Crestor Medication

Key:BPRHUIZQVSMCRT-VEUZHWNKSA-N NN YRosuvastatin, sold under the trade name Crestor among others, is a medication, used to prevent in those at high risk and treat. It is recommended to be used together with dietary changes, exercise, and weight loss. It is taken by mouth.Common side effects include abdominal pain, nausea, headaches,. Serious side effects may include, liver problems,. Use during may harm the baby.

Crestor is a HMG-CoA inhibitor, also known as a statin. Drugs in this class help treat high cholesterol by blocking a substance your liver needs to make cholesterol.

Like all statins, rosuvastatin works by inhibiting, an found in the that plays a role in producing.Rosuvastatin was patented in 1991, and approved for medical use in the United States in 2003. It is available as a. In the United States, the wholesale cost per dose is less than US$0.15 as of 2018. In the United Kingdom, it costs the about GB£0.65 per dose as of 2018. In 2017, it was the 39th most commonly prescribed medication in the United States, with more than 19 million prescriptions. Rosuvastatin (marketed as Crestor) 10 mg tabletsThe primary use of rosuvastatin is for prevention of cardiovascular disease in those at high risk and the treatment of.

Effects on cholesterol levels The effects of rosuvastatin on (LDL) cholesterol are dose-related. Higher doses were more efficacious in improving the lipid profile of patients with hypercholesterolemia than milligram-equivalent doses of and milligram-equivalent or higher doses of and.Meta-analysis showed that rosuvastatin is able to modestly increase levels of (HDL) cholesterol as well, as with other statins. A 2014 Cochrane review determined there was good evidence for rosuvastatin lowering non-HDL levels linearly with dose. HDL increases by 7% with no dose effect noted. Side effects and contraindications Side effects are uncommon. The following side effects should be reported to the prescribing doctor if they persist or get worse:. or.The following rare side effects are more serious.

Like all statins, rosuvastatin can possibly cause,. Further information:Rosuvastatin is a of the enzyme, having a mechanism of action similar to that of other statins.Putative beneficial effects of rosuvastatin therapy on chronic may be negated by increases in collagen turnover markers as well as a reduction in plasma levels in patients with chronic heart failure. Pharmacodynamics In a Cochrane systematic review the dose-related magnitude of rosuvastatin on blood lipids was determined. Over the dose range of 1 to 80 mg/day strong linear dose‐related effects were found; total cholesterol was reduced by 22.1% to 44.8%, LDL cholesterol by 31.2% to 61.2%, non-HDL cholesterol by 28.9% to 56.7% and triglycerides by 14.4% to 26.6%. Pharmacokinetics Absolute of rosuvastatin is about 20% and is reached in 3 to 5 hours; administration with food did not affect the according to the original sponsor submitted clinical study and as per product label.

However, a subsequent clinical study has shown a marked reduction in rosuvastatin exposure when administered with food. It is 88%, mainly to. Fraction absorbed of rosuvastatin is frequently misquoted in the literature as approximately 0.5 (50%) due to a miscalculated hepatic extraction ratio in the original submission package subsequently corrected by the FDA reviewer. It is likely that closer to 0.25 (25%) of the administered dose is absorbed.Rosuvastatin is metabolized mainly by and not extensively metabolized; approximately 10% is recovered as N-desmethyl rosuvastatin. It is excreted in (90%) primarily and the is approximately 19 hours.

Society and culture Rosuvastatin is the. Indications and regulation Rosuvastatin is approved in the United States for the treatment of high , total cholesterol , and/or. In February 2010, rosuvastatin was approved by the FDA for the primary prevention of cardiovascular events.As of 2004, rosuvastatin was approved in 154 countries and launched in 56. Approval in the United States by the (FDA) came on 13 August 2003. Patent protection and generic versions The main patent protecting rosuvastatin (RE37,314 — due to expire in 2016) was challenged as being an improper reissue of an earlier patent.

This challenge was rejected in 2010, confirming protection until 2016.In April 2016, the FDA approved the first version of rosuvastatin (from Watson Pharmaceuticals Inc). In July 2016, gained approval for its generic rosuvastatin calcium. Marketing The drug was billed as a 'super-statin' during its clinical development; the claim was that it offers high potency and improved cholesterol reduction compared to rivals in the class. The main competitors to rosuvastatin are. However, people can also combine with either simvastatin or atorvastatin and other agents on their own, for somewhat similar augmented response rates. As of 2006 some published information for comparing rosuvastatin, atorvastatin, and ezetimibe/simvastatin results is available, but many of the relevant studies are still in progress.First launched in 2003, sales of rosuvastatin were $129 million and $908 million in 2003, and 2004, respectively, with a total patient treatment population of over four million by the end of 2004. Annual cost to the UK (NHS) in 2018 for 5-40mg rosuvastatin daily was £24-40, compared to £10-20 for 20-80mg simvastatin.In 2013, it was the fourth-highest selling drug in the United States, accounting for approximately $5.2 billion in sales.

