Ciprofloxacin (EENT) (Monograph)

Brand names: Cetraxal, Ciloxan, Otiprio
Drug class: Antibacterials

Introduction

Antibacterial; fluoroquinolone.¹ ⁵ ⁸ ⁵⁵ ¹¹⁹ ¹²⁵ ¹²⁶ ¹²⁷ ¹³³ ¹³⁴

Uses for Ciprofloxacin (EENT)

Bacterial Ophthalmic Infections

Topical treatment of bacterial conjunctivitis caused by susceptible Staphylococcus aureus, S. epidermidis, Streptococcus pneumoniae, or Haemophilus influenzae (0.3% ophthalmic solution).¹ ¹³⁴

Topical treatment of bacterial conjunctivitis caused by susceptible S. aureus, S. epidermidis, S. pneumoniae, viridans streptococci, or H. influenzae (0.3% ophthalmic ointment).¹¹⁹

Mild, acute bacterial conjunctivitis often resolves spontaneously without anti-infective treatment.¹³⁵ ¹³⁶ ¹³⁷ ¹⁴¹ Although topical ophthalmic anti-infectives may shorten time to resolution and reduce severity and risk of complications,¹³⁵ ¹³⁶ ¹³⁷ ¹⁴¹ avoid indiscriminate use of topical anti-infectives.¹³⁵ ¹⁴¹ Treatment of acute bacterial conjunctivitis generally is empiric;¹³⁵ ¹³⁶ ¹⁴¹ use of a broad-spectrum topical ophthalmic antibacterial usually recommended.¹³⁵ ¹³⁶ ¹⁴¹ In vitro staining and/or cultures of conjunctival material may be indicated in management of recurrent, severe, or chronic purulent conjunctivitis or when acute conjunctivitis does not respond to initial empiric topical treatment.¹³⁵ ¹³⁶ ¹⁴¹

Topical treatment of keratitis (corneal ulcer) caused by susceptible S. aureus, S. epidermidis, S. pneumoniae, viridans streptococci, Serratia marcescens, or Pseudomonas aeruginosa (0.3% ophthalmic solution).¹ ²⁴ ²⁵ ²⁶ ²⁷ ¹⁰¹ ¹⁰² ¹⁰³ ¹¹² ¹³⁴

Because bacterial keratitis may be associated with subsequent loss of vision as the result of corneal scarring or topographic irregularities and because untreated or severe bacterial keratitis may result in corneal perforation with potential for endophthalmitis and possible loss of the eye, optimal management involves rapid evaluation and diagnosis, timely initiation of treatment, and appropriate follow-up.¹³⁸ Treatment of community-acquired bacterial keratitis generally is empiric;¹³⁸ use of a broad-spectrum topical ophthalmic antibacterial usually recommended.¹³⁸ Subconjunctival anti-infectives may be necessary if scleral spread or perforation is imminent.¹³⁸ In vitro staining and/or cultures of corneal material are indicated in management of keratitis involving corneal infiltrates that are central, large, and extend to the middle to deep stroma or when keratitis is chronic or unresponsive to a broad-spectrum topical anti-infective.¹³⁸

Bacterial Otic Infections

Topical treatment of acute otitis externa caused by susceptible S. aureus or Ps. aeruginosa (0.2% otic solution).¹³³

Intratympanic treatment of bilateral otitis media with effusion in pediatric patients undergoing tympanostomy tube placement (6% otic suspension for intratympanic use).¹²⁷

Fixed combination of ciprofloxacin and dexamethasone (ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension): Topical treatment of acute otitis externa caused by susceptible S. aureus or Ps. aeruginosa.¹²⁵

Fixed combination of ciprofloxacin and hydrocortisone (ciprofloxacin 0.2% and hydrocortisone 1% otic suspension): Topical treatment of acute otitis externa caused by susceptible S. aureus, Proteus mirabilis, or Ps. aeruginosa.¹²⁰

