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Look Up > Drugs > Pravastatin
Pravastatin
Pronunciation
U.S. Brand Names
Generic Available
Synonyms
Pharmacological Index
Use
Pregnancy Risk Factor
Contraindications
Warnings/Precautions
Adverse Reactions
Overdosage/Toxicology
Drug Interactions
Mechanism of Action
Pharmacodynamics/Kinetics
Usual Dosage
Dietary Considerations
Monitoring Parameters
Cardiovascular Considerations
Mental Health: Effects on Mental Status
Mental Health: Effects on Psychiatric Treatment
Dental Health: Local Anesthetic/Vasoconstrictor Precautions
Dental Health: Effects on Dental Treatment
Patient Information
Nursing Implications
Dosage Forms
References

Pronunciation
(PRA va stat in)

U.S. Brand Names
Pravachol®

Generic Available

No


Synonyms
Pravastatin Sodium

Pharmacological Index

Antilipemic Agent (HMG-CoA Reductase Inhibitor)


Use

"Primary prevention" in hypercholesterolemic patients without clinically-evident coronary heart disease to reduce the risk of myocardial infarction, reduce the risk of undergoing myocardial revascularization procedures, reduce the risk of cardiovascular mortality with no increase in death from noncardiovascular causes

"Secondary prevention" in hypercholesterolemic patients with clinically-evident coronary artery disease, including prior myocardial infarction, to slow the progression of coronary atherosclerosis, and reduce the risk of acute coronary events

"Secondary prevention" in patients with previous myocardial infarction, and normal cholesterol levels; to reduce the risk of recurrent myocardial infarction; reduce the risk of undergoing myocardial revascularization procedures; and reduce the risk of stroke or transient ischemic attack (TIA)

Adjunct to diet to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B (apo-B) and triglyceride levels, and increasing HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson types IIa and IIb); Fredrickson type IV, type III (who do not respond adequately to diet)


Pregnancy Risk Factor

X


Contraindications

Hypersensitivity to pravastatin or any component; active liver disease; unexplained persistent elevations of serum transaminases; pregnancy


Warnings/Precautions

Liver function must be monitored by periodic laboratory assessment. Rhabdomyolysis with acute renal failure has occurred with other HMG-CoA reductase inhibitors. Risk is increased with concurrent use of clarithromycin, danazol, diltiazem, fluvoxamine, indinavir, nefazodone, nelfinavir, ritonavir, verapamil, troleandomycin, cyclosporine, fibric acid derivatives, erythromycin, niacin, or azole antifungals. The risk of combining any of these drugs with pravastatin is minimal. Temporarily discontinue in any patient experiencing an acute or serious condition predisposing to renal failure secondary to rhabdomyolysis. Use with caution in patients who consume large amounts of alcohol or have a history of liver disease.


Adverse Reactions

1% to 10%:

Central nervous system: Headache (1.7% to 6.2%), fatigue (3.8%), dizziness (1% to 3.3%)

Cardiovascular: Chest pain (3.7%)

Dermatologic: Rash (4%)

Gastrointestinal: Nausea/vomiting (7.3%), diarrhea (6.2%), heartburn (2.9%)

Hepatic: Increased transaminases (>3x normal on two occasions - 1.3%)

Neuromuscular & skeletal: Myalgia (2.4%)

Respiratory: Cough (2.6%)

Miscellaneous: Influenza (2.4%)

<1%: Weakness, neuropathy, myopathy

Case reports: Lichenoid eruption, porphyria cutanea tarda

Additional class-related events or case reports (not necessarily reported with pravastatin therapy): Myopathy, increased CPK (>10x normal), rhabdomyolysis, renal failure (secondary to rhabdomyolysis), alteration in taste, impaired extraocular muscle movement, facial paresis, tremor, memory loss, vertigo, paresthesia, peripheral neuropathy, peripheral nerve palsy, anxiety, depression, psychic disturbance, hypersensitivity reaction, angioedema, anaphylaxis, systemic lupus erythematosus-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, increased ESR, eosinophilia, arthritis, urticaria, photosensitivity, fever, chills, flushing, malaise, dyspnea, rash, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, pancreatitis, hepatitis, cholestatic jaundice, fatty liver, cirrhosis, fulminant hepatic necrosis, hepatoma, anorexia, vomiting, alopecia, pruritus, nodules, skin discoloration, dryness of skin/mucous membranes, nail changes, gynecomastia, decreased libido, erectile dysfunction, impotence, cataracts, ophthalmoplegia, elevated transaminases, increased alkaline phosphatase, increased GGT, hyperbilirubinemia, thyroid dysfunction


