Complete SPL Sections#
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
Pravastatin sodium tablets are indicated: To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. o Hypertriglyceridemia.
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
Pravastatin Sodium Tablets, USP are supplied as: 10 mg tablets: White to off-white, Rectangular-shaped, biconvex tablets, debossed with “B 10” on one side and plain on other side. 20 mg tablets: White to off-white, Rectangular-shaped, biconvex tablets, debossed with “B 20” on one side and plain on other side. 40 mg tablets: White to off-white, Rectangular-shaped, biconvex tablets, debossed with “B 40” on one side and plain on other side. 80 mg tablets: White to off-white, Oval-shaped, biconvex tablets, debossed with “B 80” on one side and plain on other side.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ]. Hypersensitivity to any pravastatin or any excipients in pravastatin sodium tablets.
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] Hepatic Dysfunction [see Warnings and Precautions (5.3) ] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4) ]
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
No specific antidotes for pravastatin are known. Contact Poison Control (1-800-222-1222) for latest recommendations.
11 DESCRIPTION
DESCRIPTION SECTION
Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-2-methyl-8-(2-methyl-1-oxobutoxy)-β,δ,6-trihydroxy-,monosodium salt, [1S- [1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula: Pravastatin sodium, USP is white to off-white powder. It is a relatively polar hydrophilic compound with a partition coefficient (n-octanol/water) of 0.59. It is soluble in water (676 mg/mL). Pravastatin sodium, USP is available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: Croscarmellose sodium, lactose Monohydrate, magnesium oxide, magnesium stearate, microcrystalline cellulose, and povidone.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
Prevention of Coronary Heart Disease In the Pravastatin Primary Prevention Study (WOS), the effect of pravastatin on fatal and nonfatal CHD was assessed in 6,595 male patients 45 to 64 years of age, without a previous MI, and with LDL-C levels between 156 to 254 mg/dL. In this randomized, double-blind, placebo-controlled study, patients were treated with standard care, including dietary advice, and either pravastatin 40 mg daily (N=3,302) or placebo (N=3,293) and followed for a median duration of 4.8 years. Median (25 th , 75 th percentile) percent changes from baseline after 6 months of pravastatin treatment in Total-C, LDL-C, TG, and HDL-C were −20.3 (−26.9, −11.7), −27.7 Pravastatin significantly reduced the rate of first coronary events (either CHD death or nonfatal MI) by 31% (248 events in the placebo group [CHD death=44, nonfatal MI=204] versus 174 events in the pravastatin group [CHD death=31, nonfatal MI=143], p=0.0001 [see figure below]). The risk reduction with pravastatin was similar across the age range studied and throughout the range of baseline LDL cholesterol levels. Pravastatin also decreased the risk for undergoing myocardial revascularization procedures (coronary artery bypass graft [CABG] surgery or percutaneous transluminal coronary angioplasty [PTCA]) by 37% (80 vs 51 patients). Cardiovascular deaths were decreased by 32% (73 vs 50) and there was no increase in death from non-cardiovascular causes. Secondary Prevention of Cardiovascular Events In the LIPID study, the effect of pravastatin, 40 mg daily, was assessed in 9,014 patients (7,498 men; 1,516 women; 3,514 patients ≥65 years; 782 patients with diabetes) who had experienced either an MI (5,754 patients) or had been hospitalized for unstable angina pectoris (3,260 patients) in the preceding 3 to 36 months. Patients in this multicenter, double-blind, placebo-controlled study participated for an average of 5.6 years (median of 5.9 years) and at randomization had Total-C between 114 and 563 mg/dL (mean 219 mg/dL), LDL-C between 46 and 274 mg/dL (mean 150 mg/dL), TG between 35 and 2,710 mg/dL (mean 160 mg/dL), and HDL-C between 1 and 103 mg/dL (mean 37 mg/dL). At baseline, 82% of patients were receiving aspirin and 76% were receiving antihypertensive medication. Treatment with pravastatin significantly reduced the risk for total mortality by reducing coronary death (see Table 7). The risk reduction due to treatment with pravastatin on CHD mortality was consistent regardless of age. Pravastatin significantly reduced the risk for total mortality (by reducing CHD death) and CHD events (CHD mortality or nonfatal MI) in patients who qualified with a history of either MI or hospitalization for unstable angina pectoris. Table 7: LIPID - Primary and Secondary Endpoints Number (%) of Subjects Event Pravastatin 40 mg (N=4,512) Placebo (N=4,502) Risk Reduction p -value Primary Endpoint CHD mortality 287 (6.4) 373 (8.3) 24% 0.0004 Secondary Endpoints Total mortality 498 (11.0) 633 (14.1) 23%
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
Myopathy and Rhabdomyolysis Advise patients that pravastatin sodium tablets may cause myopathy and rhabdomyolysis. Inform patients that the risk is increased when taking certain types of medication and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ]. Hepatic Dysfunction Inform patients that pravastatin sodium tablets may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Warnings and Precautions (5.3) ]. Increases in HbA1c and Fasting Serum Glucose Levels Inform patients that increases in HbA1c and fasting serum glucose levels may occur with pravastatin sodium tablets. Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices [see Warnings and Precautions (5.4) ]. Pregnancy Advise pregnant patients and patients who may become pregnant of the potential risk to a fetus. Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if pravastatin sodium tablets should be discontinued [see Use in Specific Populations (8.1) ]. Lactation Advise patients that breastfeeding is not recommended during treatment with pravastatin sodium tablets [see Use in Specific Populations (8.2) ]. Manufactured by: Appco Pharma LLC Piscataway, NJ 08854 USA Or Biocon Generics Inc. 1 Duncan Drive, Cranbury, NJ 08512 Manufactured for: Biocon Pharma Inc., 485 US Highway 1 S Suite B305, Iselin NJ 08830-3009 USA Revised: February 2026
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (90 Tablets Bottle)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70377-045-12 Rx only Pravastatin Sodium Tablets, USP 10 mg Biocon Pharma Inc. 90 Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (90 Tablets Bottle)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70377-046-12 Rx only Pravastatin Sodium Tablets, USP 10 mg Biocon Pharma Inc. 90 Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg (90 Tablets Bottle)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70377-047-12 Rx only Pravastatin Sodium Tablets, USP 40 mg Biocon Pharma Inc. 90 Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 80 mg (90 Tablets Bottle)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70377-048-12 Rx only Pravastatin Sodium Tablets, USP 80 mg Biocon Pharma Inc. 90 Tablets
