ARTHROTEC 50 Rx
Generic Name and Formulations:
Diclofenac sodium 50mg (e-c), misoprostol 200mcg; tabs.
Indications for ARTHROTEC 50:
Osteoarthritis (OA) or rheumatoid arthritis (RA) in patients at high risk for developing NSAID-induced gastric or duodenal ulcers.
Swallow whole; food may reduce diarrhea. ≥18yrs: OA: one Arthrotec 50 tab 3 times daily. RA: one Arthrotec 50 tab 3–4 times daily. Both: if not tolerated, may reduce to one Arthrotec 50 or one Arthrotec 75 tablet twice daily (this may be less effective in preventing ulcers). Concomitant CYP2C9 inhibitors: max Arthrotec 50mg twice daily. See full labeling.
<18yrs: not established.
NSAID + prostaglandin E1 analogue.
Pregnancy (Cat.X). Aspirin allergy. Coronary artery bypass graft surgery. Active GI bleeding.
For women of childbearing potential: obtain negative serum pregnancy test within 2 weeks before start of therapy; begin Arthrotec therapy on 2nd or 3rd day of menstrual period; maintain contraception during therapy; give oral and written warnings on risks in pregnancy. Increased risk of serious cardiovascular events, MI, and stroke. Increased risk of serious GI adverse events (eg, bleeding, ulceration, perforation). Advanced renal disease: not recommended. History of ulcer disease or GI bleeding. Edema. Heart failure. Hypertension. Pre-existing asthma. Hepatic or renal dysfunction. Monitor BP, CBCs, blood chemistry, hepatic and renal function. Check ALT (SGPT) within 4–8 wks then periodically. Discontinue if signs/symptoms of liver or renal disease develop, or if abnormal liver function tests persist or worsen. Hepatic porphyria. Dehydration. SLE. Elderly. Debilitated. Labor & delivery. Avoid in late pregnancy. Nursing mothers.
Avoid magnesium-containing antacids, salicylates, aspirin, other NSAIDs (including COX-2 inhibitors). May be potentiated by CYP2C9 inhibitors (eg, voriconazole); caution. May be antagonized by CYP2C9 inducers (eg, rifampin); caution. May antagonize ACE-inhibitors (coadministration may reduce renal function), diuretics. Possible nephrotoxicity with tacrolimus. Monitor for digoxin, methotrexate, cyclosporine, lithium, warfarin toxicity. Hyper- or hypoglycemia possible with insulin, oral hypoglycemic agents. Increased risk of GI bleed with oral corticosteroids, anticoagulants (monitor), alcohol, smoking, prolonged NSAID therapy. Increased serum potassium with K+-sparing diuretics. Caution with concomitant drugs that are known to be hepatotoxic (eg, antibiotics, anti-epileptics).
Abdominal pain, diarrhea, dyspepsia, nausea, flatulence, GI bleed/ulcer, other GI disturbances, rash (may be serious, eg, Stevens Johnson Syndrome; discontinue if occurs), elevated transaminase levels, anemia; anaphylactic reactions, aseptic meningitis (rare), renal toxicity (w. long-term use). See full labeling re: risk of cardiovascular or GI events.
Arthrotec 50—60, 90; Arthrotec 75—60