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RISING PHARM
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16571012050

ciprofloxacin 0.3% eye drop

Generic
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Uses

Ciprofloxacin ophthalmic solution is used in the treatment of keratitis and conjunctivitis caused by susceptible bacteria. Ciprofloxacin ophthalmic ointment is used in the treatment of conjunctivitis caused by susceptible bacteria.

Ciprofloxacin in fixed combination with hydrocortisone is applied to the ear canal for the treatment of acute otitis externa caused by susceptible bacteria.

Ciprofloxacin in fixed combination with dexamethasone is instilled into the ear for the treatment of acute otitis media caused by susceptible bacteria in pediatric patients with tympanostomy tubes. Ciprofloxacin in fixed combination with dexamethasone also is applied to the ear canal for the treatment of acute otitis externa caused by susceptible bacteria.

Ophthalmic Infections

Keratitis

Ciprofloxacin ophthalmic solution is used in the treatment of keratitis (corneal ulcer) caused by susceptible Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, S. epidermidis, Streptococcus pneumoniae, or viridans streptococci. Results of comparative studies in patients receiving a fluoroquinolone ophthalmic solution (e.g., ciprofloxacin, ofloxacin) for bacterial keratitis suggests that such therapy produces results comparable to those observed with more complex treatment regimens (e.g., a topical ''fortified'' aminoglycoside used in conjunction with a topical cephalosporin).

In a multicenter study, treatment with ciprofloxacin 0.3% ophthalmic solution in the recommended dosage resulted in clinical cure (i.e., complete reepithelization, no evidence of bacterial infection, absence of symptoms) in 76% of patients with bacterial keratitis; complete reepithelization 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. 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 opportunistic 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.

Ciprofloxacin also has been used successfully as a 0.3% ophthalmic ointment in patients with bacterial keratitis.

Conjunctivitis

Ciprofloxacin ophthalmic solution is used in the treatment of conjunctivitis caused by susceptible Staphylococcus aureus , S. epidermidis,Streptococcus pneumoniae, or Haemophilus influenzae.

Ciprofloxacin ophthalmic ointment is used in the treatment of conjunctivitis caused by susceptible S. aureus, S. epidermidis, S. pneumoniae, viridans streptococci, or H. influenzae.

Although most cases of acute bacterial conjunctivitis improve without anti-infective therapy, topical application of anti-infectives may shorten the infectious process. In addition, topical application of anti-infectives may reduce recurrence rate and morbidity associated with bacterial conjunctivitis.

Results from 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 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.

Otic Infections

Otitis Externa

Ciprofloxacin hydrochloride and hydrocortisone otic suspension is applied to the ear canal for the treatment of acute bacterial otitis externa caused by susceptible strains of S. aureus, Ps. aeruginosa, or Proteus mirabilis. Because commercially available ciprofloxacin and hydrocortisone otic suspension is nonsterile, it should not be used if the tympanic membrane is perforated.

Ciprofloxacin hydrochloride and dexamethasone otic suspension is applied to the external ear canal for the treatment of acute otitis externa caused by susceptible strains of S. aureus or Ps. aeruginosa. The commercially available formulation is a sterile suspension.

Although acute bacterial otitis externa localized in the external auditory canal may be effectively treated using topical anti-infectives (e.g., ciprofloxacin otic suspension, ofloxacin otic solution), malignant otitis externa is an invasive, potentially life-threatening infection, especially in immunocompromised patients such as those with diabetes mellitus or human immunodeficiency virus (HIV) infection, and requires prompt diagnosis and long-term treatment with parenteral anti-infectives (e.g., ceftazidime and/or ciprofloxacin).

Acute Otitis Media

Ciprofloxacin hydrochloride and dexamethasone otic suspension is applied to the ear canal and middle ear for the treatment of acute otitis media caused by susceptible strains of S. aureus, S. pneumoniae, H. influenzae, Moraxella catarrhalis, or Ps. aeruginosa in pediatric patients' tympanostomy tubes.

Systemic Uses

For systemic uses of ciprofloxacin,

Dosage and Administration

Administration

Ciprofloxacin hydrochloride is applied topically to the eye as an ophthalmic solution or ointment. Ciprofloxacin in fixed combination with hydrocortisone or dexamethasone is applied topically to the ear canal as a suspension. Care should be taken to avoid contamination of the container.

While intravitreal injection of extemporaneously prepared ciprofloxacin solutions has been studied in animals,commercially available ciprofloxacin hydrochloride ophthalmic solution is not for injection and should not be injected subconjunctivally or directly into the anterior chamber of the eye. Otic suspensions containing ciprofloxacin are not for ophthalmic use or for injection.

