If diclofenac sodium topical gel is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.Correct volume status in dehydrated or hypovolemic patients prior to initiating diclofenac sodium topical gel. Pharmacokinetic Parameters and Comparison of diclofenac sodium topical gel to Oral Diclofenac Sodium Tablets After Repeated AdministrationTable 4. Use the enclosed dosing card to apply the medication to the affected area. Of these, 513 patients received diclofenac sodium topical gel for osteoarthritis of the knee and 400 were treated for osteoarthritis of the hand. Look what happened to the COX2 inhibitors. Of these, 355 patients were treated for osteoarthritis of 1 knee and 228 were treated for osteoarthritis of both knees. You may report side effects to the FDA at 1-800-332-1088. Co-morbid conditions such as coagulation disorders, concomitant use of warfarin, other anticoagulants, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk. Read the medication guides developed for NSAIDs and this product What are the storage instructions for diclofenac sodium (topical)? All drugs may cause side effects. * WOMAC = Western Ontario McMaster Osteoarthritis Index.† Difference is adjusted using an analysis of covariance (ANCOVA) model with main effects of treatment and center and baseline covariate.‡ Difference is adjusted using an analysis of covariance (ANCOVA) model with main effects of treatment, center, indicator of pain in the CMC-1joint, and baseline as a covariate, and the treatment-by-CMC-1 strata.Diclofenac sodium topical gel, 1% is an opaque white gel and is available in tubes containing 100 grams of the topical gel in each tube. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestineThe risk of getting an ulcer or bleeding increases with:Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you:You should not take NSAIDs after 29 weeks of pregnancy.Tell your healthcare provider about all of the medicines you take, including prescription or over-thecounter medicines, vitamins or herbal supplementsSee “What is the most important information I should know about medicines called Nonsteroidal Antiinflammatory Drugs (NSAIDs)?Get emergency help right away if you get any of the following symptoms:Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:If you take too much of your NSAID, call your healthcare provider or get medical help right awayGeneral information about the safe and effective use of NSAIDsImportant: Use the dosing card that is inside the diclofenac sodium topical gel carton to correctly measure each dose. Exercise caution when prescribing diclofenac sodium topical gel with concomitant drugs that are known to be potentially hepatotoxic (e.g., acetaminophen, antibiotics, anti-epileptics).NSAIDs, including diclofenac sodium topical gel, can lead to new onset of hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. (4)What is the pregnancy category for diclofenac sodium (topical)?What are the other counseling points for diclofenac sodium (topical)? The entire foot includes the sole, top of the foot and the toes. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. Do not shower, bathe, or wash the affected area for at least 1 hour after application 6. Almost all meaningful elevations in transaminases were detected before patients became symptomatic. NSAIDs like diclofenac gel (1%) may affect egg release (ovulation) in women. A summary of the pharmacokinetic parameters is presented in Table 2.Systemic exposure (area under the concentration-time curve) and maximum plasma concentrations of diclofenac are significantly lower with diclofenac sodium topical gel than with comparable oral treatment of diclofenac sodium.Systemic exposure with recommended use of diclofenac sodium topical gel (4 x 4 g per day applied to 1 knee) is on average 17 times lower than with oral treatment. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Call your doctor or get medical The increase in CV thrombotic risk has been observed most consistently at higher doses.To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible.