CIPROFLOXACIN HYDROCHLORIDE solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ciprofloxacin hydrochloride (UNII: 4BA73M5E37) (ciprofloxacin - UNII:5E8K9I0O4U)

Tilgjengelig fra:

Rebel Distributors Corp

INN (International Name):

ciprofloxacin hydrochloride

Sammensetning:

ciprofloxacin hydrochloride 3.5 mg in 1 mL

Administreringsrute:

OPHTHALMIC

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

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.

Autorisasjon status:

New Drug Application

Preparatomtale

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