Xibrom Eye Drops

Xibrom 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. 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.

 

General indications of Xibrom (Non-steroidal anti-inflammatory) Eye drops in Ocular Diseases

1- Treatment for postoperative inflammation in patients who underwent cataract eye surgeries. This is the main indication for bromfenac sodium.Ocular inflammations signs include; pain, redness, swelling and unusual cells and proteins in the anterior chamber.

2- Prevent intraoperative miosis during cataract eye surgeries.

3- Reduce pain and discomfort in patients who underwent ocular surgeries such as cataract eye surgery and refractive surgeries.

4- Prevention and treatment of macular edema (cystoids macular edema) after cataract surgery.

5- Can be used as adjunctive therapy in treatment of allergic conjunctivitis and anterior uveitis.

Xibrom bottles is supplied in two containers 10 ml and 7.5 container.

 

 

How to Use it:

1- One drop/ twice a day for patient who underwent cataract eye surgery, starting 24 hours after the surgery. FDA approved this drug for this indication in 2005.

2- New (bromfenac ophthalmic solution0.09%) called Bromday from Ista Pharmaceuticals' supplemental was approved recently from FDA for once-daily eye drop for post cataract surgery inflammation.

This new eye drops will be launched before the end of 2010 and it will replace Xibrom which is used in a twice daily.

 

Side Effects of Xibrom Eye Drops

These are the common side effects that were reported with the usage of Xibrom Eye Drops:

1- Foreign body sensation.

2- Conjunctival hyperemia or eye redness.

3- Burning and stinging sensation.

4- Eye pain.

5- Eye itching eye.

6- Headache.

7- Iritis which means inflammation of the iris. It will cause eye pain with cells in the anterior chamber.

These side effects were reported in 2-7% of patients.

If you notice any of these side effects you should tell your doctor immediately

 

Corneal Side Effects of Xibrom Eye Drops

It can cause sterile non-infection keratitis in the form of:

1-
Epithelial breakdown.

2- corneal thinning.

3- corneal erosion which can lead to ulceration and perforation.


It should be used with caution in patients with corneal diseases such as dry eye and corneal dystrophies. These medications should be discontinued immediately if the patients have evidence of epithelial breakdown.

 

 

Allergic Reactions from Xibrom Eye Drops

Signs and symptoms of allergic reaction:

1- Anaphylactic symptoms.

2- Asthmatic episodes wit trouble breathing.

3- Rash.

4- Itching.

5- Swelling of face, tongue and/or throat.

Xibrom Contains sodium sulfite which may cause allergic reactions.

If you notice any of these signs or symptoms, you should seek immediate medical attention

 

Drug interactions with Xibrom Eye Drops

1- Interaction with other NSAIDs

There is the potential for cross-reaction wit Aspirin(Acetylsalicylic acid),phenylacetic acid derivatives, and other NSAIDs. This means if you have any sensitivity reaction against these medications, you probably will be sensitive to Xibrom. In this case you should tell your doctor about this condition.

2- Anti-coagulant and Anti-platelets medications

It can interfere with platelet aggregation and therefore they can increase the bleeding time. It should be used in caution and under doctor supervision if the patient has ocular bleeding, underwent recent ocular surgery, with blood disorders or on medications that affect the blood such as anti-platelets( Clopidogrel) and anti-coagulant(Warfarin and Heparin).

3- Corticosteroid Eye drops

It can interfere with wound healing because it can slow or delay healing. It should be used with caution if the patients on corticosteroid eye drops because corticosteroid also will delay or slow healing.

 

 

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