Z-BROM  

Bromfenac sodium 0.09% Eye drops

Composition
Each ml contains
Bromfenac sodium equivalent to Bromfenac free acid                                0.9mg
Benzalkonium chloride solution                                                               I.P.0.01% w\v

Dosage form
Ophthalmic solution (Eye drops)

Category
NSAIDS (Non steroidal anti inflammatory drugs)

Description
Bromfenac is a non steroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclo oxygenase 1 and 2.

Indications
Z-Brom ophthalmic solution is indicated for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract extraction.

Dosage
For the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract extraction, one drop of Z-Brom ophthalmic solution should be applied to the affected eye(s) two times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.

Contraindications
Z-Brom ophthalmic solution is contraindicated in patients with known hypersensitivity to any ingredient in the formulation.

Warnings
There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives,and other NSAIDs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

With some NSAIDs, there exists the potential for increased bleeding time due to interference with platelet aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.

Precautions General
All topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

Use of topical NSAIDs may result in keratitis.In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.

It is recommended that Z-Brom ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day (360 times the recommended human ophthalmic dose [RHOD] of 1.67 µg/kg in 60 kg person on a mg/kg/basis, assuming 100% absorbed) and 5.0 mg/kg/day (3000 times RHOD), respectively revealed no significant increases in tumor incidence.

Bromfenac did not show mutagenic potential in various mutagenicity studies,including the reverse mutation, chromosomal aberration, and micronucleus tests.

Bromfenac did not impair fertility when administered orally to male and female rats at doses up to 0.9 mg/kg/day and 0.3 mg/kg/day, respectively (540 and 180 times RHOD, respectively)

Pregnancy Category C.
There are no adequate and well-controlled studies in pregnant women. this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Side effects
The most commonly reported adverse experiences reported following use of Z-Brom after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache, and iritis. These events were reported in 2-7% of patients.

Nursing Mothers Caution should be exercised when Z-Brom ophthalmic solution is administered to a nursing woman.

Pediatric Use
Safety and efficacy in pediatric patients below the age of 18 have not been established.

Geriatric Use
There is no evidence that the efficacy or safety profiles for Z-Brom differ in patients 65 years of age and older compared to younger adult patients.

Storage
Store in a cool dark place

Presentation
Z-Brom eye drops is available in 5 ml bottle.                                 << Back

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