CIPROFLOXACIN- ciprofloxacin_solution/ drops

CLINICAL PHARMACOLOGY
Systemic Absorption A systemic absorption study was performed in which Ciprofloxacin Ophthalmic Solution was administered in each eye every two hours while awake for two days followed by every four hours while awake for an additional 5 days. The maximum reported plasma concentration of ciprofloxacin was less than 5 ng/mL. The mean concentration was usually less than 2.5 ng/mL. Microbiology Ciprofloxacin has in vitro Ciprofloxacin has been shown to be active against most strains of the following organisms both in vitro Error! Hyperlink reference not valid. 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 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 Klebsiella pneumoniae Klebsiella oxytoca Legionella pneumophila Moraxella (Branhamella) catarrhalis Morganella morganii Neisseria gonorrhoeae Neisseria meningitidis Pasteurella multocida Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Salmonella enteritidis Salmonella typhi Shigella sonneii Shigella flexneri Vibrio cholerae 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. Clinical Studies Following therapy with Ciprofloxacin Ophthalmic Solution, 76% of the patients with corneal ulcers and positive bacterial cultures were clinically cured and complete re-epithelialization occurred in about 92% of the ulcers. In 3 and 7 day multicenter clinical trials, 52% of the patients with conjunctivitis and positive conjunctival cultures were clinically cured and 70-80% had all causative pathogens eradicated by the end of treatment.
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 by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev. 282:02 1/09 MG #18143 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 *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

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 Error! Hyperlink reference not valid.

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.

Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Protect from light.

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.

Proficient Rx LP

CIPROFLOXACIN- ciprofloxacin_solution/ drops Product manual source documgent