Fixed combination of ciprofloxacin and dexamethasone (ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension): Topical treatment of acute otitis media caused by susceptible S. aureus, S. pneumoniae, H. influenzae, Moraxella catarrhalis, or Ps. aeruginosa in pediatric patients with tympanostomy tubes.¹²⁵

Fixed combination of ciprofloxacin and fluocinolone acetonide (ciprofloxacin 0.3% and fluocinolone acetonide 0.025% otic suspension): Topical treatment of acute otitis media caused by susceptible S. aureus, S. pneumoniae, H. influenzae, M. catarrhalis, or Ps. aeruginosa in pediatric patients with tympanostomy tubes.¹²⁶

Diffuse, uncomplicated acute otitis externa in otherwise healthy patients usually treated initially with topical therapy (e.g., otic anti-infective or antiseptic with or without an otic corticosteroid).¹³⁹ ¹⁴³ Supplement with systemic anti-infective therapy if patient has a medical condition that could impair host defenses (e.g., diabetes mellitus, HIV infection) or if infection has spread into pinna or skin of the neck or face, or into deeper tissues such as occurs with malignant otitis externa.¹³⁹ Malignant otitis externa is an invasive, potentially life-threatening infection, especially in immunocompromised patients, and requires prompt diagnosis and long-term treatment with systemic anti-infectives.¹²³ ¹²⁴ ¹³⁹

Ciprofloxacin (EENT) Dosage and Administration

Administration

Ophthalmic Administration

Apply 0.3% ophthalmic solution or 0.3% ophthalmic ointment topically to the eye.¹ ¹¹⁹ ¹³⁴

For topical ophthalmic use only;¹ ¹¹⁹ ¹³⁴ do not inject into eye.¹ ¹¹⁹ ¹³⁴

Avoid contaminating applicator tip with material from any source.¹ ¹¹⁹ ¹³⁴

Otic Administration (Topical)

Instill 0.2% otic solution topically into ear canal.¹³³

Instill fixed-combination otic preparations containing ciprofloxacin and a corticosteroid (i.e., dexamethasone, fluocinolone acetonide, or hydrocortisone) topically into ear canal.¹²⁰ ¹²⁵ ¹²⁶

For topical otic use only;¹²⁰ ¹²⁵ ¹²⁶ ¹³³ not for ophthalmic use, injection, or inhalation.¹²⁰ ¹²⁵ ¹²⁶ ¹³³

To avoid dizziness that may result from instilling a cold preparation into ear, warm container of otic preparation in hands for 1–2 minutes before use.¹²⁰ ¹²⁵ ¹²⁶ ¹³³

Shake otic suspensions well before use.¹²⁰ ¹²⁵

Lie with affected ear upward.¹²⁰ ¹²⁵ ¹²⁶ ¹³³ Instill appropriate amount of otic solution or suspension into ear;¹²⁰ ¹²⁵ ¹²⁶ ¹³³ maintain position for ≥1 minute to facilitate penetration into ear canal.¹²⁰ ¹²⁵ ¹²⁶ ¹³³ When treating acute otitis media, pump tragus 4 or 5 times by pushing inward to facilitate penetration into middle ear.¹²⁵ ¹²⁶ Repeat procedure for opposite ear if necessary.¹²⁰ ¹²⁵ ¹²⁶ ¹³³

Avoid contaminating applicator tip with material from ear, fingers, or other source.¹²⁰ ¹²⁵

Otic Administration (Intratympanic)

Administer 6% otic suspension intratympanically.¹²⁷

The 6% otic suspension is for intratympanic administration only.¹²⁷

Consult manufacturer's instructions for specific information regarding preparation and intratympanic administration.¹²⁷

The 6% otic suspension is thermosensitive and exists as a liquid at room temperature or lower, but thickens (gels) when warmed.¹²⁷ ¹⁴² Keep the suspension cold during preparation;¹²⁷ if thickening occurs, place back into refrigerator.¹²⁷

Each vial is for single-patient use only and contains volume sufficient to provide 2 doses (1 dose in each ear to be administered using a different syringe for each ear).¹²⁷ Use syringes and needles provided by the manufacturer only.¹²⁷ After syringes are prepared, keep them on their side either at room temperature or in the refrigerator;¹²⁷ discard if not used within 3 hours.¹²⁷

