Ophthalmic ointment: Treatment of conjunctivitis caused by susceptible strains of Staphylococcus aureus, S. epidermidis, Streptococcus pneumoniae, Haemophilus influenzae, or viridans streptococci.
Ophthalmic solution: Treatment of conjunctivitis caused by susceptible strains of S. aureus, S. epidermidis, S. pneumoniae, or H. influenzae.
Some clinicians suggest that quinolones be reserved principally for severe bacterial conjunctivitis because of potential development of quinolone resistance, and possibly, cost considerations.
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.
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.
Bacterial Otic Infections
Ciprofloxacin-dexamethasone otic suspension: Treatment of acute otitis externa caused by susceptible strains of S. aureus or Ps. aeruginosa.
Ciprofloxacin-hydrocortisone otic suspension: Treatment of acute otitis externa caused by susceptible strains of S. aureus, Ps. aeruginosa, or Proteus mirabilis.
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.
Dosage and Administration
General
Avoid contamination of container.
Administration
Ophthalmic Administration
Apply topically to the eye as an ophthalmic ointment or solution.
Not for injection.
Remove contact lenses before administration of ophthalmic solution.
For treatment of bacterial keratitis, administer ophthalmic solution around the clock.
Otic Administration
Administered as otic suspension in fixed combination with dexamethasone or hydrocortisone.
For otic use only. Not for ophthalmic use. Not for injection.
Discard unused portion after therapy is completed.
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. Shake well before use.
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. Repeat for opposite ear if necessary.
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. Pump tragus 5 times by pushing inward to facilitate penetration of drops into middle ear; maintain position for 60 seconds. Repeat for opposite ear if necessary.
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.
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.
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. On the second day, instill 2 drops into affected eye(s) every hour, and on days 3–14, instill 2 drops every 4 hours. May continue longer than 14 days if corneal reepithelialization is not complete.
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.
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.
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.
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.
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.
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. On the second day, instill 2 drops into affected eye(s) every hour, and on days 3–14, instill 2 drops every 4 hours. May continue longer than 14 days if corneal reepithelialization is not complete.
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.
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.
Because commercially available ciprofloxacin-hydrocortisone fixed combination otic suspension is nonsterile, do not use if tympanic membrane is perforated.
Warnings/Precautions
Sensitivity Reactions
Hypersensitivity
Serious, potentially fatal hypersensitivity reactions possible, occasionally after initial systemic dose. If allergic reaction occurs, discontinue ciprofloxacin and institute appropriate therapy if indicated.
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.
Otic: If otic infection is not improved after 1 week of treatment, obtain cultures to guide further treatment. 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).
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). Precipitate does not appear to preclude continued use nor adversely affect visual outcome or clinical course of corneal ulcer.
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.
Lactation
Distributed into milk after systemic administration; it is not known whether distributed into milk after topical application to the eye or ear.
Caution advised if ophthalmic solution or ointment is used in nursing women.
Discontinue nursing or ciprofloxacin-steroid otic suspension preparations.
Pediatric Use
Ophthalmic ointment: Safety and efficacy not established in children <2 years of age.
Ophthalmic solution: Safety and efficacy not established in children <1 year of age.
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.
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.
Common Adverse Effects
Ophthalmic: local burning or discomfort, lid margin crusting, crystals/scales, foreign body sensation, itching, conjunctival hyperemia, bad taste, keratopathy.
Otic: otic discomfort/pain/pruritus.
Interactions
No formal drug interaction studies to date. Since systemic absorption may occur following ophthalmic or otic administration, consider possible drug interactions such as those reported with systemic administration.
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.
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).
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. Peak plasma ciprofloxacin and dexamethasone concentrations were attained within 15 minutes to 2 hours.
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.
Distribution
Extent
Distribution into human ocular tissues and fluids following topical ophthalmic or systemic administration not fully characterized to date.
Distributed into milk after systemic administration; it is not known whether distributed into milk after topical application to the eye or ear.
Stability
Storage
Ophthalmic
Ointment
2–25°C.
Solution
2–25°C. Protect from light.
Otic
Suspension
Ciprofloxacin-dexamethasone otic suspension: 15–30°C. Avoid freezing; protect from light.
Ciprofloxacin-hydrocortisone otic suspension: <25°C. Avoid freezing; protect from light.
Actions
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.
Advice to Patients
Importance of discontinuing drug and informing clinician at first sign of rash or other sign of hypersensitivity.
Importance of learning and adhering to proper administration techniques to avoid contamination of the product.
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.
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.
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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