pravastatin (Rx)

Brand and Other Names:Pravachol
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablets

  • 10mg
  • 20mg
  • 40mg
  • 80mg

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

May be beneficial for prophylaxis of cardiovascular events in at-risk patients, even if patients have normal levels of cholesterol.

10-40 mg PO qDay; not to exceed 80 mg/day

Initiate with 10 mg qHS if taking immunosuppressants like cyclosporine concurrently; 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

Dosing Considerations

Overdose management

  • Adverse drug reactions from overdose may include peripheral neuropathy, diarrhea, increased K+, myopathy, rhabdomyolysis, acute renal failure, elevated LFTs, eye lens opacities
  • Treatment is supportive

Dosing Modifications

Renal impairment

  • 10 mg PO qDay initially

Hepatic impairment

  • Contraindicated if active liver disease or unexplained persistent elevations of serum transaminases

Dosage Forms & Strengths

tablets

  • 10mg (generic only)
  • 20mg
  • 40mg
  • 80mg

Heterozygous Familial Hypercholesterolemia

8-13 years: 20 mg PO qDay

14-18 years: 40 mg PO qDay

Coadministration with cyclosporine: Initiate with 10 mg qHS; 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

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Interactions

Interaction Checker

and pravastatin

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            Contraindicated (2)

            • gemfibrozil

              gemfibrozil increases toxicity of pravastatin by Other (see comment). Contraindicated. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • red yeast rice

              pravastatin, red yeast rice. Either increases toxicity of the other by pharmacodynamic synergism. Contraindicated. May increase creatine kinase levels and increase risk of myopathy or rhabdomyolysis; red yeast rice contains monocolin K (reportedly identical to lovastatin).

            Serious - Use Alternative (13)

            • colchicine

              colchicine, pravastatin. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased risk of rhabdomyolysis (incl a fatality).

            • cyclosporine

              cyclosporine increases toxicity of pravastatin by Other (see comment). Avoid or Use Alternate Drug. Comment: Cyclosporine, an OATP1B1 inhibitor, with pravastatin, OATP1B1 substrate, may increase risk of myopathy. Initiate pravastatin dose at 10 mg/day and not to exceed 20 mg/day in patients who are also receiving cyclosporine.

            • eltrombopag

              eltrombopag increases toxicity of pravastatin by Other (see comment). Avoid or Use Alternate Drug. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • eluxadoline

              pravastatin increases levels of eluxadoline by decreasing metabolism. Avoid or Use Alternate Drug. Decrease eluxadoline dose to 75 mg PO BID if coadministered with OATP1B1 inhibitors. .

            • fenofibrate

              fenofibrate, pravastatin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Fenofibrate may further increase risk for rhabdomyolysis when added to optimal statin regimen to further decrease TG and increase HDLs.

            • fenofibrate micronized

              fenofibrate micronized, pravastatin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Fenofibrate may further increase risk for rhabdomyolysis when added to optimal statin regimen to further decrease TG and increase HDLs.

            • fenofibric acid

              fenofibric acid, pravastatin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Fenofibrate may further increase risk for rhabdomyolysis when added to optimal statin regimen to further decrease TG and increase HDLs.

            • gemfibrozil

              gemfibrozil, pravastatin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Gemfibrozil may further increase risk for rhabdomyolysis when added to optimal statin regimen to further decrease TG and increase HDLs.

            • lasmiditan

              lasmiditan increases levels of pravastatin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

            • lonafarnib

              pravastatin will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.

            • niacin

              niacin, pravastatin. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased risk of rhabdomyolysis (>1 g/day niacin).

            • sotorasib

              sotorasib will decrease the level or effect of pravastatin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.

            • tepotinib

              tepotinib will increase the level or effect of pravastatin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

            Monitor Closely (67)

            • apalutamide

              apalutamide will decrease the level or effect of pravastatin by increasing elimination. Use Caution/Monitor. Apalutamide weakly induces OATP1B1 and may decrease systemic exposure of drugs that are OATP1B1 substrates.

            • atogepant

              pravastatin will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • avapritinib

              pravastatin will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • axitinib

              pravastatin increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • bempedoic acid

              bempedoic acid increases levels of pravastatin by unknown mechanism. Modify Therapy/Monitor Closely. Avoid concomitant use with pravastatin dose 40 mg.