Suction middle ear effusions prior to intratympanic administration of the 6% otic suspension.¹²⁷

Dosage

Available for topical ophthalmic administration¹ ¹¹⁹ ¹³⁴ and topical otic administration¹²⁰ ¹²⁵ ¹²⁶ ¹³³ as ciprofloxacin hydrochloride; dosage expressed in terms of ciprofloxacin.¹ ¹¹⁹ ¹²⁰ ¹²⁵ ¹²⁶ ¹³³ ¹³⁴

Pediatric Patients

Bacterial Ophthalmic Infections

Conjunctivitis

Ophthalmic

Ciprofloxacin 0.3% (ophthalmic solution): On days 1 and 2, instill 1 or 2 drops in conjunctival sac of affected eye(s) every 2 hours while awake (up to 8 times daily).¹ ¹³⁴ On days 3 through 7, instill 1 or 2 drops every 4 hours while awake.¹ ¹³⁴

Ciprofloxacin 0.3% (ophthalmic ointment) in children ≥2 years of age: On days 1 and 2, apply approximately 1.27-cm (½-inch) ribbon in conjunctival sac of affected eye(s) 3 times daily.¹¹⁹ On days 3 through 7, apply same amount twice daily.¹¹⁹

Usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5–10 days;¹³⁵ ¹³⁶ ¹⁴¹ some experts state 5–7 days usually adequate for mild bacterial conjunctivitis.¹³⁵

Keratitis

Ophthalmic

Ciprofloxacin 0.3% (ophthalmic solution): On day 1, instill 2 drops in affected eye(s) every 15 minutes during first 6 hours, followed by 2 drops every 30 minutes for remainder of the day.¹ ¹³⁴ On day 2, instill 2 drops in affected eye(s) every hour; on days 3 through 14, instill 2 drops every 4 hours.¹ ¹³⁴

Manufacturers state treatment may continue for >14 days if corneal reepithelialization has not occurred.¹ ¹³⁴ Some experts recommend reevaluating and modifying initial regimen if keratitis has not improved or stabilized within 48 hours after treatment initiation.¹³⁸

Bacterial Otic Infections

Otitis Externa

Otic

Ciprofloxacin 0.2% (otic solution) in pediatric patients ≥1 year of age: Instill contents of a single-use container (0.25 mL) into affected ear(s) twice daily (approximately 12 hours apart) for 7 days.¹³³

Ciprofloxacin 0.3% and dexamethasone 0.1% (otic suspension) in pediatric patients ≥6 months of age: Instill 4 drops into canal of affected ear(s) twice daily for 7 days.¹²⁵

Ciprofloxacin 0.2% and hydrocortisone 1% (otic suspension) in pediatric patients ≥1 year of age: Instill 3 drops into canal of affected ear(s) twice daily for 7 days.¹²⁰

Optimal duration of topical treatment of acute otitis externa not determined, but 7–10 days usually recommended.¹³⁹ Appropriate treatment should result in improvement in symptoms (otalgia, itching, fullness) within 48–72 hours, although symptom resolution may take up to 2 weeks.¹³⁹ If no improvement after 1 week of treatment, manufacturers state use cultures to help guide further treatment.¹²⁰ ¹²⁵ ¹³³ (See Precautions Related to Otic Administration under Cautions.)

Acute Otitis Media

Otic

Ciprofloxacin 0.3% and dexamethasone 0.1% (otic suspension) in pediatric patients ≥6 months of age with tympanostomy tubes: Instill 4 drops through the tympanostomy tube in affected ear(s) twice daily for 7 days.¹²⁵

Ciprofloxacin 0.3% and fluocinolone acetonide 0.025% (otic solution) in pediatric patients ≥6 months of age with tympanostomy tubes: Instill contents of a single-dose vial (0.25 mL) into canal of affected ear(s) twice daily (approximately every 12 hours) for 7 days.¹²⁶

Otitis Media with Effusion

Intratympanic

Ciprofloxacin 6% (otic suspension for intratympanic use) in pediatric patients ≥6 months of age with bilateral otitis media with effusion undergoing tympanostomy tube placement: Single dose of 0.1 mL (6 mg) given intratympanically into each affected ear.¹²⁷

Adults

Bacterial Ophthalmic Infections

Conjunctivitis

Ophthalmic

Ciprofloxacin 0.3% (ophthalmic ointment): On days 1 and 2, apply approximately 1.27-cm (½-inch) ribbon in conjunctival sac of affected eye(s) 3 times daily.¹¹⁹ On days 3 through 7, apply same amount twice daily.¹¹⁹

Keratitis

Ophthalmic

Manufacturer states treatment may continue for >14 days if corneal reepithelialization has not occurred.¹ ¹³⁴ Some experts recommend reevaluating and modifying initial regimen if keratitis has not improved or stabilized within 48 hours after treatment initiation.¹³⁸

Otic Infections

Otitis Externa

Otic

Ciprofloxacin 0.2% (otic solution): Instill contents of a single-use container (0.25 mL) into affected ear(s) twice daily (approximately 12 hours apart) for 7 days.¹³³

Ciprofloxacin 0.3% and dexamethasone 0.1% (otic suspension): Instill 4 drops into canal of affected ear(s) twice daily for 7 days.¹²⁵

Ciprofloxacin 0.2% and hydrocortisone 1% (otic suspension): Instill 3 drops into canal of affected ear(s) twice daily for 7 days.¹²⁰

Cautions for Ciprofloxacin (EENT)

Contraindications

Ciprofloxacin 0.3% (ophthalmic solution and ointment): Hypersensitivity to ciprofloxacin or any ingredient in the formulation.¹ ¹¹⁹ ¹³⁴ May be contraindicated in patients hypersensitive to other quinolones.¹ ¹¹⁹ ¹³⁴
Ciprofloxacin 0.2% (otic solution): Hypersensitivity to ciprofloxacin.¹³³
Ciprofloxacin 6% (otic suspension for intratympanic use): Hypersensitivity to ciprofloxacin, other quinolones, or any ingredient in the formulation.¹²⁷
Ciprofloxacin 0.3% and dexamethasone 0.1% (otic suspension): Hypersensitivity to ciprofloxacin, other quinolones, or any ingredient in the formulation.¹²⁵ Also, patients with viral infections of external ear canal, including herpes simplex infections, or fungal otic infections.¹²⁵
Ciprofloxacin 0.3% and fluocinolone acetonide 0.025% (otic solution): Hypersensitivity to ciprofloxacin or other quinolones, fluocinolone acetonide or other corticosteroids, or any ingredient in the formulation.¹²⁶ Also, patients with viral infections of external ear canal, including varicella and herpes simplex infections, or fungal otic infections.¹²⁶
Ciprofloxacin 0.2% and hydrocortisone 1% (otic suspension): Hypersensitivity to hydrocortisone, ciprofloxacin, or other quinolones.¹²⁰ Also, patients with viral infections of external ear canal, including varicella and herpes simplex infections.¹²⁰ This otic suspension is nonsterile;¹²⁰ do not use if tympanic membrane is known or suspected to be perforated.¹²⁰

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions reported in patients receiving systemic quinolones, including ciprofloxacin;¹ ³⁷ ¹¹⁹ ¹²⁰ ¹²⁵ ¹²⁶ ¹³³ ¹³⁴ these reactions have occurred with initial systemic dose.¹ ¹¹⁹ ¹²⁰ ¹²⁵ ¹²⁶ ¹³³ ¹³⁴

Immediately discontinue ophthalmic or otic preparation at first sign of rash or hypersensitivity reaction.¹ ¹¹⁹ ¹²⁰ ¹²⁵ ¹²⁶ ¹³³

Serious acute hypersensitivity reactions require immediate emergency treatment; administer appropriate therapy (e.g., epinephrine, corticosteroids, maintenance of an adequate airway, oxygen, maintenance of BP) as clinically indicated.¹ ¹¹⁹ ¹³⁴

