rosuvastatin (Rx)

Brand and Other Names:Crestor, Ezallor Sprinkle
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet (Crestor)

  • 5mg
  • 10mg
  • 20mg
  • 40mg

capsule (Ezallor Sprinkle)

  • 5mg
  • 10mg
  • 20mg
  • 40mg

Hypercholesterolemia

Indicated as adjunctive therapy to diet in adults with hypertriglyceridemia, hyperlipidemia, mixed dyslipidemia, or primary dysbetalipoproteinemia

Tablets and capsules: 10-20 mg PO qDay; not to exceed 40 mg/day

After initiation or upon titration, analyze lipid levels within 2-4 weeks and adjust dosage accordingly

Homozygous Familial Hypercholesterolemia

Indicated as adjunctive therapy in adults with homozygous familial hypercholesterolemia

Tablets and capsules: 20 mg PO qDay; not to exceed 40 mg/day

After initiation or upon titration, analyze lipid levels within 2-4 weeks and adjust dosage accordingly

Slowing Progression of Atherosclerosis

Indicated as adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower total cholesterol and LDL cholesterol to target levels

Tablets and capsules: 10-20 mg PO qDay; not to exceed 40 mg/day

After initiation or upon titration, analyze lipid levels within 2-4 weeks and adjust dosage accordingly

Primary Prevention

Indicated to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in individuals without clinically evident coronary heart disease with risk factors

Risk factors

  • Age (>50 years in men; >60 years in women), AND
  • Elevated high-sensitivity C-reactive protein level (>2 mg/L), AND
  • Presence of ≥1 additional cardiovascular risk factor (eg, high blood pressure, low HDL cholesterol, smoking, family history of premature heart disease)

Tablets: 10-20 mg PO qDay; not to exceed 40 mg/day

Dosage range 5-40 mg/day

Dosage Modifications

Dosing in Asian patients

  • Consider starting at 5 mg PO qDay, owing to increased rosuvastatin plasma concentrations
  • May increase up to 20 mg/day if patients are not adequately controlled

Dosage adjustment for rosuvastatin with concomitant therapy

  • Coadministered with cyclosporine: Do not exceed rosuvastatin 5 mg qDay
  • Coadministered with gemfibrozil: Avoid use; if use cannot be avoided, initiate rosuvastatin at 5 mg qDay; not to exceed 10mg/day
  • Coadministered with atazanavir and ritonavir, lopinavir and ritonavir, or simeprevir: Initiate rosuvastatin at 5 mg qDay; not to exceed 10mg/day

Renal impairment

  • Mild or moderate (CrCl ≥30 mL/min/1.73m²): No dosage adjustment necessary
  • Severe (CrCl <30 mL/min/1.73m²) and not on hemodialysis: Decrease starting dose to 5 mg PO qDay; not to exceed 10 mg/day

Hepatic impairment

  • Active liver disease: Contraindicated
  • Chronic alcoholic liver disease: Use with caution; known to increase rosuvastatin exposure

Dosing Considerations

Initiating therapy or switching from another HMG-CoA reductase inhibitor: Start on appropriate dose and then titrate based on patient’s response and individualized goal of therapy

Limitation of use: Not studied in Fredrickson type I and V dyslipidemias

Dosage Forms & Strengths

tablet (Crestor)

  • 5mg
  • 10mg
  • 20mg
  • 40mg

Familial Hypercholesterolemia

Heterozygous

  • Adjunctive therapy to diet to reduce total cholesterol, LDL cholesterol, and ApoB levels in children and adolescents (8-17 years) with heterozygous familial hypercholesterolemia after an inadequate response to diet therapy
  • Inadequate response defined as when the following findings are present: LDL cholesterol >190 mg/dL OR >160 mg/dL with a positive family history of premature cardiovascular disease (CVD) or ≥2 CVD risk factors
  • <8 years: Safety and efficacy not established
  • 8 to <10 years: 5-10 mg PO qDay
  • 10-17 years: 5-20 mg PO qDay; may adjust dose at intervals of at least 4 wk; not to exceed 20 mg/day

Homozygous

  • Adjunctive therapy to diet to reduce LDL cholesterol, total cholesterol, non-HDL cholesterol, and ApoB in children and adolescents (7-17 year) with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (eg, LDL apheresis)
  • <7 years: Safety and efficacy not established
  • 7-17 years: 20 mg PO qDay

