As with other NSAIDs, anaphylactoid reactions may occur in patients without prior exposure to diclofenac sodium topical gel. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2-4% for major malformations, and 15-20% for pregnancy loss. They are easy to use and are proven to be effective against minor ailments.Topical medications range from creams, gels, foams, lotions, and ointments.When compared to oral diclofenac, the sodium gel is easier to use. Since cross reactivity, including bronchospasm, between aspirin and other non-steroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, diclofenac sodium topical gel should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.Patients should minimize or avoid exposure to natural or artificial sunlight on treated areas because studies in animals indicated topical diclofenac treatment resulted in an earlier onset of ultraviolet light induced skin tumors. The dosing card is re-usable. The molecular weight is 318.14. Before you use diclofenac sodium topical gel for the first time, your healthcare provider or pharmacist should show you how to correctly measure your dose using the dosing card.Do not use more than a total of 32 grams of diclofenac sodium topical gel each day. There are some normally used NSAIDs like aspirin and ibuprofen which are taken when the person experiences mild to moderate pain. If these occur, instruct patients to stop diclofenac sodium topical gel and seek immediate medical therapy [Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Diclofenac sodium topical gel should not be given to patients with the aspirin triad. Borderline elevations (i.e. NSAIDs, including diclofenac sodium topical gel should be used with caution in patients with hypertension. Diclofenac sodium is a white to slightly yellow crystalline powder.
The gel should be applied within the rectangular area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4g for each knee, ankle, or foot). Patients should be advised that if eye contact occurs, they should immediately wash out the eye with water or saline and consult a physician if irritation persists for more than an hour.Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. The optimum times for making the first and subsequent transaminase measurements are not known.
Therefore, concurrent use of diclofenac sodium topical 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 diclofenac sodium 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 diclofenac sodium topical 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 diclofenac sodium topical 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 diclofenac sodium based on bioavailability and BSA comparison).Study 1 evaluated the efficacy of diclofenac sodium topical gel for the treatment of osteoarthritis of the knee in a 12-week, randomized, double-blind, multicenter, placebo-controlled, parallel-group trial. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:The risk of getting an ulcer or bleeding increases with: Before taking NSAIDs, tell your health care provider about all of your medical conditions, including if you:You should not take NSAIDs after 29 weeks of pregnancy.Tell your health care provider about all of the medicines you take, including prescription or over-the- counter medicines, vitamins or herbal supplements.