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.¹ ¹¹⁹ ¹²⁰ ¹²⁵ ¹²⁶ ¹²⁷ ¹³³ ¹³⁴

If superinfection occurs, discontinue ciprofloxacin ophthalmic or otic preparation and institute appropriate therapy.¹ ¹¹⁹ ¹²⁰ ¹²⁵ ¹²⁶ ¹²⁷ ¹³³ ¹³⁴

Precautions Related to Ophthalmic Administration

Whenever clinical judgment dictates, examine patient with the aid of magnification (e.g., slit lamp biomicroscopy) and, if appropriate, fluorescein staining.¹ ¹¹⁹ ¹³⁴

In patients with bacterial keratitis, white granular or crystalline precipitate in superficial portion of corneal defect reported.¹ ³ ²⁵ ¹³⁴ Onset generally is within 1–7 days after initiation of therapy (when solution is administered repeatedly at relatively short intervals) and resolution usually occurs during later phase of continued therapy (when administration frequency is reduced).¹ ³ ²⁵ ¹³⁴ Precipitate does not appear to preclude continued use nor adversely affect visual outcome or clinical course of corneal ulcer.¹ ³ ²⁵ ¹¹⁵ ¹¹⁶ ¹¹⁷ ¹³⁴

Manufacturer cautions that ophthalmic ointments may retard corneal healing and cause visual blurring.¹¹⁹

Do not wear contact lenses during topical ophthalmic treatment.¹ ¹³⁴

Precautions Related to Otic Administration

If otic infection not improved after 1 week of treatment, obtain cultures to guide further treatment.¹²⁰ ¹²⁵ ¹²⁶ ¹³³

If otorrhea persists after full course of topical therapy or if ≥2 episodes of otorrhea occur within 6 months, further evaluate to exclude underlying condition (e.g., cholesteatoma, foreign body, tumor).¹²⁵ ¹²⁶

Fixed-combination otic suspension containing ciprofloxacin and hydrocortisone: Do not use if tympanic membrane is known or suspected to be perforated.¹²⁰

Ciprofloxacin 6% otic suspension for intratympanic use in patients with otitis media with effusion undergoing tympanostomy tube placement: Drainage from the ear may occur during first few days following ear tube surgery;¹²⁷ consult clinician if there is continuous ear discharge or if ear becomes painful or fever develops.¹²⁷

Use of Fixed Combination Containing Corticosteroids

When otic preparations containing ciprofloxacin in fixed combination with a corticosteroid (i.e., dexamethasone, fluocinolone acetonide, or hydrocortisone) used, consider cautions, precautions, and contraindications associated with the corticosteroid.¹²⁰ ¹²⁵ ¹²⁶

Specific Populations

Pregnancy

Ciprofloxacin topical ophthalmic preparations: Data not available regarding use in pregnant women;¹ ¹¹⁹ ¹³⁴ use during pregnancy only when potential benefits justify possible risks to fetus.¹ ¹¹⁹ ¹³⁴

Ciprofloxacin topical otic preparations, including fixed-combination preparations containing ciprofloxacin and a corticosteroid. Data not available regarding use in pregnant women;¹²⁰ ¹²⁵ ¹³³ use with caution during pregnancy.¹²⁰ ¹²⁵ ¹³³

Ciprofloxacin 6% (otic suspension for intratympanic use): Data not available regarding use in pregnant women.¹²⁷ Manufacturer states that negligible systemic exposure expected following intratympanic administration and there is minimal risk for maternal and fetal toxicity if used during pregnancy.¹²⁷

Ciprofloxacin 0.3% and fluocinolone acetonide 0.025% (otic solution): Data not available regarding use in pregnant women.¹²⁶ Manufacturer states that negligible amounts of ciprofloxacin or fluocinolone acetonide are absorbed following topical otic application and use during pregnancy not expected to result in fetal exposure to either drug.¹²⁶

