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.
Use lowest effective dose for shortest duration. 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.
Pregnancy. 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; use effective contraception during therapy; give oral and written warnings on risks in pregnancy. Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease, GI bleeding, or inflammatory bowel disease. Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Advanced renal disease: not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Premature closure of fetal ductus arteriosus. Elderly. Debilitated. Labor & delivery. Nursing mothers.
Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate), other NSAIDs, magnesium-containing antacids. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. May be potentiated by CYP2C9 inhibitors (eg, voriconazole); see Adult. May be antagonized by CYP2C9 inducers (eg, rifampin); adjust dose. Caution with concomitant hepatotoxic drugs (eg, antibiotics, antiepileptics).
NSAID + prostaglandin E1 analogue.
Abdominal pain, diarrhea, dyspepsia, nausea, flatulence, gastritis, vomiting, constipation, headache, dizziness; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia.
Arthrotec 50—60, 90; Arthrotec 75—60