CIPROFLOXACIN HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (CIPROFLOXACIN - UNII:5E8K9I0O4U)

Available from:

STAT Rx USA LLC

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Composition:

CIPROFLOXACIN HYDROCHLORIDE 3.5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Safety and effectiveness in pediatric patients below the age of 1 year have not been established. Although ciprofloxacin and other quinolones cause arthropathy in immature animals after oral administration, topical ocular administration of ciprofloxacin to immature

Product summary:

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. 5 mL  -  NDC # 16590-421-05 STORAGE: Store at 2° to 25°C (36° to 77°F). Protect from light. Relabeling and Repackaging by : STAT Rx USA LLC Gainesville, GA  30501

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CIPROFLOXACIN HYDROCHLORIDE - CIPROFLOXACIN HYDROCHLORIDE SOLUTION
STAT RX USA LLC
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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%, edetate 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.
Ciprofloxacin has been shown