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ciprofloxacin 0.3% eye drop generic ciloxan

In stock Manufacturer SANDOZ 61314065605
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Uses

Bacterial Ophthalmic Infections

Conjunctivitis

Ciprofloxacin 0.3% ophthalmic solution is used for the topical treatment of bacterial conjunctivitis caused by susceptible Staphylococcus aureus, S. epidermidis,Streptococcus pneumoniae, or Haemophilus influenzae.

Ciprofloxacin 0.3% ophthalmic ointment is used for the topical treatment of bacterial conjunctivitis caused by susceptible S. aureus, S. epidermidis, S. pneumoniae, viridans streptococci, or H. influenzae.

Although mild, acute bacterial conjunctivitis often resolves spontaneously without anti-infective treatment, topical ophthalmic anti-infectives may shorten the time to resolution and reduce severity and risk of complications. Treatment of acute bacterial conjunctivitis generally is empiric and use of a broad-spectrum topical ophthalmic antibacterial usually is recommended; however, indiscriminate use of topical anti-infectives should be avoided. In vitro staining and/or cultures of conjunctival material may be indicated in the management of recurrent, severe, or chronic purulent conjunctivitis or when acute conjunctivitis does not respond to initial empiric topical treatment.

Clinical Experience

Results of a placebo-controlled and a comparative study indicate that ciprofloxacin 0.3% ophthalmic solution is more effective than placebo (e.g., vehicle) and as effective as tobramycin 0.3% ophthalmic solution in patients with acute bacterial conjunctivitis caused by various gram-positive and -negative bacteria. In these studies, topical application of ciprofloxacin 0.3% ophthalmic solution to the eye for 3-7 days was effective in reducing or eradicating all conjunctival pathogens in approximately 70-95% of patients with acute bacterial conjunctivitis but produced clinical cures less frequently.

In clinical studies, treatment with ciprofloxacin 0.3% ophthalmic ointment was associated with clinical cure in approximately 75% of patients with bacterial conjunctivitis and positive conjunctival cultures, and the presumed pathogens were eradicated by day 7 in approximately 80% of patients.

Keratitis

Ciprofloxacin 0.3% ophthalmic solution is used for the topical treatment of keratitis (corneal ulcers) caused by susceptible S. aureus, S. epidermidis, S. pneumoniae, viridans streptococci, Serratia marcescens, or Pseudomonas aeruginosa.

Ciprofloxacin ophthalmic solution also has been used with variable success with other systemic and/or ophthalmic anti-infectives in the management of keratitis caused by nontuberculous mycobacteria (e.g., Mycobacterium gordonae, M. fortuitum, M. chelonae). Treatment with more than one anti-infective agent may be needed for the treatment of keratitis caused by such organisms.

Because many forms of bacterial keratitis are 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 perforation of the cornea with the 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 and use of a broad-spectrum topical ophthalmic antibacterial usually is recommended. Subconjunctival therapy with an appropriate anti-infective may be necessary if scleral spread or perforation is imminent. In vitro staining and/or cultures are indicated in the management of keratitis involving corneal infiltrates that are central, large, and extending to the middle to deep stroma or when keratitis is chronic or unresponsive to treatment with a broad-spectrum topical anti-infective.

Clinical Experience

In a multicenter study in patients with corneal ulcers and positive conjunctival cultures, treatment with ciprofloxacin 0.3% ophthalmic solution in the recommended dosage resulted in clinical cure (i.e., complete reepithelialization, no evidence of bacterial infection, absence of symptoms) in 76% of patients; complete reepithelialization with no evidence of bacterial infection occurred in 92% of patients. In this study, success of ciprofloxacin therapy did not depend on the severity (initial size) of the corneal ulcer, and such therapy also was effective in most patients with bacterial keratitis that did not respond to treatment with other ophthalmic anti-infectives.

Bacterial Otic Infections

Otitis Externa

Ciprofloxacin 0.2% otic solution is used for the topical treatment of acute bacterial otitis externa caused by susceptible S. aureus or Ps. aeruginosa.

The fixed-combination ciprofloxacin and dexamethasone otic suspension (ciprofloxacin 0.3% and dexamethasone 0.1%) is used for the topical treatment of acute otitis externa caused by susceptible S. aureus or Ps. aeruginosa.

The fixed-combination ciprofloxacin and hydrocortisone otic suspension (ciprofloxacin 0.2% and hydrocortisone 1%) is used for the topical treatment of acute bacterial otitis externa caused by susceptible S. aureus, Proteus mirabilis, or Ps. aeruginosa. Unlike other otic preparations containing ciprofloxacin, the commercially available fixed-combination ciprofloxacin and hydrocortisone otic suspension is nonsterile and should not be used if the tympanic membrane is known or suspected to be perforated.

Diffuse, uncomplicated acute otitis externa in otherwise healthy patients usually should be treated initially with topical therapy (e.g., otic anti-infective or antiseptic with or without an otic corticosteroid). Topical therapy should be supplemented with systemic anti-infective therapy if the patient has a medical condition that could impair host defenses (e.g., diabetes mellitus, human immunodeficiency virus [HIV] infection) or if the infection has spread into the 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.

Clinical Experience

In a randomized, multicenter, evaluator-blinded study in patients with acute otitis externa, patients received either ciprofloxacin 0.2% otic solution (twice daily for 7 days) or a fixed-combination otic solution containing neomycin, polymyxin B sulfates, and hydrocortisone (3 times daily for 7 days). In the per-protocol population, clinical cure was achieved at the end of the 7-day regimen in 70% of those treated with the ciprofloxacin otic solution versus 60% of those who received the fixed-combination preparation.

Safety and efficacy of the fixed-combination otic suspension containing ciprofloxacin and dexamethasone (ciprofloxacin 0.3% and dexamethasone 0.1%) for the treatment of acute otitis externa were evaluated in 2 randomized, multicenter, controlled trials. The clinical cure rate in the per-protocol population in trial 1 or 2 was 87 or 94%, respectively, in patients treated with the fixed-combination ciprofloxacin and dexamethasone otic suspension compared with 84 or 89%, respectively, in those treated with a fixed-combination otic suspension containing neomycin, polymyxin B, and hydrocortisone. Among culture-positive patients in these 2 studies, clinical cures were obtained in 86 or 92% of patients treated with the fixed-combination ciprofloxacin and dexamethasone otic suspension compared with 84 or 89% of patients treated with the fixed-combination neomycin, polymyxin B, and hydrocortisone otic suspension; microbiologic eradication rates were 86 or 92% compared with 85 or 85%, respectively.

Acute Otitis Media

The fixed-combination ciprofloxacin and dexamethasone otic suspension (ciprofloxacin 0.3% and dexamethasone 0.1%) is used topically for the treatment of acute otitis media caused by susceptible S. aureus, S. pneumoniae, H. influenzae, Moraxella catarrhalis, or Ps. aeruginosa in patients with tympanostomy tubes.

The fixed-combination ciprofloxacin and fluocinolone acetonide otic solution (ciprofloxacin 0.3% and fluocinolone acetonide 0.025%) is used topically for the treatment of acute otitis media caused by susceptible S. aureus, S. pneumoniae, H. influenzae, M. catarrhalis, or Ps. aeruginosa in patients with tympanostomy tubes.

Clinical Experience

In a randomized, multicenter, controlled trial in patients with tympanostomy tubes and acute otitis media, the clinical cure rate in the per-protocol population was 86% in patients treated with the fixed-combination otic suspension containing ciprofloxacin and dexamethasone (ciprofloxacin 0.3% and dexamethasone 0.1%) twice daily for 7 days compared with 79% in patients treated with ofloxacin 0.3% otic solution twice daily for 10 days. Among culture-positive patients, clinical cures were achieved in 90% of those treated with the fixed-combination ciprofloxacin and dexamethasone otic suspension compared with 79% of those treated with ofloxacin 0.3% otic solution; microbiologic eradication rates were 91 and 82%, respectively.

Safety and efficacy of the fixed-combination otic solution containing ciprofloxacin and fluocinolone acetonide (ciprofloxacin 0.3% and fluocinolone acetonide 0.025%) were evaluated in 2 multicenter, randomized, double-blind, active-controlled, phase 3 trials that included 662 pediatric patients 6 months to 12 years of age with acute otitis media with tympanostomy tubes. In both studies, patients were randomized to receive the fixed-combination otic solution, single-entity ciprofloxacin otic solution, or single-entity fluocinolone acetonide otic solution. In trial 1 or 2, cessation of otorrhea by day 22 was reported in 79 or 78% of patients, respectively, treated with the fixed-combination otic preparation of ciprofloxacin and fluocinolone acetonide compared with 67 or 69%, respectively, of patients treated with the otic preparation containing ciprofloxacin alone and 48 or 44%, respectively, of patients treated with the otic preparation containing the corticosteroid alone. The median time to cessation of otorrhea was 4 or 5 days in those treated with the fixed combination of ciprofloxacin and fluocinolone acetonide in study 1 or 2, respectively, compared with 8 or 7 days in those treated with the otic preparation containing ciprofloxacin alone.

Otitis Media with Effusion

Ciprofloxacin 6% otic suspension is administered intratympanically for the treatment of bilateral otitis media with effusion in pediatric patients undergoing tympanostomy tube placement.

Clinical Experience

Safety and efficacy of an intraoperative dose of ciprofloxacin 6% otic suspension (0.1 mL) for the treatment of bilateral otitis media with effusion in pediatric patients undergoing myringotomy with tympanostomy tube placement were evaluated in 2 randomized, multicenter, controlled, phase 3 clinical trials that included 532 patients. Enrolled patients had a median age of 1.5 years; 62% were 6 months through 2 years of age and 38% were older than 2 years of age. The efficacy end point for both trials was the cumulative proportion of study treatment failures through day 15, defined as the occurrence of any of the following: otorrhea as determined by a blinded assessor on or after 3 days postsurgery, use of otic or systemic antibacterials for any reason any time postsurgery, or patients who missed visits or were lost to follow-up. In trial 1 or 2, treatment failure occurred in 25 or 21% of patients, respectively, who received intratympanic ciprofloxacin 6% otic suspension compared with 45 or 46% of patients, respectively, who received sham treatment (tympanostomy tube placement only). There was no evidence of impaired hearing function, middle ear function, or tube patency at day 29 after intratympanic administration of ciprofloxacin 6% otic suspension.