Dosage Modifications

Dosing in Asian patients

  • Consider starting at 5 mg PO qDay, owing to increased rosuvastatin plasma concentrations
  • May increase up to 20 mg/day if patients are not adequately controlled

Dosage adjustment for rosuvastatin with concomitant therapy

  • Coadministered with cyclosporine: Do not exceed rosuvastatin 5 mg qDay
  • Coadministered with gemfibrozil: Avoid use; if use cannot be avoided, initiate rosuvastatin at 5 mg qDay; not to exceed 10mg/day
  • Coadministered with atazanavir and ritonavir, lopinavir and ritonavir, or simeprevir: Initiate rosuvastatin at 5 mg qDay; not to exceed 10mg/day

Renal impairment

  • Mild or moderate (CrCl ≥30 mL/min/1.73m²): No dosage adjustment necessary
  • Severe (CrCl <30 mL/min/1.73m²) and not on hemodialysis: Decrease starting dose to 5 mg PO qDay; not to exceed 10 mg/day

Hepatic impairment

  • Active liver disease: Contraindicated
  • Chronic alcoholic liver disease: Use with caution; known to increase rosuvastatin exposure

Dosing Considerations

Initiating therapy or switching from another HMG-CoA reductase inhibitor: Start on appropriate dose and then titrate based on patient’s response and individualized goal of therapy

Limitation of use: Not studied in Fredrickson type I and V dyslipidemias

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Interactions

Interaction Checker

and rosuvastatin

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    Interactions Found

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      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (2)

            • gemfibrozil

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

            • red yeast rice

              rosuvastatin, 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 (20)

            • atazanavir

              atazanavir increases levels of rosuvastatin by unknown mechanism. Avoid or Use Alternate Drug. Potential for increased toxicity. Use alternatives if available. Increased risk of myopathy and rhabdomyolysis. Limit rosuvastatin dose to 10 mg/day; ritonavir component of atazanavir/ritonavir regimen decreases rosuvastatin metabolism.

            • clarithromycin

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

            • colchicine

              colchicine, rosuvastatin. 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 rosuvastatin by Other (see comment). Avoid or Use Alternate Drug. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • darolutamide

              darolutamide will increase the level or effect of rosuvastatin by Other (see comment). Avoid or Use Alternate Drug. Darolutamide is a BCRP inhibitor. Avoid coadministration with BCRP inhibitors. If use is unavoidable, closely monitor for adverse reactions; dose of rosuvastatin should not exceed 5 mg once daily (refer BCRP substrate prescribing information).

            • eltrombopag

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

            • fenofibrate

              fenofibrate, rosuvastatin. 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, rosuvastatin. 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, rosuvastatin. 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, rosuvastatin. 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. If concomitant use cannot be avoided, initiate rosuvastatin at 5 mg once daily; the dose of rosuvastatin should not exceed 10 mg once daily.

            • indinavir

              indinavir increases toxicity of rosuvastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Risk of myopathy and rhabdomyolysis increased when atorvastatin coadministered with CYP3A4 inhibitors; use lowest statin dose possible.

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

            • ketoconazole

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

            • lasmiditan

              lasmiditan increases levels of rosuvastatin by Other (see comment). Avoid or Use Alternate Drug. Comment: Lasmiditan inhibits BCRP in vitro. Avoid coadministration of lasmiditan with BCRP substrates.

            • lopinavir

              lopinavir increases levels of rosuvastatin by decreasing metabolism. Avoid or Use Alternate Drug. Limit rosuvastatin dose to 10 mg/day; ritonavir component of lopinavir/ritonavir decreases rosuvastatin metabolism.

            • mifepristone

              mifepristone increases toxicity of rosuvastatin by Other (see comment). Avoid or Use Alternate Drug.

            • nelfinavir

              nelfinavir increases toxicity of rosuvastatin by Other (see comment). Avoid or Use Alternate Drug.

            • niacin

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

            • ombitasvir/paritaprevir/ritonavir & dasabuvir

              ombitasvir/paritaprevir/ritonavir & dasabuvir increases toxicity of rosuvastatin by Other (see comment). Avoid or Use Alternate Drug.

            • ritonavir

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

            • saquinavir

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

            Monitor Closely (54)

            • acalabrutinib

              acalabrutinib increases levels of rosuvastatin by Other (see comment). Use Caution/Monitor. Comment: Acalabrutinib may increase exposure to coadministered BCRP substrates by inhibition of intestinal BCRP.