Debate and criticisms In October 2003, several months after its introduction in Europe, the editor of the, criticized the way Crestor had been introduced. 'AstraZeneca's tactics in marketing its cholesterol-lowering drug, rosuvastatin, raise disturbing questions about how drugs enter clinical practice and what measures exist to protect patients from inadequately investigated medicines,' according to his editorial. The Lancet's editorial position is that the data for Crestor's superiority rely too much on extrapolation from the lipid profile data (surrogate end-points) and too little on hard clinical end-points, which are available for other statins that had been on the market longer. The manufacturer responded by stating that few drugs had been tested so successfully on so many patients. In correspondence published in The Lancet, AstraZeneca's CEO called the editorial 'flawed and incorrect' and slammed the journal for making 'such an outrageous critique of a serious, well-studied medicine.' In 2004, the consumer interest organization filed a with the FDA, asking that Crestor be withdrawn from the US market.

On 11 March 2005, the FDA issued a letter to Sidney M. Of Public Citizen both denying the petition and providing an extensive detailed analysis of findings that demonstrated no basis for concerns about rosuvastatin compared with the other statins approved for marketing in the United States. References.

Generic Name:rosuvastatin (roe SOO va sta tin)
Brand Names:Crestor

Medically reviewed by Sophia Entringer, PharmD Last updated on Nov 5, 2019.

Overview

What is Crestor?

Crestor (rosuvastatin) belongs to a a group of drugs called HMG CoA reductase inhibitors, or 'statins.' Rosuvastatin is used together with diet to lower blood levels of 'bad' cholesterol (low-density lipoprotein, or LDL), to increase levels of 'good' cholesterol (high-density lipoprotein, or HDL), and to lower triglycerides (a type of fat in the blood).

Crestor is used in adults and children who are at least 8 years old to lower cholesterol and triglycerides in the blood.

Crestor is used in adults to slow the progression of atherosclerosis (a build-up of plaque in blood vessels that can block blood flow).

Crestor is used to lower the risk of stroke, heart attack, and certain other heart complications in men 50 years and older and women 60 years and older who have coronary heart disease or other risk factors.

Crestor is also used to treat hereditary forms of high cholesterol, including the heterozygous type (inherited from one parent) and the homozygous type (inherited from both parents). For the heterozygous type, Crestor can be used in children who are at least 8 years old. For the homozygous type, this medicine can be used in children as young as 7 years old.

Important information

Crestor can harm an unborn baby or cause birth defects. Do not use rosuvastatin if you are pregnant.

Before taking Crestor, tell your doctor if you have ever had liver or kidney disease, diabetes, or a thyroid disorder, if you are of Chinese descent, or if you drink more than 2 alcoholic beverages daily.

In rare cases, Crestor can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

You should not take rosuvastatin if you have liver disease, or if you are breast-feeding a baby.

Avoid eating foods that are high in fat or cholesterol. Crestor will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

There are many other drugs that can increase your risk of serious medical problems if you take them together with Crestor. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Crestor is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Before taking this medicine

You should not take Crestor if you are allergic to rosuvastatin, or if you have:

liver disease/high levels of liver enzymes in your blood; or
if you are pregnant or breast-feeding.

Do not take Crestor if you are pregnant. Rosuvastatin could harm the unborn baby or cause birth defects. Stop taking this medicine and tell your doctor right away if you become pregnant. Use effective birth control to prevent pregnancy while you are taking this medicine.

Rosuvastatin may pass into breast milk and could harm a nursing baby. Do not breastfeed while you are taking this medicine.

To make sure Crestor is safe for you, tell your doctor if you have ever had:

liver problems;
kidney disease;
a thyroid disorder;
a habit of drinking more than 2 alcoholic beverages per day;
if you are of Asian descent; or
if you are 65 or older.

Crestor can cause the breakdown of muscle tissue, which can lead to kidney failure. This happens more often in women, in older adults, or people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

People of Asian descent may absorb rosuvastatin at a higher rate than other people which may cause muscle weakness/dysfunction. Make sure your doctor knows if you are Asian. You may need a lower than normal starting dose.

How should I take Crestor?

Take Crestor exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Crestor is usually taken once a day, with or without food. Take the medicine at the same time each day.

While using this medicine, you may need frequent blood tests.

Keep using this medicine as directed, even if you feel well. High cholesterol usually has no symptoms. You may need to take Crestor on a long-term basis.

You may need to stop using this medicine for a short time if you have:

uncontrolled seizures;
an electrolyte imbalance (such as high or low potassium levels in your blood);
severely low blood pressure;
a severe infection or illness;
dehydration; or
surgery or a medical emergency.

You should not stop using Crestor unless your doctor tells you to.

Crestor is only part of a treatment program that may also include diet, exercise, and weight control. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light.