MOXIFLOXACIN solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Lupin Pharmaceuticals, Inc.

Vía de administración:

OPHTHALMIC

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Moxifloxacin ophthalmic solution USP is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerococcus viridans* Corynebacterium macginleyi* Enterococcus faecalis* Micrococcus luteus* Staphylococcus arlettae* Staphylococcus aureus Staphylococcus capitis Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus saprophyticus* Staphylococcus warneri* Streptococcus mitis* Streptococcus pneumoniae Streptococcus parasanguinis* Escherichia coli* Haemophilus influenza Klebsiella pneumoniae* Propionibacterium acnes Chlamydia trachomatis* *Efficacy for this organism was studied in fewer than 10 infections. None. Risk Summary There are no adequate and well-controlled studies with moxifloxacin ophthalmic solution in pregnant women to inform any drug-associated risks. Oral administration of moxifloxacin to pregnant rats and monkeys and intravenously to pregnant rabbits during the period of organogenesis did not produce advers

Resumen del producto:

Moxifloxacin ophthalmic solution USP, 0.5% is supplied as a sterile ophthalmic solution in a sterile 5 mL natural low density polyethylene bottle fitted with a natural low density polyethylene nozzle and sealed with a tan coloured high density polyethylene cap as follows: 3 mL in a 5 mL bottle (NDC 68180-421-01) Storage: Store at 2°C to 25°C (36°F to 77°F).

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

MOXIFLOXACIN - MOXIFLOXACIN SOLUTION
LUPIN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOXIFLOXACIN OPHTHALMIC
SOLUTION USP, 0.5% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR MOXIFLOXACIN
OPHTHALMIC SOLUTION USP, 0.5%.
MOXIFLOXACIN OPHTHALMIC SOLUTION USP, 0.5%
FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Warnings and Precautions (5.1) 8/2021
INDICATIONS AND USAGE
Moxifloxacin Ophthalmic Solution USP is a topical fluoroquinolone
anti-infective indicated for the treatment
of bacterial conjunctivitis caused by susceptible strains of the
following organisms:
_Aerococcus viridans*, Corynebacterium macginleyi*, Enterococcus
faecalis*, Micrococcus luteus*,_
_Staphylococcus arlettae*, Staphylococcus aureus, Staphylococcus
capitis, Staphylococcus epidermidis,_
_Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus
saprophyticus*, Staphylococcus_
_warneri*, Streptococcus mitis*, Streptococcus pneumoniae,
Streptococcus parasanguinis*, Escherichia_
_coli*, Haemophilus influenzae, Klebsiella pneumoniae*,
Propionibacterium acnes, Chlamydia trachomatis*_
*Efficacy for this organism was studied in fewer than 10 infections.
(1)
DOSAGE AND ADMINISTRATION
Instill 1 drop in the affected eye(s) 2 times daily for 7 days. (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing moxifloxacin 0.5%. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Corneal Endothelial Damage and Toxic Anterior Segment Syndrome :
Intracameral injections will cause
harm to endothelium. (5.1)
Hypersensitivity Reactions : 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. If superinfection
occurs, discontinue use and institute alternative therapy. (5.3)
Avoid Contact Lens Wear : Patients should not wear contact lenses if
they have signs or symptoms of
bacterial conjun