Monograph Details
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Cardiovascular System
> Hyperlipoproteinemias
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PRAVIGARD PAC 81mg/40mg |
| Manufacturer |
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Bristol-Myers Squibb |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Antiplatelet/salicylate + HMG-CoA reductase inhibitor. |
| Generic Name |
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Buffered aspirin 81mg; pravastatin sodium 40mg (30 tabs of each). |
| Also |
• PRAVIGARD PAC 325mg/20mg
• PRAVIGARD PAC 325mg/40mg
• PRAVIGARD PAC 325mg/80mg
• PRAVIGARD PAC 81mg/20mg
• PRAVIGARD PAC 81mg/80mg
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| Indications |
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Adjunct to diet in cardio- or cerebrovascular disease when treatment with both pravastatin and aspirin is appropriate, including to reduce the risk of cardiovascular events (eg, MI, TIA, death). |
| Children |
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<18yrs: not recommended. |
| Adults |
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≥18yrs: usually pravastatin 40mg + aspirin 81mg or 325mg per day; base pravastatin dose on cholesterol level. |
| Contraindications |
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Aspirin triad. NSAID allergy. Active liver disease. Unexplained, persistent elevated serum transaminases. Viral infection in children and teenagers. Pregnancy (Cat.X). Nursing mothers. |
| Precautions |
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Monitor liver function before therapy, at dose increases, then periodically; discontinue if serum transaminases ≥3xULN persist. History or symptoms of liver disease, heavy alcohol use, asthma, or peptic ulcer. Renal dysfunction. Discontinue if myopathy or markedly elevated CPK levels occur; suspend if a predisposition to development of renal failure due to rhabdomyolysis develops. Reevaluate if endocrine dysfunction occurs. Homozygous familial hypercholesterolemia. Bleeding disorders. Diabetes. Gout. |
| Interactions |
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Avoid fibrates. Monitor for myopathy with cyclosporine, erythromycin, niacin. Enhanced effects of pravastatin with cholestyramine, colestipol (give 1 hr before or 4 hrs after). Caution with drugs that decrease levels or activity of steroid hormones (eg, cimetidine, ketoconazole, spironolactone). Potentiates anticoagulants, acetazolamide, hypoglycemics, valproic acid, methotrexate, highly protein-bound drugs. Urinary alkalinizers, corticosteroids, antacids may increase aspirin excretion. May antagonize ACEIs, diuretics, β-blockers, uricosurics. Increased bleeding risk with NSAIDs or chronic, heavy alcohol use. NSAIDs increase risk of renal dysfunction. |
| Adverse Reactions |
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Headache, GI upset/ bleed, myalgia, rash, dizziness, elevated serum transaminases, myopathy, rhabdomyolysis with renal dysfunction, prolonged bleeding time, anaphylaxis, salicylism. |
| Extra Text |
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Note: For more information refer to the separate entries for Pravachol and aspirin. |
| How Supplied |
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Pravigard PAC (60 tabs)—1 |
| Additional Resources |
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• Related Prescribing Note |
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