Lactation

Not known whether ciprofloxacin distributed into milk after topical application to the eye or ear;¹ ¹¹⁹ ¹²⁰ ¹²⁵ ¹²⁷ ¹³³ ¹³⁴ distributed into milk after systemic administration.¹ ¹¹⁹ ¹²⁰ ¹²⁵ ¹²⁷ ¹³³ ¹³⁴

Ciprofloxacin topical ophthalmic preparations: Use with caution in nursing women.¹ ¹¹⁹ ¹³⁴

Ciprofloxacin topical otic preparations, including fixed-combination preparations containing ciprofloxacin and a corticosteroid: Discontinue nursing or the otic preparation, taking into account the importance of the drug to the woman.¹²⁰ ¹²⁵ ¹³³

Ciprofloxacin 6% (otic suspension for intratympanic use): Manufacturer states that negligible systemic exposure expected following intratympanic use and that breast-feeding infants should not be affected.¹²⁷

Ciprofloxacin 0.3% and fluocinolone acetonide 0.025% (otic solution): Manufacturer states that negligible amounts of ciprofloxacin and fluocinolone acetonide are absorbed following topical otic application and use is not expected to result in exposure to either drug in breast-feeding infants.¹²⁶

Pediatric Use

Ciprofloxacin 0.3% (ophthalmic solution): Safety and efficacy in pediatric patients supported by evidence from adequate and well-controlled studies in adults, children, and neonates.¹ One manufacturer states safety and efficacy not established in pediatric patients <1 year of age.¹³⁴

Ciprofloxacin 0.3% (ophthalmic ointment): Safety and efficacy not established in pediatric patients <2 years of age.¹¹⁹

Ciprofloxacin 0.2% (otic solution): Safety and efficacy not established in pediatric patents <1 year of age.¹³³

Ciprofloxacin 6% (otic suspension for intratympanic use): Safety and efficacy not established in pediatric patients <6 months of age.¹²⁷

Ciprofloxacin 0.3% and dexamethasone 0.1% (otic suspension): Safety and efficacy not established in pediatric patients <6 months of age.¹²⁵

Ciprofloxacin 0.3% and fluocinolone acetonide 0.025% (otic solution): Safety and efficacy not established in pediatric patients <6 months of age.¹²⁶

Ciprofloxacin 0.2% and hydrocortisone 1% (otic suspension): Safety and efficacy not established in pediatric patients <2 years of age;¹²⁰ manufacturer states efficacy for use in those ≥1 year of age has been extrapolated based on studies in adults and older pediatric patients.¹²⁰

Geriatric Use

Ciprofloxacin topical ophthalmic preparations: No overall differences in safety and efficacy relative to younger adults.¹ ¹¹⁹ ¹³⁴

Ciprofloxacin topical otic preparations: No overall differences in safety and efficacy relative to younger adults.¹³³

Ciprofloxacin 0.3% and fluocinolone acetonide 0.025% (otic solution): Data from clinical trials insufficient to determine if patients ≥65 years of age respond differently than younger patients.¹²⁶ Other reported clinical experience has not identified differences in responses between geriatric and younger patients.¹²⁶

Common Adverse Effects

Ophthalmic administration: Local discomfort (burning, stinging), lid margin crusting, crystals/scales, foreign body sensation, itching, conjunctival hyperemia, keratopathy, taste abnormality (bad taste).¹ ¹¹⁹ ¹³⁴

Otic administration (topical): Ear discomfort/pain/pruritus, headache.¹²⁰ ¹²⁵ ¹³³

Otic administration (intratympanic): Nasopharyngitis, irritability, rhinorrhea.¹²⁷

Drug Interactions

No specific drug interaction studies using ciprofloxacin ophthalmic preparations.¹ ¹¹⁹ ¹³⁴

Since systemic absorption may occur following topical application to the eye,¹ ¹¹⁹ ¹²⁵ consider possibility of drug interactions such as those reported with some systemic quinolones (e.g., interactions with theophylline, caffeine, oral anticoagulants, cyclosporine).¹ ¹¹⁹ ¹³⁴

