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.
Risk of uterine rupture, abortion, premature birth, and birth defects. Risk of serious cardiovascular and gastrointestinal events.
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.
NSAID + prostaglandin E1 analogue.
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).
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