            • aluminum hydroxide

              aluminum hydroxide decreases levels of rosuvastatin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

            • apalutamide

              apalutamide will decrease the level or effect of rosuvastatin by increasing elimination. Use Caution/Monitor. Apalutamide induces UGT and weakly induces BCRP and OATP1B1. Drugs that are eliminated via these pathways may have decreased systemic exposure if coadministered with apalutamide.

            • atazanavir

              atazanavir increases levels of rosuvastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Potential for increased toxicity. Use alternatives if available. Increased risk of myopathy and rhabdomyolysis. .

            • calcium carbonate

              calcium carbonate decreases levels of rosuvastatin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

            • carbamazepine

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

            • caspofungin

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

            • cholestyramine

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

            • clotrimazole

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

            • cobicistat

              cobicistat will increase the level or effect of rosuvastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. For HMG-CoA reductase inhibitors that are not contraindicated with cobicistat, dose should not exceed 20 mg/day.

            • crofelemer

              crofelemer increases toxicity of rosuvastatin by Other (see comment). Use Caution/Monitor. Comment: Crofelemer has the potential to inhibit transporters MRP2 and OATP1A2 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed.

            • daptomycin

              rosuvastatin, 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 will increase the level or effect of rosuvastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. For HMG-CoA reductase inhibitors that are not contraindicated with cobicistat, dose should not exceed 20 mg/day.

            • dasabuvir

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

            • elagolix

              elagolix decreases levels of rosuvastatin by unknown mechanism. Modify Therapy/Monitor Closely. Consider increasing the dose of rosuvastatin.

            • elbasvir/grazoprevir

              elbasvir/grazoprevir increases levels of rosuvastatin by unknown mechanism. Modify Therapy/Monitor Closely. If coadministered, do not exceed rosuvastatin dose of 10 mg/day.

            • eluxadoline

              eluxadoline increases levels of rosuvastatin by decreasing metabolism. Use Caution/Monitor. Eluxadoline may increase the systemic exposure of coadministered OATP1B1 or BCRP substrates. Potential for increased risk of myopathy/rhabdomyolysis with rosuvastatin. Decrease rosuvastatin to lowest effective dose.

            • erythromycin base

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

            • erythromycin ethylsuccinate

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

            • erythromycin lactobionate

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

            • erythromycin stearate

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

            • eslicarbazepine acetate

              eslicarbazepine acetate will decrease the level or effect of rosuvastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Dose adjustment of some statins may be needed if a clinically significant change in lipids is noted.

            • fostamatinib

              fostamatinib will increase the level or effect of rosuvastatin by decreasing metabolism. Use Caution/Monitor. Concomitant use of fostamatinib may increase concentrations of BCRP substrate drugs. Monitor for toxicities of BCRP substrate drug that may require dosage reduction when given concurrently with fostamatinib.

            • fostemsavir

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

            • glecaprevir/pibrentasvir

              glecaprevir/pibrentasvir increases levels of rosuvastatin 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, do not exceed 10 mg/day of rosuvastatin.

            • glyburide

              glyburide increases toxicity of rosuvastatin by Other (see comment). Use Caution/Monitor. Comment: Coadministration of rosuvastatin with OATP1B1 inhibitors may increase rosuvastatin levels and risk for myopathy.

            • lanthanum carbonate

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

            • ledipasvir/sofosbuvir

              ledipasvir/sofosbuvir will increase the level or effect of rosuvastatin by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Coadministration of ledipasvir/sofosbuvir with rosuvastatin may be associated withincreased risk of myopathy,including rhabdomyolysis. Monitor closely.

            • letermovir

              letermovir increases levels of rosuvastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of letermovir with fluvastatin may require a dosage reduction. Closely monitor patients for myopathy and rhabdomyolysis. When letermovir is coadministered with cyclosporine, the dose of rosuvastatin should not exceed 5 mg PO qDay . .

            • levonorgestrel oral/ethinylestradiol/ferrous bisglycinate

              rosuvastatin increases levels of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Coadministration of rosuvastatin and certain combined hormonal contraceptives (CHCs) containing EE increase AUC values for EE by approximately 20-25%.

            • mesterolone

              mesterolone increases toxicity of rosuvastatin 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 rosuvastatin by Other (see comment). Use Caution/Monitor.

            • mipomersen

              mipomersen increases toxicity of rosuvastatin by Other (see comment). Use Caution/Monitor.

            • ombitasvir/paritaprevir/ritonavir & dasabuvir

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of rosuvastatin by decreasing hepatic clearance. Modify Therapy/Monitor Closely. Maximum daily dose of rosuvastatin should be limited to 10 mg/day

            • paclitaxel

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

            • pazopanib

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

            • pioglitazone

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

            • ponatinib

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

            • ranolazine

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

            • regorafenib

              regorafenib will increase the level or effect of rosuvastatin by Other (see comment). Modify Therapy/Monitor Closely. Regorafenib likely inhibits BCRP (ABCG2) transport. Coadministration with a BCRP substrate may increase systemic exposure to the substrate and related toxicity.

            • repaglinide

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

            • rifampin

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

            • ritonavir

              ritonavir will increase the level or effect of rosuvastatin by decreasing metabolism. Use Caution/Monitor.

            • rolapitant

              rolapitant will increase the level or effect of rosuvastatin by Other (see comment). Use Caution/Monitor. Monitor for adverse reactions when unable to avoid rolapitant coadministration with narrow therapeutic index BCRP substrates. Use the lowest effective dose of rosuvastatin.

            • rosiglitazone

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

            • safinamide

              safinamide will increase the level or effect of rosuvastatin by Other (see comment). Use Caution/Monitor. Safinamide and its major metabolite may inhibit intestinal BCRP. Monitor BCRP substrates for increased pharmacologic or adverse effects.

            • sodium bicarbonate

              sodium bicarbonate decreases levels of rosuvastatin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

            • sodium citrate/citric acid

              sodium citrate/citric acid decreases levels of rosuvastatin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

            • sofosbuvir/velpatasvir

              sofosbuvir/velpatasvir will increase the level or effect of rosuvastatin by Other (see comment). Modify Therapy/Monitor Closely. Velpatasvir is an inhibitor of the drug transporter BCRP. Coadministration may increase systemic exposure of drugs that are BCRP substrates. Coadministration may significantly increase rosuvastatin serum concentration, which is associated with increased risk of myopathy, including rhabdomyolysis. If coadministered, do not exceed rosuvastatin dose of 10 mg/day.

              sofosbuvir/velpatasvir will increase the level or effect of rosuvastatin by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Coadministration of sofosbuvir/velpatasvir with rosuvastatin may significantly increase the concentration of rosuvastatin, which may increase risk of myopathy,including rhabdomyolysis. Rosuvastatin may beadministered with sofosbuvir/velpatasvir at a dose that does not exceed 10 mg.

            • stiripentol

              stiripentol will increase the level or effect of rosuvastatin by Other (see comment). Modify Therapy/Monitor Closely. Stiripentol is a BCRP transport inhibitor. Consider dosage reduction for BCRP substrates if adverse effects are experienced when coadministered.

            • tafamidis

              tafamidis will increase the level or effect of rosuvastatin by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.

            • tafamidis meglumine

              tafamidis meglumine will increase the level or effect of rosuvastatin by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.

            • tipranavir

              tipranavir increases levels of rosuvastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. This interaction is the net effect of tipranavir being coadministered with ritonavir (boosted therapy); increased risk of myopathy including rhabdomyolysis; do not exceed rosuvastatin dose of 10 mg/day.

            • warfarin

              rosuvastatin increases effects of warfarin by unspecified interaction mechanism. Use Caution/Monitor.

            Minor (12)

            • coenzyme Q10

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

            • colestipol

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

            • erythromycin base

              erythromycin base decreases levels of rosuvastatin by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate decreases levels of rosuvastatin by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

            • erythromycin lactobionate

              erythromycin lactobionate decreases levels of rosuvastatin by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

            • erythromycin stearate

              erythromycin stearate decreases levels of rosuvastatin by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

            • ethinylestradiol

              rosuvastatin increases levels of ethinylestradiol by unspecified interaction mechanism. Minor/Significance Unknown.

            • isradipine

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

            • mestranol

              rosuvastatin increases levels of mestranol by unspecified interaction mechanism. Minor/Significance Unknown.

