Ciprofloxacin Hydrochloride eent

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

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

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

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

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

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

Specific Populations

Category C.1 119 120 125

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

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

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

Storage

Ophthalmic

2–25°C.119

2–25°C.1 Protect from light.1 108

Otic

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

• 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

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.