PRAVACHOL- pravastatin sodium tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

pravastatin sodium (UNII: 3M8608UQ61) (pravastatin - UNII:KXO2KT9N0G)

Available from:

E.R. Squibb & Sons, L.L.C.

INN (International Name):

pravastatin sodium

Composition:

pravastatin sodium 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. In hypercholesterolemic patients without clinically evident coronary heart disease (CHD), PRAVACHOL (pravastatin sodium) is indicated to: In patients with clinically evident CHD, PRAVACHOL is indicated to: PRAVACHOL is indicated: PRAVACHOL has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V). 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 dru

Product summary:

PRAVACHOL ® (pravastatin sodium) Tablets are supplied as: 20 mg tablets: Yellow, rounded, rectangular-shaped, biconvex with a “P” embossed on one side and “PRAVACHOL 20” engraved on the opposite side. They are supplied in bottles of 90 (NDC 0003-5178-05). Bottles contain a desiccant canister. 40 mg tablets: Green, rounded, rectangular-shaped, biconvex with a “P” embossed on one side and “PRAVACHOL 40” engraved on the opposite side. They are supplied in bottles of 90 (NDC 0003-5194-10). Bottles contain a desiccant canister. 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.

Authorization status:

New Drug Application

Summary of Product characteristics

PRAVACHOL- PRAVASTATIN SODIUM TABLET
E.R. SQUIBB & SONS, L.L.C.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRAVACHOL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PRAVACHOL.
PRAVACHOL (PRAVASTATIN SODIUM) TABLETS
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions:
Immuned-Mediated Necrotizing Myopathy (5.2) 08/2020
INDICATIONS AND USAGE
PRAVACHOL is an HMG-CoA reductase inhibitor (statin) indicated as an
adjunctive therapy to diet to:
•Reduce the risk of MI, revascularization, and cardiovascular
mortality in hypercholesterolemic patients without clinically
evident CHD. (1.1)•Reduce the risk of total mortality by reducing
coronary death, MI, revascularization, stroke/TIA, and
the progression of coronary atherosclerosis in patients with
clinically evident CHD. (1.1)•Reduce elevated Total-C, LDL-C,
ApoB, and TG levels and to increase HDL-C in patients with primary
hypercholesterolemia and mixed dyslipidemia.
(1.2)•Reduce elevated serum TG levels in patients with
hypertriglyceridemia. (1.2)•Treat patients with primary
dysbetalipoproteinemia who are not responding to diet. (1.2)•Treat
children and adolescent patients ages 8 years and older
with heterozygous familial hypercholesterolemia after failing an
adequate trial of diet therapy. (1.2)
Limitations of use:
•PRAVACHOL has not been studied in _Fredrickson_ Types I and V
dyslipidemias. (1.3)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•Tablets: 20 mg and 40 mg (3)
CONTRAINDICATIONS
Hypersensitivity to any component of this medication. (4.1, 6.2, 11)
Active liver disease or unexplained, persistent elevations of serum
transaminases. (4.2, 5.3)
Pregnancy (4.3, 8.1, 8.3)
Lactation (4.4, 8.2)
WARNINGS AND PRECAUTIONS
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis):
predisposing factors include advanced age (≥65),
uncontrolled hypothyroidism, and renal impairment. Patients should be
advised to promptly report t