CIPROFLOXACIN- ciprofloxacin hydrochloride_solution/ drops

CLINICAL PHARMACOLOGY:
Systemic Absorption: Microbiology: in vitro in vitro INDICATIONS AND USAGE Gram-Positive: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus Gram-Negative: 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 Escherichia coli Proteus mirabilis subsp. anitratus Haemophilus ducreyi Proteus vulgaris Aeromonas caviae Haemophilus parainfluenzae Providencia rettgeri Aeromonas hydrophila Kiebsiella pneumoniae Providencia stuartii Brucella melitensis Kiebsiella oxytoca Salmonella enteritidis Campylobacter coli Legionella pneumophila Salmonella typhi Campylobacter jejuni Moraxella (Branhamella) Shigella sonneii Citrobacter diversus catarrhalis Shigella flexneri Citrobacter freundii Morganella morganii Vibrio cholerae Edwardsiella tarda Neisseria gonorrhoeae Vibrio parahaemolyticus Enterobacter aerogenes Neisseria meningitidis Vibrio vulnificus Enterobacter cloacae Pasteurella multocida Yersinia enterocolitica Other Organisms: Chlamydia trachomatis Mycobacterium tuberculosis Most strains of Pseudomonas cepacia Pseudomonas maltophilia Bacteroides fragilis Clostridium difficile 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. Clinical Studies:
ANIMAL PHARMACOLOGY:
Ciprofloxacin and related drugs have been shown to cause arthropathy in immature animals of most species tested following oral administration. However, a one-month topical ocular study using immature Beagle dogs did not demonstrate any articular lesions. Rx Only Manufactured in India for: Nexus Pharmaceuticals Inc., Distributed by: Pack Pharmaceuticals, LLC, Buffalo Grove, IL, 60089. Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

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 *

Corneal Ulcers: corneal ulcers Bacterial Conjunctivitis: bacterial conjunctivitis How Supplied: 5 mL NDC 63187-150 STORAGE:

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

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.

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.
OVERDOSAGE:
A topical overdose of Ciprofloxacin Ophthalmic Solution may be flushed from the eye(s) with warm tap water.

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CIPROFLOXACIN- ciprofloxacin hydrochloride_solution/ drops Product manual source documgent