CIPROFLOXACIN HYDROCHLORIDE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Composition:

CIPROFLOXACIN 3 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 (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. 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 neon

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. 2.5 mL in 8mL bottle NDC 61314-656-25 5 mL in 8mL bottle NDC 61314-656-05 10 mL in 10mL bottle NDC 61314-656-10 STORAGE Store at 2° to 25°C (36° to 77°F). Protect from light.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CIPROFLOXACIN HYDROCHLORIDE- CIPROFLOXACIN HYDROCHLORIDE SOLUTION/
DROPS
SANDOZ INC
----------
CIPROFLOXACIN OPHTHALMIC SOLUTION 0.3%
STERILE
DESCRIPTION: Ciprofloxacin ophthalmic solution 0.3% 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 OPHTHALMIC SOLUTION 0.3% CONTAINS: ACTIVE:
ciprofloxacin HCl 3.5 mg
equivalent to 3 mg base. PRESERVATIVE: benzalkonium chloride 0.006%.
INACTIVES: 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 ophthalmic
solution 0.3% 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 to be active against most strains of the
follow