Voltral Emulgel 1% 10mg

Serious Warnings

• Black Box Warning: 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. Diclofenac sodium topical solution is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. **Gastrointestinal Bleeding, Ulceration, and Perforation:** 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 and patients with a history of peptic ulcer disease and/or gastrointestinal bleeding are at greater risk for serious GI events.
• Patients should be monitored for various serious adverse events.
• **Cardiovascular Risks:** NSAIDs, including topical diclofenac, may 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.
• Patients with pre-existing cardiovascular disease or risk factors are at higher risk.
• Diclofenac is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
• **Gastrointestinal Risks:** NSAIDs can cause 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.
• Patients with a history of GI diseases, active peptic ulcer, or long-term NSAID therapy are at greater risk.
• **Hepatotoxicity:** NSAIDs can cause elevations of liver enzymes and severe hepatic reactions, including liver failure.
• Monitor liver function, particularly in patients on long-term therapy.
• **Renal Toxicity and Hyperkalemia:** NSAID use may lead to renal papillary necrosis and other renal injury.
• Patients with pre-existing renal disease, heart failure, liver dysfunction, those taking diuretics or ACE inhibitors, and the elderly are at increased risk.
• Monitor renal function.
• NSAIDs may also cause hyperkalemia.
• **Hypertension and Edema:** NSAIDs can lead to new onset hypertension or worsening of pre-existing hypertension.
• Fluid retention and edema, which can exacerbate heart failure, have also been reported.
• Use with caution in patients with heart disease, hypertension, or conditions predisposing to fluid retention.
• **Anaphylactic Reactions:** Hypersensitivity reactions, including anaphylaxis, can occur, especially in individuals with a history of asthma, urticaria, or other allergic-type reactions to aspirin or other NSAIDs.
• **Serious Skin Reactions:** NSAIDs can cause serious skin adverse reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), which can be fatal.
• **Hematologic Toxicity:** NSAIDs can cause anemia and may inhibit platelet aggregation.
• Monitor patients with blood disorders or those on long-term therapy.
• **Pregnancy and Lactation:** This medicine is not recommended during pregnancy unless no alternate safer option is available, and should only be used after consulting a doctor.
• It is not recommended for use in nursing females.
• **Other Precautions:** Monitor patients receiving long-term therapy, patients with gastrointestinal diseases, heart, renal, and hepatic disease, elderly patients, patients with blood volume depletion (extracellular), high blood pressure, porphyria, and any blood disorders.
• Inform your doctor about your complete medical history, including any gastrointestinal disorders, liver or kidney impairment, peptic ulcer, or recent heart surgery, before using this medicine.