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gatifloxacin 0.5% eye drops generic zymaxid

Out of Stock Manufacturer LUPIN PHARMACEU 68180043501
Out of Stock

Uses

Ophthalmic Infections

Bacterial Conjunctivitis

Gatifloxacin 0.5% ophthalmic solution is used for the topical treatment of bacterial conjunctivitis caused by susceptible Staphylococcus aureus, S. epidermidis, Streptococcus mitis group, S. oralis, S. pneumoniae, or Haemophilus influenzae.

Although many cases of mild, acute bacterial conjunctivitis resolve spontaneously without anti-infective therapy, topical ophthalmic anti-infectives may shorten the time to resolution and reduce severity and risk of complications. Treatment of acute bacterial conjunctivitis generally is empiric and use of a broad-spectrum topical ophthalmic antibacterial usually is recommended; however, indiscriminate use of topical anti-infectives should be avoided. In vitro staining and/or cultures of conjunctival material may be indicated in the diagnosis and management of recurrent, severe, or chronic purulent conjunctivitis or when acute conjunctivitis does not respond to initial empiric topical treatment.

Clinical Experience

Efficacy and safety of gatifloxacin 0.5% ophthalmic solution for the topical treatment of conjunctivitis have been evaluated in 2 randomized, double-masked, vehicle-controlled, multicenter trials that included 658 pediatric and adult patients (range: 1-89 years of age) with conjunctivitis and positive conjunctival cultures. Patients were randomized to receive gatifloxacin 0.5% ophthalmic solution or vehicle control administered topically twice daily for 5 days and clinical success (resolution of conjunctival hyperemia and conjunctival discharge) was assessed on day 6. The clinical success rate was 58% in patients treated with gatifloxacin ophthalmic solution compared with 45% in those treated with vehicle control. Although microbiologic eradication does not always correlate with clinical outcome in anti-infective trials, the microbiologic eradication rate was 90% in the gatifloxacin group and 70% in the vehicle control group.

Dosage and Administration

Administration

Ophthalmic Administration

Gatifloxacin is applied topically to the eye as a 0.5% ophthalmic solution.

Gatifloxacin ophthalmic solution is for topical ophthalmic use only and should not be injected directly into the anterior chamber of the eye.(See Administration Precautions under Cautions: Warnings/Precautions.)

Care should be taken to avoid contaminating the applicator tip with material from the eye, fingers, or other source.

Dosage

Bacterial Conjunctivitis

For the topical treatment of bacterial conjunctivitis in adults and children 1 year of age and older, 1 drop of gatifloxacin 0.5% ophthalmic solution should be instilled in the affected eye(s) every 2 hours while awake (up to 8 times daily) on day 1, then 1 drop should be instilled 2-4 times daily while awake on days 2 through 7.

Cautions

Contraindications

Gatifloxacin 0.5% ophthalmic solution is contraindicated in patients with known hypersensitivity to gatifloxacin, other quinolones, or any component in the formulation.

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity reactions, including anaphylactic reactions, angioedema (e.g., pharyngeal, laryngeal, or facial edema), dyspnea, urticaria, and itching, have been reported in patients receiving gatifloxacin ophthalmic solution. Stevens-Johnson syndrome also has been reported rarely in association with gatifloxacin ophthalmic solution. Hypersensitivity reactions to the drug have occurred following a single dose.

Gatifloxacin ophthalmic solution should be discontinued immediately at the first sign of rash or hypersensitivity reaction.

Administration Precautions

Gatifloxacin 0.5% ophthalmic solution is for topical ophthalmic use only.

Corneal endothelial cell injury may occur if gatifloxacin ophthalmic solution is introduced directly into the anterior chamber of the eye.

Superinfection

As with other anti-infectives, prolonged use of gatifloxacin ophthalmic solution may result in overgrowth of nonsusceptible organisms, including fungi.

If superinfection occurs, gatifloxacin ophthalmic solution should be discontinued and appropriate therapy instituted.

Patient Monitoring

Whenever clinical judgment dictates, the patient should be examined with the aid of magnification (e.g., slit lamp biomicroscopy) and, if appropriate, fluorescein staining.

Contact Lenses

Contact lenses should not be worn during topical treatment with gatifloxacin ophthalmic solution and should not be worn if any signs or symptoms of bacterial conjunctivitis are present.

Specific Populations

Pregnancy

Data are not available regarding use of gatifloxacin 0.5% ophthalmic solution in pregnant women.

In animal studies using oral gatifloxacin, teratogenic effects (e.g., skeletal/craniofacial malformations, delayed ossification, atrial enlargement) and reduced fetal weight were reported at dosages equal to or greater than 150 mg/kg daily (approximately 600-fold higher than recommended human ophthalmic dosage on a mg/m basis).

Lactation

Gatifloxacin is distributed into milk in rats after oral administration. It is not known whether gatifloxacin is distributed into human milk following topical application to the eye.

Benefits of breast-feeding and the importance of gatifloxacin ophthalmic solution to the woman should be considered along with the potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.

Pediatric Use

Safety and efficacy of gatifloxacin 0.5% ophthalmic solution have not been established in children younger than 1 year of age.

Geriatric Use

No overall differences in safety and efficacy of gatifloxacin 0.5% ophthalmic solution have been observed between geriatric and younger adults.

Common Adverse Effects

Adverse effects reported in 1% or more of patients treated with gatifloxacin 0.5% ophthalmic solution include worsening of the conjunctivitis, eye irritation, dysgeusia, and eye pain.

Drug Interactions

No formal drug interaction studies have been performed using gatifloxacin 0.5% ophthalmic solution.

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