Ciloxan eent

Generic Name: Ciprofloxacin Hydrochloride eent
Class: Antibacterials
Molecular Formula: C17H18FN3O3•ClH•H2O
CAS Number: 86393-32-0

Introduction

Fluoroquinolone antibacterial.1 2 5 6 8

Uses for Ciloxan

Bacterial Ophthalmic Infections

Ophthalmic ointment: Treatment of conjunctivitis caused by susceptible strains of Staphylococcus aureus, S. epidermidis, Streptococcus pneumoniae, Haemophilus influenzae, or viridans streptococci.119

Ophthalmic solution: Treatment of conjunctivitis caused by susceptible strains of S. aureus, S. epidermidis, S. pneumoniae, or H. influenzae.1

Some clinicians suggest that quinolones be reserved principally for severe bacterial conjunctivitis because of potential development of quinolone resistance, and possibly, cost considerations.4 111 116

Ophthalmic solution: Treatment of keratitis (corneal ulcer) caused by susceptible strains of Pseudomonas aeruginosa, Serratia marcescens, S. aureus , S. epidermidis, S. pneumoniae, or viridans streptococci.1 24 25 26 27 101 102 103 112

Some clinicians suggest that single-agent topical fluoroquinolone therapy be considered for initial treatment in patients with equivocal gram stain results on diagnostic corneal smear, presence of >1 organism, contact lens associated keratitis (suspected to be caused by gram-negative bacteria), or in settings where culture and sensitivity tests are impossible or impractical.118

Bacterial Otic Infections

Ciprofloxacin-dexamethasone otic suspension: Treatment of acute otitis externa caused by susceptible strains of S. aureus or Ps. aeruginosa.125

Ciprofloxacin-hydrocortisone otic suspension: Treatment of acute otitis externa caused by susceptible strains of S. aureus, Ps. aeruginosa, or Proteus mirabilis.120

Ciprofloxacin-dexamethasone otic suspension: Treatment of acute otitis media caused by susceptible strains of S. aureus, S. pneumoniae, H. influenzae, Moraxella catarrhalis, or Ps. aeruginosa in patients with tympanostomy tubes.125

Ciloxan Dosage and Administration

General

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic ointment or solution.1 116 119

Not for injection.1 119

Remove contact lenses before administration of ophthalmic solution.1

For treatment of bacterial keratitis, administer ophthalmic solution around the clock.25 115

Otic Administration

Administered as otic suspension in fixed combination with dexamethasone or hydrocortisone.120 125

For otic use only.120 125 Not for ophthalmic use.120 125 Not for injection.120 125

Discard unused portion after therapy is completed.120 125

Prior to administration, warm container in hand for 1–2 minutes before use to avoid dizziness associated with instillation of cold solution into ear canal.120 125 Shake well before use.120 125

To administer fixed combination otic suspensions of ciprofloxacin with dexamethasone or hydrocortisone for treatment of acute otitis externa, instill drops while patient lies with affected ear upward; maintain position for 30–60 seconds to facilitate penetration of drops into ear.120 125 Repeat for opposite ear if necessary.120 125

To administer ciprofloxacin-dexamethasone otic suspension for treatment of acute otitis media in pediatric patients with tympanostomy tubes, instill drops while patient lies with affected ear upward.125 Pump tragus 5 times by pushing inward to facilitate penetration of drops into middle ear; maintain position for 60 seconds.125 Repeat for opposite ear if necessary.125

Dosage

Available as ciprofloxacin hydrochloride; dosage expressed in terms of ciprofloxacin.1 108 119 120 125

Pediatric Patients

Ophthalmic Infections
Conjunctivitis (S. aureus, S. epidermidis, S. pneumoniae, H. influenzae, or viridans streptococci)
Ophthalmic

Ointment: In children ≥2 years of age, apply approximately 1.27 cm (½ inch) ribbon into conjunctival sac of affected eye(s) 3 times daily for 2 days, then twice daily for next 5 days.119

Conjunctivitis (S. aureus, S. epidermidis, S. pneumoniae, or H. influenzae)
Ophthalmic

Solution: In children ≥1 year of age, 1 or 2 drops of 0.3% solution into conjunctival sac of affected eye(s) every 2 hours while awake for 2 days, then 1–2 drops every 4 hours while awake for next 5 days.1 3

