Rosuvastatin

DRUG INFORMATION

  ADULT
    - ( 2.1 ) • Dose range: 5 to 40 mg once daily.
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'dosage and
      administration', retrieved 2026-08-29
    - Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg.
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.1 ) • Adult HoFH : Starting dose 20 mg/day.
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Pediatric use information for patients 7 to 17 years of age is approved for
      AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to
      AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with
      that pediatric information.
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'pediatric
      use', retrieved 2026-08-29
    - DOSAGE & ADMINISTRATION • Rosuvastatin tablets can be taken with or without food,
      at any time of day. ( 2.1 ) • Dose range: 5 to 40 mg once daily. Use 40 mg dose
      only for patients not reaching LDL-C goal with 20 mg. ( 2.1 ) • Adult HoFH :
      Starting dose 20 mg/day. ( 2. 1) 2.1 General Dosing Information The dose range for
      rosuvastatin tablets in adults is 5 to 40 mg orally once daily. The usual starting
      dose is 10 to 20 mg once daily.
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'dosage and
      administration', retrieved 2026-08-29
    - However, due to AstraZeneca’s marketing exclusivity rights, this drug product is
      not labeled with that pediatric information. 2.3 Dosing in Asian Patients In Asian
      patients, consider initiation of rosuvastatin tablets therapy with 5 mg once daily
      due to increased rosuvastatin plasma concentrations.The increased systemic
      exposure should be taken into consideration when treating Asian patients not
      adequately controlled at doses up to 20 mg/day.
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - • Females of reproductive potential: Advise females of reproductive potential to
      use effective contraception during treatment with rosuvastatin tablets (8.3) •
      Severe renal impairment (not on hemodialysis) : Starting dose is 5 mg, not to
      exceed 10 mg.
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'use in
      specific populations', retrieved 2026-08-29
    - Elderly patients are at higher risk of myopathy and rosuvastatin tablets should be
      prescribed with caution in the elderly [ see Warnings and Precautions (5.1) and
      Clinical Pharmacology (12.3) ]. 8.6 Renal Impairment Rosuvastatin exposure is not
      influenced by mild to moderate renal impairment (CLcr ≥30 mL/min/1.73 m 2 ).
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'use in
      specific populations', retrieved 2026-08-29
    - Exposure to rosuvastatin is increased to a clinically significant extent in
      patients with severe renal impairment (CL cr <30 mL/min/1.73 m 2 ) who are not
      receiving hemodialysis and dose adjustment is required [ see Dosage and
      Administration (2.5) , Warnings and Precautions (5.1) and Clinical Pharmacology
      (12.3) ].
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'use in
      specific populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Exposure to rosuvastatin is increased to a clinically significant extent in
      patients with severe renal impairment (CL cr <30 mL/min/1.73 m 2 ) who are not
      receiving hemodialysis and dose adjustment is required [ see Dosage and
      Administration (2.5) , Warnings and Precautions (5.1) and Clinical Pharmacology
      (12.3) ].
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'use in
      specific populations', retrieved 2026-08-29
    - Chronic alcohol liver disease is known to increase rosuvastatin exposure;
      rosuvastatin tablets should be used with caution in these patients [ see
      Contraindications (4) , Warning and Precautions ( 5.3 ), and Clinical Pharmacology
      (12.3) ]. 8.8 Asian Patients Pharmacokinetic studies have demonstrated an
      approximate 2–fold increase in median exposure to rosuvastatin in Asian subjects
      when compared with Caucasian controls.
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'use in
      specific populations', retrieved 2026-08-29
    - There were no cases of liver failure or irreversible liver disease in these
      trials.
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'warnings
      and cautions', retrieved 2026-08-29

  PREGNANCY   [ AVOID ]
    The label says not to use it. Read the quote below before deciding.
    - Risk Summary Rosuvastatin tablets is contraindicated for use in pregnant women
      since safety in pregnant women has not been established and there is no apparent
      benefit to therapy with rosuvastatin tablets during pregnancy.
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'pregnancy',
      retrieved 2026-08-29
    - Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly
      the synthesis of other biologically active substances derived from cholesterol,
      rosuvastatin tablets may cause fetal harm when administered to pregnant women.
      rosuvastatin tablets should be discontinued as soon as pregnancy is recognized
      [see Contraindications (4) ] .
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'pregnancy',
      retrieved 2026-08-29
    - Limited published data on the use of rosuvastatin are insufficient to determine a
      drug-associated risk of major congenital malformations or miscarriage.
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Contraception Rosuvastatin tablets may cause fetal harm when administered to a
      pregnant woman [see Use in Specific Populations (8.1)].
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'nursing
      mothers', retrieved 2026-08-29
    - Advise females of reproductive potential to use effective contraception during
      treatment with rosuvastatin tablets.
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'nursing
      mothers', retrieved 2026-08-29
    - In pregnant rats given 2, 10 and 50 mg/kg/day of rosuvastatin from gestation day 7
      through lactation day 21 (weaning), decreased pup survival occurred at 50
      mg/kg/day (dose equivalent to 12 times the MRHD of 40 mg/day based body surface
      area).
      Source: US FDA label for rosuvastatin (Rosuvastatin Calcium), section 'use in
      specific populations', retrieved 2026-08-29