Bromfenac

Bromfenac is a Cyclooxygenase-1 and 2 (COX-1 and 2) inhibitor / non-steroidal anti-inflammatory drugs (NSAIDs) belonging to Analgesic / anti-inflammatory.

Bromfenac is an NSAID used to treat postoperative pain and inflammation of the eye.

The plasma concentration of Bromfenac following ocular administration in humans is unknown. Bromfenac has Plasma protein binding of 99.8%. Bromfenac is Mainly metabolized by CYP2C9 isoenzyme in the liver.

Bromfenac shows common side effects like Stinging or burning of the eyes, red or itchy eyes, feeling that something is in the eye, headache.

Bromfenac is available in the form of Ophthalmic suspension.

Bromfenac is available in India, US, Philippine, Malaysia, Spain, Canada, Australia, China, and Africa.

Bromfenac is an Analgesic / anti-inflammatory belonging to the class Cyclooxygenase-1 and2 (COX-1 and 2) inhibitor / non-steroidal anti-inflammatory drug (NSAIDs).

Bromfenac inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase 1 and 2, which results in decreased formation of prostaglandin precursors.

The onset and duration of action of Bromfenac is not clinically established.

Bromfenac is available in the form of Ophthalmic suspension.

Bromfenac Ophthalmic suspension is usually instilled in eyes once a day.

Bromfenac is a pain-relieving medicine. It is used in the treatment of pain and swelling caused by cataract surgery (an eye surgery to correct the blurring of vision). It works by blocking the release of certain chemicals that cause pain and swelling.

Bromfenac is a Cyclooxygenase-2 (COX-2) inhibitor belonging to non-steroidal anti-inflammatory drugs (NSAIDs).

The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.

Bromfenac is approved for use in the following clinical indications

• Postoperative ocular inflammation/pain:

Bromfenac is an NSAID used to treat postoperative pain and inflammation of the eye.

• Postoperative ocular inflammation/pain:

Ophthalmic (0.07%): Instill 1 drop into affected eye(s) once daily beginning 1 day prior to cataract surgery and continue the day of surgery and for 14 days postoperatively.

Ophthalmic (0.075%): Instill 1 drop into affected eye(s) twice daily beginning 1 day prior to cataract surgery and continue the day of surgery and for 14 days postoperatively.

Ophthalmic (0.09% once-daily formulation): Instill 1 drop into affected eye(s) once daily beginning 1 day prior to cataract surgery and continue the day of surgery and for 14 days postoperatively.

Ophthalmic (0.09% twice-daily formulation): Instill 1 drop into affected eye(s) twice daily beginning 24 hours after cataract surgery and continue through the first 14 days postoperatively.

Bromfenac is available in the form of Ophthalmic solution.

Bromfenac is contraindicated in patients with

• Bromfenac ophthalmic solution is contraindicated in patients with known hypersensitivity to any ingredient in the formulation.

• Aspirin/NSAID sensitivity

Use with caution in patients with previous sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including patients who experience bronchospasm, asthma, rhinitis, or urticaria following NSAID or aspirin therapy.

• Corneal effects

May cause keratitis. Continued use may cause severe corneal adverse effects, including corneal thinning, erosion, perforation, or ulceration; may result in loss of vision. Discontinue use in patients with evidence of corneal epithelial damage.

• Delayed healing

Healing time may be slowed or delayed. Use with caution in patients receiving concomitant topical steroid therapy due to an increased risk for healing problems.

• Bleeding disorders

Use with caution in patients with a predisposition to bleeding (bleeding tendencies or medications which interfere with coagulation). Increased intraocular bleeding (including hyphema) has been reported following surgery.

• Diabetes

Use with caution in patients with diabetes mellitus; may be at risk of corneal adverse events, potentially resulting in loss of vision.

• Ocular disease

Use with caution in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, ocular surface disease, or repeat ocular surgeries (within a short timeframe); may be at risk of corneal adverse events, potentially resulting in loss of vision.

• Rheumatoid arthritis

Use with caution in patients with rheumatoid arthritis; may be at risk of corneal adverse events, potentially resulting in loss of vision.

Caution should be exercised when Bromfenac ophthalmic solution is administered to a nursing woman.

Pregnancy category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

• Common

Headache, Anterior chamber inflammation, blurred vision, eye pain, foreign body sensation of eye, iritis, ocular hypertension (1% to 8%), photophobia (3% to 8%), vitreous opacity.

• Rare

Corneal perforation, keratitis.

• Anticoagulants

Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the anticoagulant effect of Anticoagulants.

• Corticosteroids (Ophthalmic)

Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed.

• Prostaglandins (Ophthalmic)

Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the therapeutic effect of Prostaglandins (Ophthalmic).

The common side effects of Bromfenac include the following

• Common side effects

Stinging or burning of the eyes, red or itchy eyes, feeling that something is in the eye, headache.

• Rare side effects

Redness or swelling of eyes, lips, tongue, or skin, rash, hives, or other skin changes, difficulty breathing or swallowing, bleeding within the eye, sensitivity of your eyes to light, eye pain, blurry, cloudy, or blocked areas of vision.

• Pregnancy

Pregnancy Category C

Teratogenic Effects

Reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (540 times RHOD) and in rabbits at oral doses up to 7.5 mg/kg/day (4500 times RHOD) revealed no evidence of teratogenicity due to Bromfenac. However, 0.9mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. Pregnant rabbits treated with 7.5 mg/kg/day caused increased post-implantation loss. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

• Nursing Mothers

Caution should be exercised when Bromfenac 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 Bromfenac differ in patients 65 years of age and older compared to younger adult patients.

• Pharmacodynamic

Bromfenac ophthalmic solution is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use.

• Pharmacokinetics

Absorption

The plasma concentration of Bromfenac following ocular administration in humans is unknown.

Distribution

Bromfenac has Plasma protein binding of 99.8%.

Metabolism and Excretion

Bromfenac is Mainly metabolized by CYP2C9 isoenzyme in the liver.

• https://www.drugs.com/pregnancy/bromfenac-ophthalmic.html
• https://go.drugbank.com/drugs/DB00963
• https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021664s010lbl.pdf
• https://www.uptodate.com/contents/bromfenac-drug-information?search=bromfenac&source=panel_search_result&selectedTitle=1~4&usage_type=panel&kp_tab=drug_general&display_rank=1
• https://www.rxlist.com/xibrom-drug.htm#description
• https://medlineplus.gov/druginfo/meds/a611018.html#:~:text=Bromfenac ophthalmic is used to,-inflammatory drugs (NSAIDs).
• https://reference.medscape.com/drug/bromsite-prolensa-bromfenac-ophthalmic-343667