Ciprofloxacin (EENT) Pharmacokinetics

Absorption

Bioavailability

Ciprofloxacin 0.3% (ophthalmic solution): Mean plasma ciprofloxacin concentrations generally averaged <2.5 ng/mL after topical application to each eye (1 drop every 2 hours while awake for 2 days, then every 4 hours while awake for 5 days).¹

Ciprofloxacin 0.3% (ophthalmic ointment): Extent of systemic absorption not evaluated, but mean maximal plasma ciprofloxacin concentrations expected to be <2.5 ng/mL, based on studies using 0.3% ophthalmic solution.¹¹⁹

Ciprofloxacin 0.2% (otic solution): Plasma concentrations not measured following topical application to the ear; peak plasma concentrations expected to be <5 ng/mL.¹³³

Ciprofloxacin 6% (otic suspension for intratympanic use): Plasma concentrations not measured following intratympanic administration.¹²⁷ Exists as liquid at room temperature; transitions to gel when exposed to body temperature in middle ear.¹⁴² ¹⁴⁴ Therefore, ciprofloxacin is solubilized over time resulting in sustained exposure to the drug in middle ear.¹²⁷ ¹⁴² ¹⁴⁴

Ciprofloxacin 0.3% and dexamethasone 0.1% (otic suspension): Following a single bilateral 4-drop otic dose in pediatric patients after tympanostomy tubes, measurable plasma ciprofloxacin or dexamethasone concentrations were observed after 6 hours in 2 or 5 of 9 patients, respectively.¹²⁵ Peak plasma ciprofloxacin and dexamethasone concentrations were attained within 15 minutes to 2 hours.¹²⁵

Ciprofloxacin 0.3% and fluocinolone acetonide 0.025% (otic solution): Following twice-daily dosing in pediatric patients 6 months to 12 years of age with acute otitis media with tympanostomy tubes, plasma concentrations of ciprofloxacin and fluocinolone acetonide undetectable in almost all patients.¹²⁶ In one patient with bilateral acute otitis media, plasma concentrations of ciprofloxacin were 3 mcg/mL after 7 days of treatment;¹²⁶ the corticosteroid was undetectable.¹²⁶

Ciprofloxacin 0.2% and hydrocortisone 1% (otic suspension): Systemic exposure to ciprofloxacin expected to be below limits of detection (50 ng/mL); peak plasma hydrocortisone concentrations predicted to be within range of endogenous hydrocortisone.¹²⁰

Distribution

Extent

Distribution into human ocular tissues and fluids following topical ophthalmic administration not fully characterized to date.⁸ ¹⁷

Distributed into milk after systemic administration; not known whether distributed into milk after topical application to the eye or ear.¹ ¹¹⁹ ¹²⁰ ¹²⁵ ¹³⁴

Stability

Storage

Ophthalmic

Ointment

Ciprofloxacin 0.3%: 2–25°C.¹¹⁹

Solution

Ciprofloxacin 0.3%: 2–25°C.¹ ¹³⁴ Protect from light.¹ ¹³⁴

Otic

Solution

Ciprofloxacin 0.2%: 15–25°C.¹³³ Protect from light;¹³³ store single-use containers in protective foil pouch.¹³³

Ciprofloxacin 0.3% and fluocinolone acetonide 0.025%: 20–25°C;¹²⁶ may be exposed to 15–30°C.¹²⁶ Store single-use vials in protective foil pouch to protect from light;¹²⁶ discard unused vials 7 days after opening pouch.¹²⁶

Suspension

Ciprofloxacin 6% for intratympanic use: 2–8°C in original container;¹²⁷ protect from light.¹²⁷ Thermosensitive;¹²⁷ exists as a liquid at room temperature or lower, but thickens (gels) when warmed.¹²⁷ Keep suspension cold while preparing doses;¹²⁷ if thickening occurs, place back into refrigerator.¹²⁷

Ciprofloxacin 0.3% and dexamethasone 0.1%: 20–25°C; may be exposed to 15–30°C.¹²⁵ Avoid freezing; protect from light.¹²⁵

