Drug Detail:Pravastatin (Pravastatin [ prav-a-stat-in ])
Drug Class: Statins
Usual Adult Dose for Hyperlipidemia
Initial dose: 40 mg orally once a day
Maintenance dose: 40 mg to 80 mg orally once a day
Comments:
- Since maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted accordingly.
Uses: As an adjunct to diet in the following conditions: to reduced total cholesterol (total-C), low density lipoprotein (LDL-C), apolipoprotein B (Apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb); for the treatment of elevated TG levels (Fredrickson Type IV); and for the treatment of primary dysbetalipoproteinemia (Fredrickson Type III) in patients who do not respond adequately to diet
Usual Adult Dose for Hyperlipoproteinemia Type IIa (Elevated LDL)
Initial dose: 40 mg orally once a day
Maintenance dose: 40 mg to 80 mg orally once a day
Comments:
- Since maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted accordingly.
Uses: As an adjunct to diet in the following conditions: to reduced total cholesterol (total-C), low density lipoprotein (LDL-C), apolipoprotein B (Apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb); for the treatment of elevated TG levels (Fredrickson Type IV); and for the treatment of primary dysbetalipoproteinemia (Fredrickson Type III) in patients who do not respond adequately to diet
Usual Adult Dose for Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL)
Initial dose: 40 mg orally once a day
Maintenance dose: 40 mg to 80 mg orally once a day
Comments:
- Since maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted accordingly.
Uses: As an adjunct to diet in the following conditions: to reduced total cholesterol (total-C), low density lipoprotein (LDL-C), apolipoprotein B (Apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb); for the treatment of elevated TG levels (Fredrickson Type IV); and for the treatment of primary dysbetalipoproteinemia (Fredrickson Type III) in patients who do not respond adequately to diet
Usual Adult Dose for Hyperlipoproteinemia Type III (Elevated beta-VLDL + IDL)
Initial dose: 40 mg orally once a day
Maintenance dose: 40 mg to 80 mg orally once a day
Comments:
- Since maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted accordingly.
Uses: As an adjunct to diet in the following conditions: to reduced total cholesterol (total-C), low density lipoprotein (LDL-C), apolipoprotein B (Apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb); for the treatment of elevated TG levels (Fredrickson Type IV); and for the treatment of primary dysbetalipoproteinemia (Fredrickson Type III) in patients who do not respond adequately to diet
Usual Adult Dose for Hyperlipoproteinemia Type IV (Elevated VLDL)
Initial dose: 40 mg orally once a day
Maintenance dose: 40 mg to 80 mg orally once a day
Comments:
- Since maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted accordingly.
Uses: As an adjunct to diet in the following conditions: to reduced total cholesterol (total-C), low density lipoprotein (LDL-C), apolipoprotein B (Apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb); for the treatment of elevated TG levels (Fredrickson Type IV); and for the treatment of primary dysbetalipoproteinemia (Fredrickson Type III) in patients who do not respond adequately to diet
Usual Adult Dose for Hypertriglyceridemia
Initial dose: 40 mg orally once a day
Maintenance dose: 40 mg to 80 mg orally once a day
Comments:
- Since maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted accordingly.
Uses: As an adjunct to diet in the following conditions: to reduced total cholesterol (total-C), low density lipoprotein (LDL-C), apolipoprotein B (Apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb); for the treatment of elevated TG levels (Fredrickson Type IV); and for the treatment of primary dysbetalipoproteinemia (Fredrickson Type III) in patients who do not respond adequately to diet
Usual Adult Dose for Prevention of Cardiovascular Disease
Initial dose: 40 mg orally once a day
Maintenance dose: 40 mg to 80 mg orally once a day
Comments:
- Since maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted accordingly.
Uses:
- In hypercholesterolemic patients without clinically evident coronary heart disease (CHD) to reduce the risk of myocardial infarction (MI); to reduce the risk of undergoing myocardial revascularization procedures; and to reduce the risk of cardiovascular (CV) mortality with no increase in death from non-CV causes
- In patients with clinically evident CHD to reduce the risk of total mortality by reducing coronary death; to reduce the risk of MI; to reduce the risk of undergoing myocardial revascularization procedures; to reduce the risk of stroke and stroke/transient ischemic attack; and to slow the progression of coronary atherosclerosis
Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia
8 to 13 years: 20 mg orally once a day; doses greater than 20 mg have not been studied in this patient population.
14 to 18 years: 40 mg orally once a day; doses greater than 40 mg have not been studied in this patient population.
Use: As an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolemia if, after an adequate trial of diet, the following findings are present: LDL-C remains 190 mg/dL or greater, or LDL-C remains 160 mg/dL or greater and there is a positive family history of premature cardiovascular disease (CVD) or 2 or more other CVD risk factors are present in the pediatric patient
Renal Dose Adjustments
Significant renal dysfunction:
- Initial dose: 10 mg orally once a day
Liver Dose Adjustments
Active liver disease (including unexplained persistent elevations in hepatic transaminase levels): Contraindicated
Dose Adjustments
Concomitant use with Clarithromycin:
- Maximum dose: 40 mg/day
Concomitant use with Immunosuppressive Drugs (e.g., cyclosporine):
- Initial dose: 10 mg orally once a day at bedtime; titrate with caution
- Maximum dose: 20 mg/day
Concomitant use with Bile Acid Resins (e.g., cholestyramine, colestipol):
- This drug should be given either 1 hour or more before or at least 4 hours following the resin.
Precautions
Safety and efficacy have not been established in patients younger than 8 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Take orally once a day, at any time of day, with or without food
Storage requirements:
- Keep tightly closed; protect from moisture and light.
General:
- Prior to initiating therapy, patients should be placed on a standard cholesterol-lowering diet and continued on this diet throughout therapy.
- This drug has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V), nor has it been studied in homozygous familial hypercholesterolemia.
- Drug therapy should only be one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia; patients should be placed on this drug only when a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures have proven inadequate.
Monitoring:
- Hepatic: Measure liver function tests prior to initiating therapy and repeat as clinically indicated.
- Metabolic: Monitor lipid levels 4 weeks after beginning therapy and adjust dosage accordingly.
Patient advice:
- Advise patients to report immediately any unexplained muscle pain, tenderness, or weakness, especially if accompanied by malaise or fever, or if muscle signs/symptoms persist after discontinuing therapy.
- Counsel patients to report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.
- Counsel patients on the importance of contraceptive methods while taking this drug.
- Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; this drug is not recommended for use during pregnancy or lactation.
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