Monograph Details
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Musculoskeletal Disorders
> Arthritis/rheumatic disorders
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ARTHROTEC 50 |
| Manufacturer |
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Pfizer Labs |
| Legal Classification |
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Rx
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| Pharmacological Class |
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NSAID + prostaglandin E1 analogue. |
| Generic Name |
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Diclofenac sodium 50mg (e-c), misoprostol 200micrograms; tabs. |
| Also |
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• ARTHROTEC 75
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| Indications |
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Osteoarthritis (OA) or rheumatoid arthritis (RA) in patients at high risk for developing NSAID-induced gastric or duodenal ulcers. |
| Children |
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<18yrs: not recommended. |
| Adults |
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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). See literature. |
| Contraindications |
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Pregnancy (Cat.X). Aspirin, NSAID, or prostaglandin allergy. Coronary artery bypass graft surgery. |
| Precautions |
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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; do appropriate counseling. GI ulceration or bleed. Edema. Heart failure. Hypertension. Asthma. Hepatic or renal dysfunction. Monitor 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. Nursing mothers: not recommended. |
| Interactions |
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Avoid magnesium-containing antacids, salicylates, aspirin, other NSAIDs. Caution with anticoagulants. May antagonize antihypertensives, diuretics. Digoxin, methotrexate, cyclosporine, lithium, warfarin toxicity. Increased serum potassium with K+-sparing diuretics. |
| Adverse Reactions |
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Abdominal pain, diarrhea, dyspepsia, nausea, flatulence, GI bleed/ulcer, other GI disturbances, rash (discontinue if occurs), elevated transaminase levels, anemia; anaphylactic reactions, aseptic meningitis (rare). See literature re: risk of cardiovascular events. |
| How Supplied |
Arthrotec 50—60, 90
Arthrotec 75—60 |
| Additional Resources |
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• Related Prescribing Note |
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