Pravastatin Sodium

A to Z Drug Facts

Pravastatin Sodium

	Action
	Indications
	Contraindications
	Route/Dosage
	Interactions
	Lab Test Interferences
	Adverse Reactions
	Precautions
Patient Care Considerations
	Administration/Storage
	Assessment/Interventions
	Patient/Family Education

(PRUH-vuh-stuh-tin SO-dee-uhm)

Pravachol

Class: Antihyperlipidemic/HMG-CoA reductase inhibitor

Action Increases rate at which body removes cholesterol from blood and reduces production of cholesterol in body by inhibiting enzyme that catalyzes early rate-limiting step in cholesterol synthesis.

Indications

Hyperlipidemias: Reduction of elevated cholesterol and low-density lipoprotein (LDL) cholesterol levels in patients with primary hypercholesterolemia (types IIa and IIb). Coronary events: In hypercholesterolemic patients without clinically evident coronary heart disease, to reduce the risk of MI; reduce the risk of undergoing myocardial revascularization procedures; reduce the risk of cardiovascular mortality with no increase in death from noncardiovascular causes. Atherosclerosis: In hypercholesterolemic patients with clinically evident coronary artery disease, including prior MI, to slow the progression of coronary atherosclerosis and reduce the risk of acute coronary events. MI: In patients with previous MI to reduce the risk of recurrent MI; reduce the risk of undergoing myocardial revascularization procedures; and reduce the risk of stroke or transient ischemic attack. Unlabeled use(s): Lowers elevated cholesterol levels in patients with heterozygous familial hypercholesterolemia, familial combined hyperlipidemia, diabetic dyslipidemia in noninsulin-dependent diabetics, hypercholesterolemia secondary to nephrotic syndrome, and homozygous familial hypercholesterolemia in patients who are not completely devoid of LDL receptors but have reduced level of LDL receptor activity.

Contraindications Active liver disease or unexplained persistent elevations of liver function tests; pregnancy; lactation.

Route/Dosage

ADULTS: PO 10 to 40 mg/day

Interactions

Bile acid sequestrants: Large decrease in pravastatin bioavailability. Gemfibrozil: Severe myopathy or rhabdomyolysis; decreased urinary excretion and protein binding of pravastatin.

Lab Test Interferences None well documented.

Adverse Reactions

CV: Chest pain. CNS: Headache; dizziness. DERM: Rash; pruritus. EENT: Dysfunction of certain cranial nerves (including alteration of taste, impairment of extraocular movement, facial paresis); lens opacities. GI: Nausea; vomiting; diarrhea; abdominal pain; constipation; flatulence; heartburn; dyspepsia; pancreatitis. HEPA: Hepatitis; jaundice; fatty changes in liver; cirrhosis; fulminant hepatic necrosis; hepatoma; increased serum transaminases. GU: Urinary abnormality. RESP: Common cold; rhinitis; cough; influenza. OTHER: Localized pain; myalgia; myopathy; rhabdomyolysis; fatigue; paresthesia; peripheral neuropathy. An apparent hypersensitivity syndrome has been reported rarely that has included one or more of these features: anaphylaxis; angioedema; lupus erythematous–like syndrome; polymyalgia rheumatica; vasculitis; purpura; thrombocytopenia; leukopenia; hemolyticanemia; positive anti-nuclear antibodies; increase in erythrocyte sedimentation rate; arthritis; arthralgia; urticaria; asthenia; photosensitivity; fever; chills; flushing; malaise; dyspnea; toxic epidermal necrolysis; erythema multiforme, including Stevens-Johnson syndrome.

Precautions

Pregnancy: Category X. Lactation: Excreted in breast milk. Children: Use in children not recommended. Liver dysfunction: Use with caution in patients who consume substantial quantities of alcohol or those with history of liver disease. Marked, persistent increases in serum transaminases have occurred. Renal impairment: Monitor patients closely. Skeletal muscle effects: Rhabdomyolysis with renal dysfunction secondary to myoglobinuria has occurred.

PATIENT CARE CONSIDERATIONS

Administration/Storage

Administer at bedtime for best results. Hepatic cholesterol production is highest during night.
Store at room temperature in tightly-closed container.

Assessment/Interventions

Obtain patient history, including drug history and any known allergies. Assess dietary history.
Ensure that total cholesterol and LDL levels have been obtained before beginning therapy and reassess periodically during therapy.
Assess for side effects (eg, nausea and vomiting, diarrhea, abdominal pain, headache).

Patient/Family Education

Caution patient that this medication must not be taken during pregnancy or when pregnancy is possible. Advise patient to use reliable form of birth control while taking this drug.
Explain that full effectiveness of drug may not occur for up to 4 wk after initiation of therapy.
Teach dietary habits that reduce cholesterol and saturated fats.
Instruct patient to report the following symptoms to their healthcare provider: any unexplained muscle pain, tenderness or weakness, especially if accompanied by fever or malaise; yellowing of skin or eyes.
Emphasize importance of follow-up visits to monitor drug effectiveness.