Do not apply more than 16 g daily to any single joint of the lower extremities.Apply the gel (2 g) to the affected hand, wrist, or elbow 4 times daily. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. Ask your doctor about any risk.Use Voltaren Gel exactly as prescribed by your doctor or as instructed on the packaging. The FDA approval was based on several studies, including two randomized, double-blind, placebo-controlled efficacy studies an… Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of Voltaren Gel at the first appearance of skin rash or any other sign of hypersensitivity. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.This Medication Guide has been approved by the U.S. Food and Drug Administration. NSAIDs are contraindicated in the setting of CABG Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.Serotonin release by platelets plays an important role in hemostasis. Additionally, patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding.In clinical trials, of oral diclofenac-containing products, meaningful elevations (i.e. May increase bleeding time especially if given with other medicines that also delay blood clotting. Therefore, concurrent use of Voltaren Gel and heat is not recommended.Carcinogenicity studies in mice and rats administered diclofenac sodium as a dietary constituent for 2 years at doses up to 2 mg/kg/day (approximately 0.5 and 1 times, respectively, the maximum recommended human topical dose of Voltaren Gel based on bioavailability and body surface area (BSA) comparison) resulted in no significant increases in tumor incidence.In a dermal carcinogenicity study conducted in albino mice, daily topical applications of a diclofenac sodium gel product for two years at concentrations up to 0.035% diclofenac sodium (a 29-fold lower diclofenac sodium concentration than present in Voltaren Gel) did not increase neoplasm incidence.In a photococarcinogenicity study conducted in hairless mice, topical application of a diclofenac sodium gel product at doses up to 0.035% diclofenac sodium (a 29-fold lower diclofenac sodium concentration than present in Voltaren Gel) resulted in an earlier median time of onset of tumors.Diclofenac was not mutagenic or clastogenic in a battery of genotoxicity tests that included the bacterial reverse mutation assay, Diclofenac did not affect male or female fertility in rats at doses up to 4 mg/kg/day (approximately 2 times than the maximum human topical dose of Voltaren Gel based on bioavailability and BSA comparison).Study 1 evaluated the efficacy of Voltaren Gel for the treatment of osteoarthritis of the knee in a 12-week, randomized, double-blind, multicenter, placebo-controlled, parallel-group trial. Item has been added to your cart. Voltaren Gel is a topical ointment that's used to help treat pain that comes along with osteoarthritis and joint problems, such as stiffness, aches, and swelling. Voltaren Gel contains diclofenac, a nonsteroidal anti-inflammatory drug (NSAID).Diclofenac works by reducing substances in the body that cause pain and inflammation. It may increase your risk of stomach bleeding.Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Topical gel, Voltaren 1% Gel: Use 1 dosing card for each application of drug product. Do not double the dose. Clinically Proven to Treat Arthritis Pain. Diclofenac sodium 1% (NSAID) • Arthritis Pain Relieving GelDiclofenac sodium 1% (NSAID) • Arthritis Pain Relieving GelWe comply with the HONcode standard for trustworthy health information - No clinically relevant differences of systemic absorption and of tolerability were found between applications of Voltaren Gel (4 x 4 g per day on 1 knee) with and under the conditions tested.