            • orlistat

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

            • trazodone

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

            • voclosporin

              voclosporin will increase the level or effect of rosuvastatin 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

            >10%

            Myalgia (3-13%)

            1-10%

            Arthralgia (10%)

            Pharyngitis (9%)

            Headache (3.1-8.5%)

            Myalgia (7.6%)

            Nausea (2.4-6.3%)

            Asthenia (0.9-6.3%)

            Constipation (2.1-4.7%)

            Dizziness (4%)

            Arthralgia (3.8%)

            CPK increased (3%)

            Diabetes mellitus (2.8%)

            Abdominal pain (2%)

            ALT increased (2%)

            Flulike illness (2%)

            UTI (2%)

            <1%

            Jaundice

            Myopathy

            Rhabdomyolysis

            Postmarketing Reports

            Arthralgia

            Peripheral neuropathy

            Depression and sleep disorders (including insomnia and nightmares)

            Fatal and nonfatal hepatic failure, hepatitis, jaundice

            Thrombocytopenia

            Gynecomastia

            Interstitial lung disease

            Immune-mediated necrotizing myopathy

            Cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion)

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            Warnings

            Contraindications

            Hypersensitivity

            Active liver disease (including unexplained persistent elevations of LFTs)

            Cautions

            Nonserious and reversible cognitive adverse effects may occur

            Increased blood glucose and glycosylated hemoglobin (HbA1c) levels reported with statin intake; in some instances, these increases may exceed the threshold for the diagnosis of diabetes mellitus

            Use caution in patients who consume large amounts of ethanol or have a history of liver disease

            Interrupt therapy if serious hepatotoxicity with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment

            Increases in AST or ALT reported with HMG-CoA reductase inhibitors; monitor liver enzymes before initiating and if signs or symptoms of liver injury occur

            Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria reported with HMG-CoA reductase inhibitors; may occur at any dose level, but are increased at the highest dose (40 mg); caution in patients with predisposing factors for myopathy (eg, age ≥65 years, inadequately treated hypothyroidism, renal impairment)

            Discontinue treatment if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected; temporarily withhold in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (eg, sepsis; hypotension; dehydration; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; uncontrolled seizures)

            Pharmacokinetic studies demonstrated an ~2-fold elevation in median exposure (AUC and peak plasma concentrations) in Asian subjects when compared with a white control group

            Hematuria and proteinuria reported without decrease in renal function; consider dosage reduction if unexplained hematuria and proteinuria persists

            Rule out secondary causes of hyperlipidemia prior to initiating therapy

            Immune-mediated necrotizing myopathy

            • Immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, reported with statin use
            • 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 interactions overview

            • Exercise caution when anticoagulants coadministered with rosuvastatin because of its potentiation of effect of coumarin-type anticoagulants in prolonging the prothrombin time/INR; monitor INR at baseline and frequently during concomitant therapy
            • Cyclosporine and gemfibrozil increased rosuvastatin exposure and may result in increased risk of myopathy
            • Coadministration of rosuvastatin with certain protease inhibitors has differing effects on rosuvastatin exposure and may increase risk of myopathy
            • Risk of skeletal muscle effects may be enhanced when used in combination with lipid-modifying doses (≥1 g/day) of niacin; use with caution when administered with rosuvastatin
            • Because the risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concomitant use of fenofibrates, use with caution
            • Cases of myopathy, including rhabdomyolysis, reported with HMG-CoA reductase inhibitors when coadministered with colchicine
            • Also see Dosage Modifications
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            Pregnancy & Lactation

            Pregnancy

            Owing to HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, fetal harm may occur when administered to pregnant females; discontinue therapy as soon as pregnancy is recognized; limited published data are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage

            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

            There is no available information on effects of drug on breastfed infant or on milk production

            Unknown whether is present in human milk; it has been shown that drugs in this class pass into human milk and atorvastatin is present in rat milk

            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: 20%

            Peak plasma time: 3-5 hr

            Distribution

            Vd: 134 L

            Protein bound: 88%

            Metabolism

            Metabolism: ~10% by hepatic CYP2C9

            Metabolites: N-desmethyl, lactone

            Elimination

            Half-Life, Elimination: 19 hr

            Excretion: Feces (90%)

            Pharmacogenomics

            Hepatic influx and efflux transporters (single-nucleotide polymorphisms [SNPs] within the solute carrier organic anion transporter 1B1 (SLCO1B1) gene, encoding the organic anion transporter polypeptide 1B1 (OATP1B1) influx transporter)

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

            This polymorphism is proposed to reduced 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 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%); decrease dose by 50% in people of Asian descent

