Available for Android and iOS devices. Adverse reactions that led to the discontinuation of the study drug were experienced in 12% of patients. Diclofenac has analgesic, anti-inflammatory, and antipyretic properties.The pharmacokinetics of diclofenac sodium topical gel were assessed in healthy volunteers following repeated applications during 7 days of diclofenac sodium topical gel to 1 knee (4 x 4 g per day) or to 2 knees and 2 hands (4 x 12 g per day) versus the recommended oral dose of diclofenac sodium for the treatment of osteoarthritis (3 x 50 mg per day). Study 2 evaluated the efficacy of diclofenac sodium topical gel for the treatment of osteoarthritis in subjects with osteoarthritis of the hand in an 8-week, randomized, double-blind, multicenter, placebo controlled, parallel-group study. DICLOFENAC (dye KLOE fen ak) is a non-steroidal anti-inflammatory drug (NSAID). 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. There are no specific antidotes. In animal studies, NSAIDS, including diclofenac, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.Reproductive and developmental studies in animals demonstrated that diclofenac sodium administration during organogenesis did not produce teratogenicity despite the induction of maternal toxicity and fetal toxicity in mice at oral doses up to 20 mg/kg/day (approximately 5 times the maximum recommended human dose (MRHD) of diclofenac sodium topical gel based on bioavailability and body surface area (BSA) comparison), and in rats and rabbits at oral doses up to 10 mg/kg/day (approximately 5 and 10 times the MRHD based on bioavailability and BSA comparison). The pharmacokinetics of diclofenac sodium topical gel has been tested under conditions of moderate heat (application of a heat patch for 15 minutes prior to gel application) and of moderate exercise (first gel application followed by a 20-minute treadmill exercise). Instruct patients to seek immediate emergency help if these occur [Advise patients to stop diclofenac sodium topical gel immediately if they develop any type of rash and to contact their healthcare provider as soon as possible [Advise females of reproductive potential who desire pregnancy that NSAIDs, includingdiclofenac sodium topical gel, may be associated with a reversible delay in ovulation [Inform pregnant women to avoid use of diclofenac sodium topical gel and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus [Inform patients that the concomitant use of diclofenac sodium topical gel with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [seeĀ Inform patients not to use low-dose aspirin concomitantly with diclofenac sodium topical gel until they talk to their healthcare provider [see Instruct patients to avoid contact of diclofenac sodium topical gel with the eyes and mucosa, although not studied, should be avoided. Diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [The dosing card can be found attached to the inside of the carton.Apply the gel (4 g) to the affected foot, ankle, or knee 4 times daily.
These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Keep all Do not flush medications down the toilet or pour them into a drain unless instructed to do so. The dosage is based on your medical condition and response to 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. Because elderly patients are more likely to have decreased renal function, care should be taken when using diclofenac sodium topical gel in the elderly, and it may be useful to monitor renal function.Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care.
These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Keep all Do not flush medications down the toilet or pour them into a drain unless instructed to do so. The dosage is based on your medical condition and response to 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. Because elderly patients are more likely to have decreased renal function, care should be taken when using diclofenac sodium topical gel in the elderly, and it may be useful to monitor renal function.Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care.