Systemic Uses

For systemic uses of ciprofloxacin,

Dosage and Administration

Administration

Ophthalmic Administration

Ciprofloxacin is applied topically to the eye as a 0.3% ophthalmic solution or 0.3% ophthalmic ointment.

Ciprofloxacin ophthalmic solution and ointment are for topical ophthalmic use only and should not be injected into the eye.

Care should be taken to avoid contaminating the applicator tip with material from any source.

Otic Administration (Topical)

Ciprofloxacin is instilled topically into the ear canal as a 0.2% otic solution.

Ciprofloxacin in fixed combination with a corticosteroid (i.e., dexamethasone, fluocinolone acetonide, or hydrocortisone) is instilled topically into the ear canal as an otic solution or suspension.

Ciprofloxacin otic solution and fixed-combination otic solutions or suspensions containing ciprofloxacin and a corticosteroid are for topical otic use only; these preparations are not for ophthalmic use, injection, or inhalation.

To avoid dizziness that may result from instilling a cold preparation into the ear canal, the container of otic solution or suspension should be warmed in the hands for 1-2 minutes before use.

Otic suspensions containing ciprofloxacin should be shaken well prior to use.

The patient should lie with the affected ear upward. The appropriate amount of otic solution or suspension should be instilled into the ear; this position should be maintained for at least 1 minute to facilitate penetration into the ear canal. When treating acute otitis media, the tragus of the ear should be pumped 4 or 5 times by pushing inward to facilitate penetration of the solution into the middle ear. The procedure should be repeated for the opposite ear if necessary.

Care should be taken to avoid contaminating the applicator tip with material from the ear, fingers, or other source.

Otic Administration (Intratympanic)

Ciprofloxacin is administered intratympanically as a 6% otic suspension.

Ciprofloxacin 6% otic suspension is for intratympanic administration only.

The manufacturer's instructions should be consulted for specific information regarding preparation and intratympanic administration of ciprofloxacin 6% otic suspension.

Ciprofloxacin 6% otic suspension is thermosensitive and exists as a liquid at room temperature or lower, but thickens (gels) when warmed. During preparation, the suspension must be kept cold and should be placed back into a refrigerator if it thickens.(See Chemistry and Stability: Stability.)

Each vial of ciprofloxacin 6% otic suspension is for single-patient use only and contains a volume sufficient to provide 2 doses (1 dose in each ear administered using a different syringe for each ear). Only the syringes and needles provided by the manufacturer should be used to administer the otic suspension. After the syringes are prepared, they should be kept on their side either at room temperature or in the refrigerator and must be discarded if not used within 3 hours.

Middle ear effusions should be suctioned prior to intratympanic administration of ciprofloxacin 6% otic suspension.

Dosage

Ciprofloxacin is commercially available for topical ophthalmic administration and for topical otic administration as ciprofloxacin hydrochloride; dosage is expressed in terms of ciprofloxacin.

Bacterial Ophthalmic Infections

Conjunctivitis

For the topical treatment of bacterial conjunctivitis in adults and pediatric patients, 1 or 2 drops of ciprofloxacin 0.3% ophthalmic solution should be instilled in the conjunctival sac of the affected eye(s) every 2 hours while awake (up to 8 times daily) on days 1 and 2, then 1 or 2 drops of the ophthalmic solution should be instilled every 4 hours while awake on days 3 through 7.

When ciprofloxacin 0.3% ophthalmic ointment is used for the topical treatment of bacterial conjunctivitis in adults and children 2 years of age and older, a ribbon of the ophthalmic ointment approximately 1.27 cm (½ inch) in length should be placed in the lower conjunctival sac of the infected eye(s) 3 times daily on days 1 and 2, then 2 times daily on days 3 through 7.

The usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5-10 days; some experts state that 5-7 days of such treatment usually is adequate for mild bacterial conjunctivitis.

Keratitis

For the topical treatment of bacterial keratitis (corneal ulcers) in adults and pediatric patients, 2 drops of ciprofloxacin 0.3% ophthalmic solution should be instilled in the affected eye(s) every 15 minutes for the first 6 hours, followed by 2 drops in the affected eye(s) every 30 minutes for the remainder of the first day of treatment. On day 2 of treatment, 2 drops of the solution should be instilled in the affected eye(s) every hour; on days 3 through 14, 2 drops should be instilled every 4 hours.

The manufacturers state that treatment may be continued for longer than 14 days if corneal reepithelialization has not occurred; in clinical trials in patients with bacterial keratitis, the duration of topical ciprofloxacin treatment averaged about 3 weeks. Some experts state that the initial regimen should be reevaluated and modified if there is no improvement or stabilization of keratitis within 48 hours after initiation of treatment.

Bacterial Otic Infections

Otitis Externa

For the topical treatment of acute bacterial otitis externa in adults and children 1 year of age and older, the contents of a single-use container of ciprofloxacin 0.2% otic solution (0.25 mL) should be instilled into the canal of the affected ear(s) twice daily (approximately 12 hours apart) for 7 days.

