GATIFLOXACIN solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Akorn

INN (International Name):

GATIFLOXACIN ANHYDROUS

Composition:

GATIFLOXACIN ANHYDROUS 5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Gatifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: *Efficacy for these organisms were studied in fewer than 10 infections. Gatifloxacin ophthalmic solution 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 gatifloxacin ophthalmic solution 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 adverse maternal, fetal or neonatal effects at clinically relevant doses. Data Animal Data Oral administration of gatifloxacin to pregnant rats throughout organogenesis produced t

Product summary:

Gatifloxacin Ophthalmic Solution, 0.5% is supplied sterile in a white, low density polyethylene (LDPE) bottle with a controlled dropper tip, and a tan cap in the following sizes: 2.5 mL in 6 mL bottle Storage: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GATIFLOXACIN- GATIFLOXACIN SOLUTION/ DROPS
AKORN
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GATIFLOXACIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GATIFLOXACIN.
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
Gatifloxacin ophthalmic solution is a quinolone antimicrobial
indicated for the treatment of bacterial
conjunctivitis caused by susceptible strains of the following
organisms: (1)
_Haemophilus influenzae, Staphylococcus aureus, Staphylococcus
epidermidis, Streptococcus mitis group,_
_Streptococcus oralis, Streptococcus pneumoniae_ (1) (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. (2)
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) (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution: 0.5% gatifloxacin (5mg/mL) (3) (3)
CONTRAINDICATIONS
Gatifloxacin ophthalmic solution is contraindicated in patients with a
history of hypersensitivity to
gatifloxacin, to other quinolones, or to any of the components in this
medication. (4) (4)
WARNINGS AND PRECAUTIONS
•
•
•
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 HI-TECH PHARMACAL CO.,
INC. AT 1- 800-
262-9010 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2022
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
5.3 Corneal Endothe