Drugplain

BROMSITE 0.075% .76 mg/mL

bromfenac · SOLUTION/ DROPS · Sun Pharmaceutical Industries, Inc.

No Recall History
Plain English

BROMSITE 0.075% is a solution/ drops containing bromfenac at .76 mg/mL, taken ophthalmic. Manufactured by Sun Pharmaceutical Industries, Inc..

Key Facts

Brand Name
BROMSITE 0.075%
Generic Name
bromfenac
NDC Code (Product)
49708-754
Manufacturer
Sun Pharmaceutical Industries, Inc.
Strength
.76 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
NDA206911
Marketing Start
05/01/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

treatment failure146 reports
off label use73 reports
product packaging quantity issue69 reports
drug ineffective61 reports
eye pain61 reports
product dose omission issue61 reports
eye irritation56 reports
product storage error35 reports
product use issue29 reports
fatigue27 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE BromSite (bromfenac ophthalmic solution) 0.075% is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. BromSite is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. (1)

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Instill one drop of BromSite to the affected eye twice daily (morning and evening) beginning 1 day prior to surgery, the day of surgery, and 14 days postsurgery. (2.1) 2.1 Recommended Dosing One drop of BromSite should be applied to the affected eye twice daily (morning and evening) 1 day prior to surgery, the day of surgery, and 14 days postsurgery. 2.2 Use with Other Topical Ophthalmic Medications BromSite should be administered at least 5 minutes after instillation of other topical medications. BromSite may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.

Contraindications

4 CONTRAINDICATIONS None None (4)

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Slow or Delayed Healing [see Warnings and Precautions (5.1)] Potential for Cross-Sensitivity [see Warnings and Precautions (5.2)] Increased Bleeding Time of Ocular Tissue [see Warnings and Precautions (5.3)] Keratitis and Corneal Reactions[see Warnings and Precautions (5.4)] Contact Lens Wear [see Warnings and Precautions (5.5)] The most commonly reported adverse reactions in 1-8% of patients were: anterior chamber inflammation, headache, vitreous floaters, iritis, eye pain and ocular hypertension. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 (toll free), or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials 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 in 1 to 8% of patients were: anterior chamber inflammation, headache, vitreo…

Frequently Asked Questions

What is BROMSITE 0.075% used for?

BROMSITE 0.075% contains bromfenac. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is BROMSITE 0.075% a controlled substance?

BROMSITE 0.075% is not classified as a controlled substance by the DEA.

What is the generic name for BROMSITE 0.075%?

The generic name for BROMSITE 0.075% is bromfenac. There are 12 other brand versions of bromfenac.

What is the NDC code for BROMSITE 0.075% .76 mg/mL?

The NDC (National Drug Code) for BROMSITE 0.075% .76 mg/mL is 49708-754, listed by Sun Pharmaceutical Industries, Inc..

Product NDC

49708-754

Package NDC

49708-754-41

Other Bromfenac Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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