Keratitis
Ophthalmic

Solution: In children ≥1 year of age, 2 drops of 0.3% solution into affected eye(s) every 15 minutes for 6 hours, followed by 2 drops every 30 minutes for remainder of first day.1 3 25 On the second day, instill 2 drops into affected eye(s) every hour, and on days 3–14, instill 2 drops every 4 hours.1 3 May continue longer than 14 days if corneal reepithelialization is not complete.1 3

Otic Infections
Otitis Externa (S. aureus or Ps. aeruginosa)
Otic

Ciprofloxacin-dexamethasone otic suspension: In children ≥6 months of age, 4 drops into canal of affected ear(s) twice daily for 7 days.125

Otitis Externa (S. aureus, Ps. aeruginosa, or P. mirabilis)
Otic

Ciprofloxacin-hydrocortisone otic suspension: In children ≥1 year of age, 3 drops into canal of affected ear(s) twice daily for 7 days.120

Otitis Media (Acute)
Otic

Ciprofloxacin-dexamethasone otic suspension: In children ≥6 months of age, 4 drops into affected ear(s) twice daily through tympanostomy tube for 7 days.125

Adults

Ophthalmic Infections
Conjunctivitis (S. aureus, S. epidermidis, S. pneumoniae, H. influenzae, or viridans streptococci)
Ophthalmic

Ointment: Apply approximately 1.27 cm (½ inch) ribbon into conjunctival sac of affected eye(s) 3 times daily for 2 days, then twice daily for next 5 days.119

Conjunctivitis (S. aureus, S. epidermidis, S. pneumoniae, or H. influenzae)
Ophthalmic

Solution: 1 or 2 drops of 0.3% solution into conjunctival sac of affected eye(s) every 2 hours while awake for 2 days, then 1–2 drops every 4 hours while awake for next 5 days.1 3

Keratitis
Ophthalmic

Solution: 2 drops of 0.3% solution into affected eye(s) every 15 minutes for 6 hours, followed by 2 drops every 30 minutes for remainder of first day.1 3 On the second day, instill 2 drops into affected eye(s) every hour, and on days 3–14, instill 2 drops every 4 hours.1 3 May continue longer than 14 days if corneal reepithelialization is not complete.1 3

Otic Infections
Otitis Externa (S. aureus or Ps. aeruginosa)
Otic

Ciprofloxacin-dexamethasone otic suspension: 4 drops into canal of affected ear(s) twice daily for 7 days.125

Otitis Externa (S. aureus, Ps. aeruginosa, or P. mirabilis)
Otic

Ciprofloxacin-hydrocortisone otic suspension: 3 drops into canal of affected ear(s) twice daily for 7 days.120

Cautions for Ciloxan

Contraindications

  • Known hypersensitivity to ciprofloxacin, other quinolones, or any ingredient in the formulation.1 119 120 125

  • Otic formulations contraindicated in patients with viral infections (i.e., herpes simplex, varicella) of external ear canal.120 125

  • Because commercially available ciprofloxacin-hydrocortisone fixed combination otic suspension is nonsterile, do not use if tympanic membrane is perforated.120

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity

Serious, potentially fatal hypersensitivity reactions possible, occasionally after initial systemic dose.1 99 119 120 125 If allergic reaction occurs, discontinue ciprofloxacin and institute appropriate therapy if indicated.1 119 120 125

General Precautions

Infectious Complications.

Possible overgrowth of nonsusceptible organisms (e.g., fungi) with prolonged use; if superinfection occurs, discontinue drug and institute other appropriate therapy.1 119 120 125

Patient Monitoring

Ophthalmic: Careful monitoring, including slit-lamp biomicroscopy and fluorescein staining when appropriate, may be necessary.1 119

Otic: If otic infection is not improved after 1 week of treatment, obtain cultures to guide further treatment.120 125 If otorrhea persists after full course of therapy with ciprofloxacin-dexamethasone otic suspension, or if ≥2 episodes of otorrhea occur within 6 months, further evaluate to exclude underlying condition (e.g., cholesteatoma, foreign body, tumor).125

