warfarin, aspirin, SSRIs/SNRIs)ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-BlockersNonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [Of the total number of subjects treated with diclofenac sodium topical gel in clinical studies, 498 were 65 years of age and over. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.For additional information about overdosage treatment, contact a poison control center (1-800-222-1222).Diclofenac Sodium Topical Gel, 1% is a nonsteroidal anti-inflammatory drug (NSAID) for topical use only. (Do not apply more than 16 g daily to any one affected joint of the lower extremities. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.No information is available from controlled clinical studies regarding the use of Diclofenac Sodium Topical Gel in patients with advanced renal disease.
Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3-6 months, and in about 2%-4% of patients treated for one year.
Duration of exposure ranged from 8 to 12 weeks for the placebo-controlled studies, and up to 12 months for the open-label safety trial.Non-serious adverse reactions that were reported during the short-term placebo-controlled studies comparing diclofenac sodium topical gel and placebo (vehicle gel) over study periods of 8 to 12 weeks (16 g per day), were application site reactions. The amount of diclofenac sodium that is systemically absorbed from diclofenac sodium topical gel is on average 6% of the systemic exposure from an oral form of diclofenac sodium.The average peak plasma concentration with recommended use of diclofenac sodium topical gel (4 x 4 g per day applied to 1 knee) is 158 times lower than with the oral treatment.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). No clinically relevant differences of systemic absorption and of tolerability were found between applications of diclofenac sodium topical gel (4 x 4 g per day on 1 knee) with and under the conditions tested. )Elderly patients may require lower doses due to increased risk for adverse effects and increased likelihood of concomitant cardiovascular, gastrointestinal, hepatic and/or renal dysfunctions.Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Diclofenac Sodium Topical Gel is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.
Avoid use of NSAIDs, including Diclofenac Sodium Topical Gel, in pregnant women starting at 30 weeks of gestation (third trimester) [Anemia has occurred in NSAID-treated patients. (4, 5.1)NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.Avoid the use of Diclofenac Sodium Topical Gel in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events.
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