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Pravastatin Dosage

Applies to the following strength(s): 10 mg20 mg40 mg80 mg

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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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