            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 than in TT homozygotes

            Genetic testing laboratories

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

            Oral Administration

            Take with or without food

            Tablets: Swallow whole

            Capsules

            • Swallow whole; do not crush or chew
            • For patients who have difficulty swallowing capsules
              • May open capsule and carefully empty granules onto 1 tsp of applesauce; swallow immediately, without chewing
              • Do not store mixture for future use
              • If not used in its entirety, discard remaining contents immediately

            Nasogastric Tube Administration

            Open capsule and empty granules into a 60-mL catheter-tipped syringe and add 40 mL of water

            Shake syringe vigorously for 15 seconds; granules may start dissolving which is acceptable

            Attach syringe to a nasogastric tube (≥16-French) and deliver contents of syringe through nasogastric tube

            After administering granules, flush nasogastric tube with 20 mL of additional water

            Use immediately after preparation and do not store for future use

            If not used in its entirety, discard remaining contents immediately

            Use with any other liquids is not recommended

            Storage

            Capsules and tablets: Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

            Protect from moisture

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Crestor oral
            -
            40 mg tablet
            Crestor oral
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            20 mg tablet
            Crestor oral
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            10 mg tablet
            Crestor oral
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            5 mg tablet
            rosuvastatin oral
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            5 mg tablet
            rosuvastatin oral
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            40 mg tablet
            rosuvastatin oral
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            10 mg tablet
            rosuvastatin oral
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            5 mg tablet
            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            10 mg tablet
            rosuvastatin oral
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            40 mg tablet
            rosuvastatin oral
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            40 mg tablet
            rosuvastatin oral
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            20 mg tablet
            rosuvastatin oral
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            rosuvastatin oral
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            5 mg tablet
            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            40 mg tablet
            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            40 mg tablet
            rosuvastatin oral
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            10 mg tablet
            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            10 mg tablet
            rosuvastatin oral
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            rosuvastatin oral
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            40 mg tablet
            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            rosuvastatin oral
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            40 mg tablet
            rosuvastatin oral
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            5 mg tablet
            rosuvastatin oral
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            5 mg tablet
            rosuvastatin oral
            -
            20 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            rosuvastatin oral

            ROSUVASTATIN - ORAL

            (roe-SUE-vuh-stah-tin)

            COMMON BRAND NAME(S): Crestor, Ezallor Sprinkle

            USES: Rosuvastatin 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 to 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. Talk with your doctor for more details.

            HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking rosuvastatin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily.If you are taking the capsule form of this medication, swallow the capsules whole. Do not crush or chew the capsules. If you have trouble swallowing the capsules, read and follow the manufacturer's Instructions for Use leaflet. You may carefully open the capsule and sprinkle the contents on 1 teaspoonful of soft food (such as applesauce, or chocolate- or vanilla-flavored pudding). Swallow all of the mixture without chewing. Use/discard the mixture within 60 minutes. Do not prepare a supply in advance.The dosage is based on your medical condition, response to treatment, age, race, 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 are of Asian descent, your doctor may direct you to start with a lower dose because you may be more sensitive to its effects.Antacids containing aluminum or magnesium can reduce the absorption of this drug. If taking this type of antacid, take it at least 2 hours after this medication.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 rosuvastatin 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.Tell your doctor right away if this unlikely but serious side effect occurs: foamy urine.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 persist 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. If you notice any of the following rare but serious side effects, tell your doctor right away: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.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), 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 rosuvastatin, 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 rosuvastatin. Ask your doctor or pharmacist for more information.Older adults may be more sensitive to the side effects of this drug, especially muscle problems.This medication must not be used during pregnancy. Rosuvastatin may harm an unborn baby. It is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control (such as condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor right away.This medication passes into breast milk. Because of the possible risk to the 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: "blood thinners" (such as warfarin), daptomycin, gemfibrozil.Other medications can affect the removal of rosuvastatin from your body, which may affect how rosuvastatin works. Examples include fostamatinib, ledipasvir, sofosbuvir/velpatasvir/voxilaprevir, among others.Do not take any red yeast rice products while you are taking rosuvastatin because some red yeast rice products may also contain a statin called lovastatin. Taking rosuvastatin 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) should be done while you are taking this medication. Keep all medical and lab appointments.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose (within 12 hours), 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 August 2021. Copyright(c) 2021 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.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • 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.