CIPROFLOXACIN- ciprofloxacin_solution

Systemic Absorption: Microbiology in vitro Ciprofloxacin has been shown to be active against most strains of the following organisms both in vitro see INDICATIONS AND USAGE Aerobic gram-Positive microorganisms: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus Aerobic gram-negative microorganisms: Haemophilus influenzae Pseudomonas aeruginosa Serratia marcescens Ciprofloxacin has been shown to be active in vitro the clinical significance of these data is unknown: Gram-Positive: Enterococcus faecalis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus saprophyticus Streptococcus pyogenes Gram-Negative Acinetobacter calcoaceticus subsp. anitratus Aeromonas caviae Aeromonas hydrophila Brucella melitensis Campylobacter coli Campylobacter jejuni Citrobacter diversus Citrobacter freundii Edwardsiella tarda Enterobacter aerogenes Enterobacter cloacae Escherichia coli Haemophilus ducreyi Haemophilus parainfluenzae Kiebsiella pneumoniae Klebsiella oxytoca Legionella pneumophila Moraxella (Branhamella) catarrhalis Morganella morganii Neisseria gonorrhoeae Neisseria meningitides Pasteurella multocida Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Salmonella enteritidis Salmonella typhi Shigella sonneii Shigella flexneri Vibrio cholera Vibrio parahaemolyticus Vibrio vulnificus Yersinia enterocolitica Other Organisms: Chlamydia trachomatis Mycobacterium tuberculosis Most strains of Pseudomonas cepacia Pseudomonas maltophilia Bacteroides fragilis Clostridium difficile. The minimal bactericidal concentration (MBC) generally does not exceed the minimal inhibitory concentration (MIC) by more than a factor of 2. Resistance to ciprofloxacin in vitro Ciprofloxacin does not cross-react with other antimicrobial agents such as beta-lactams or aminoglycosides; therefore, organisms resistant to these drugs may be susceptible to ciprofloxacin.

Ciprofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Corneal Ulcers: Pseudomonas aeruginosa Serratia marcescens Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus Conjunctivitis: Haemophilus influenzae Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae *Efficacy for this organism was studied in fewer than 10 infections.

Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis

The most frequently reported drug related adverse reaction was local burning or discomfort. In corneal ulcer studies with frequent administration of the drug, white crystalline precipitates were seen in approximately 17% of patients (see PRECAUTIONS To report SUSPECTED ADVERSE REACTIONS, contact LEADING PHARMA AT 1-844-740-7500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

A history of hypersensitivity to ciprofloxacin or any other component of the medication is a contraindication to its use. A history of hypersensitivity to other quinolones may also contraindicate the use of ciprofloxacin.

Pregnancy
Reproduction studies have been performed in rats and mice at doses up to six times the usual daily human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to ciprofloxacin. In rabbits, as with most antimicrobial agents, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion. No teratogenicity was observed at either dose.After intravenous administration, at doses up to 20 mg/kg, no maternal toxicity was produced and no mbryotoxicity or teratogenicity was observed. There are no adequate and well controlled studies in pregnant women. Ciprofloxacin ophthalmic solution 0.3% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers:
It is not known whether topically applied ciprofloxacin is excreted in human milk. However, it is known that orally administered ciprofloxacin is excreted in the milk of lactating rats and oral ciprofloxacin has been reported in human breast milk after a single 500 mg dose. Caution should be exercised when Ciprofloxacin ophthalmic solution 0.3% is administered to a nursing mother.
Pediatric Use:
The safety and effectiveness of Ciprofloxacin ophthalmic solution 0.3% have been established in all ages. Use of Ciprofloxacin ophthalmic solution is supported by evidence from adequate and well controlled studies of Ciprofloxacin ophthalmic solution in adults, children and neonates [ see Clinical Studies
Geriatric Use:
No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Specific drug interaction studies have not been conducted with ophthalmic ciprofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant, warfarin, and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

WARNINGS
NOT FOR INJECTION INTO THE EYE. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated. Remove contact lenses before using.
Carcinogenesis,Mutagenesis, Impairment of Fertility:
Eight in vitro Salmonella E. coli Mouse Lymphoma Cell Forward Mutation Assay (Positive) Chinese Hamster V 79 Syrian Hamster Embryo Cell Transformation Assay (Negative) Saccharomyces cerevisiae Saccharomyces cerevisiae Rat Hepatocyte DNA Repair Assay (Positive) Thus, two of the eight tests were positive, but the results of the following three in vivo Rat Hepatocyte DNA Repair Assay Micronucleus Test (Mice) Dominant Lethal Test (Mice) Long term carcinogenicity studies in mice and rats have been completed. After daily oral dosing for up to two years, there is no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects in these species.
OVERDOSAGE
A topical overdose of Ciprofloxacin ophthalmic solution 0.3% may be flushed from the eye(s) with warm tap water.

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