Drug information of Bromfenac

Bromfenac

Drug group:

Nonsteroidal Anti-inflammatory Drug (NSAID), 

Mechanism of effect

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

Pharmacodynamic

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

Drug indications

Postoperative ocular inflammation/pain: Treatment of postoperative inflammation and reduction of ocular pain following cataract surgery.

Dosage

Dosing: Adult

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 on 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 on 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 on 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.

Dosing: Geriatric

Refer to adult dosing.

Drug contraindications

There are no contraindications listed in the manufacturer’s labeling.

Side effects

Gastrointestinal

Gastrointestinal side effects have frequently included dyspepsia (12%), abdominal pain, constipation, diarrhea, eructation, flatulence, liver enzyme elevations (less than 3 times the upper limit of normal), nausea, and vomiting. Anorexia, colitis, dry mouth, gastritis, gastroenteritis, gastrointestinal hemorrhage, increased appetite, liver test abnormalities, (less or equal to 3 times the upper limit of normal), pancreatitis, peptic ulcer, periodontal abscess, positive fecal occult blood test, rectal disorder, stomatitis, and tenesmus have also been reported (<1%).[Ref]

 

Nervous system

Nervous system side effects have included dizziness and somnolence. Abnormal dreams, amnesia, anxiety, confusion, depression, emotional lability, euphoria, hallucination, incoordination, insomnia, increased libido, nervousness, paresthesia, psychosis, tremor, and twitching have also been reported (<1%).[Ref]

General

General effects have frequently included asthenia and headache. Back pain, chest pain, chills, face edema, fever, flu syndrome, generalized edema, infection, and malaise have also been reported (<1%).[Ref]

Cardiovascular

Cardiovascular side effects have included arrhythmias, hemorrhage, hypertension, migraine, myocardial infarction, palpitations, phlebitis, syncope, and vasodilation (<1%).[Ref]

Endocrine

Endocrine effects have included glycosuria (<1%).[Ref]

Hematologic

Hematologic side effects have included anemia, ecchymosis, and leukopenia (<1%).[Ref]

Metabolic

Metabolic side effects have included increased blood urea nitrogen, edema, hypoglycemia, hypokalemia, increased serum creatinine, thirst, weight gain, and weight loss (<1%).[Ref]

Musculoskeletal

Musculoskeletal side effects have included leg cramps and myalgia (<1%).[Ref]

Respiratory

Respiratory side effects have included asthma, increased cough, dyspnea, epistaxis, hiccup, hyperventilation, pharyngitis, rhinitis, and sinusitis (<1%).[Ref]

Dermatologic

Dermatologic side effects have included alopecia, pruritus, rash, seborrhea, skin infections, skin ulcer, sweating, and urticaria (<1%).[Ref]

Ocular

Ocular side effects have included abnormal vision, blepharitis, cataract, conjunctivitis, dry eyes, lacrimation, and photophobia (<1%).[Ref]

Acetylsalicylic acid – Alclofenac -  Aloxiprin  -   Antipyrine  -   Antrafenine - Bendazac - Betulinic Acid - Carbaspirin calcium - Carprofen - Choline magnesium trisalicylate - Choline salicylate - Clonixin - Dersalazine - Dexibuprofen - Dexketoprofen - Difenpiramide - Droxicam - Ebselen - Epirizole - Ethenzamide - Etofenamate - Felbinac - Fentiazac - Firocoxib - Floctafenine - Flunixin - Flunoxaprofen - Flurbiprofen axetil - Guacetisal - Ibuproxam - Imidazole salicylate - Indobufen - Indoprofen - Isoxicam - Kebuzone - Licofelone - Lonazolac - Loxoprofen - Lumiracoxib - Meclofenamic acid - Metamizole - Mofebutazone - Morniflumate - Nifenazone - Niflumic acid - Nimesulide - Nitroaspirin - NS-398 - Phenyl aminosalicylate - Pirprofen

Alerts

Concerns related to adverse effects:

• 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.

Points of recommendation

Store at 15°C to 25°C (59°F to 77°F).

Pregnancy level

C

Bromfenac has been assigned to pregnancy category C by the FDA.
Bromfenac is only recommended for use during pregnancy when the benefit outweighs risk. Because nonsteroidal anti-inflammatory drugs are known to delay parturition or cause premature closure of the ductus arteriosus, bromfenac should be avoided during late pregnancy.

Breast feeding warning

There are no data on the excretion of bromfenac into human milk.

Bromfenac is excreted into the milk of lactating rats.There are no data on the excretion of bromfenac into human milk.

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