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:

Preferred Pharmaceuticals 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. 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 ophthalmi

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 68788-582-3 Storage: Store at 2°- 25°C (36°- 77°F).

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

MOXIFLOXACIN- MOXIFLOXACIN SOLUTION/ DROPS
PREFERRED 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 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
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 HEMORRHAGE, AND
TEARING. THESE EVENTS OCCURRED IN APPROXIMATELY 1-6% OF PATIENTS.
(6)TO REPORT SUSPECTED ADVERSE
REACTIONS, CONTACT APOTEX CORP. AT 1-800-667-4708 OR FDA AT
1-800-FDA-1088 OR www.fda.gov/medwatch.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND U