Ezetimibe/rosuvastatin

Ezetimibe/rosuvastatin, sold under the brand name Ridutrin among others, is a combination medication used to treat high cholesterol.^[6][7] In some countries it is sold as a kit or a pack containing two distinct pills.^[8][9]

Ezetimibe/rosuvastatin

Ezetimibe (top) and rosuvastatin (bottom)
Combination of
Ezetimibe	Hypolipidemic agent
Rosuvastatin	Statin
Clinical data
Trade names	Ridutrink, Roszet, others
AHFS/Drugs.com	Multum Consumer Information
License data	US DailyMed: Ezetimibe and rosuvastatin
Pregnancy category	AU: D[1]
Routes of administration	By mouth
ATC code	C10BA06 (WHO)
Legal status
Legal status	AU: S4 (Prescription only)[1][2] US: ℞-only[3][4] EU: Rx-only[5] In general: ℞ (Prescription only)
Identifiers
KEGG	D11520

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

Medical uses

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.^[10]

Pharmacology

Ezetimibe/rosuvastatin combines two lipid-lowering therapies.

• Ezetimibe inhibits NPC1L1, the transporter that is responsible for absorption of dietary cholesterol from the intestine.^[3]
• Rosuvastatin inhibits HMG-CoA reductase, an enzyme involved in synthesis of new cholesterol in the liver.^[3]

References

1. "TGA eBS - Product and Consumer Medicine Information Licence". Archived from the original on 29 March 2022. Retrieved 25 March 2021.
2. "EZESTAT COMPOSITE PACK (Pharmacor Pty Ltd)". Department of Health and Aged Care. Archived from the original on 18 March 2023.
3. "DailyMed - Roszet- rosuvastatin and ezetimibe tablet Roszet (- rosuvastatin and ezetimibe tablet". dailymed.nlm.nih.gov. Archived from the original on 14 August 2022. Retrieved 14 January 2024.
4. "Roszet: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 24 March 2021.
5. "Ezetimibe/rosuvastatin: List of nationally authorised medicinal products" (PDF). European Medicines Agency (EMA). 21 March 2018. PSUSA/00010271/201707. Retrieved 17 February 2020.
6. "Ridutrin SmPC" (PDF). Medicines Data Bank. 30 May 2019. Archived (PDF) from the original on 18 February 2020. Retrieved 17 February 2020.
7. 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.
8. "Rosuzet Composite Pack". NPS MedicineWise. 8 January 2020. Archived from the original on 18 February 2020. Retrieved 17 February 2020.
9. "Rosuvastatin international". Drugs.com. 3 February 2020. Archived from the original on 18 February 2020. Retrieved 17 February 2020.
10. Sharretts J (23 March 2021). "NDA Approval Letter for Roszet (rosuvastatin and ezetimibe)" (PDF). U.S. Food and Drug Administration. Archived (PDF) from the original on 7 April 2023. Retrieved 25 March 2021.

External links

• "Ridutrin (rosuvastatin zinc/ezetimibe) Public Assessment Report Scientific discussion" (PDF). NL/H/3017/001-003/DC.