CIPROFLOXACIN HYDROCHLORIDE solution/ drops

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

NuCare Pharmaceuticals,Inc.

INN (الاسم الدولي):

CIPROFLOXACIN HYDROCHLORIDE

تركيب:

CIPROFLOXACIN 3 mg in 1 mL

طريقة التعاطي:

OPHTHALMIC

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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

ملخص المنتج:

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. NDC 68071-3351-3 Box of 10mL STORAGE: Store at 2° to 25°C (36° to 77°F). Protect from light.

الوضع إذن:

New Drug Application Authorized Generic

خصائص المنتج

CIPROFLOXACIN HYDROCHLORIDE- CIPROFLOXACIN HYDROCHLORIDE SOLUTION/
DROPS
NUCARE PHARMACEUTICALS,INC.
----------
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
17
18
3
3
2
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.