Ciprofloxacin 0.2% and hydrocortisone 1%: <25°C.¹²⁰ Avoid freezing; protect from light.¹²⁰

Actions and Spectrum

Fluoroquinolone anti-infective.¹ ¹¹⁹ ¹²⁵ ¹²⁶ ¹²⁷ ¹³³ ¹³⁴
Like other fluoroquinolones, inhibits DNA synthesis via inhibition of type II DNA topoisomerases (DNA gyrase, topoisomerase IV).¹ ³ ⁷ ³¹ ³⁶ ⁴³ ⁴⁴ ⁵⁰ ⁵¹ ⁵² ⁵³
Usually bactericidal.¹ ³ ³⁷ ⁴⁰ ⁴¹ ⁴² ⁴³ ⁴⁴ ⁴⁵ ⁴⁷ ⁵⁵
Active in vitro against most gram-negative aerobic bacteria and many gram-positive aerobic bacteria,¹ ³ ⁵ ⁸ ³⁰ ³¹ ³² ⁴⁰ ⁴² ⁴⁶ ⁵⁴ including penicillinase-producing, nonpenicillinase-producing, and oxacillin-resistant staphylococci;¹ ³ ⁵ ⁸ ³⁰ ³¹ ⁴⁰ ⁴² ⁴⁶ ⁵⁹ ⁶⁰ generally less active against gram-positive than gram-negative bacteria³⁰ ³¹ ⁴² ⁴⁶ ⁶⁷ ⁶⁸ ⁶⁹ and less active in vitro on a weight basis against streptococci than against staphylococci.³ ⁵ ⁸ ⁴⁰ ⁴² ⁵⁵ ⁶⁴ ⁶⁵ ⁶⁶ ⁶⁷ ⁶⁸
Most strains of Ps. cepacia, some strains of Ps. maltophilia, and most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile, are resistant.¹ ³ Inactive against fungi and viruses.¹ ³ ⁵ ⁸ ⁵⁵
Cross-resistance can occur between ciprofloxacin and other fluoroquinolones.¹²⁶

Advice to Patients

Advise patients to avoid contaminating applicator tip with material from the eye or ear, fingers, or other source.¹ ¹¹⁹ ¹²⁰ ¹²⁵ ¹³⁴
Inform patients that systemic fluoroquinolones, including ciprofloxacin, have been associated with hypersensitivity reactions, even following a single dose.¹ ¹¹⁹ ¹²⁰ ¹²⁵ ¹²⁶ ¹³³ ¹³⁴ Advise patients to immediately discontinue ciprofloxacin ophthalmic or otic preparation and contact a clinician at first sign of rash or allergic reaction.¹ ¹¹⁹ ¹²⁰ ¹²⁵ ¹²⁶ ¹³³ ¹³⁴
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹ ¹¹⁹ ¹²⁰ ¹²⁵
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ ¹¹⁹ ¹²⁰ ¹²⁵
Importance of informing patients of other important precautionary information. (See Cautions.)¹ ¹¹⁹ ¹²⁰ ¹²⁵

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Ciprofloxacin
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Otic	Suspension, for intratympanic use	6%	Otiprio	Otonomy

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ciprofloxacin Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Ointment	0.3% (of ciprofloxacin)	Ciloxan	Alcon
	Solution	0.3% (of ciprofloxacin)*	Ciloxan	Alcon
			Ciprofloxacin Hydrochloride Ophthalmic Solution
Otic	Solution	0.3% (of ciprofloxacin)	Cetraxal	Wraser

Ciprofloxacin Hydrochloride Combinations
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Otic	Solution	0.3% (of ciprofloxacin) with Fluocinolone Acetonide 0.025%	Otovel	Arbor
	Suspension	0.2% (of ciprofloxacin) with Hydrocortisone 1%	Cipro HC Otic	Alcon
		0.3% (of ciprofloxacin) with Dexamethasone 0.1%	Ciprodex	Alcon

References

1. Alcon Laboratories. Ciloxan (ciprofloxacin) 0.3% ophthalmic solution prescribing information. Fort Worth, TX; 2017 Mar.

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