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Pravastatin

    DEA Class; Rx

    Common Brand Names; Pravachol

    • Lipid-Lowering Agents, Statins; 
    • HMG-CoA Reductase Inhibitors

    Oral HMG Co-A reductase inhibitor (statin)
    Used for hypercholesterolemia, hyperlipoproteinemia, hypertriglyceridemia, primary or secondary prevention of coronary heart disease, and for stroke prophylaxis in adults; used for heterozygous familial hypercholesterolemia in adult and pediatric patients 8 years and older
    Hepatotoxicity, myopathy, rhabdomyolysis, and immune-mediated necrotizing myopathy have occurred with statin therapy

    Indicated for the treatment of hypercholesterolemia, including heterozygous familial hypercholesterolemia, hyperlipidemia, hyperlipoproteinemia, or hypertriglyceridemia, as an adjunct to dietary control.

    For myocardial infarction prophylaxis or stroke prophylaxis.
    For cerebral vasospasm prophylaxis after aneurysmal subarachnoid hemorrhage.

    Hypersensitivity

    Active liver disease elevated LFTs, decompensated cirrhosis

    Nausea/vomiting (7%)

    Diarrhea (6%)

    Headache (2-6%)

    Chest pain (4%)

    Fatigue (4%)

    Rash (4%)

    Cough (3%)

    Heartburn (3%)

    Flulike symptoms (2%)

    Myalgia (2%)

    Frequency Not Defined

    Myopathy

    Rhabdomyolysis

    Musculoskeletal: Polymyositis

    Respiratory: Interstitial lung disease

    Psychiatric: Nightmare

    Nervous system: Dysfunction of certain cranial nerves (including alteration of taste, impairment of extraocular movement, facial paresis), peripheral nerve palsy; rare postmarketing reports of cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use; cognitive impairment was generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks)

    Reduced cholesterol synthesis could theoretically lead to a reduction in gonadal or adrenal steroid hormone production; data is inconsistent; evaluate and treat as clinically indicated patients with signs or symptoms of endocrine dysfunction; use caution when coadministering with concomitant medication that could reduce steroid hormone levels, including ketoconazole, cimetidine, or spironolactone

    Fatal and nonfatal hepatic failure reported with use; interrupt therapy if symptoms of hepatotoxicity occur, including jaundice or hyperbilirubinemia; obtain liver enzyme tests at baseline and as clinically indicated; alcohol may increase hepatic effects; patient should avoid excessive intake of alcohol

    Nonserious and reversible cognitive side effects may occur

    Increased blood sugar and glycosylated hemoglobin (HbA1c) levels reported with statin intake; optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices

    Risk of rhabdomyolysis; predisposing factors include advanced age (≥65), uncontrolled hypothyroidism, and renal impairment; discontinue if myopathy develops

    Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever

    Max response 4-6 weeks

    Temporarily discontinue therapy in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis, eg, sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy

    Rule out secondary causes of hyperlipidemia before initiating therapy

    Discontinue therapy when pregnancy recognized; alternatively, consider ongoing therapeutic needs of individual patient; therapy decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, therapy may cause fetal harm when administered to pregnant patients based on mechanism of action

    Based on one lactation study in published literature, pravastatin is present in human milk; there is no available information on effects of drug on breastfed infant or effects of drug on milk production

    Adults

    80 mg/day PO.

    Geriatric

    80 mg/day PO.

    Adolescents

    14 to 18 years: 40 mg/day PO is the FDA-approved maximum dose; however, higher doses were reported in a small study (exact maximum dosage for this age group was not defined, overall maximum for the study was 60 mg/day).
    13 years: 20 mg/day PO is the FDA-approved maximum dose; however, higher doses were reported in a small study (exact maximum dosage for this age was not defined, overall maximum for the study was 60 mg/day).

    Children

     8 to 12 years: 20 mg/day PO is the FDA-approved maximum dose; however, higher doses were reported in a small study (exact maximum dosage for this age group was not defined, overall maximum for the study was 60 mg/day).
    4 to 7 years: Safety and efficacy have not been established; however, doses of 10 mg/day PO or more were reported in a small study (exact maximum dosage for this age group was not defined, overall maximum for the study was 60 mg/day).
    1 to 3 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Pravastatin sodium

    tablets

    • 10mg
    • 20mg
    • 40mg
    • 80mg