When the fixed-combination otic suspension containing ciprofloxacin and dexamethasone (ciprofloxacin 0.3% and dexamethasone 0.1%) is used for the topical treatment of acute bacterial otitis externa in adults and children 6 months of age and older, 4 drops of the otic suspension should be instilled into the canal of the affected ear(s) twice daily for 7 days.

When the fixed-combination otic suspension containing ciprofloxacin and hydrocortisone (ciprofloxacin 0.2% and hydrocortisone 1%) is used for the topical treatment of acute bacterial otitis externa in adults and children 1 year of age and older, 3 drops of the otic suspension should be instilled into the canal of the affected ear(s) twice daily for 7 days.

The optimal duration of topical therapy for the treatment of acute otitis externa has not been determined, but 7-10 days is usually recommended. Some experts state that appropriate treatment of acute otitis externa should result in improvement in symptoms (otalgia, itching, fullness) within 48-72 hours, although resolution of symptoms may take up to 2 weeks. The manufacturers state that if there is no improvement in acute otitis externa after 1 week of treatment, cultures should be used to help guide further treatment.(See Precautions Related to Otic Administration under Cautions: Precautions and Contraindications.)

Acute Otitis Media

When the fixed-combination otic suspension containing ciprofloxacin and dexamethasone (ciprofloxacin 0.3% and dexamethasone 0.1%) is used for the topical treatment of acute otitis media in pediatric patients 6 months of age or older with tympanostomy tubes, 4 drops of the otic suspension should be instilled through the tympanostomy tube in the affected ear(s) twice daily for 7 days.

When the fixed-combination otic solution containing ciprofloxacin and fluocinolone acetonide (ciprofloxacin 0.3% and fluocinolone acetonide 0.025%) is used for the topical treatment of acute otitis media in pediatric patients 6 months of age or older with tympanostomy tubes, the contents of a single-dose vial (0.25 mL) of the otic solution should be instilled into the canal of the affected ear(s) twice daily (approximately every 12 hours) for 7 days.

Otitis Media with Effusion

For the treatment of bilateral otitis media with effusion in pediatric patients 6 months of age or older undergoing tympanostomy tube placement, a single dose of 0.1 mL (6 mg) of ciprofloxacin 6% otic suspension should be administered intratympanically into each affected ear.

Cautions

Ciprofloxacin ophthalmic and otic preparations generally are well tolerated following topical application. In most cases, adverse effects reported with topical ciprofloxacin therapy have been mild and have resolved without specific treatment.

Ophthalmic Administration

Local Effects

Overall, the most frequent adverse effects following topical application of ciprofloxacin ophthalmic solution or ointment are transient ocular discomfort (e.g., burning, stinging). Such effects have been reported in approximately 10% of patients in clinical studies receiving ciprofloxacin ophthalmic solution for various ophthalmic conditions. Ocular discomfort occurred in 2% of patients receiving ciprofloxacin ophthalmic ointment.

In patients with bacterial keratitis (corneal ulcers), the principal reported ocular effect has been the development of a white granular or crystalline precipitate in the superficial portion of the corneal defect, being observed in approximately 17% of patients with keratitis treated with ciprofloxacin ophthalmic solution in clinical studies. This corneal precipitate, identified as ciprofloxacin, generally appears during the early intensive phase of therapy for keratitis (e.g., within 1-7 days of initiating therapy) when the solution is administered repeatedly at relatively short intervals and usually resolves during the later phase of continued therapy when dosage (e.g., frequency of administration) of the drug is reduced. Presence of this precipitate does not appear to preclude continued therapy with ciprofloxacin nor to affect visual outcome or the clinical course of the corneal ulcer, and adjunctive therapy for its management is not necessary. In one study in patients with bacterial keratitis, the precipitate was observed more frequently in geriatric patients (older than 60 years of age) than in younger patients, but the risk of development appeared to be unrelated to gender, stromal depth of the ulcer or infiltrate, organism cultured, or time to resolution of infection. Factors contributing to ocular precipitation of ciprofloxacin, other than dosage (e.g., frequency of administration), remain to be elucidated.

Other adverse ocular effects have been reported in less than 10% of patients receiving topical ciprofloxacin ophthalmic solution in clinical studies and include lid margin crusting, crystals/scales on eyelashes, foreign body sensation, itching, and conjunctival hyperemia. Corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, decrease in vision, and corneal infiltrates have been reported in less than 1% of patients.

Keratopathy has been reported in 2% of patients receiving topical ciprofloxacin ophthalmic ointment. Allergic reactions, blurred vision, corneal staining, decreased visual acuity, dry eye, edema, epitheliopathy, ocular pain, foreign body sensation, hyperemia, irritation, keratoconjunctivitis, lid erythema, lid margin hyperemia, photophobia, pruritus, or tearing was reported in less than 1% of patients receiving topical ciprofloxacin ophthalmic ointment.

Systemic Effects

Since systemic absorption may occur following topical application of ciprofloxacin to the eye, the possibility of adverse systemic effects exists.

Taste abnormality (e.g., bad taste in the mouth) has been reported in 5% of patients in clinical studies receiving topical application of ciprofloxacin ophthalmic solution to the eye for various ophthalmic conditions. Taste abnormality or dermatitis has occurred in less than 1% of patients receiving ciprofloxacin ophthalmic ointment. Nausea has been reported in less than 1% of patients receiving the ophthalmic solution or ointment.

Otic Administration (Topical)

Local Effects

Following topical administration of ciprofloxacin 0.2% otic solution in patients with acute otitis externa, application site pain, ear pruritus, and fungal ear superinfection were reported in 2-3% of patients.

Otic discomfort, pain, or pruritus has been reported in 1.5-4% of patients receiving the fixed-combination otic suspension containing ciprofloxacin and dexamethasone (ciprofloxacin 0.3% and dexamethasone 0.1%).

Otorrhea was reported in 5% and ear infection, ear pruritus, and tympanic membrane disorder were each reported in 1% of patients receiving the fixed-combination otic solution containing ciprofloxacin and fluocinolone acetonide (ciprofloxacin 0.3% and fluocinolone acetonide 0.025%).

Ear canal erythema, ear congestion, hypoacusis, and medication residue have been reported rarely in patients receiving the fixed-combination otic suspension containing ciprofloxacin and hydrocortisone (ciprofloxacin 0.2% and hydrocortisone 1%).

Systemic Effects

Headache was reported in 2-3% of patients receiving ciprofloxacin 0.2% otic solution.

Taste perversion and irritability were reported rarely in patients receiving the fixed-combination otic suspension containing ciprofloxacin and hydrocortisone.

Headache or pruritus occurred in 1.2 or 0.4% of patients, respectively, receiving the fixed-combination otic suspension of ciprofloxacin and hydrocortisone; dizziness, migraine headache, hypoesthesia, paresthesia, fungal dermatitis, cough, rash, urticaria, and alopecia also have been reported.

There was no evidence of cochlear toxicity when the fixed-combination otic suspension of ciprofloxacin and hydrocortisone was administered intratympanically twice daily for 30 days in guinea pigs.

Otic Administration (Intratympanic)

Systemic Effects

Nasopharyngitis, irritability, and rhinorrhea have been reported in 3-5% of patients following intratympanic administration of ciprofloxacin 6% otic suspension.

There was no evidence of drug-related structural or functional changes of the cochlear hair cells when the ciprofloxacin 6% otic suspension was administered into the middle ear in guinea pigs.

For additional information on adverse effects of ciprofloxacin, .

Precautions and Contraindications

Ciprofloxacin 0.3% ophthalmic solution and 0.3% ophthalmic ointment are contraindicated in patients hypersensitive to ciprofloxacin or any ingredient in the formulation. These preparations also may be contraindicated in patients hypersensitive to other quinolones.

Ciprofloxacin 0.2% otic solution for topical use is contraindicated in patients hypersensitive to ciprofloxacin.

Ciprofloxacin 6% otic suspension for intratympanic use is contraindicated in patients hypersensitive to ciprofloxacin, other quinolones, or any ingredient in the formulation.

The fixed-combination ciprofloxacin and dexamethasone otic suspension (ciprofloxacin 0.3% and dexamethasone 0.1%) is contraindicated in patients hypersensitive to ciprofloxacin, other quinolones, or any ingredient in the formulation. In addition, the fixed combination is contraindicated in patients with viral infections of the external ear canal, including herpes simplex infections, or fungal otic infections.

The fixed-combination ciprofloxacin and fluocinolone acetonide otic solution (ciprofloxacin 0.3% and fluocinolone acetonide 0.025%) is contraindicated in patients hypersensitive to ciprofloxacin or other quinolones, fluocinolone acetonide or other corticosteroids, or any ingredient in the formulation. In addition, the fixed combination is contraindicated in patients with viral infections of the external ear canal, including varicella and herpes simplex infections, or fungal otic infections.

The fixed-combination ciprofloxacin and hydrocortisone otic suspension (ciprofloxacin 0.2% and hydrocortisone 1%) is contraindicated in patients hypersensitive to hydrocortisone, ciprofloxacin, or other quinolones. In addition, the fixed combination is contraindicated in patients with viral infections of the external ear canal, including varicella and herpes simplex infections. Unlike other otic preparations containing ciprofloxacin, the otic suspension containing ciprofloxacin and hydrocortisone is nonsterile and should not be used if the tympanic membrane is known or suspected to be perforated.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving systemic quinolones, including systemic ciprofloxacin, and these reactions have been reported following the initial systemic dose. Patients receiving ciprofloxacin ophthalmic or otic preparations should be advised of this possibility and instructed to discontinue the drug and contact a clinician at the first sign of rash or any other sign of hypersensitivity. Serious acute hypersensitivity (anaphylactic) reactions require immediate emergency treatment; appropriate therapy (e.g., epinephrine, corticosteroids, maintenance of an adequate airway, oxygen, maintenance of blood pressure) should be initiated as clinically indicated.

As with other anti-infectives, prolonged use of ciprofloxacin or fixed-combination preparations containing ciprofloxacin may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the drug should be discontinued and appropriate therapy instituted.

Precautions Related to Ophthalmic Administration

When ciprofloxacin ophthalmic solution or ointment is used for the topical treatment of bacterial ophthalmic infections, examination with slit lamp microscopy and, when appropriate, fluorescein staining should be performed as clinically indicated.

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

Contact lenses should not be worn during treatment with ciprofloxacin ophthalmic solution.

