PRAVASTATIN SODIUM- pravastatin sodium tablet
1 INDICATIONS AND USAGE
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
1.1 Prevention of Cardiovascular Disease
In hypercholesterolemic patients without clinically evident coronary heart disease (CHD), pravastatin sodium tablets are indicated to:
- reduce the risk of myocardial infarction (MI).
- reduce the risk of undergoing myocardial revascularization procedures.
- reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes.
In patients with clinically evident CHD, pravastatin sodium tablets are indicated to:
- reduce the risk of total mortality by reducing coronary death.
- reduce the risk of MI.
- reduce the risk of undergoing myocardial revascularization procedures.
- reduce the risk of stroke and stroke/transient ischemic attack (TIA).
- slow the progression of coronary atherosclerosis.
Pravastatin sodium tablets are indicated:
- as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and triglyceride (TG) levels and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia ( Fredrickson Types IIa and IIb). 1
- as an adjunct to diet for the treatment of patients with elevated serum TG levels ( Fredrickson Type IV).
- for the treatment of patients with primary dysbetalipoproteinemia ( Fredrickson Type III) who do not respond adequately to diet.
- as an adjunct to diet and lifestyle modification for treatment of heterozygous familial hypercholesterolemia (HeFH) in children and adolescent patients ages 8 years and older if after an adequate trial of diet the following findings are present:
- LDL-C remains ≥190 mg/dL or
- LDL-C remains ≥160 mg/dL and:
- there is a positive family history of premature cardiovascular disease (CVD) or
- two or more other CVD risk factors are present in the patient.
1.3 Limitations of Use
Pravastatin sodium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons ( Fredrickson Types I and V).
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
The patient should be placed on a standard cholesterol-lowering diet before receiving pravastatin sodium and should continue on this diet during treatment with pravastatin sodium [see NCEP Treatment Guidelines for details on dietary therapy].
2.2 Adult Patients
The recommended starting dose is 40 mg once daily. If a daily dose of 40 mg does not achieve desired cholesterol levels, 80 mg once daily is recommended. Pravastatin sodium can be administered orally as a single dose at any time of the day, with or without food. Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient’s response to therapy and established treatment guidelines.
2.3 Patients with Renal Impairment
In patients with severe renal impairment, a starting dose of 10 mg pravastatin daily is recommended.
2.4 Pediatric Patients
Children (Ages 8 to 13 Years, Inclusive)
The recommended dose is 20 mg once daily in children 8 to 13 years of age. Doses greater than 20 mg have not been studied in this patient population.
Adolescents (Ages 14 to 18 Years)
The recommended starting dose is 40 mg once daily in adolescents 14 to 18 years of age. Doses greater than 40 mg have not been studied in this patient population.
Children and adolescents treated with pravastatin should be reevaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult goals for LDL-C [see Indications and Usage (1.2)].
2.5 Concomitant Lipid-Altering Therapy
Pravastatin sodium may be used with bile acid resins. When administering a bile-acid-binding resin (e.g., cholestyramine, colestipol) and pravastatin, pravastatin sodium should be given either 1 hour or more before or at least 4 hours following the resin. [See Clinical Pharmacology (12.3).]
2.6 Dosage in Patients Taking Cyclosporine
In patients taking immunosuppressive drugs such as cyclosporine concomitantly with pravastatin, therapy should begin with 10 mg of pravastatin sodium once-a-day at bedtime and titration to higher doses should be done with caution. Most patients treated with this combination received a maximum pravastatin sodium dose of 20 mg/day. In patients taking cyclosporine, therapy should be limited to 20 mg of pravastatin sodium once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.1)].
2.7 Dosage in Patients Taking Clarithromycin
In patients taking clarithromycin, therapy should be limited to 40 mg of pravastatin sodium once daily [see Drug Interactions (7.2)].
3 DOSAGE FORMS AND STRENGTHS
Pravastatin sodium tablets, USP are supplied as:
10 mg tablets: Yellow colored, circular shaped, flat faced tablets with “G5” debossed on one side and “10” debossed on the other side.
20 mg tablets: Yellow rounded-rectangular, biconvex tablets with “G5” debossed on one side and “20” debossed on the other side.
40 mg tablets: Green rounded-rectangular, biconvex tablets with “G5” debossed on one side and “40” debossed on the other side.
80 mg tablets: Yellow oval, biconvex tablets with “G5” debossed on one side and “80” debossed on the other side.
Hypersensitivity to any component of this medication.
Active liver disease or unexplained, persistent elevations of serum transaminases [see Warnings and Precautions (5.3)].
Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). Since statins decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they are contraindicated during pregnancy and in nursing mothers. PRAVASTATIN SHOULD BE ADMINISTERED TO WOMEN OF CHILDBEARING AGE ONLY WHEN SUCH PATIENTS ARE HIGHLY UNLIKELY TO CONCEIVE AND HAVE BEEN INFORMED OF THE POTENTIAL HAZARDS. If the patient becomes pregnant while taking this class of drug, therapy should be discontinued immediately and the patient apprised of the potential hazard to the fetus [see Use in Specific Populations ( 8.1, 8.3) ].
Pravastatin is present in human milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require pravastatin sodium treatment should not breastfeed their infants [see Use in Specific Populations (8.2)].
5 WARNINGS AND PRECAUTIONS
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