Monograph Details
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Musculoskeletal Disorders
> Arthritis/rheumatic disorders
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PREVACID NAPRAPAC 375 |
| Manufacturer |
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TAP Pharmaceutical Products, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Acid pump inhibitor + NSAID (arylacetic acid deriv.). |
| Generic Name |
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Lansoprazole 15mg (7 caps containing e-c granules) + naproxen 375mg (14 tabs); per weekly blister card. |
| Also |
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• PREVACID NAPRAPAC 500
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| Indications |
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To reduce risk of NSAID-associated gastric ulcers in patients with history of documented gastric ulcer who need an NSAID for treating signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. |
| Children |
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Not recommended. |
| Adults |
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Caps: swallow whole. Take AM dose before eating. Lansoprazole 15mg daily in the AM + naproxen 375mg or 500mg twice daily in the AM + PM. Max naproxen dose: 1g/day (renal insufficiency, liver disease, elderly: adjust dose). Reevaluate after 12 weeks. |
| Contraindications |
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Aspirin allergy. 3rd trimester pregnancy. Coronary artery bypass graft surgery. |
| Precautions |
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Advanced renal disease: not recommended. Active peptic ulcer. History of GI disease. Impaired renal or hepatic function. Heart failure. Edema. Hypertension. Bleeding disorders. Monitor blood, hepatic, renal, and ocular function in chronic use. Elderly. Debilitated. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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Avoid aspirin, other forms of naproxen. May potentiate protein bound drugs (eg, hydantoins, sulfonamides, sulfonylureas). Monitor warfarin, theophylline. May antagonize diuretics, β-blockers, other antihypertensives. Increased renal toxicity with ACE inhibitors. Methotrexate excretion reduced. Increases lithium levels. Probenecid increases naproxen plasma levels and delays elimination. May alter absorption of pH-dependent drugs (eg, ketoconazole, digoxin, iron, ampicillin). Give lansoprazole at least 30 minutes before sucralfate. May give antacids concomitantly. |
| Adverse Reactions |
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Constipation, heartburn, abdominal pain, nausea, dyspepsia, stomatitis, diarrhea, headache, dizziness, drowsiness, pruritus, rash, sweating, purpura, tinnitus, visual/auditory disturbances, edema, dyspnea, palpitations, thirst; rarely: GI bleed, nephritis, abnormal liver function tests, others. See literature re: risk of cardiovascular events. |
| How Supplied |
Weekly blister card—1
Monthly pack (4 blister cards/pack)—1 |
| Additional Resources |
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• Related Prescribing Note |
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