Ciprofloxacin (EENT) (Monograph)

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

Introduction

Antibacterial; fluoroquinolone.

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).

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

Mild, acute bacterial conjunctivitis often resolves spontaneously without anti-infective treatment. Although topical ophthalmic anti-infectives may shorten time to resolution and reduce severity and risk of complications, avoid indiscriminate use of topical anti-infectives. Treatment of acute bacterial conjunctivitis generally is empiric; use of a broad-spectrum topical ophthalmic antibacterial usually recommended. 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.

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).

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. Treatment of community-acquired bacterial keratitis generally is empiric; use of a broad-spectrum topical ophthalmic antibacterial usually recommended. Subconjunctival anti-infectives may be necessary if scleral spread or perforation is imminent. 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.

Bacterial Otic Infections

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

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

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.

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.

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.

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.

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). 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. 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.

Ciprofloxacin (EENT) Dosage and Administration

Administration

Ophthalmic Administration

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

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

Avoid contaminating applicator tip with material from any source.

Otic Administration (Topical)

Instill 0.2% otic solution topically into ear canal.

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

For topical otic use only; not for ophthalmic use, injection, or inhalation.

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.

Shake otic suspensions well before use.

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

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

Otic Administration (Intratympanic)

Administer 6% otic suspension intratympanically.

The 6% otic suspension is for intratympanic administration only.

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

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

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). Use syringes and needles provided by the manufacturer only. After syringes are prepared, keep them on their side either at room temperature or in the refrigerator; discard if not used within 3 hours.

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

Dosage

Available for topical ophthalmic administration and topical otic administration as ciprofloxacin hydrochloride; dosage expressed in terms of ciprofloxacin.

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). On days 3 through 7, instill 1 or 2 drops every 4 hours while awake.

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. On days 3 through 7, apply same amount twice daily.

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

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. On day 2, instill 2 drops in affected eye(s) every hour; on days 3 through 14, instill 2 drops every 4 hours.

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

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.

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.

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.

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

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.

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.

Adults

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). On days 3 through 7, instill 1 or 2 drops every 4 hours while awake.

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. On days 3 through 7, apply same amount twice daily.

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

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. On day 2, instill 2 drops in affected eye(s) every hour; on days 3 through 14, instill 2 drops every 4 hours.

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

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.

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

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

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

Cautions for Ciprofloxacin (EENT)

Contraindications

• Ciprofloxacin 0.3% (ophthalmic solution and ointment): Hypersensitivity to ciprofloxacin or any ingredient in the formulation. May be contraindicated in patients hypersensitive to other quinolones.

• Ciprofloxacin 0.2% (otic solution): Hypersensitivity to ciprofloxacin.

• Ciprofloxacin 6% (otic suspension for intratympanic use): Hypersensitivity to ciprofloxacin, other quinolones, or any ingredient in the formulation.

• Ciprofloxacin 0.3% and dexamethasone 0.1% (otic suspension): Hypersensitivity to ciprofloxacin, other quinolones, or any ingredient in the formulation. Also, patients with viral infections of external ear canal, including herpes simplex infections, or fungal otic infections.

• 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. Also, patients with viral infections of external ear canal, including varicella and herpes simplex infections, or fungal otic infections.

• Ciprofloxacin 0.2% and hydrocortisone 1% (otic suspension): Hypersensitivity to hydrocortisone, ciprofloxacin, or other quinolones. Also, patients with viral infections of external ear canal, including varicella and herpes simplex infections. This otic suspension is nonsterile; do not use if tympanic membrane is known or suspected to be perforated.

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions reported in patients receiving systemic quinolones, including ciprofloxacin; these reactions have occurred with initial systemic dose.

Immediately discontinue ophthalmic or otic preparation at first sign of rash or hypersensitivity reaction.

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.

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.

If superinfection occurs, discontinue ciprofloxacin ophthalmic or otic preparation and institute appropriate therapy.

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.

In patients with bacterial keratitis, white granular or crystalline precipitate in superficial portion of corneal defect reported. 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). Precipitate does not appear to preclude continued use nor adversely affect visual outcome or clinical course of corneal ulcer.

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

Do not wear contact lenses during topical ophthalmic treatment.

Precautions Related to Otic Administration

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

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).

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

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; consult clinician if there is continuous ear discharge or if ear becomes painful or fever develops.

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.

Specific Populations

Pregnancy

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

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

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

Ciprofloxacin 0.3% and fluocinolone acetonide 0.025% (otic solution): Data not available regarding use in pregnant women. 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.

Lactation

Not known whether ciprofloxacin distributed into milk after topical application to the eye or ear; distributed into milk after systemic administration.

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

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.

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.

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.

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. One manufacturer states safety and efficacy not established in pediatric patients <1 year of age.

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

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

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

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

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

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

Geriatric Use

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

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

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. Other reported clinical experience has not identified differences in responses between geriatric and younger patients.

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).

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

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

Drug Interactions

No specific drug interaction studies using ciprofloxacin ophthalmic preparations.

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

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).

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.

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

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

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. Peak plasma ciprofloxacin and dexamethasone concentrations were attained within 15 minutes to 2 hours.

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. In one patient with bilateral acute otitis media, plasma concentrations of ciprofloxacin were 3 mcg/mL after 7 days of treatment; the corticosteroid was undetectable.

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.

Distribution

Extent

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

Distributed into milk after systemic administration; not known whether distributed into milk after topical application to the eye or ear.

Stability

Storage

Ophthalmic

Ointment

Ciprofloxacin 0.3%: 2–25°C.

Solution

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

Otic

Solution

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

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

Suspension

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

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

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

Actions and Spectrum

• Fluoroquinolone anti-infective.

• Like other fluoroquinolones, inhibits DNA synthesis via inhibition of type II DNA topoisomerases (DNA gyrase, topoisomerase IV).

• Usually bactericidal.

• Active in vitro against most gram-negative aerobic bacteria and many gram-positive aerobic bacteria, including penicillinase-producing, nonpenicillinase-producing, and oxacillin-resistant staphylococci; generally less active against gram-positive than gram-negative bacteria and less active in vitro on a weight basis against streptococci than against staphylococci.

• Most strains of Ps. cepacia, some strains of Ps. maltophilia, and most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile, are resistant. Inactive against fungi and viruses.

• Cross-resistance can occur between ciprofloxacin and other fluoroquinolones.

Advice to Patients

• Advise patients to avoid contaminating applicator tip with material from the eye or ear, fingers, or other source.

• Inform patients that systemic fluoroquinolones, including ciprofloxacin, have been associated with hypersensitivity reactions, even following a single dose. Advise patients to immediately discontinue ciprofloxacin ophthalmic or otic preparation and contact a clinician at first sign of rash or allergic reaction.

• Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, as well as any concomitant illnesses.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

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.

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

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