PRAVACHOL Tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

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

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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. ...

2. Dosage and Administration

2.1 General Dosing Information The patient should be placed on a standard cholesterol-lowering diet before receiving PRAVACHOL and should continue on this diet during treatment with PRAVACHOL [see ...

3. Dosage Forms and Strengths

PRAVACHOL 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. 40 mg tablets: ...

4. Contraindications

4.1 Hypersensitivity Hypersensitivity to any component of this medication. 4.2 Liver Active liver disease or unexplained, persistent elevations of serum transaminases [see Warnings and Precautions ...

5. Warnings and Precautions

5.1 Skeletal Muscle Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with pravastatin and other drugs in this class. A history of renal impairment ...

6. Adverse Reactions

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 ...

6.1. Clinical Trials Experience

Short-Term Controlled Trials In the PRAVACHOL placebo-controlled clinical trials database of 1313 patients (age range 20-76 years, 32.4% women, 93.5% Caucasians, 5% Blacks, 0.9% Hispanics, 0.4% Asians, ...

6.2. Postmarketing Experience

In addition to the events reported above, as with other drugs in this class, the following events have been reported during postmarketing experience with PRAVACHOL, regardless of causality assessment: ...

7. Drug Interactions

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 ...

8. Use in Specific Populations

8.6 Homozygous Familial Hypercholesterolemia Pravastatin has not been evaluated in patients with rare homozygous familial hypercholesterolemia. In this group of patients, it has been reported that statins ...

8.1. Pregnancy

Risk Summary PRAVACHOL is contraindicated for use in pregnant woman because of the potential for fetal harm. As safety in pregnant women has not been established and there is no apparent benefit to therapy ...

8.2. Lactation

Risk Summary Pravastatin use is contraindicated during breastfeeding [see Contraindications (4.4)]. Based on one lactation study in published literature, pravastatin is present in human milk. ...

8.3. Females and Males of Reproductive Potential

Contraception Females PRAVACHOL may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception ...

8.4. Pediatric Use

The safety and effectiveness of PRAVACHOL in children and adolescents from 8 to 18 years of age have been evaluated in a placebo-controlled study of 2 years duration. Patients treated with pravastatin ...

8.5. Geriatric Use

Two secondary prevention trials with pravastatin (CARE and LIPID) included a total of 6593 subjects treated with pravastatin 40 mg for periods ranging up to 6 years. Across these 2 studies, 36.1% of pravastatin ...

10. Overdosage

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 ...

11. Description

PRAVACHOL (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 ...

12.1. Mechanism of Action

Pravastatin is a reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate limiting step in ...

12.3. Pharmacokinetics

General Absorption PRAVACHOL is administered orally in the active form. In studies in man, peak plasma pravastatin concentrations occurred 1 to 1.5 hours upon oral administration. Based on urinary recovery ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year study in rats fed pravastatin at doses of 10, 30, or 100 mg/kg body weight, there was an increased incidence of hepatocellular carcinomas in males at the highest dose (p<0.01). These effects ...

13.2. Animal Toxicology and/or Pharmacology

CNS Toxicity CNS vascular lesions, characterized by perivascular hemorrhage and edema and mononuclear cell infiltration of perivascular spaces, were seen in dogs treated with pravastatin at a dose of 25 ...

14. Clinical Studies

14.1 Prevention of Coronary Heart Disease In the Pravastatin Primary Prevention Study (WOS),3 the effect of PRAVACHOL on fatal and nonfatal CHD was assessed in 6595 men 45 to 64 years of age, ...

15. References

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, ...

16.1. How Supplied

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. ...

16.2. Storage and Handling

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.

17. Patient Counseling Information

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 ...