MOXIFLOXACIN solution/ drops

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE (UNII: B8956S8609) (MOXIFLOXACIN - UNII:U188XYD42P)

Disponible des:

Golden State Medical Supply, Inc.

Vía de administración:

OPHTHALMIC

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 influenza 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. Risk Summary   There are no adequate and well-controlled studies with moxiflox

Resumen del producto:

Moxifloxacin ophthalmic solution, USP is supplied as a sterile ophthalmic solution in a white translucent 5 mL LDPE bottle with an LDPE dropper tip, and a tan HDPE cap. 3 mL in a 5 mL bottle - NDC 51407-321-03 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/ DROPS
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
MOXIFLOXACIN OPHTHALMIC SOLUTION, USP. THESE HIGHLIGHTS DO NOT INCLUDE
ALL THE
INFORMATION NEEDED TO USE MOXIFLOXACIN OPHTHALMIC SOLUTION, USP SAFELY
AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MOXIFLOXACIN
OPHTHALMIC SOLUTION,
USP.
MOXIFLOXACIN OPHTHALMIC SOLUTION, USP 0.5%
STERILE TOPICAL OPHTHALMIC SOLUTION
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Dosage and Administration (2) 6/2020
Warnings and Precautions, Topical Ophthalmic Use (5.1) Removed 6/2020
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
Hypersensitivity Reactions: Hypersensitivity and anaphylaxis have been
reported with systemic use of
moxifloxacin. ( 5.1)
Prolonged Use: May result in overgrowth of non-susceptible organisms,
including fungi. If superinfection
occurs, discontinue use and institute alternative therapy. ( 5.2)
Avoid Contact Lens Wear: Patients should not wear contact lenses if
they have sig