Precautions Related to Otic Administration

When ciprofloxacin otic preparations, including fixed-combination preparations containing ciprofloxacin and a corticosteroid, are used for the topical treatment of bacterial otic infections, cultures should be obtained to guide further treatment if the infection has not improved after 1 week of therapy.

If otorrhea persists after completion of topical ciprofloxacin therapy or if 2 or more episodes of otorrhea occur within 6 months, further evaluation is indicated to exclude underlying conditions such as cholesteatoma, foreign body, or tumor.

The fixed-combination otic suspension containing ciprofloxacin and hydrocortisone should not be used if the tympanic membrane is known or suspected to be perforated.

When ciprofloxacin 6% otic suspension is used intratympanically in patients with otitis media with effusion undergoing tympanostomy tube placement, patients and/or their caregiver should be advised that there may be drainage from the ear during the first few days following ear tube surgery; however, a clinician should be consulted if there is continuous ear discharge or if the ear becomes painful or fever develops.

Precautions Related to Use of Fixed Combinations Containing Corticosteroids

When otic preparations containing ciprofloxacin in fixed combination with a corticosteroid (i.e., dexamethasone, fluocinolone acetonide, or hydrocortisone) are used, the usual cautions, precautions, and contraindications associated with the corticosteroid also must be considered.

Pediatric Precautions

Ciprofloxacin 0.3% ophthalmic solution: Safety and efficacy in pediatric patients is supported by evidence from adequate and well-controlled studies in adults, children, and neonates. One manufacturer states that safety and efficacy of the ophthalmic solution have not been established in pediatric patients younger than 1 year of age.

Ciprofloxacin 0.3% ophthalmic ointment: Safety and efficacy have not been established in pediatric patients younger than 2 years of age.

Ciprofloxacin 0.2% otic solution: Safety and efficacy have not been established in pediatric patients younger than 1 year of age.

Ciprofloxacin 6% otic suspension for intratympanic use: Safety and efficacy have not been established in pediatric patients younger than 6 months of age.

Fixed-combination ciprofloxacin and dexamethasone otic suspension (ciprofloxacin 0.3% and dexamethasone 0.1%): Safety and efficacy have not been established in pediatric patients younger than 6 months of age.

Fixed-combination ciprofloxacin and fluocinolone acetonide otic solution (ciprofloxacin 0.3% and fluocinolone acetonide 0.025%): Safety and efficacy have not been established in pediatric patients younger than 6 months of age.

Fixed-combination ciprofloxacin and hydrocortisone otic suspension (ciprofloxacin 0.2% and hydrocortisone 1%): Safety and efficacy have not been established in pediatric patients younger than 2 years of age. However, efficacy for use in those 1 year of age and older has been extrapolated based on studies in adults and older pediatric patients.

Quinolones, including ciprofloxacin, have caused arthropathy in immature animals of various species following oral administration. In young beagles, ciprofloxacin given in a dosage of 100 mg/kg daily for 4 weeks caused degenerative articular changes in the knee joint; in a daily dosage of 30 mg/kg, effects on the joint were minimal, although some damage to weight-bearing joints was observed even at the lower dosage. However, topical application of a ciprofloxacin ophthalmic preparation for 1 month to the eye(s) of young beagles did not cause arthropathy or have any effects on weight-bearing joints. In addition, there is no evidence that topical application of otic preparations of quinolones has any effect on weight-bearing joints.

No evidence of cochlear toxicity was observed when the fixed-combination ciprofloxacin and hydrocortisone otic suspension was administered intratympanically twice daily for 30 days in guinea pigs.

Geriatric Precautions

No overall differences in safety and efficacy of ciprofloxacin 0.3% ophthalmic solution, ciprofloxacin 0.3% ophthalmic ointment, or ciprofloxacin 0.2% otic solution have been observed between geriatric and younger adults.

Clinical studies of the fixed-combination ciprofloxacin and fluocinolone acetonide otic solution (ciprofloxacin 0.3% and fluocinolone acetonide 0.025%) did not include sufficient numbers of patients 65 years of age or older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between geriatric and younger patients.

Mutagenicity and Carcinogenicity

Ciprofloxacin was not mutagenic in vivo in the rat hepatocyte DNA repair assay or dominant lethal or micronucleus tests in mice. Ciprofloxacin was positive for mutagenicity in the mouse lymphoma cell forward mutation assay and in vitro in the rat hepatocyte DNA repair assay; however, the drug was not mutagenic in other in vitro studies, including the Ames microbial (Salmonella) mutagen test with metabolic activation, Escherichia coli DNA repair assay, Chinese hamster V-79 cell HGPRT test, Syrian hamster embryo cell transformation assay, Saccharomyces cerevisiae point mutation assay, and mitotic crossover and gene conversion assays.

No evidence of carcinogenic potential was seen in mice and rats receiving oral ciprofloxacin daily for up to 2 years.

Pregnancy, Fertility, and Lactation

Pregnancy

There are no adequate and controlled studies to date using ciprofloxacin ophthalmic solution or ointment in pregnant women, and these preparations should be used during pregnancy only when potential benefits justify possible risks to the fetus.

There are no adequate and controlled studies using ciprofloxacin otic preparations, including fixed-combination preparations containing ciprofloxacin and a corticosteroid, in pregnant women, and these preparations should be used with caution during pregnancy. The manufacturer of the fixed combination of ciprofloxacin and fluocinolone acetonide states that negligible amounts of ciprofloxacin or fluocinolone acetonide are absorbed following topical administration of the otic solution and use of the fixed combination during pregnancy is not expected to result in fetal exposure to either drug.

Animal reproduction studies have not been performed using ciprofloxacin 6% otic suspension for intratympanic use and there are no adequate and well-controlled studies using the preparation in pregnant women. The manufacturer states that negligible systemic exposure is expected following intratympanic administration of the 6% otic suspension and there is minimal risk for maternal and fetal toxicity if the otic suspension is used during pregnancy.

Reproduction studies in rats and mice receiving oral ciprofloxacin dosages up to 6 times the usual human oral dosage have not revealed evidence of harm to the fetus. In rabbits, oral ciprofloxacin dosages of 30 and 100 mg/kg caused adverse GI effects resulting in maternal weight loss and an increased incidence of abortion, but there was no evidence of teratogenicity at either dosage. IV ciprofloxacin given to rabbits in dosages up to 20 mg/kg has not resulted in maternal toxicity, embryotoxicity, or teratogenicity.

Fertility

Reproduction studies in rats and mice using oral ciprofloxacin dosages up to 6 times the usual human oral dosage have not revealed evidence of impaired fertility.

Lactation

It is not known whether ciprofloxacin is distributed into milk following topical application to the eye or ear; however, ciprofloxacin is distributed into milk following oral administration.

Ciprofloxacin ophthalmic preparations should be used with caution in nursing women.

Because of the potential for serious adverse reactions to the drug in nursing infants, a decision should be made whether to discontinue nursing or otic preparations containing ciprofloxacin, including fixed-combinations preparations containing ciprofloxacin and a corticosteroid, taking into account the importance of the drug to the woman. The manufacturer of the fixed combination of ciprofloxacin and fluocinolone acetonide states that negligible amounts of ciprofloxacin and fluocinolone acetonide are absorbed following topical administration of the otic solution and use of the fixed-combination otic solution in the woman is not expected to result in exposure to either drug in her breast-feeding infant.

The manufacturer of ciprofloxacin 6% otic suspension for intratympanic use states that breast-feeding infants of women treated with the otic preparation should not be affected since negligible systemic exposure is expected in the woman.

Drug Interactions

Specific drug interaction studies have not been performed using ciprofloxacin ophthalmic preparations. However, since systemic absorption may occur following topical application of ciprofloxacin to the eye, the manufacturers state that the possibility of drug interactions such as those reported with some systemic quinolones (e.g., interactions with theophylline, caffeine, oral anticoagulants, cyclosporine) should be considered.

Pharmacokinetics

In all studies described in the Pharmacokinetics section, ciprofloxacin was administered as the hydrochloride salt; dosages and concentrations of the drug are expressed in terms of ciprofloxacin.

Absorption

Ophthalmic Administration

The extent of ocular and systemic absorption of ciprofloxacin following topical application to the eye has not been fully elucidated; however, serum concentrations achieved following such application to uninflamed eyes are minimal relative to those produced by usual oral or parenteral doses of the drug. Following topical application to the eye, ciprofloxacin is absorbed through the cornea into aqueous humor; absorption is enhanced in the presence of ocular inflammation and/or epithelial defects.

Following topical application to the eye of 1 drop of a 0.3% solution of ciprofloxacin (150 mcg) every 15 minutes for 1 hour and then every hour for 10 hours in patients undergoing keratoplasty, concentrations of the drug in corneal stromal tissue harvested within 1 hour after the last dose of ciprofloxacin averaged 5.28 mcg/g (range: 1.4-10.6 mcg/g). In anesthetized rabbits with intact ocular epithelium, topical application to the eye of 1 drop of a 0.3% solution of ciprofloxacin every 30 minutes for 6 doses produced aqueous humor concentrations averaging approximately 4.8 and 3.1 mcg/mL 30 and 90 minutes, respectively, after the last dose; in rabbits with ocular epithelial defects, aqueous humor concentrations averaged 12.9 and 7 mcg/mL 30 and 90 minutes, respectively, after application of the last dose. Following topical application to the eye of 1 drop of ciprofloxacin 0.75% every 15 minutes for 4 doses and then every 30 minutes for 3 hours in anesthetized rabbits, drug concentrations in aqueous humor 1 hour after the last dose averaged 30.5 mcg/mL. Following intravitreal injection of 100 mcg of ciprofloxacin in rabbits, peak drug concentrations in aqueous and vitreous humor at 1 hour were approximately 0.6 and 27.3 mcg/mL, respectively.

Some systemic absorption of ciprofloxacin occurs following topical application of the drug to the eyes. Following topical application to the eyes in healthy adults of 1 drop of a 0.3% solution of ciprofloxacin every 2 hours while awake for 2 days, then every 4 hours while awake for 5 days, serum ciprofloxacin concentrations reportedly ranged from undetectable to 4.7 ng/mL but generally averaged less than 2.5 ng/mL. In contrast, peak serum concentrations generally average 0.8-1.5 mcg/mL (800-1500 ng/mL) following administration of a single 250-mg oral dose of ciprofloxacin in healthy, fasting adults.

