JAMP GATIFLOXACIN

2 Recommended Dose and Dosage Adjustment  The recommended dosage regimen for JAMP Gatifloxacin in the treatment of patients 1 year of age and older with bacterial conjunctivitis is: - Days 1 and 2: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times daily.

- Days 3 to 7: Instill one drop four times daily in the affected eye(s) while awake. - Doses should be evenly spaced throughout the day. 4 Administration Patients should be instructed to avoid allowing the tip of the bottle to contact the eye or surrounding JAMP Gatifloxacin (Gatifloxacin Ophthalmic Solution) Page 5 of 34 structures to avoid eye injury and contamination of the eye drops.

Patients wearing soft (hydrophilic) contact lenses should be instructed to remove contact lenses prior to administration of JAMP Gatifloxacin and wait at least 15 minutes following administration before reinserting soft contact lenses.

5 Missed Dose Patients should be instructed to instill the drops as soon as they remember, and then to return to their regular routine. 5. OVERDOSAGE A topical overdosage of JAMP Gatifloxacin is considered to be a remote possibility.

Discontinue medication when heavy or protracted use is suspected. A topical overdosage may be flushed from the eye(s) with warm tap water. 5 mg/kg of gatifloxacin. 0 mg/kg). 6. 005% w/v, as preservative, edetate disodium, sodium chloride, and water for injection.

May contain hydrochloric acid and/or sodium hydroxide to adjust pH. JAMP Gatifloxacin is supplied in a white, low density polyethylene (LDPE) sterilized bottle with a white sterilized LDPE dropper insert, high density polyethylene (HDPE) screw-on cap, and tamper-evident ring.

JAMP Gatifloxacin is supplied in a 10 mL sterile bottle. For management of a suspected drug overdose, including accidental ingestion, contact your regional poison control centre. JAMP Gatifloxacin (Gatifloxacin Ophthalmic Solution) Page 6 of 34 7.

WARNINGS AND PRECAUTIONS General NOT FOR INJECTION INTO THE EYE. FOR TOPICAL OPHTHALMIC USE ONLY. JAMP Gatifloxacin should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. JAMP Gatifloxacin contains the preservative benzalkonium chloride.

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Systemic quinolones have been associated with hypersensitivity reactions, even following a single dose. In patients receiving systemic quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported.

Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. As with all antibiotics, serious and sometimes fatal events, some due to hypersensitivity and some due to uncertain etiology, have been reported in patients receiving systemic quinolone therapy.

These events may be severe and generally occur following administration of multiple doses. , toxic epidermal necrolysis, Stevens-Johnson syndrome); vasculitis, arthralgia, myalgia, serum sickness; allergic pneumonitis, interstitial nephritis; acute renal insufficiency or failure; hepatitis, jaundice, acute hepatic necrosis or failure; anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.

Musculoskeletal and Connective Tissue Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including gatifloxacin, particularly in elderly patients and in those treated concurrently with corticosteroids. Treatment with JAMP Gatifloxacin should be discontinued at the first sign of tendon inflammation.

JAMP Gatifloxacin (Gatifloxacin Ophthalmic Solution) Page 7 of 34 Arthropathy As with other members of the quinolone class, gatifloxacin has caused arthropathy and/or chondrodysplasia in juvenile rats and dogs when given systemically.

See 16 NON-CLINICAL TOXICOLOGY. Arthrotoxic and osteotoxic potential of gatifloxacin ophthalmic solution was not assessed in animals. Ophthalmologic Contact Lenses Patients should not wear contact lenses while they have signs and symptoms of bacterial conjunctivitis.

JAMP Gatifloxacin contains the preservative benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses. Susceptibility/Resistance Development of Drug Resistant Bacteria Prescribing JAMP Gatifloxacin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant organisms.

Potential for Microbial Overgrowth As with other anti-infectives, prolonged use of JAMP Gatifloxacin 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. 1. Pregnant Women There are no adequate and well-controlled studies of gatifloxacin ophthalmic solution in pregnant women.

This drug should not be used in pregnant women unless, in the physician’s opinion, the potential benefit to the mother justifies the potential risk to the fetus. Gatifloxacin ophthalmic solution has not been studied in pregnant animals.

Oral and intravenous studies in pregnant animals indicate that gatifloxacin crosses the placenta and that reproductive and fetal effects occur at doses of  150 mg/kg/day, which cause maternal toxicity. See 16 NON-CLINICAL TOXICOLOGY.

2. Breast-feeding It is not known whether gatifloxacin is excreted in human milk, although gatifloxacin has been shown to be excreted in the breast milk of rats. Because gatifloxacin may be excreted in human milk, a decision should be made either to discontinue nursing or to discontinue the administration of JAMP Gatifloxacin, taking into account the importance of JAMP Gatifloxacin therapy to the mother and the possible risk to the infant.

3. Pediatrics The safety and efficacy of gatifloxacin ophthalmic solution in infants under 1 year of age have not been established. Gatifloxacin ophthalmic solution has been used to treat conjunctivitis in 14 infants between 1 to 2 years of age and 47 children between 3 to 12 years of age.

4. Geriatrics JAMP Gatifloxacin (Gatifloxacin Ophthalmic Solution) Page 8 of 34 No overall differences in safety or effectiveness have been observed between elderly and younger patients. 8. 1 Adverse Reaction Overview In clinical studies 364 patients were treated with gatifloxacin ophthalmic solution for up to 5 days.

6% (53/364) of patients. 5% of patients included, conjunctival disorder, conjunctivitis, chemosis, conjunctival cyst, conjunctival hemorrhage, corneal deposits, eye disorder, photophobia, subepithelial opacities, blurred vision, dermatitis, generalized urticaria, nausea, sore throat, sneezing, dizziness, and iritis.

Gatifloxacin ophthalmic solution was discontinued due to an adverse event, either related or […]