            • berotralstat

              berotralstat will increase the level or effect of pravastatin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.

            • bosutinib

              bosutinib increases levels of pravastatin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • carbamazepine

              carbamazepine increases toxicity of pravastatin by Other (see comment). Modify Therapy/Monitor Closely. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • caspofungin

              caspofungin increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • cholestyramine

              cholestyramine decreases levels of pravastatin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • clarithromycin

              clarithromycin increases levels of pravastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor for myopathy; do not exceed pravastatin dose of 40 mg/day when coadministered with clarithromycin .

              clarithromycin increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • clotrimazole

              clotrimazole increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • cobicistat

              cobicistat will increase the level or effect of pravastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. For HMG-CoA reductase inhibitors that are not contraindicated with cobicistat, start with the lowest recommended dose and titrate while monitoring for safety.

            • crizotinib

              crizotinib increases levels of pravastatin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • daptomycin

              pravastatin, daptomycin. Either increases toxicity of the other by Other (see comment). Modify Therapy/Monitor Closely. Comment: Coadministration of daptomycin with HMG-CoA reductase inhibitors may increase CPK levels and risk for myopathy; consider temporary suspension of HMG-CoA reductase inhibitors during daptomycin therapy.

            • darunavir

              darunavir increases levels of pravastatin by unknown mechanism. Use Caution/Monitor.

              darunavir will increase the level or effect of pravastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. For HMG-CoA reductase inhibitors that are not contraindicated with darunavir, start with the lowest recommended dose and titrate while monitoring for safety.

            • elagolix

              elagolix will increase the level or effect of pravastatin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • eliglustat

              eliglustat increases effects of pravastatin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the P-gp substrate and titrate to clinical effect.

            • encorafenib

              encorafenib will increase the level or effect of pravastatin by Other (see comment). Modify Therapy/Monitor Closely. Encorafenib (a OATP1B1, OATP1B3, and BCRP inhibitor) may increase the concentration and toxicities of OATP1B1, OATP1B3, and BCRP substrates. Closely monitor for signs and symptoms of increased exposure and consider adjusting the dose of these substrates. Screen reader support enabled.

            • erythromycin base

              erythromycin base increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • erythromycin lactobionate

              erythromycin lactobionate increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • erythromycin stearate

              erythromycin stearate increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • finerenone

              pravastatin will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.

            • flibanserin

              pravastatin will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.

            • fostemsavir

              fostemsavir will increase the level or effect of pravastatin by Other (see comment). Modify Therapy/Monitor Closely. Fostemsavir inhibits OATP1B1/3 transporter. If possible, avoid coadministration or modify dose of OATP1B1/3 substrates coadministered with fostemsavir. Use lowest possible starting dose for statins and monitor for associated adverse events.

            • glecaprevir/pibrentasvir

              glecaprevir/pibrentasvir increases levels of pravastatin by Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased statin concentrations resulting from OATP1B1 inhibition may increase risk of myopathy, including rhabdomyolysis. If coadministered, reduce pravastatin dose by 50%.

            • glyburide

              glyburide increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • indinavir

              indinavir increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • isavuconazonium sulfate

              pravastatin will increase the level or effect of isavuconazonium sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • istradefylline

              istradefylline will increase the level or effect of pravastatin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.

            • ivacaftor

              ivacaftor increases levels of pravastatin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Ivacaftor and its M1 metabolite has the potential to inhibit P-gp; may significantly increase systemic exposure to sensitive P-gp substrates with a narrow therapeutic index.

              pravastatin increases levels of ivacaftor by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor when coadministered with weak CYP3A4 inhibitors .

            • ketoconazole

              ketoconazole increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • lanthanum carbonate

              lanthanum carbonate decreases levels of pravastatin by cation binding in GI tract. Use Caution/Monitor. Administer statin at least 2 hr before or 2 hr after lanthanum. Monitor serum concentrations.

            • lemborexant

              pravastatin will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.

            • letermovir

              letermovir increases levels of pravastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of letermovir with pravastatin may require a dosage reduction. Closely monitor patients for myopathy and rhabdomyolysis. When letermovir is coadministered with cyclosporine, the dose of pravastatin should not exceed 20 mg PO qDay.

            • levoketoconazole

              levoketoconazole increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • lomitapide

              pravastatin increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lomitapide dose should not exceed 30 mg/day.

              lomitapide increases levels of pravastatin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing dose when used concomitantly with lomitapide.

            • lonafarnib

              lonafarnib will increase the level or effect of pravastatin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.

            • mesterolone

              mesterolone increases toxicity of pravastatin by decreasing metabolism. Use Caution/Monitor. Risk of rhabdomyolysis (theoretical interaction based on case reports of combination of danazol and >20 mg/day lovastatin).

            • metyrapone

              metyrapone increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • midazolam intranasal

              pravastatin will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.

            • mifepristone

              mifepristone increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • mipomersen

              mipomersen increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: Both drugs have potential to increase hepatic enzymes; monitor LFTs; OATP1B1 inhibitors may increase risk of myopathy.

            • nelfinavir

              nelfinavir increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)

              ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC) will increase the level or effect of pravastatin by decreasing hepatic clearance. Modify Therapy/Monitor Closely. Maximum daily dose of pravastatin should be limited to 40 mg/day

              ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC) increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • paclitaxel

              paclitaxel increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • pazopanib

              pazopanib increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • pioglitazone

              pioglitazone increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • ponatinib

              ponatinib increases levels of pravastatin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              ponatinib increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • ranolazine

              ranolazine increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • repaglinide

              repaglinide increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • rifampin

              rifampin increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • ritonavir

              ritonavir increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • rosiglitazone

              rosiglitazone increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • sacubitril/valsartan

              sacubitril/valsartan increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

              pravastatin will increase the level or effect of sacubitril/valsartan by Other (see comment). Use Caution/Monitor. The results from an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1; coadministration with OATP1B1 inhibitors may increase valsartan systemic exposure

            • saquinavir

              saquinavir increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • sarecycline

              sarecycline will increase the level or effect of pravastatin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.

            • stiripentol

              stiripentol will increase the level or effect of pravastatin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.

            • tacrolimus

              tacrolimus increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • telmisartan

              telmisartan increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • tenapanor

              tenapanor decreases levels of pravastatin by Other (see comment). Use Caution/Monitor. Comment: Tenapanor (an inhibitor of intestinal uptake transporter, OATP2B1) may reduce the exposure of OATP2B1 substrates.

            • tinidazole

              pravastatin will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tucatinib

              tucatinib will increase the level or effect of pravastatin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

            • valsartan

              pravastatin will increase the level or effect of valsartan by Other (see comment). Use Caution/Monitor. The results from an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1; coadministration with OATP1B1 inhibitors may increase valsartan systemic exposure

              valsartan increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • vemurafenib

              vemurafenib increases levels of pravastatin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • warfarin

              pravastatin increases effects of warfarin by anticoagulation. Use Caution/Monitor. Dosage adjustment of anticoagulant based in INR and clinical response may be necessary.

            Minor (8)

            • coenzyme Q10

              pravastatin decreases levels of coenzyme Q10 by unspecified interaction mechanism. Minor/Significance Unknown.

            • colestipol

              colestipol decreases levels of pravastatin by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

            • isradipine

              isradipine decreases levels of pravastatin by unknown mechanism. Minor/Significance Unknown.

            • orlistat

              orlistat increases effects of pravastatin by pharmacodynamic synergism. Minor/Significance Unknown.

            • ruxolitinib

              pravastatin will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • ruxolitinib topical

              pravastatin will increase the level or effect of ruxolitinib topical by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • trazodone

              trazodone increases levels of pravastatin by unspecified interaction mechanism. Minor/Significance Unknown.

            • voclosporin

              voclosporin will increase the level or effect of pravastatin by Other (see comment). Minor/Significance Unknown. Information suggests voclosporin (an OATP1B1 inhibitor) may increase in the concentration of OATP1B1 substrates is possible. Monitor for adverse reactions of OATP1B1 substrates when coadministered with voclosporin.

