MOXIFLOXACIN- moxifloxacin solution/ drops

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

Moxifloxacin Hydrochloride (UNII: C53598599T) (Moxifloxacin - UNII:U188XYD42P)

Доступно од:

Lake Erie Medical DBA Quality Care Products LLC

Пут администрације:

OPHTHALMIC

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Moxifloxacin Ophthalmic Solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species* Micrococcus luteus* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri* Streptococcus pneumoniae Streptococcus viridans group Acinetobacter lwoffii* Haemophilus influenzae Haemophilus parainfluenzae* Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections. Moxifloxacin Ophthalmic Solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. Pregnancy Category C. Teratogenic Effects: Moxifloxacin was not teratogenic when administered to pregnant rats during organogenesis at oral doses as high as 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose); however, decreased fetal body weights an

Резиме производа:

Moxifloxacin Ophthalmic Solution, USP is supplied as a sterile ophthalmic solution in a 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. 3 mL in 5 mL bottle - NDC 55700-657-03 Storage: Store at 2° to 25°C (36° to 77°F).

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

MOXIFLOXACIN- MOXIFLOXACIN SOLUTION/ DROPS
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOXIFLOXACIN OPHTHALMIC
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MOXIFLOXACIN OPHTHALMIC
SOLUTION.
MOXIFLOXACIN OPHTHALMIC SOLUTION, USP 0.5%
STERILE TOPICAL OPHTHALMIC SOLUTION
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Moxifloxacin Ophthalmic Solution is a topical fluoroquinolone
anti-infective indicated for the treatment of bacterial
conjunctivitis caused by susceptible strains of the following
organisms:
_Corynebacterium_ species*_, Micrococcus luteus*, Staphylococcus
aureus, Staphylococcus epidermidis, Staphylococcus_
_haemolyticus, Staphylococcus hominis, Staphylococcus warneri*,
Streptococcus pneumoniae, Streptococcus viridans_ group_,_
_Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus
parainfluenzae*, Chlamydia trachomatis_ *Efficacy for this
organism was studied in fewer than 10 infections. (1)
DOSAGE AND ADMINISTRATION
Instill one drop in the affected eye 3 times a day for 7 days. (2)
DOSAGE FORMS AND STRENGTHS
5 mL bottle filled with 3 mL sterile ophthalmic solution of
moxifloxacin, 0.5%. (3)
CONTRAINDICATIONS
Moxifloxacin Ophthalmic Solution is contraindicated in patients with a
history of hypersensitivity to moxifloxacin, to other
quinolones, or to any of the components in this medication. (4)
WARNINGS AND PRECAUTIONS
Topical ophthalmic use only. (5.1)
Hypersensitivity and anaphylaxis have been reported with systemic use
of moxifloxacin. (5.2)
Prolonged use may result in overgrowth of non-susceptible organisms,
including fungi. (5.3)
Patients should not wear contact lenses if they have signs or symptoms
of bacterial conjunctivitis. (5.4)
ADVERSE REACTIONS
The most frequently reported ocular adverse events were
conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular
discomfort, ocular hyperemia, ocular pain, ocular pruritus,
subconjunctival