Biifenac 500
Generic name: diclofenac sodium and menthol
Dosage form: kit
On This Page
- Boxed Warning
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How Supplied/Storage and Handling
- Patient Counseling Information
- Medication Guide
- Warnings
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
- Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see WARNINGS AND PRECAUTIONS (5.1)].
- Diclofenac sodium is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.1)].
Gastrointestinal Bleeding, Ulceration, and Perforation
- NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms.
- Elderly patients and patients with a prior history of peptic ulcer disease and or GI bleeding are at greater risk for serious GI events [see WARNINGS AND PRECAUTIONS (5.2)].
Indications and Usage for Biifenac 500
Diclofenac sodium is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).
Biifenac 500 Dosage and Administration
General Dosing Instructions
Use the lowest effective dosage for the shortest du...
