ROSUVASTATIN,EZETIMIBE

Background and Date of Approval

Rosuvastatin and ezetimibe are lipid-lowering medications used to help reduce cholesterol levels. Rosuvastatin belongs to the class of HMG-CoA reductase inhibitors, commonly known as statins, while ezetimibe is classified as a 2-azetidinone derivative. The combination received approval from the U.S. Food and Drug Administration (FDA) for medical use on March 31, 2023.

Uses

It is used to reduce total cholesterol levels, LDL (bad cholesterol), and fatty substances called triglycerides in your blood. It also helps to raise levels of HDL (good cholesterol). It is used in patients whose cholesterol levels cannot be controlled by a cholesterol-lowering diet alone. It is used in patients with heart disease. This medicine reduces the risk of heart attack, stroke, surgery to increase heart blood flow, or hospitalization for chest pain.

How is it administered?

It is an orally available prescription drug. Your doctor will decide the dose and duration of Rosuvastatin + Ezetimibe based on the disease condition and other factors. Always take this medicine as prescribed by your doctor. Take the tablet at the same time everyday, with or without food. Do not break, chew, crush, or break the tablet. Swallow the whole tablet with water.

Side Effects

The common side effects of Rosuvastatin + Ezetimibe are abdominal pain, constipation, diarrhea, nausea, increased liver enzymes, muscle, bone, and joint pain, headache, fatigue, cold and fever. Other serious side effects of these tablets are increased blood sugar levels increased liver enzymes and liver injury, muscle problems, kidney problems, and sleep disturbances.

Warnings

This drug is indicated to cause severe muscle disease. Promptly report to your physician about unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. Long-term use of Rosuvastatin + Ezetimibe may cause severe liver damage. Do not take this medicine if you are allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine, if you have liver disease or severe kidney impairment, or if you are pregnant or breastfeeding. Stop taking this medicine and inform your doctor immediately if you develop a severe skin rash or skin peeling, blistering, or mouth sores after taking this tablet.

Precautions

Do not take Rosuvastatin + Ezetimibe if you have liver disease, severe kidney impairment, and if you are pregnant or breastfeeding. Stop taking this medicine and inform your doctor immediately if you develop a severe skin rash or skin peeling, blistering, or mouth sores after taking this tablet. Inform your physician if you have kidney or liver diseases, muscle pain, respiratory failure, and are over 70 years old. Notify your physician if you regularly drink alcohol. This medicine may increase your chances of developing diabetes. Inform your healthcare provider about all the medicines you take, including prescription, over-the-counter, nutritional or vitamin supplements, and herbal products. Certain medications interact with rosuvastatin + ezetimibe and reduce their effectiveness by causing undesirable side effects. Do not take cyclosporin while taking this medicine.

Word of Advice

Store Rosuvastatin + Ezetimibe at 20°C to 25°C. Protect the medicine from light and excessive moisture. Keep the medicine out of reach of children and pets. If you forget to take a tablet, simply take your next dose at the scheduled time. Do not take a double dose to make up for a missed dose. You should follow a low-cholesterol diet and exercise while taking this medicine. If you need to take an antacid, take it at least 2 hours after using this medicine. Inform your doctor if you have thyroid problems before starting treatment. This medicine may affect the liver; your doctor will regularly carry out liver function tests during treatment. You are at increased risk of developing diabetes if you have high levels of blood sugar and fats, are overweight, and have high blood pressure.

References

Package leaflet: Information for the user rosuvastatin/Ezetimibe Abbott . Available at: https://file.wuxuwang.com/hma/NL_H_4917_001_FinalPL.pdf (Revised: March 2023) (Accessed: 29 May 2023). “Highlights Of Prescribing Information - Rosuvastatin + Ezetimibe.” (Revised March 2021) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213072s000lbl.pdf Barrios, Vivencio, and Carlos Escobar. “Fixed-Dose Combination of Rosuvastatin and Ezetimibe: Treating Hypercholesteremia according to Cardiovascular Risk.” Expert Review of Clinical Pharmacology , vol. 14, no. 7, 24 May 2021, pp. 793–806, pubmed.ncbi.nlm.nih.gov/33970743/#:~:text=Rosuvastatin%20is%20a%20high%2Dintensity,to%20reduce%20LDL%2DC%20levels., https://doi.org/10.1080/17512433.2021.1925539 . (Accessed 2 Dec. 2021.)

Frequently Asked Questions

Can Rosuvastatin + Ezetimibe be taken at any time of the day?

Yes, Rosuvastatin + Ezetimibe can be taken at any time of the day. However, taking it at the same time each day is generally recommended for better medication adherence. It can be taken with or without food, as directed by your healthcare provider.

Can I stop taking my other cholesterol-lowering medications if I start taking Rosuvastatin + Ezetimibe?

Depending on your specific condition, your doctor may sometimes recommend stopping, decreasing the dose, or taking other cholesterol-lowering medications. It is important to follow the guidance of your healthcare professional completely while taking this medicine.

Can Rosuvastatin + Ezetimibe cause muscle pain or weakness?

Although it is relatively rare, muscle pain or weakness is a potential side effect of Rosuvastatin + Ezetimibe. If you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise, it is important to contact your healthcare provider promptly. They can evaluate your symptoms and make any necessary adjustments to your medication regimen.

Is it necessary to follow a special diet while taking Rosuvastatin + Ezetimibe?

While taking Rosuvastatin + Ezetimibe, following your cholesterol-lowering diet with exercises is generally recommended. A diet low in saturated fats and cholesterol can support the effectiveness of the medication in managing cholesterol levels. Your healthcare provider or a registered dietitian can provide specific dietary recommendations tailored to your needs.

Can Rosuvastatin + Ezetimibe be taken with certain supplements or herbal products?

Certain supplements or herbal products may interact with Rosuvastatin + Ezetimibe, affecting its effectiveness or increasing the risk of side effects. It is important to inform your healthcare provider about all your supplements or herbal products before starting or modifying your medication regimen.

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS