ZYMAXID- gatifloxacin solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

gatifloxacin (UNII: L4618BD7KJ) (gatifloxacin - UNII:L4618BD7KJ)

Available from:

Physicians Total Care, Inc.

INN (International Name):

gatifloxacin

Composition:

gatifloxacin 5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ZYMAXID® (gatifloxacin ophthalmic solution) 0.5% solution 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 this organism was studied in fewer than 10 infections. None Pregnancy Category C Teratogenic Effects: There were no teratogenic effects observed in rats or rabbits following oral gatifloxacin doses up to 50 mg/kg/day (approximately 1000-fold higher than the maximum recommended ophthalmic dose). However, skeletal/craniofacial malformations or delayed ossification, atrial enlargement, and reduced fetal weight were observed in fetuses from rats given ≥150 mg/kg/day (approximately 3000-fold higher than the maximum recommended ophthalmic dose). In a perinatal/postnatal study, increased late post-implantation l

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 54868-6303-0 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
PHYSICIANS TOTAL CARE, 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%
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
ZYMAXID ophthalmic solution is a topical fluoroquinolone
anti-infective 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_
Efficacy for this organism was studied in fewer than 10 infections.
(1)
DOSAGE AND ADMINISTRATION
Patients 1 year of age or older: Instill one drop every two hours in
the affected eye(s) while awake, up to 8 times on Day 1.
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
5 mL size bottle filled with 2.5 mL of gatifloxacin ophthalmic
solution, 0.5%. (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Topical Ophthalmic Use Only (5.1)
Growth of Resistant Organisms with Prolonged Use (5.2)
Avoidance of Contact Lenses. Patients should not wear contact lenses
if they have signs or symptoms of bacterial
conjunctivitis or during the course of therapy with ZYMAXID (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: 2/2012
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 Topical Ophthalmic Use Only
5.2 Growth of Resistant Organisms with Prolo