Overdosage/Toxicology

Very little adverse events; treatment is symptomatic


Drug Interactions

CYP3A3/4 enzyme substrate

Cholestyramine and colestipol (bile acid sequestrants): Cholesterol-lowering effects are additive.

Clofibrate and fenofibrate may increase the risk of myopathy and rhabdomyolysis.

Colestipol reduces pravastatin absorption.

Gemfibrozil: Increased risk of myopathy and rhabdomyolysis.

Niacin may increase the risk of myopathy and rhabdomyolysis.


Mechanism of Action

Pravastatin is a competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, which is the rate-limiting enzyme involved in de novo cholesterol synthesis.


Pharmacodynamics/Kinetics

Onset of action: Several days

Absorption: Poor

Metabolism: In the liver to at least two metabolites

Bioavailability: 17%

Half-life, elimination: ~2-3 hours

Time to peak serum concentration: 1-1.5 hours

Elimination: Up to 20% excreted in urine (8% unchanged)


Usual Dosage

Adults: Oral: 10-40 mg once daily at bedtime. Dosing adjustment in renal impairment:10 mg daily.


Dietary Considerations

Before initiation of therapy, patients should be placed on a standard cholesterol-lowering diet for 3-6 months and the diet should be continued during drug therapy.


Monitoring Parameters

Creatine phosphokinase due to possibility of myopathy


Cardiovascular Considerations

HMG-CoA reductase inhibitors are effective in secondary prevention of cardiovascular events in patients with hyperlipidemia. In these situations, the target of therapy is a reduction in LDL cholesterol to <100 mg/dL. HMG-CoA reductase inhibitors have also been shown to be effective in primary prevention of coronary artery disease in individuals without established cardiovascular disease but who have multiple risk factors. Selection of lipid-lowering therapy should be based on the patient's lipid profile, concomitant disease states, and the cost of therapy. The benefits of lipid-lowering are also compelling in women and in the elderly. Important side effects relate to elevated liver enzymes and rhabdomyolysis. LFTs need to be monitored at specified intervals.


Mental Health: Effects on Mental Status

May cause dizziness


Mental Health: Effects on Psychiatric Treatment

None reported


Dental Health: Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions


Dental Health: Effects on Dental Treatment

No effects of complications reported


Patient Information

Take at bedtime since highest rate of cholesterol synthesis occurs between midnight and 5 AM. Do not change dosage without consulting prescriber. Maintain diet and exercise program as as prescribed. Have periodic ophthalmic exam while taking pravastatin (check for cataracts). You may experience mild GI disturbances (gas, diarrhea, constipation); inform prescriber if these are severe, or if you experience severe muscle pain or tenderness accompanied with malaise, blurred vision, or chest pain. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Do not get pregnant during or for 1 month following therapy. Consult prescriber for instruction on appropriate barrier contraceptive measures. This drug may cause severe fetal defects. Do not breast-feed.


Nursing Implications

Liver enzyme elevations may be observed during therapy with pravastatin; diet, weight reduction, and exercise should be attempted prior to therapy with pravastatin


Dosage Forms

Tablet, as sodium: 10 mg, 20 mg, 40 mg


References

Lintott CJ and Scott RS, "HMG-CoA Reductase Inhibitor Use in the Aged: A Review of Clinical Experience," Drugs Aging, 1992, 2(6):518-29.

"Summary of the Second Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults," JAMA, 1993, 269(23):3015-23.


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