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            Adverse Effects

            1-10%

            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

            Postmarketing Reports

            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)

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            Warnings

            Contraindications

            Hypersensitivity

            Active liver disease elevated LFTs, decompensated cirrhosis

            Cautions

            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

            Hepatic dysfunction

            • Use caution in recent liver disease, symptoms of liver disease; discontinue therapy if markedly elevated CK levels occur or myopathy is diagnosed or suspected; muscle symptoms and CK increases may resolve if therapy is discontinued
            • Increases in serum transaminases reported with therapy; in most cases, these changes appeared soon after initiation, were transient, were not accompanied by symptoms, and resolved or improved on continued therapy or after a brief interruption in therapy
            • Persistent increases to more than three times the ULN in serum transaminases have occurred; marked persistent increases of hepatic transaminases have also occurred; there have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking this therapy and other statins
            • Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury
            • Consider liver enzyme testing before therapy initiation and when clinically indicated thereafter
            • Therapy is contraindicated in patients with acute liver failure or decompensated cirrhosis; if serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue therapy

            Immune-mediated necrotizing myopathy

            • Immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, reported with statin use, including reports of recurrence when the same or a different statin was administered
            • IMNM is characterized by muscle biopsy showing necrotizing myopathy without significant inflammation improvement with immunosuppressive agents, proximal muscle weakness, and elevated serum creatine kinase, which persist despite discontinuation of statin treatment
            • Treatment with immunosuppressive agents may be required
            • Advice all patients starting therapy or whose dose is being increased, about the risk of myopathy, including rhabdomyolysis
            • Patients should report promptly any unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing therapy; additional neuromuscular and serologic testing may be necessary
            • Therapy should be discontinued immediately if myopathy is diagnosed or suspected
            • Discontinue therapy if markedly elevated creatine kinase (CK) levels occur or if myopathy diagnosed or suspected
            • Therapy should be temporarily withheld in any patient experiencing an acute or serious condition predisposing to development of renal failure secondary to rhabdomyolysis, eg, sepsis; hypotension; dehydration; major surgery; trauma; severe metabolic, endocrine, and electrolyte disorders; or uncontrolled epilepsy
            • Consider risk of IMNM carefully prior to initiation of a different statin
            • If therapy is initiated with a different statin, monitor for signs and symptoms of IMNM
            • Additional neuromuscular and serologic testing may be necessary
            • Treatment with immunosuppressive agents may be required
            • Consider risk of IMNM carefully prior to initiation of a different statin
            • If therapy is initiated with a different statin, monitor for signs and symptoms of IMNM

            Drug interaction overview

            • Not recommended in patients taking gemfibrozil; there are pravastatin dosage restrictions for patients taking cyclosporin and select macrolide antibiotics
            • The following drugs when used concomitantly with pravastatin may increase risk of myopathy and rhabdomyolysis, niacin, fibrates, and colchicine
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            Pregnancy & Lactation

            Pregnancy

            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

            Treatment of hyperlipidemia is not generally necessary during pregnancy; atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on outcome of long-term therapy of primary hyperlipidemia for most patients

            Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations

            Published data from prospective and retrospective observational cohort studies with use in pregnant women are insufficient to determine if there is drug-associated risk of miscarriage

            Animal data

            • In animal reproduction studies, no evidence of fetal malformations was seen in pregnant rats or rabbits orally administered pravastatin during period of organogenesis at doses that resulted in 10 times and 120 times, respectively, the human exposure at maximum recommended human dose (MRHD) of 80 mg/day, based on body surface area (mg/m2)
            • An imbalance in some fetal skeletal variations increased offspring mortality, and developmental delays occurred when pregnant rats were exposed to 10 times to 12 times MRHD during organogenesis to parturition

            Contraception

            Advise females of reproductive potential to use effective contraception during treatment

            FDA MedWatch

            • On July 20, 2021, the FDA request to remove the contraindication against HMG-CoA reductase inhibitors in pregnant females
            • Despite the changes, most females found to be pregnant should stop therapy

            Lactation

            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

            Statins, decrease cholesterol synthesis and possibly synthesis of other biologically active substances derived from cholesterol and may cause harm to breastfed infant

            Because of potential for serious adverse reactions in breastfed infant, based on mechanism of action, advise patients that breastfeeding is not recommended during treatment

