Bromfenac Ophthalmic Solution

Dosage Forms And Strengths

Topical ophthalmic solution: bromfenac 0.09%.

Bromday (bromfenac ophthalmic solution) 0.09% is supplied in a white LDPE plastic squeeze bottle with a 15 mm LDPE white dropper-tip and 15 mm polypropylene gray cap as follows:

1.7 ml in 7.5 ml container (NDC 67425-999- 17)

Storage

Store at 155° - 255°C (595° - 77°F).

Manufactured for: ISTA Pharmaceuticals, Inc. Irvine, CA 92618. Manufactured By: Bausch & Lomb Incorporated Tampa, FL 33637. Under license from: Senju Pharmaceuticals Co., Ltd. Osaka, Japan 541-0046. Revised: 9/2010

Mechanism of Action

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. 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.

Pharmacokinetics

The plasma concentration of bromfenac following ocular administration of 0.09% Bromday (bromfenac ophthalmic solution) in humans is unknown. Based on the maximum proposed dose of one drop to the eye (0.045 mg) and PK information from other routes of administration, the systemic concentration of bromfenac is estimated to be below the limit of quantification (50 ng/mL) at steady-state in humans.

Clinical Studies

Clinical efficacy was evaluated in three randomized, double-masked, placebo-controlled trials in which subjects requiring cataract surgery were assigned to Bromday (bromfenac ophthalmic solution) or placebo. Patients were dosed with one drop per eye starting the day before surgery and continuing for 14 days. The primary endpoint was clearing of ocular inflammation by day 15. An additional efficacy endpoint was the number of patients who were pain free on day 1 after cataract surgery.

In 2 of the 3 studies, Bromday (bromfenac ophthalmic solution) ophthalmic solution had statistically significant higher incidence of completely clearing inflammation (46-47% vs. 25-29%) and also had a statistically significant higher incidence of subjects that were pain free at day 1 post cataract surgery (83-89% vs. 51-71%).

PROLENSA™ (bromfenac ophthalmic solution) 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The most commonly reported adverse reactions reported following use of bromfenac 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 reactions were reported in 2 to 7% of patients.

Post-Marketing Experience

The following reactions have been identified during post-marketing use of bromfenac ophthalmic solution 0.09% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical bromfenac ophthalmic solution 0.09% or a combination of these factors, include corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown [see WARNINGS AND PRECAUTIONS].

No information provided.

Slowed Or Delayed Healing

Advise patients of the possibility that slow or delayed healing may occur while using NSAIDs.

Sterility Of Dropper Tip

Advise patients to not touch dropper tip to any surface, as this may contaminate the contents.

Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery.

Concomitant Use Of Contact Lenses

Advise patients that contact lenses should not be worn during the use of this product. The preservative in Xibrom, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Xibrom.

Concomitant Topical Ocular Therapy

Advise patients that if more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart

• Voltaren Ophthalmic

© Prolensa Patient Information is supplied by Cerner Multum, Inc. and Prolensa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• bleeding in the white part of your eye
• breathing problems
• sores in the eye or eye irritation that gets worse

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• burning or stinging after instilling the drops
• dry, red, or itchy eyes

This medicine is only for use in the eye. Do not take by mouth. Follow the directions on the prescription label. Remove contact lenses before use. Wash hands before and after use. Tilt your head back slightly and pull your lower eyelid down with your index finger to form a pouch. Try not to touch the tip of the dropper to your eye, fingertips, or any other surface. Squeeze the prescribed number of drops into the pouch. Close the eye gently to spread the drops. Your vision may blur for a few minutes. Use your doses at regular intervals. Do not use your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

They need to know if you have any of these conditions:

• asthma
• bleeding problems
• diabetes
• dry eye syndrome, other eye problems, or recent eye surgery
• wear soft contact lenses
• an unusual or allergic reaction to bromfenac, aspirin, other NSAIDS, sulfites, other medicines, foods, dyes or preservatives
• pregnant or trying to get pregnant
• breast-feeding

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

Tell your doctor or health care professional if your eye symptoms do not get better within 2 to 3 days. Do not use for longer than directed by your doctor or health care professional.

Unless your doctor or health care professional gives you other instructions, you should not wear contact lenses while you are using this medicine. If it is okay to wear your lenses, then wait 10 minutes after using this medicine before inserting your lenses.

Keep out of the reach of children.

Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Throw away any unused medicine after the expiration date on the label.