varicella, herpes simplex)
• Fungal infections of the external ear without concurrent antifungal treatment
• Non-intact tympanic membrane, unless otherwise advised by a physician

• Tympanic Membrane Perforation: Use with caution if membrane is perforated; increased systemic absorption and potential ototoxicity.
• Prolonged Use: May lead to fungal or secondary bacterial superinfection.
• Allergic Reactions: Discontinue immediately if rash, itching, or hypersensitivity occurs.
• Pediatric Use: Approved for children ≥1 year; safety not established in infants.
• Steroid Effects: Prolonged use of corticosteroids may suppress the hypothalamic-pituitary-adrenal (HPA) axis, though unlikely with otic use.

Common (1–5%):

• Ear discomfort
• Pruritus (itching)
• Ear residue or debris
• Irritation or stinging

Uncommon/Rare:

• Rash
• Secondary fungal infection
• Headache
• Tinnitus

Serious (rare):

• Hypersensitivity reactions (e.g., urticaria, anaphylaxis)
• Ototoxicity (rare and primarily with prolonged use or membrane perforation)

Dose/Duration Dependency:

• Adverse effects are generally mild and resolve upon discontinuation. Risks increase with inappropriate or prolonged use.

• Systemic Interactions: Minimal due to negligible systemic exposure.
• Enzymatic Interactions:
• Ciprofloxacin may interact with CYP1A2 substrates if absorbed systemically (rare with otic use).
• Hydrocortisone may be affected by CYP3A4 inhibitors (again negligible in otic use).
• Topical Cautions: Avoid concurrent use with other otic agents unless prescribed. Clean ear prior to each administration.

• FDA/EMA Status: No major recent label changes.
• Clinical Guidelines: Reaffirmed as first-line treatment for uncomplicated bacterial otitis externa with inflammation in pediatric and adult patients.
• Antibiotic Stewardship: Emphasizes limited use to reduce resistance and avoid unnecessary steroid exposure.

• Store at controlled room temperature: 20°C to 25°C.
• Do not freeze.
• Protect from excessive heat and direct light.
• Shake well before use.
• Discard after the full course or within 14–28 days of opening (follow product label).
• Keep container tightly closed and out of reach of children.