What are the main uses of rosuvastatin calcium. How does this statin medication work to lower cholesterol. When did the FDA approve the first generic version of Crestor. What are the potential side effects and precautions for taking rosuvastatin.

Understanding Rosuvastatin: A Powerful Statin Medication

Rosuvastatin calcium, commonly known by its brand name Crestor, is a potent statin medication used to manage cholesterol levels and reduce the risk of cardiovascular diseases. This drug has gained significant attention in the medical community due to its effectiveness in lowering low-density lipoprotein (LDL) cholesterol, often referred to as “bad cholesterol.”

How does rosuvastatin work? The medication functions by inhibiting an enzyme called HMG-CoA reductase, which plays a crucial role in cholesterol production within the body. By blocking this enzyme, rosuvastatin effectively reduces the amount of cholesterol manufactured by the liver, leading to lower overall cholesterol levels in the bloodstream.

Key Uses of Rosuvastatin in Lipid Management

Rosuvastatin is prescribed for various lipid-related conditions. Its primary uses include:

• Treatment of high triglycerides (hypertriglyceridemia) in adults, when combined with a proper diet
• Management of primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia), a disorder affecting the breakdown of cholesterol and triglycerides
• Treatment of homozygous familial hypercholesterolemia, either as a standalone therapy or in combination with other cholesterol-lowering treatments

Can rosuvastatin be used for prevention of cardiovascular events? Yes, in addition to its lipid-lowering effects, rosuvastatin has shown promise in reducing the risk of heart attacks, strokes, and other cardiovascular events in individuals with elevated cholesterol levels or other risk factors for heart disease.

Side Effects and Precautions of Rosuvastatin

While rosuvastatin is generally well-tolerated, it’s important to be aware of potential side effects. Common side effects reported in clinical trials include:

• Headache
• Muscle pain (myalgia)
• Abdominal pain
• Unusual weakness (asthenia)
• Nausea

Are there any serious side effects associated with rosuvastatin? Yes, although rare, some serious side effects may occur. These include:

1. Muscle problems, potentially leading to rhabdomyolysis or autoimmune myopathy
2. Liver problems, characterized by yellowing of eyes/skin, dark urine, or severe abdominal pain
3. Diabetes onset or worsening in some individuals
4. Mild memory problems or confusion in a small number of users

It’s crucial to inform your healthcare provider immediately if you experience any of these symptoms while taking rosuvastatin.

Special Precautions for Rosuvastatin Use

Who should avoid taking rosuvastatin? The medication is contraindicated in:

• Pregnant women or those who may become pregnant, due to potential fetal harm
• Nursing mothers, as it may pass into breast milk
• Individuals with known hypersensitivity to rosuvastatin or any component of the formulation

Always consult your healthcare provider before starting or stopping rosuvastatin, especially if you have any pre-existing medical conditions or are taking other medications.

Generic Rosuvastatin: Increasing Accessibility to Statin Therapy

On April 29, 2016, the U.S. Food and Drug Administration (FDA) made a significant announcement regarding rosuvastatin. What was this announcement about? The FDA approved the first generic version of Crestor (rosuvastatin calcium) tablets, marking a milestone in increasing accessibility to this important medication.

Who received approval to market generic rosuvastatin? Watson Pharmaceuticals Inc. of Parsippany, New Jersey was granted approval to market generic rosuvastatin calcium in multiple strengths. This approval opened the door for more affordable alternatives to the brand-name Crestor.

Impact of Generic Rosuvastatin on Patient Care

How does the availability of generic rosuvastatin benefit patients? The introduction of generic versions typically leads to:

• Reduced medication costs for patients
• Increased access to statin therapy for those who may have found brand-name Crestor cost-prohibitive
• Greater flexibility in treatment options for healthcare providers

Is generic rosuvastatin as effective as brand-name Crestor? According to the FDA, generic drugs must meet rigorous scientific and quality standards. Generic rosuvastatin is required to have the same quality, strength, and efficacy as the brand-name version.

Rosuvastatin in the Context of Cardiovascular Health

Rosuvastatin plays a crucial role in the management of cardiovascular health. How does it contribute to heart disease prevention? By effectively lowering LDL cholesterol and triglycerides, rosuvastatin helps reduce the risk of atherosclerosis, the buildup of plaque in arteries that can lead to heart attacks and strokes.

