Monograph Details
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Cardiovascular System
> Hypertension
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CADUET 5mg/80mg |
| Manufacturer |
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Pfizer Labs |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Calcium channel blocker + HMG-CoA reductase inhibitor. |
| Generic Name |
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Amlodipine (as besylate) 5mg + atorvastatin (as calcium) 80mg; tabs. |
| Also |
• CADUET 10mg/10mg
• CADUET 10mg/20mg
• CADUET 10mg/40mg
• CADUET 10mg/80mg
• CADUET 2.5mg/10mg
• CADUET 2.5mg/20mg
• CADUET 2.5mg/40mg
• CADUET 5mg/10mg
• CADUET 5mg/20mg
• CADUET 5mg/40mg
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| Indications |
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Hypertension (HTN) and/or angina (vasospastic or chronic stable) with dyslipidemias in patients for whom treatment with both amlodipine and atorvastatin is appropriate. See literature. (Amlodipine: indications include hypertension, chronic stable angina, and vasospastic angina. Atorvastatin: indications include use in patients with multiple risk factors, but no clinical evidence of, coronary heart disease, to reduce risk of MI and reduce risk of revascularization procedures and angina; treatment of hypercholesterolemia to reduce elevated total-C, LDL-C, apo B, and TG and to increase HDL-C; elevated triglycerides; dysbetalipoproteinemias; certain pediatric patients with elevated LDL-C.) |
| Children |
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<10yrs: not recommended. ≥10yrs: individualize; see literature. |
| Adults |
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Individualize; see literature. May substitute for individually titrated components, or may be added to existing therapy for patients already taking either amlodipine or atorvastatin. Or, may be used to start therapy in patients with hyperlipidemia and either HTN or angina. |
| Contraindications |
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Active liver disease. Unexplained persistent elevated serum transaminases. Pregnancy (Cat.X). Nursing mothers. |
| Precautions |
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Monitor liver function (before therapy, at 12 weeks after starting or dose increase, then periodically); reduce dose or discontinue if serum transaminase levels >3XULN persist. History of liver disease. Substantial alcohol ingestion. Discontinue if myopathy or elevated CPK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Severe obstructive coronary disease. Severe aortic stenosis. CHF. Elderly. Labor & delivery. |
| Interactions |
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See literature. Increased risk of myopathy with fibrates, erythromycin, nicotinic acid, azole antifungals, cyclosporine. Additive effects with colestipol. May increase serum levels of digoxin, oral contraceptives. Caution with drugs that reduce levels or activity of steroid hormones. |
| Adverse Reactions |
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Edema, dizziness, palpitation, flushing, fatigue, constipation, dyspepsia, abdominal pain, drowsiness, myopathy, elevated liver enzymes, rhabdomyolysis with renal dysfunction. |
| How Supplied |
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Tabs—30 |
| Additional Resources |
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• Related Prescribing Note |
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