Diclofenac

6. DRUG INTERACTIONS Drugs That Interfere with Hemostasis Monitor patients with concomitant use of diclofenac external with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding. Aspirin Concomitant use of diclofenac external and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding. ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment. Diuretics During concomitant use of diclofenac external with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects. Digoxin During concomitant use of diclofenac external and digoxin, monitor serum digoxin levels. Lithium During concomitant use of diclofenac external and lithium, monitor patients for signs of lithium toxicity. Methotrexate During concomitant use of diclofenac external and methotrexate, monitor patients for methotrexate toxicity. Cyclosporine During concomitant use of diclofenac external and cyclosporine, monitor patients for signs of worsening renal function. Pemetrexed Concomitant use of diclofenac external and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity.

Diclofenac sodium delayed-release tablets are indicated for "the acute and chronic treatment of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis."

Dosage and Administration Section DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). After observing the response to initial therapy with diclofenac sodium delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs. For the relief of osteoarthritis, the recommended dosage is 100 to 150 mg/day in divided doses (50 mg twice a day or three times a day, or 75 mg twice a day). For the relief of rheumatoid arthritis, the recommended dosage is 150 to 200 mg/day in divided doses (50 mg three times a day or four times a day, or 75 mg twice a day). For the relief of ankylosing spondylitis, the recommended dosage is 100 to 125 mg/day, administered as 25 mg four times a day, with an extra 25 mg dose at bedtime if necessary. Different formulations of diclofenac (diclofenac sodium enteric-coated tablets; diclofenac sodium extended-release tablets; diclofenac potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.

Gastrointestinal symptoms" were "the most common adverse effects...occurring in about 20%" of patients, including "peptic ulceration and gastrointestinal bleeding," which "can occur at any time, with or without warning symptoms." These were followed by central nervous system effects such as "headache (7%) and dizziness (3%).