Country: United States
Language: English
Source: NLM (National Library of Medicine)
ciprofloxacin hydrochloride (UNII: 4BA73M5E37) (ciprofloxacin - UNII:5E8K9I0O4U)
Rebel Distributors Corp
ciprofloxacin hydrochloride
ciprofloxacin hydrochloride 3.5 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
Ciprofloxacin Hydrochloride 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 (Viridans Group)* Conjunctivitis: - Haemophilus influenzae - Staphylococcus aureus - Staphylococcus epidermidis - Streptococcus pneumoniae *Efficacy for this organism was studied in fewer than 10 infections. 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.
As a sterile ophthalmic solution in Alcon’s DROP-TAINER** dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package. 2.5 mL – NDC 21695-259-25 5 mL – NDC 21695-259-05 10 mL – NDC 21695-259-10 **DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd.
New Drug Application
CIPROFLOXACIN HYDROCHLORIDE- CIPROFLOXACIN HYDROCHLORIDE SOLUTION REBEL DISTRIBUTORS CORP ---------- CIPROFLOXACIN HYDROCHLORIDE OPHTHALMIC SOLUTION 0.3% AS BASE STERILE DESCRIPTION Ciprofloxacin Hydrochloride Ophthalmic Solution is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)- 3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C H FN O •HCl•H O and its chemical structure is as follows: Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of Ciprofloxacin Hydrochloride Ophthalmic Solution contains: ACTIVE: ciprofloxacin HCl 3.5 mg equivalent to 3 mg base. PRESERVATIVE: benzalkonium chloride 0.006%. INACTIVE: sodium acetate, acetic acid, mannitol 4.6%, edentate disodium 0.05%, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm. CLINICAL PHARMACOLOGY SYSTEMIC ABSORPTION A systemic absorption study was performed in which Ciprofloxacin Hydrochloride 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_ activity against a wide range of gram-negative and gram-positive organisms. The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA. 17 18 3 3 2 Ciprofloxaci Read the complete document