MOXIFLOXACIN OPHTHALMIC SOLUTION- moxifloxacin ophthalmic solution/ drops

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

MOXIFLOXACIN HYDROCHLORIDE (UNII: C53598599T) (MOXIFLOXACIN - UNII:U188XYD42P)

Disponibbli minn:

Fosun Pharma USA Inc.

Rotta amministrattiva:

OPHTHALMIC

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 C

Sommarju tal-prodott:

Moxifloxacin ophthalmic solution USP, 0.5% is supplied as a sterile ophthalmic solution in 5 mL round screw neck bottle made with natural low density polyethylene and pump with a dip tube made with natural low density polyethylene and tan brown opaque screw cap made with high density polyethylene. 3 mL in a 5 mL bottle - NDC 72266-158-01 Storage: Store at 2°C to 25°C (36°F to 77°F).

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

MOXIFLOXACIN OPHTHALMIC SOLUTION- MOXIFLOXACIN OPHTHALMIC SOLUTION/
DROPS
FOSUN PHARMA USA INC.
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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: (1)
_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, ocu