MOXIFLOXACIN OPHTHALMIC SOLUTION- moxifloxacin ophthalmic solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Gland Pharma Limited

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 influenzae 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 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 rabb

Product summary:

Moxifloxacin ophthalmic solution USP, 0.5% is supplied as a sterile ophthalmic solution in 5 mL round screw neck bottle made with natural low density polyethylene and pump with a dip tube made with natural low density polyethylene and tan brown opaque screw cap made with high density polyethylene. 3 mL in a 5 mL bottle - NDC 68083-210-01 Storage: Store at 2°C to 25°C (36°F to 77°F).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MOXIFLOXACIN OPHTHALMIC SOLUTION - MOXIFLOXACIN OPHTHALMIC SOLUTION/
DROPS
GLAND PHARMA LIMITED
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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
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
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 r