Ocular Effects

In patients with bacterial keratitis, white crystalline precipitate in superficial portion of corneal defect possible; onset generally is within 1–7 days after initiation of therapy (when solution is administered repeatedly at relatively short intervals) and resolution usually during later phase of continued therapy (when administration frequency is reduced).1 3 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

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Category C.1 119 120 125

Lactation

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

Caution advised if ophthalmic solution or ointment is used in nursing women.1 119

Discontinue nursing or ciprofloxacin-steroid otic suspension preparations.120 125

Pediatric Use

Ophthalmic ointment: Safety and efficacy not established in children <2 years of age.119

Ophthalmic solution: Safety and efficacy not established in children <1 year of age.1

Ciprofloxacin-dexamethasone otic suspension: Safety and efficacy not established in children <6 months of age, but there are no known safety concerns or differences in disease process to preclude use in children <6 months of age.125

Ciprofloxacin-hydrocortisone otic suspension: Safety and efficacy not established in children <2 years of age, but there are no known safety concerns or differences in disease process to preclude use in children ≥1 year of age.120

Common Adverse Effects

Ophthalmic: local burning or discomfort, lid margin crusting, crystals/scales, foreign body sensation, itching, conjunctival hyperemia, bad taste, keratopathy.1 119

Otic: otic discomfort/pain/pruritus.120 125

Interactions for Ciloxan

No formal drug interaction studies to date.1 119 125 Since systemic absorption may occur following ophthalmic or otic1 119 125 administration, consider possible drug interactions such as those reported with systemic administration.1 119 125

Ciloxan Pharmacokinetics

Absorption

Bioavailability

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

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

Ciprofloxacin-dexamethasone otic suspension: Following a single bilateral 4-drop otic dose in pediatric patients after tympanostomy tube insertion, 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-hydrocortisone otic suspension: Systemic exposure to ciprofloxacin expected to be below assay quantitation limits (0.05 mg/mL) and maximum plasma hydrocortisone concentration is predicted to be within range of endogenous hydrocortisone.120

Distribution

Extent

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

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

Stability

Storage

Ophthalmic

Ointment

2–25°C.119

Solution

2–25°C.1 Protect from light.1 108

Otic

Suspension

Ciprofloxacin-dexamethasone otic suspension: 15–30°C.125 Avoid freezing; protect from light.125

Ciprofloxacin-hydrocortisone otic suspension: <25°C.120 Avoid freezing; protect from light.120

Actions and Spectrum

  • 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 99

  • Usually bactericidal.1 3 6 37 40 41 42 43 44 45 47

  • 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 6 8 40 42 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 6 8

Advice to Patients

  • Importance of discontinuing drug and informing clinician at first sign of rash or other sign of hypersensitivity.1 99 116 119 120 125

  • Importance of learning and adhering to proper administration techniques to avoid contamination of the product.1 116 119 120 125

  • Importance of not wearing contact lenses in presence of signs and symptoms of ophthalmic bacterial infections.119

  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.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.

Ciprofloxacin Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

0.3% (of ciprofloxacin)

Ciloxan

Alcon

Solution

0.3% (of ciprofloxacin)

Ciloxan (with benzalkonium chloride)

Alcon

Ciprofloxacin Ophthalmic Solution (with benzalkonium chloride)

Bausch & Lomb, Hi-Tech, Novex

Ciprofloxacin Hydrochloride Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Otic

Suspension

0.2% (of ciprofloxacin) with Hydrocortisone 1%

Cipro HC Otic Drops (with benzyl alcohol 0.9%)

Alcon

0.3% (of ciprofloxacin) with Dexamethasone 0.1%

Ciprodex (with benzalkonium chloride)

Alcon

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Ciloxan 0.3% Ointment (ALCON VISION): 4/$109.03 or 11/$292.19

Ciloxan 0.3% Solution (ALCON VISION): 5/$83.90 or 15/$229.89

Cipro HC 0.2-1% Suspension (ALCON VISION): 10/$148.27 or 30/$417.56

Ciprofloxacin HCl 0.3% Solution (SANDOZ): 3/$19.99 or 8/$45.97

Ciprofloxacin HCl 0.3% Solution (SANDOZ): 5/$29.99 or 15/$79.96

Ciprofloxacin HCl 0.3% Solution (SANDOZ): 10/$59.99 or 30/$159.96

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 1, 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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