Indication
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| Clinical Information | Administration Information |
|---|---|
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Age: Adults |
Dose: Oral – 40 mg Frequency: once daily Note: Recommended starting dose. Use 80 mg dose only for patients not reaching LDL-C goal with 40 mg. |
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Age: Adults Condition: Hepatic Impairment (liver cirrhosis) |
Dose: Oral – 40 mg Frequency: once daily Note: Shows a large inter-subject variability in pharmacokinetics. |
| Clinical Information | Administration Information |
|---|---|
|
Age: Children (ages 8 to 13 years, inclusive) |
Dose: Oral – 20 mg Frequency: once daily Note: recommended starting dose |
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Age: Adolescents (ages 14 to 18 years) |
Dose: Oral – 40 mg Frequency: once daily Note: recommended starting dose |
| Clinical Information | Administration Information |
|---|---|
|
Condition: Severe renal impairment |
Dose: Pravastatin sodium – 10 mg Frequency: once daily Note: Recommended starting dose. Maximum recommended dosage is 40 mg once daily. Renal impairment is a risk factor for myopathy and rhabdomyolysis. Monitor all patients with renal impairment for development of myopathy. |
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Condition: Mild or moderate renal impairment |
Dose: Pravastatin sodium – Same as patients with normal renal function Note: Renal impairment is a risk factor for myopathy and rhabdomyolysis. Monitor all patients with renal impairment for development of myopathy. |
Pravastatin sodium is administered orally as a tablet and can be taken with or without food. It is typically taken once daily, preferably in the evening. The tablet should be swallowed whole with water. Dose adjustments are required for patients with severe renal impairment, necessitating a lower starting dose. It is contraindicated in patients with active liver disease or unexplained persistent elevations in hepatic transaminases. Precautions include a risk of immune-mediated necrotizing myopathy and rhabdomyolysis, particularly when used concurrently with certain other medications, such as fibrates or cyclosporine. It is approved for use in specific pediatric populations with familial hypercholesterolemia. Elderly patients generally require no specific dose adjustments but should be monitored closely for muscle pain and weakness, as they are at higher risk for myopathy.
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Clinical & regulatory information on this page is compiled from the following government sources:
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