Ezetimibe/rosuvastatin

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Ezetimibe/rosuvastatin
Combination of
EzetimibeHypolipidemic agent
RosuvastatinStatin
Clinical data
Trade namesRidutrin,Cholerose Plus, Lipocomb, Rosuzet, others[1][2]
AHFS/Drugs.comMultum Consumer Information
License data
Pregnancy
category
Routes of
administration
By mouth
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only) [3]
  • US: ℞-only [4]
  • EU: Rx-only [2]
  • In general: ℞ (Prescription only)
Identifiers
KEGG

Ezetimibe/rosuvastatin, sold under the brand name Ridutrin among others, is a combination medication used to treat high cholesterol.[5][6] In some countries it is sold as a kit or a pack containing two distinct pills.[7][1] It is also available in the form of a composite package containing the two separate pills.[3]

The combination was approved for medical use in the United States in March 2021.[4]

Medical uses[edit]

Ezetimibe/rosuvastatin is indicated as an adjunct to diet in people with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C); and alone or as an adjunct to other LDL-C-lowering therapies in people with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.[8]

References[edit]

  1. ^ a b "Rosuvastatin international". Drugs.com. 3 February 2020. Retrieved 17 February 2020.
  2. ^ a b "Ezetimibe/rosuvastatin: List of nationally authorised medicinal products" (PDF). European Medicines Agency (EMA). 21 March 2018. PSUSA/00010271/201707. Retrieved 17 February 2020.
  3. ^ a b c "TGA eBS - Product and Consumer Medicine Information Licence".
  4. ^ a b "Roszet: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 24 March 2021.
  5. ^ "Ridutrin SmPC" (PDF). Medicines Data Bank. 30 May 2019. Retrieved 17 February 2020.
  6. ^ Willihnganz MJ, Gurevitz SL, Clayton BD (November 2021). "HMG-CoA Reductase Inhibitor Combination Products". Clayton's Basic Pharmacology for Nurses - E-Book. Elsevier Health Sciences. p. 344. ISBN 978-0-323-81258-0.
  7. ^ "Rosuzet Composite Pack". NPS MedicineWise. 8 January 2020. Retrieved 17 February 2020.
  8. ^ Sharretts J (23 March 2021). "NDA Approval Letter for Roszet (rosuvastatin and ezetimibe)" (PDF). Center for Drug Evaluation and Research. U.S. Food and Drug Administration.

External links[edit]