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Ciprofloxacin eent

Class: Antibacterials
Chemical Name: 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid
Molecular Formula: C17H18FN3O3•ClH•H2O
CAS Number: 85721-33-1
Brands: Cetraxal, Ciloxan, Otiprio

Introduction

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

Uses for Ciprofloxacin

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 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 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): 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

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

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.)

Cautions for Ciprofloxacin

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

Interactions for Ciprofloxacin

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 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

AHFS DI Essentials. © Copyright 2018, Selected Revisions March 12, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

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

2. Alcon Laboratories. Product information form for American hospital formulary service: Ciloxan (ciprofloxacin HCl) 0.3% as base sterile ophthalmic solution. Fort Worth, TX: 1991 Mar.

3. Alcon Laboratories. Ciloxan product monograph. Ciloxan (ciprofloxacin HCl) 0.3% as base sterile ophthalmic solution. Fort Worth, TX: 1991 Apr.

5. Campoli-Richards DM, Monk JP, Price A et al. Ciprofloxacin: a review of its antibacterial activity, pharmacokinetic properties and therapeutic use. Drugs. 1988; 35:373-447. http://www.ncbi.nlm.nih.gov/pubmed/3292209?dopt=AbstractPlus

7. Hooper DC. Mechanisms of action and resistance of older and newer fluoroquinolones. Clin Infect Dis. 2000; 31(Suppl 2):S24-8. http://www.ncbi.nlm.nih.gov/pubmed/10984324?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=2573401&blobtype=pdf

8. Vance-Bryan K, Guay DRP, Rotschafer JC. Clinical pharmacokinetics of ciprofloxacin. Clin Pharmacokinet. 1990; 19:434-61. http://www.ncbi.nlm.nih.gov/pubmed/2292168?dopt=AbstractPlus

9. Reidy JJ, Hobden JA, Hill JM et al. The efficacy of topical ciprofloxacin and norfloxacin in the treatment of experimental pseudomonas keratitis. Cornea. 1991; 10:25-8. http://www.ncbi.nlm.nih.gov/pubmed/1902152?dopt=AbstractPlus

10. McDermott ML, Tran TD, Cowden JW et al. Corneal stromal penetration of topical ciprofloxacin in humans. Ophthalmology. 1993; 100:197-200. http://www.ncbi.nlm.nih.gov/pubmed/8437827?dopt=AbstractPlus

11. O’Brien TP, Sawusch MR, Dick JD et al. Topical ciprofloxacin treatment of pseudomonas keratitis in rabbits. Arch Ophthalmol. 1988; 106:1444-6. http://www.ncbi.nlm.nih.gov/pubmed/3140772?dopt=AbstractPlus

12. Rootman DS, Savage P, Hasany SM et al. Toxicity and pharmacokinetics of intravitreally injected ciprofloxacin in rabbit eyes. Can J Ophthalmol. 1992; 27:277-82. http://www.ncbi.nlm.nih.gov/pubmed/1451014?dopt=AbstractPlus

13. Behrens-Baumann W, Martell J. Ciprofloxacin concentration in the rabbit aqueous humor and vitreous following intravenous and subconjuctival administration. Infection. 1988; 16:54-7. http://www.ncbi.nlm.nih.gov/pubmed/3360498?dopt=AbstractPlus

14. Skoutelis AT, Gartaganis SP, Chrysanthopoulos CJ et al. Aqueous humor penetration of ciprofloxacin in the human eye. Arch Ophthalmol. 1988; 106:404-5. http://www.ncbi.nlm.nih.gov/pubmed/3345156?dopt=AbstractPlus

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