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.
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.
To date, there has been limited experience with overdosage of pravastatin. If an overdose occurs, it should be treated symptomatically with laboratory monitoring and supportive measures should be instituted as required.
16.1 How Supplied Pravastatin Sodium Tablets, USP are supplied as: 40 mg tablets: White to off-white, rounded, rectangular-shaped, biconvex tablets debossed with “B 40” on one side and plain on other side. They are supplied in bottles of 1000’s Count (NDC: 63629-8911-1). Bottles contain a desiccant canister. 16.2 Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504
Pravastatin Sodium 40mg Tablet
| Class | Version | Type | Effective |
|---|---|---|---|
| PRAVASTATIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 36361c23-a766-1581-d616-2080c781a50c | Product name | 5 | 20190314 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-8911-1 | EA - Each | 63629-8911 | 50036985-2bdc-4f19-9299-7d5a20b30a24 | 1 | 2022-01-06 |
| 70377-047-12 | EA - Each | 70377-047 | 92b15b8d-1f14-4e04-a4ad-97975220b9f6 | 1 | 2021-08-05 |
| 70377-047-14 | EA - Each | 70377-047 | f12cf03b-e6c4-4bf2-be40-b27c8b49561b | 1 | 2021-08-05 |
| Product NDC | Package NDC |
|---|---|
| 63629-8911 | 63629-8911-1 |
| 70377-047 |
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM OXIDE | 3A3U0GI71G | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| PRAVASTATIN SODIUM | 3M8608UQ61 | ACTIB |
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.
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.
Pravastatin is generally well tolerated; adverse reactions have usually been mild and transient. In 4-month-long placebo-controlled trials, 1.7% of pravastatin-treated patients and 1.2% of placebo-treated patients were discontinued from treatment because of adverse experiences attributed to study drug therapy; this difference was not statistically significant.
For the concurrent therapy of either cyclosporine, fibrates, niacin (nicotinic acid), or erythromycin, the risk of myopathy increases [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].
To date, there has been limited experience with overdosage of pravastatin. If an overdose occurs, it should be treated symptomatically with laboratory monitoring and supportive measures should be instituted as required.
Pravastatin sodium is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium 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 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 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.
Fredrickson DS, Levy RI, Lees RS. Fat transport in lipoproteins - An integrated approach to mechanisms and disorders. N Engl J Med. 1967;276: 34-44, 94-103, 148-156, 215-225, 273-281. Manson JM, Freyssinges C, Ducrocq MB, Stephenson WP. Postmarketing surveillance of lovastatin and simvastatin exposure during pregnancy. Reprod Toxicol. 1996;10(6):439-446. Shepherd J, Cobbe SM, Ford I, et al, for the West of Scotland Coronary Prevention Study Group (WOS). Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. N Engl J Med. 1995;333:1301-1307. The Long-term Intervention with Pravastatin in Ischemic Disease Group (LIPID). Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med. 1998;339:1349-1357. Sacks FM, Pfeffer MA, Moye LA, et al, for the Cholesterol and Recurrent Events Trial Investigators (CARE). The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. N Engl J Med. 1996;335:1001-1009. Pitt B, Mancini GBJ, Ellis SG, et al, for the PLAC I Investigators. Pravastatin limitation of atherosclerosis in the coronary arteries (PLAC I): Reduction in atherosclerosis progression and clinical events. J Am Coll Cardiol. 1995;26:1133-1139. Jukema JW, Bruschke AVG, van Boven AJ, et al, for the Regression Growth Evaluation Statin Study Group (REGRESS). Effects of lipid lowering by pravastatin on progression and regression of coronary artery disease in symptomatic man with normal to moderately elevated serum cholesterol levels. Circ. 1995;91:2528-2540. Crouse JR, Byington RP, Bond MG, et al. Pravastatin, lipids, and atherosclerosis in the carotid arteries: Design features of a clinical trial with carotid atherosclerosis outcome (PLAC II). Control Clin Trials. 1992;13:495-506. Salonen R, Nyyssonen K, Porkkala E, et al. Kuopio Atherosclerosis Prevention Study (KAPS). A population-based primary preventive trial of the effect of LDL lowering on atherosclerotic progression in carotid and femoral arteries. Circ. 1995;92:1758-1764.
16.1 How Supplied Pravastatin Sodium Tablets, USP are supplied as: 40 mg tablets: White to off-white, rounded, rectangular-shaped, biconvex tablets debossed with “B 40” on one side and plain on other side. They are supplied in bottles of 1000’s Count (NDC: 63629-8911-1). Bottles contain a desiccant canister. 16.2 Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504
Muscle Pain Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing Pravastatin Sodium [see Warnings and Precautions (5.1) ]. Liver Enzymes It is recommended that liver enzyme tests be performed before the initiation of Pravastatin Sodium, and thereafter when clinically indicated. All patients treated with Pravastatin Sodium should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.3) ]. Embryofetal Toxicity Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment, and to inform their healthcare provider of a known or suspected pregnancy [see Contraindications (4.3) , Use in Specific Populations (8.1, 8.3) ]. Lactation Advise women not to breastfeed during treatment with Pravastatin Sodium [see Contraindications (4.4) , Use in Specific Populations (8.2) ]. Manufactured by: Appco Pharma LLC Piscataway, NJ 08854 Manufactured for: Biocon Pharma Inc., 485 US Highway 1 S Suite B305, Iselin NJ 08830-3009 USA Revised: 10/2020
Pravastatin Sodium 40mg Tablet
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 103 | 2025-04-23 | full-release | 2026-05-31 21:32:05 |