Pravastatin

Pravastatinis indicated for prevention ofcardiovascular disease, and to treathyperlipidemia.

In hypercholesterolemic patients without clinically evident coronaryheart disease(CHD), pravastatin is indicated to:

• reduce the risk ofmyocardial infarction(MI)
• reduce the risk of undergoing myocardial revascularization procedures
• reduce the risk ofcardiovascularmortality with no increase in death from non-cardiovascular causes

In patients with clinically evident CHD, pravastatin is indicated to:

• reduce the risk of total mortality by reducing coronary death
• reduce the risk ofheart attack(myocardialinfarction, or MI)
• reduce the risk of undergoing myocardial revascularization procedures
• reduce the risk ofstrokeand stroke/transient ischemic attack(TIA)
• slow the progression of coronaryatherosclerosis

In the treatment of hyperlipidemia, pravastatin is indicated:

• as an adjunct to diet to reduce elevated totalcholesterol(Total-C), low-densitylipoproteincholesterol (LDL-C), apolipoprotein B (ApoB), and triglyceride (TG) levels and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primaryhypercholesterolemiaand mixeddyslipidemia(Fredrickson类型活动花絮和IIb)。1作为一个兼职diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV). for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet. as an adjunct to diet and lifestyle modification for treatment of heterozygousfamilial hypercholesterolemia(HeFH) in children and adolescent patients ages 8 years and older if after an adequate trial of diet the following findings are present:
  • LDL-C remains 190 mg/dL or greater, or
  • LDL-C remains 160 mg/dL or greater, and:
    • there is a positive family history of premature cardiovascular disease (CVD) or
    • two or more other CVD risk factors are present in the patient

Pravastatin is available under the following different brand names:Pravachol.

Dosages of Pravastatin:

Adult and Pediatric Dosage Forms and Strengths

Tablet aspotassium

• 10 mg (genericonly)
• 20 mg
• 40 mg
• 80 mg

Dosage Considerations – Should be Given as Follows:

Hyperlipidemia, Primary Prevention of Coronary Events, Secondary Prevention of Cardiovascular Events

• May be beneficial forprophylaxisof cardiovascular events in at-risk patients, even if patients have normal levels of cholesterol
• 10-40 mg orally once/day; not to exceed 80 mg/day
• Initiate with 10 mg at bedtime if taking immunosuppressants likecyclosporineconcurrently; not to exceed 20 mg/day
• Limit maximum to 40 mg/day if taking concurrently withclarithromycin
• Dose adjustments should be made at intervals of 4 weeks or more; individualize dosing according to baseline LDL cholesterol levels

HeterozygousFamilialHypercholesterolemia

• Children 8-13 years: 20 mg orally once/day
• Children 14-18 years: 40 mg orally once/day
• Co-administration with cyclosporine: Initiate with 10 mg at bedtime; not to exceed 20 mg/day
• Limit maximum to 40 mg/day if taking concurrently with clarithromycin
• Dose adjustments should be made at intervals of 4 weeks or more; individualize dosing according to baseline LDL cholesterol levels

Overdose management

• Adverse drug reactions from overdose may includeperipheral neuropathy, diarrhea, increased potassium,myopathy,rhabdomyolysis,acute renal failure, elevated liver function tests (LFTs), eyelensopacities
• Treatment is supportive

Dosing Modifications

Renal impairment

• 10 mg orally once/day initially

Hepatic impairment

• Contraindicated if activeliver diseaseor unexplained persistent elevations of serum transaminases

Side effects associated with use of Pravastatin, include the following:

• Nausea/vomiting
• Diarrhea
• Headache
• Chest pain
• Fatigue
• Rash
• Cough
• Heartburn
• Flulike symptoms
• Muscle pain

Other side effects of pravastatin include:

• Muscle disease
• Musclewasting(rhabdomyolysis)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Severe interactions of pravastatin include:
  • gemfibrozil
  • red yeast rice
• Serious Interactions of pravastatin include:
  • colchicine
  • cyclosporine
  • eltrombopag
  • eluxadoline
  • fenofibrate
  • fenofibrate micronized
  • fenofibric acid
  • gemfibrozil
  • ivacaftor
  • niacin
• Pravastatin has moderate interactions with at least 53 different drugs.
• Mild Interactions of pravastatin include:
  • coenzyme Q10
  • colestipol
  • isradipine
  • orlistat
  • ruxolitinib
  • trazodone

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

• This medication contains pravastatin. Do not take Pravachol if you are allergic to pravastatin or any ingredients contained in this drug
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Hypersensitivity
• Active liver disease, elevated LFTs
• Pregnancy, lactation

Effects of Drug Abuse

• No information provided

Short-Term Effects

• See "What Are Side Effects Associated with Using Pravastatin?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Pravastatin?"

Cautions

• Non-serious and reversiblecognitiveside effects may occur
• Increased blood sugar andglycosylated hemoglobin(HbA1c) levels reported with statin intake
• Risk of rhabdomyolysis; predisposing factors include advanced age (65 years or older), uncontrolledhypothyroidism, and renal impairment; discontinue if myopathy develops
• Rare reports of immune-mediated necrotizing myopathy (IMNM), characterized by increased serumcreatinekinase that persists despite discontinuation of statin
• Maximum response 4-6 weeks
• Recent liver disease, symptoms of liver disease
• Heavy alcohol use
• Use caution with other drugs that increase risk of myopathy (e.g., fibrates)
• 排除继发性hyperlipedemia before initiating therapy
• Monitor liver function periodically
• Postmarketing Reports:
  • Musculoskeletal: Polymyositis
  • Respiratory:Interstitiallung disease
  • Psychiatric: Nightmare

Pregnancy and Lactation

• Administer pravastatin to women of childbearing age only when patients are highly unlikely to conceive and have been informed of potential hazards; if the patient becomes pregnant while taking this class of drug, discontinue therapy immediately and apprise patient of the potential hazard to a fetus
• Pravastatin enters breast milk; its use is contraindicated while breastfeeding