ZYMAXID- gatifloxacin solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GATIFLOXACIN (UNII: L4618BD7KJ) (GATIFLOXACIN ANHYDROUS - UNII:81485Y3A9A)

Available from:

Allergan, Inc.

INN (International Name):

GATIFLOXACIN

Composition:

GATIFLOXACIN 5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ZYMAXID® is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:    - Aerobic gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus mitis group* Streptococcus oralis * Streptococcus pneumoniae - Aerobic gram-negative bacteria: Haemophilus influenzae *Efficacy for these organisms were studied in fewer than 10 infections.   ZYMAXID®  is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [see Warnings and Precautions ( 5.1 )] . Risk Summary There are no available data on the use of ZYMAXID® in pregnant women to inform a drug-associated risk. Administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses. Administration of gatifloxacin to rats during late gestation through lactation did not produce a

Product summary:

ZYMAXID®   (gatifloxacin ophthalmic solution) 0.5% is supplied sterile in a white, low density polyethylene (LDPE) bottle with a controlled dropper tip, and a tan, high impact polystyrene (HIPS) cap in the following size: 2.5 mL in 5 mL bottle: NDC 0023-3615-25 Storage:   Store at 15°-25°C (59°-77°F). Protect from freezing.

Authorization status:

New Drug Application

Summary of Product characteristics

ZYMAXID- GATIFLOXACIN SOLUTION/ DROPS
ALLERGAN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZYMAXID SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZYMAXID .
ZYMAXID (GATIFLOXACIN OPHTHALMIC SOLUTION) 0.5% FOR TOPICAL OPHTHALMIC
USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Contraindications, Hypersensitivity (4)
09/2016
Warnings and Precautions, Hypersensitivity (5.1) 09/2016
INDICATIONS AND USAGE
ZYMAXID is a quinolone antimicrobial indicated for the treatment of
bacterial conjunctivitis caused by susceptible strains
of the following organisms:
_Haemophilus influenzae, Staphylococcus aureus, Staphylococcus
epidermidis, Streptococcus mitis _group_, Streptococcus_
_oralis, Streptococcus pneumoniae _(1)
DOSAGE AND ADMINISTRATION
Day 1: Instill one drop every two hours in the affected eye(s) while
awake, up to 8 times on Day 1.
Days 2 through 7: Instill one drop two to four times daily in the
affected eye(s) while awake on Days 2 through 7. (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution: 0.5% gatifloxacin (5mg/mL) (3)
CONTRAINDICATIONS
ZYMAXID is contraindicated in patients with a history of
hypersensitivity to gatifloxacin, to other quinolones, or to any of
the components in this medication. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity (5.1)
Growth of Resistant Organisms with Prolonged Use (5.2)
Corneal Endothelial Cell Injury (5.3)
ADVERSE REACTIONS
Most common adverse reactions occurring in ≥ 1 % of patients
included worsening of conjunctivitis, eye irritation,
dysgeusia, and eye pain. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALLERGAN AT
1-800-433-8871 OR FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 9/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 HYPERSENSITIVITY
5.2 GROWTH OF RESISTANT ORGANISMS WITH PROLONGED USE
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