Prior to administration, ciprofloxacin hydrochloride and hydrocortisone or dexamethasone otic suspension should be warmed by holding the bottle in the hand for 1-2 minutes since instillation of a cold solution into the ear canal could precipitate dizziness. In addition, the suspension should be shaken well prior to use.

Contact lenses should be removed prior to administration of ciprofloxacin ophthalmic solution. In addition, patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.

Dosage

Dosage of ciprofloxacin hydrochloride is expressed in terms of ciprofloxacin.

Ophthalmic Infections

Keratitis

For the treatment of bacterial keratitis, the manufacturer recommends that ciprofloxacin ophthalmic solution be administered around the clock. The dosage of ciprofloxacin recommended by the manufacturer for the treatment of this infection is 2 drops of a 0.3% solution in the affected eye(s) every 15 minutes for 6 hours, followed by 2 drops in the affected eye(s) every 30 minutes for the remainder of the first day of treatment. On the second day of therapy, 2 drops of the solution may be instilled in the affected eye(s) every hour, and on days 3-14, this dose may be instilled in the affected eye(s) every 4 hours. Treatment may be continued for longer than 14 days if corneal reepithelialization is not complete; in clinical trials in patients with bacterial keratitis, the duration of ciprofloxacin therapy reportedly averaged about 3 weeks.

Conjunctivitis

For the treatment of bacterial conjunctivitis, the dosage of ciprofloxacin recommended by the manufacturer is 1 or 2 drops of a 0.3% solution in the affected eye(s) every 2 hours while awake for 2 days, then 1-2 drops every 4 hours while awake for the next 5 days.

For the treatment of bacterial conjunctivitis, a ribbon of ciprofloxacin 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 for 2 days, then 2 times daily for the next 5 days.

Otic Infections

Otitis Externa

For the treatment of acute bacterial otitis externa, 3 drops of ciprofloxacin hydrochloride and hydrocortisone otic suspension are instilled into the canal of the affected ear(s) twice daily for 7 days. Adults and children 1 year of age or older should lie with the affected ear upward and the suspension should be instilled into the ear canal; this position should be maintained for 30-60 seconds to facilitate penetration of the drops into the ear. This procedure should be repeated if necessary for the opposite ear.

For the treatment of acute bacterial otitis externa in adults and pediatric patients 6 months of age and older, 4 drops of ciprofloxacin hydrochloride and dexamethasone otic suspension are instilled into the canal of the affected ear(s) twice daily for 7 days. The patient should lie with the affected ear upward and the suspension should be instilled into the ear canal; this position should be maintained for 60 seconds to facilitate penetration of the drops into the ear. This procedure should be repeated if necessary for the opposite ear.

Acute Otitis Media

For the treatment of acute otitis media in pediatric patients 6 months of age and older, ciprofloxacin hydrochloride and dexamethasone otic suspension should be administered through the tympanostomy tube by having the patient lie with the affected ear upward and then instilling 4 drops of the suspension into the ear canal twice daily for 7 days. The tragus of the ear then should be pressed gently in a pumping action 5 times to allow the suspension to pass through the tympanostomy tube into the middle ear. Gently pulling the outer ear lobe upward and backward will allow the suspension to flow down into the ear canal. The patient should remain on their side for at least 60 seconds. If the other ear also is infected, these procedures should be repeated.

Cautions

Ciprofloxacin hydrochloride ophthalmic solution, ophthalmic ointment, and otic suspension 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.

Ocular Effects

Overall, the most frequent adverse effects of topical ciprofloxacin are transient ocular discomfort (e.g., burning, stinging) following instillation of the solution or ointment. 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, however, 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 treated with ciprofloxacin ophthalmic solution for this infection 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. A white precipitate also was observed in approximately 13% of patients receiving ciprofloxacin ophthalmic ointment in clinical studies. Factors contributing to such 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 topically applied ciprofloxacin solution in clinical studies and include lid margin crusting, crystals/scales on eyelashes, foreign body sensation, itching, and conjunctival hyperemia. Corneal staining, keratopathy/keratitis, sensitivity reactions, lid edema, tearing, photophobia, decrease in vision, and corneal infiltrates have been reported in less than 1% of patients.

Keratopathy occurred in 2% of patients receiving ciprofloxacin ophthalmic ointment. Allergic reaction, 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 ciprofloxacin ophthalmic ointment.

Systemic Effects

Taste abnormality (e.g., bad taste in the mouth) following instillation of ciprofloxacin ophthalmic solution has been reported in 5% of patients in clinical studies receiving the drug 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.

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

Headache or pruritus occurred in 1.2 or 0.4% of patients, respectively, receiving ciprofloxacin hydrochloride and hydrocortisone otic suspension; other events that occurred in patients receiving the combination included migraine headache, hypoesthesia, paresthesia, fungal dermatitis, cough, rash, urticaria, and alopecia. Otic discomfort, pain, or pruritus has been reported in patients receiving ciprofloxacin hydrochloride and dexamethasone otic suspension.

Ciprofloxacin, like most other quinolone antibacterials, causes arthropathy in immature animals of various species. In young beagles, ciprofloxacin given in a dosage of 100 mg/kg 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, application of ciprofloxacin ophthalmic solution for 1 month to the eye(s) of young beagles did not cause articular changes in weight-bearing joints.

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

For additional information on adverse systemic effects of ciprofloxacin, .

Precautions and Contraindications

The use of ciprofloxacin may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the drug should be discontinued and appropriate therapy instituted.

Careful monitoring, including slit lamp microscopy and fluorescein staining when appropriate, may be necessary in some patients receiving topical ophthalmic ciprofloxacin therapy.

Ciprofloxacin, like other quinolones, can cause serious, potentially fatal hypersensitivity reactions, occasionally following the initial systemic dose. Patients receiving ciprofloxacin should be advised of this possibility and instructed to discontinue the drug and contact their physician at the first sign of rash or any other sign of hypersensitivity. Topical ciprofloxacin hydrochloride is contraindicated in patients with a history of hypersensitivity to ciprofloxacin or any ingredient in the formulation. The manufacturers state that a history of hypersensitivity to other quinolones (e.g., gatifloxacin, gemifloxacin, levofloxacin, lomefloxacin, norfloxacin, ofloxacin, sparfloxacin) also may contraindicate use of topical ciprofloxacin.

Ciprofloxacin and hydrocortisone otic suspension should not be used if the tympanic membrane is perforated. Ciprofloxacin and hydrocortisone or dexamethasone otic suspension is contraindicated in patients with viral infections (i.e., varicella, herpes simplex) of the external ear canal.

Pediatric Precautions

Safety and efficacy of ciprofloxacin hydrochloride ophthalmic solution in children younger than 1 year of age have not been established. Safety and efficacy of ciprofloxacin ophthalmic ointment and ciprofloxacin and hydrocortisone otic suspension in children younger than 2 years of age have not been established. Safety and efficacy of ciprofloxacin and dexamethasone otic suspension in pediatric patients 6 months of age and older have been established in adequate and well-controlled studies involving 937 patients. While ciprofloxacin and hydrocortisone or dexamethasone otic suspension has not been evaluated in children younger than 2 years or 6 months of age, respectively, there are no known safety concerns or differences in the disease process in these children to preclude administration of the respective formulations in children 1 year of age or older or in those younger than 6 months of age, respectively.

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

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. There are no adequate and controlled studies to date using ophthalmic ciprofloxacin in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. There are no adequate and controlled studies using otic suspension preparations containing ciprofloxacin and a corticosteroid in pregnant women, and these preparations should be used with caution in pregnant women.

Fertility

Reproduction studies in rats and mice receiving 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 systemic administration . The ophthalmic solution and ointment 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 the ciprofloxacin-corticosteroid otic suspension, taking into account the importance of the drug to the woman.

Drug Interactions

Specific drug interaction studies involving ciprofloxacin hydrochloride ophthalmic solution or ophthalmic ointment and other drugs have not been conducted to date. However, since systemic absorption may occur following topical application of ciprofloxacin hydrochloride to the eye, the manufacturer states that the possibility of drug interactions such as those reported with systemic administration of ciprofloxacin 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

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 (50 mcL) 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, although systemic effects resulting from such absorption have not been reported to date. 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 the 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.

Plasma ciprofloxacin concentration following administration of 3 drops of ciprofloxacin and hydrocortisone otic suspension is expected to be lower than the limit of detection of the assay (50 ng/mL).

Following administration of 4 drops of ciprofloxacin and dexamethasone otic suspension into each ear canal in pediatric patients with tympanostomy tubes, plasma ciprofloxacin concentrations averaged 1.39 ng/mL.

Distribution

Distribution of ciprofloxacin into human ocular tissues and fluids following topical ophthalmic or systemic 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. Current 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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