Xibrom Eye Drops
Publish date 06-03-2016


Xibrom Eye Drops (Bromfenac sodium ophthalmic solution0.09%) is a sterile, topical, non-steroidal anti-inflammatory(NSAIDs) eye drops

 

 

 

Xibrom Eye Drops (Bromday Eye Drops)



Xibrom Eye Drops (Bromfenac sodium ophthalmic solution0.09%) is a sterile, topical, non-steroidal anti-inflammatory (NSAIDs) eye drops.
Bromday Eye Drops
Each mL contains 1.035 mg Bromfenac sodium equivalent to 0.9 mg Bromfenac free acid.

This Eye drops is used twice a day while Bromday Eye drops which has the same active ingredients is approved by FDA for once daily application and for this reason it will be discontinued from the market and will be replaced with Bromday Eye Drops.


 

Ingredients of Xibrom Eye Drops

Each mL this Eye drop contains:


Active:

Bromfenac sodium hydrates 0.1035%.

Preservatives:

Benzalkonium chloride (0.05 mg/mL).

Inactives:

Boric acid, Disodium edetate (0.2 mg/mL), Polysorbate 80 (1.5 mg/mL), Povidone (20 mg/mL), sodium borate, sodium sulfite anhydrous (2 mg/mL), sodium hydroxide to adjust the pH, and water for injection, USP.

 

 

 

Mechanism of Action

Bromfenac sodium is a non-steroidal anti-inflammatory drug. These in general will inhibit specific enzyme called cyclooxygenase which play a major role in the synthesis of prostaglandin.

Prostaglandin plays roles in many forms of systemic and localized inflammatory reaction such as inflammation in ocular tissues. It can cause disruption of the blood-aqueous humor barrier.

Disruption of blood retina barrier will cause vasodilation (dilation of the blood vessels), increased vascular permeability (increase the permeability of blood vessels and so increase the leakage of proteins and cells from the blood vessels to the surrounding tissue), leukocytosis (Which means increase the number of White blood cells) and increase in intraocular pressure.



Carcinogenesis and Impairment of Fertility

1- Bromfenac did not show mutagenic potential in various mutagenicity studies.

2- Bromfenac did not impair fertility when administered orally to male and female rats.



Pregnant and nursing mothers

There are no adequate and well-controlled studies in pregnant or nursing mothers. But it should be avoided during late pregnancy because of the known effects of Anti- prostaglandin drugs can affect the closure of fetal ductus arteriosus which can have its effects on cardiovascular system.

Pediatric Use

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