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Loxiget (Ophthalmic Solution & Ointment)

 

DESCRIPTION

Loxiget Ophthalmic Solution/Ointment (Gatifloxacin 0.3%) is a sterile ophthalmic solution/ointment. Structure and Empirical Formula: C19H22FN3O4 1.5H2O Mol Wt 402.42 Chemical Name: (±)-1- cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid sesquihydrate.

COMPOSITION

Loxiget Eye Drops:

Each ml contains:
Gatifloxacin………………..3mg
With: Benzalkonium chloride 0.005% (as preservative), sodium chloride, edetate disodium and purified water.May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Loxiget Eye Ointment:

Each gram contains:
Gatifloxacin……………….3mg
Preservative: None
Product is self-preserved.
Inactives: Mineral oil & white petrolatum.

CLINICAL PHARMACOLOGY

Microbiology: Gatifloxacin is an 8-methoxyfluoroquinolone with a 3-methylpiperazinyl substituent at C7. The antibacterial action of gatifloxacin results from inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.The mechanism of action of fluoroquinolones including gatifloxacin is different from that of aminoglycoside, macrolide, and tetracycline antibiotics. Therefore, gatifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to gatifloxacin. There is no cross-resistance between gatifloxacin and the aforementioned classes of antibiotics. Cross resistance has been observed between systemic gatifloxacin and some other fluoroquinolones.Resistance to gatifloxacin in vitro develops via multiple-step mutations. Resistance to gatifloxacin in vitro occurs at a general frequency of between 1 x 10-7 to 10-10.

INDICATIONS AND USAGE

Loxiget Eye Drops/Ointment are indicated for the bacterial conjunctivitis caused by susceptible strains of the following organisms:

Aerobes, Gram-Positive Bacteria
Corynebacterium propinquum*
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus mitis*
Streptococcus pneumoniae

Aerobes, Gram-Negative

Haemophilus influenzae
* Efficacy for this organism was studied in fewer than 10 infections.

CONTRAINDCATIONS

Loxget Eye Drops/Ointment are contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication.

PRECAUTIONS

General: As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.

Pregnancy: Teratogenic Effects. Pregnancy Category C:
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).

Nursing Mothers: Gatifloxacin is excreted in the breast milk of rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when gatifloxacin is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in infants below the age of one year have not been established.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

WARNINGS NOT FOR INJECTION.

Loxiget Eye Drops/Ointment should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.

ADVERSE REACTIONS

Ophthalmic Use: The most frequently reported adverse events in the overall study population were conjunctival irritation, increased lacrimation, keratitis, and papillary conjunctivitis. These events occurred in approximately 5-10% of patients. Other reported reactions occurring in 1-4% of patients were chemosis, conjunctival hemorrhage, dry eye, eye discharge, eye irritation, eye pain, eyelid edema, headache, red eye, reduced visual acuity and taste disturbance.

DOSAGE AND ADMINISTRATION

Loxiget Eye Drope The recommended dosage regimen for the treatment of bacterial conjunctivitis is:
Days 1 and 2: Instil one drop every two hours in the affected eye(s) while awake, up to 8 times daily.
Days 3 through 7: Instill one drop up to four times daily while awake or as directed by the ophthalmologist.
Loxiget Eye Ointment: Apply a half inch ribbon into the conjunctival sac(s) three time on the first two days, then apply a half inch ribbon two times a day for the next five days or as directed by the Ophthalmologist.

HOW SUPPLIED

Loxiget Eye Drops are available as a sterile solution 5 ml in pilfer proof plastic dropper bottles (Gamma Irradiated).
Loxiget Eye Ointment is available as a sterile ointment 3.5 gm in ophthalmic tube (Gamma Irradiated).

STORAGE

Protect from sunlight and heat. Keep away from children’s reach. Do not freeze. Store between 15˚C-25˚C.
After opening the bottle,use within 4 weeks.