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:

Aidarex Pharmaceuticals 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 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. 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); h

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 Storage: Store at 2°- 25°C (36°- 77°F).

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

MOXIFLOXACIN- MOXIFLOXACIN SOLUTION/ DROPS
AIDAREX PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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
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(s) 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 hemorrha