            FDA MedWatch

            • On July 20, 2021, the FDA request to remove the contraindication against HMG-CoA reductase inhibitors in pregnant females
            • Breastfeeding is still not recommended if taking statins; drug may still pass through milk and pose a risk breastfed children
            • For patients with lower risk, temporarily stop statin therapy until breastfeeding ends
            • Patients who are at high risk of heart attack or stroke who require statins after delivery should not breastfeed and should use alternatives such as infant formula

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            HMG-CoA reductase inhibitor; inhibits the rate-limiting step in cholesterol biosynthesis by competitively inhibiting HMG-CoA reductase

            Absorption

            Bioavailability: 17%

            Onset: 2 weeks

            Peak effect: 4 weeks

            Peak serum time: 1-1.5 hr

            Distribution

            Protein bound: 43-55%

            Vd: 0.46 L/kg

            Metabolism

            Undergoes extensive first-pass extraction by liver

            Metabolites: 3-alpha-hydroxy isomer and 3-alpha, 5-beta, 6-beta trihydroxy metabolite (inactive)

            Elimination

            Half-life: 2.6-3.2 hr

            Excretion: Feces (71%); urine (<20%)

            Pharmacogenomics

            SLCO1B1 (OATP1B1) CC genotype significantly increases AUCs of parent drug and metabolites compared with the CT or TT genotypes

            This polymorphism is proposed to reduce transport into the liver, the main site of statin metabolism and elimination, resulting in elevated plasma concentrations

            SLCO1B1 polymorphism is thought to have a lesser effect on the more hydrophilic statins (eg, rosuvastatin, fluvastatin), compared with more those that are more lipophilic (eg, atorvastatin, pravastatin, simvastatin)

            Other genetic polymorphisms of elimination (eg, CYP450, P-glycoprotein) for each individual drug must also be considered to explain variability for statin clearance among patients that exhibit SCLO1B1 polymorphism

            SLCO1B1 CC genotype is most common in Caucasians and Asians (15%)

            Risk of myopathy is 2.6- to 4.3-fold higher if the C allele is present and 16.9-fold higher in CC homozygotes compared with TT homozygotes

            Genetic testing laboratories

            • Optivia Biotechnology, Inc (http://optiviabio.com)
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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
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            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            pravastatin oral

            PRAVASTATIN - ORAL

            (PRAV-uh-stat-in)

            COMMON BRAND NAME(S): Pravachol

            USES: Pravastatin is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. It belongs to a group of drugs known as "statins." It works by reducing the amount of cholesterol made by the liver. Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks.In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

            HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually once daily.The dosage is based on your medical condition, response to treatment, age, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take pravastatin at least 1 hour before or at least 4 hours after taking these medications. These products can react with pravastatin, preventing its full absorption.Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. Keep taking this medication even if you feel well. Most people with high cholesterol or triglycerides do not feel sick.It is very important to continue to follow your doctor's advice about diet and exercise. It may take up to 4 weeks before you get the full benefit of this drug.

            SIDE EFFECTS: Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very small number of people taking pravastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor.Rarely, statins may cause or worsen diabetes. Talk to your doctor about the benefits and risks.This drug may rarely cause muscle problems (which can rarely lead to very serious conditions called rhabdomyolysis and autoimmune myopathy). Tell your doctor right away if you develop any of these symptoms during treatment and if these symptoms last after your doctor stops this drug: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), signs of kidney problems (such as change in the amount of urine).This medication may rarely cause liver problems. Tell your doctor right away if you develop symptoms of liver problems, including: nausea/vomiting that doesn't stop, yellowing eyes/skin, dark urine, stomach/abdominal pain.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking pravastatin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with pravastatin. Ask your doctor or pharmacist for more information.Older adults may be more sensitive to the side effects of this drug, especially muscle problems.During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: See also How To Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: colchicine, daptomycin, gemfibrozil.Do not take any red yeast rice products while you are taking pravastatin because some red yeast rice products may also contain a statin called lovastatin. Taking pravastatin and red yeast rice products together can increase your risk of serious muscle and liver problems.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.Lab and/or medical tests (such as blood cholesterol/triglyceride levels, liver function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised April 2022. Copyright(c) 2022 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.