Pravastatin

DEA Class; Rx

Common Brand Names; Pravachol

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

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