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Selected Safety Information
Read information about the safety profile and tolerability of ZETIA when used alone or with a statin. -
Dosage: Once-Daily Tablet
ZETIA 10-mg tablets offer convenient, once-daily dosing and can be taken with (or without) any statin, with or without food.
- Safety Profile and Tolerability:
Patients Aged <65 and ≥65 Years
Read information about the safety profile and tolerability of ZETIA in patients aged <65 and ≥65 years.
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The effect of ZETIA on cardiovascular morbidity and mortality has not been determined. |
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ZETIA, administered alone or in combination with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated TOTAL-C, LDL-C, and Apo B in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia when diet alone is not enough. |
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| Contraindications: hypersensitivity to any component of this medication. |
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| Statin contraindications apply when used with a statin: active liver disease; unexplained persistent elevations in hepatic transaminase levels. Statins are contraindicated in pregnant and nursing women. Refer to the statin label for details. |
| SELECTED CAUTIONARY INFORMATION | |
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| When using ZETIA with a statin, also follow the label recommendations for that specific statin. |
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When ZETIA was coadministered with a statin, consecutive elevations in hepatic transaminase levels (≥3 × ULN) were slightly higher (1.3%) than those of statins alone (0.4%). Liver function tests should be performed when ZETIA is added to statin therapy and according to statin recommendations. Should an increase in ALT or AST ≥3 × ULN persist, consider withdrawal of ZETIA and/or the statin. |
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Patients should be advised to promptly report muscle pain, tenderness, or weakness. Risk for skeletal muscle toxicity increases with higher statin doses, advanced age (>65), hypothyroidism, renal impairment, and depending on the statin used, concomitant use of other drugs. Discontinue drug if myopathy is diagnosed or suspected. |
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ZETIA is not recommended in patients with moderate to severe hepatic impairment. |
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The coadministration of ZETIA with fibrates other than fenofibrate is not recommended until use in patients is adequately studied. |
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Exercise caution when using ZETIA and cyclosporine concomitantly because exposure to both drugs is increased. Cyclosporine concentrations should be monitored in these patients. |
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ZETIA should be used in pregnant or nursing women only if the benefit outweighs the risk. |
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In clinical trials, regardless of causality assessment, the most frequent side effects for ZETIA coadministered with a statin vs statin alone included nasopharyngitis (3.7% vs 3.3%), myalgia (3.2% vs 2.7%), upper respiratory tract infection (2.9% vs 2.8%), arthralgia (2.6% vs 2.4%), and diarrhea (2.5% vs 2.2%); for ZETIA administered alone vs placebo: upper respiratory tract infection (4.3% vs 2.5%), diarrhea (4.1% vs 3.7%), arthralgia (3.0% vs 2.2%), sinusitis (2.8% vs 2.2%), pain in extremity (2.7% vs 2.5%), and fatigue (2.4% vs 1.5%). |
Before prescribing ZETIA, please read the Prescribing Information.
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