Leximenth
Generic name: diclofenac sodium, lidocaine, menthol
Dosage form: topical solution
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
Leximenth™ contains:
Diclofenac Sodium Topical Solution (1.5% w/w, 150 mL) and Menthotral™ Cream (Lidocaine 3.88% / Menthol 3%, 8 fl oz / 237 mL).
THESE PRODUCTS ARE INTENDED ONLY FOR USE AS DESCRIBED.
The individual products contained in this package should not be used alone or in combination for other purposes. The information described in this labeling concerns only the use of these products as indicated in this administration package.
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK
Cardiovascular Risk
- Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see Warnings and Precautions (5.1)].
- Diclofenac sodium topical solution is contraindicated in the perioperative setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4)].
Gastrointestinal Risk
- NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events [see Warnings and Precautions (5.2)].
1. INDICATIONS AND USAGE
Diclofenac sodium topical solution is a nonsteroidal an..
