MOXIFLOXACIN HYDROCHLORIDE solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Upsher-Smith Laboratories, LLC

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 species1 Micrococcus luteus1 Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri1 Streptococcus pneumoniae Streptococcus viridans group Acinetobacter lwoffii1 Haemophilus influenza Haemophilus parainfluenzae1 Chlamydia trachomatis 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 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 adverse maternal or fetal effects at cli

Resumen del producto:

Moxifloxacin hydrochloride ophthalmic solution, USP is supplied as a sterile ophthalmic solution in a low-density polyethylene dropper tip bottle with a tan polypropylene cap closure. Tamper evidence is provided with a band around the neck area of the package. 3 mL in a 5 mL bottle – NDC 0832-1410-03 Storage: Store at 2°C to 25°C (36°F to 77°F).

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE SOLUTION
UPSHER-SMITH LABORATORIES, 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, FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Dosage and Administration (2)
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
Ophthalmic solution containing 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 signs or symptoms of
bacterial conjunctivitis. (5.3)
ADVERSE REACTIONS
The most frequently reported ocular adverse events were
conjunctivitis, decreased visua