BROMFENAC SODIUM (Generic for BROMSITE)

Bromfenac Sodium 0.07%, Ophthalmic drops, solution

High Fat Foods

· Severity: Major

· Notes for Consumers: Take Bromfenac on an empty stomach, 1 hour before or 2 hours after a meal. If taken with food, higher doses may be needed.

· Notes for Professionals: Food high in fat decreases the overall bioavailability of bromfenac. Bromfenac administered with high-fat meals causes a 75 percent reduction in bromfenac peak plasma concentrations and a 60 percent reduction in total AUC. In vivo pharmacokinetic studies show that the absorption of bromfenac is greatly reduced if administered with, or up to 3.5 hours after, a high fat meal.

Bromfenac Sodium 0.07%, Ophthalmic drops, solution

Alcohol

· Severity: Major

· Notes for Consumers: Do not drink alcohol while taking this medication. Drinking alcohol while taking this medication increases the risk of stomach bleeding. Contact your care team right away if you experience bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds.

· Notes for Professionals: Advise patients to avoid alcohol and alcohol-containing products while taking NSAIDs. Concomitant ingestion of alcohol with NSAIDs increases the risk of developing gastric irritation and GI mucosal bleeding. Alcohol is a mucosal irritant and NSAIDs decrease platelet aggregation. Routine ingestion of alcohol and NSAIDs can cause significant GI bleeding, which may or may not be overt. Even occasional concomitant use of NSAIDs and alcohol should be avoided. Chronic alcohol ingestion is often associated with hypoprothrombinemia and this condition increases the risk of bleeding.

Bromfenac Sodium 0.07%, Ophthalmic drops, solution

Tobacco

· Severity: Major

· Notes for Consumers: Do not smoke or use tobacco products while taking this medication. Smoking while taking this medication increases the risk for stomach bleeding. Contact your care team right away if you experience bloody or black, tar-like stools, or vomiting blood or brown material that looks like coffee grounds.

· Notes for Professionals: Advise patients to avoid smoking tobacco while taking nonsteroidal anti-inflammatory drugs (NSAIDs). Concomitant use of NSAIDs with tobacco smoking may enhance the risk of gastrointestinal side effects, including peptic ulcer and GI bleeding. Patients using tobacco and NSAIDs concurrently should be monitored closely for GI adverse reactions.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>