The extent of systemic absorption of ciprofloxacin following topical administration of ciprofloxacin ophthalmic ointment has not been fully evaluated. Based on studies using ciprofloxacin 0.3% ophthalmic solution, the maximum plasma ciprofloxacin concentration following application of the ophthalmic ointment is expected to average less than 2.5 ng/mL.

Otic Administration (Topical)

The manufacturer of ciprofloxacin 0.2% otic solution states that plasma concentrations of the drug have not been measured following topical otic application of the solution; however, peak plasma concentrations following topical otic application are expected to be less than 5 ng/mL.

Following topical application of 4 drops of the fixed-combination otic suspension containing ciprofloxacin and dexamethasone (ciprofloxacin 0.3% and dexamethasone 0.1%) into each ear canal in pediatric patients with tympanostomy tubes, peak plasma concentrations of ciprofloxacin ranged from 0.54-3.45 ng/mL (mean: 1.39 ng/mL). These peak plasma concentrations were on average approximately 0.1% of peak plasma concentrations of ciprofloxacin attained following a 250-mg oral dose of the drug.

Following topical application of the fixed-combination otic solution containing ciprofloxacin and fluocinolone acetonide (ciprofloxacin 0.3% and fluocinolone acetonide 0.025%) into the ears of pediatric patients 6 months to 12 years of age with acute otitis media with tympanostomy tubes (0.75 mg of ciprofloxacin and 0.0625 mg of fluocinolone acetonide twice daily), ciprofloxacin and fluocinolone acetonide were undetectable in the plasma of almost all patients. In one patient with bilateral acute otitis media, plasma concentrations of ciprofloxacin were 3 mcg/mL after 7 days of treatment, but the corticosteroid was undetectable.

The manufacturer of the fixed-combination otic suspension containing ciprofloxacin and hydrocortisone (ciprofloxacin 0.2% and hydrocortisone 1%) states that plasma concentrations of ciprofloxacin following topical otic application of 3 drops of the fixed combination are expected to be lower than the limit of detection of the assay (50 ng/mL) and peak plasma concentrations of hydrocortisone are predicted to be within the range of endogenous hydrocortisone.

Otic Administration (Intratympanic)

The manufacturer of ciprofloxacin 6% otic suspension for intratympanic use states that plasma concentrations of ciprofloxacin have not been measured following bilateral intratympanic administration of 0.1-mL doses of the suspension. Because the commercially available ciprofloxacin 6% otic suspension contains poloxamer 407, a thermosensitive polymer, the suspension exists as a liquid at room temperature and transitions to a gel when exposed to body temperature in the middle ear. This allows ciprofloxacin to be solubilized over time and results in sustained exposure to the drug in the middle ear.

Distribution

Distribution of ciprofloxacin into human ocular tissues and fluids following topical ophthalmic administration has not been fully characterized to date. Limited data in animals with experimentally induced ocular infection and in patients with intact corneal epithelium suggest that the drug penetrates into the cornea and other ocular tissues (e.g., aqueous humor) following topical application of a 0.3% solution of ciprofloxacin and is present in these tissues at concentrations exceeding the MIC of most corneal and conjunctival pathogens; the presence of ocular epithelial defects would likely result in enhanced penetration of the drug into ocular tissues.

Ciprofloxacin is widely distributed into body tissues and fluids following oral or IV administration. Information on the distribution of ciprofloxacin into ocular tissues and fluids following systemic administration of the drug is based principally on studies in patients with uninflamed and/or uninfected eyes; distribution is likely to be greater in the presence of inflammation or infection because of disruption of the blood/ocular barrier. Following oral or IV administration of ciprofloxacin in patients undergoing cataract extraction, peak drug concentrations in aqueous humor generally have averaged 3-33% of concurrent serum concentrations. Following single-dose oral or IV administration of ciprofloxacin in patients undergoing ocular surgery, concentrations in vitreous humor averaged about 20% of concurrent serum concentrations. Following IV administration of a single 12-mg dose of the drug in rabbits, ciprofloxacin concentrations in aqueous or vitreous humor averaged approximately 10 or approximately 1-5%, respectively, of concurrent serum concentrations.

Ciprofloxacin is 16-43% bound to serum proteins in vitro.

Ciprofloxacin crosses the placenta and is distributed into amniotic fluid in humans; the drug also is distributed into milk.

Elimination

The metabolic fate and elimination characteristics of ciprofloxacin following topical application to the eye have not been elucidated. In a study in rabbits, the half-life of ciprofloxacin in aqueous humor was 1-2 hours. The serum elimination half-life of ciprofloxacin in adults with normal renal function is 3-5 hours.

Systemically absorbed ciprofloxacin is eliminated by renal and nonrenal mechanisms. The drug is partially metabolized in the liver to at least 4 metabolites; these metabolites have microbiologic activity that is less than that of ciprofloxacin but may be similar to or greater than that of other quinolones. Ciprofloxacin and its metabolites are excreted in urine and feces. Unchanged ciprofloxacin is excreted in urine by both glomerular filtration and tubular secretion. Most, but not all, unchanged ciprofloxacin in feces appears to result from biliary excretion.

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