What makes rosuvastatin unique among statins? Rosuvastatin is known for its high potency and efficacy in lowering LDL cholesterol. It has been shown to provide significant reductions in LDL levels, even at lower doses compared to some other statins.

Rosuvastatin and Cardiovascular Risk Reduction

Can rosuvastatin reduce the risk of cardiovascular events in high-risk individuals? Several large-scale clinical trials have demonstrated the effectiveness of rosuvastatin in reducing cardiovascular events in various patient populations, including:

• Individuals with elevated C-reactive protein levels and normal cholesterol levels
• Patients with established cardiovascular disease
• People with multiple risk factors for heart disease

These studies have contributed to the widespread use of rosuvastatin in both primary and secondary prevention of cardiovascular disease.

Monitoring and Managing Rosuvastatin Therapy

Proper monitoring is essential for patients taking rosuvastatin. What should healthcare providers monitor during rosuvastatin therapy?

• Lipid levels: Regular blood tests to assess the effectiveness of the medication in lowering cholesterol and triglycerides
• Liver function: Periodic liver enzyme tests to detect any potential liver-related side effects
• Muscle symptoms: Awareness of any muscle pain, tenderness, or weakness that could indicate muscle-related complications
• Blood glucose levels: Monitoring for potential effects on blood sugar, especially in patients at risk for diabetes

How often should these parameters be monitored? The frequency of monitoring may vary based on individual patient factors and should be determined by the healthcare provider. Typically, more frequent monitoring is recommended at the start of therapy and may be adjusted over time.

Lifestyle Modifications to Complement Rosuvastatin Therapy

While rosuvastatin is highly effective, it’s most beneficial when combined with lifestyle modifications. What lifestyle changes can enhance the effectiveness of rosuvastatin?

1. Adopting a heart-healthy diet low in saturated fats and rich in fruits, vegetables, and whole grains
2. Engaging in regular physical activity, aiming for at least 150 minutes of moderate-intensity exercise per week
3. Maintaining a healthy body weight or losing weight if overweight or obese
4. Quitting smoking and limiting alcohol consumption
5. Managing stress through relaxation techniques or mindfulness practices

These lifestyle modifications not only complement the cholesterol-lowering effects of rosuvastatin but also contribute to overall cardiovascular health and well-being.

Future Directions in Statin Therapy and Rosuvastatin Research

The field of lipid management and statin therapy continues to evolve. What are some areas of ongoing research related to rosuvastatin?

• Investigating the potential pleiotropic effects of rosuvastatin beyond lipid-lowering, such as anti-inflammatory properties
• Exploring the use of rosuvastatin in new patient populations or for novel indications
• Studying long-term outcomes and safety profiles in diverse patient groups
• Developing combination therapies that pair rosuvastatin with other lipid-lowering or cardiovascular medications

How might these research directions impact future use of rosuvastatin? As our understanding of cardiovascular disease and lipid metabolism grows, we may see expanded indications for rosuvastatin, more personalized dosing strategies, and potentially new formulations or delivery methods to enhance its efficacy and tolerability.

Personalized Medicine and Rosuvastatin Therapy

The concept of personalized medicine is gaining traction in cardiovascular care. How might this approach affect rosuvastatin prescribing practices? Factors such as genetic markers, individual cardiovascular risk profiles, and even gut microbiome composition are being studied to optimize statin therapy. In the future, healthcare providers may be able to tailor rosuvastatin dosing and use based on a patient’s unique genetic and metabolic characteristics, potentially improving outcomes and minimizing side effects.

Patient Education and Adherence to Rosuvastatin Therapy

Patient education plays a crucial role in the success of rosuvastatin therapy. What key information should patients understand about taking rosuvastatin?

• The importance of taking the medication consistently as prescribed
• Potential side effects and when to seek medical attention
• The need for ongoing monitoring and follow-up appointments
• The role of lifestyle modifications in conjunction with medication
• The long-term benefits of statin therapy in reducing cardiovascular risk

How can healthcare providers improve patient adherence to rosuvastatin therapy? Strategies may include:

1. Providing clear, easy-to-understand information about the medication and its benefits
2. Addressing patient concerns and misconceptions about statin therapy
3. Utilizing reminder systems or mobile apps to help patients stay on track with their medication regimen
4. Simplifying treatment regimens when possible, such as once-daily dosing
5. Regularly assessing and reinforcing the importance of adherence during follow-up visits

By focusing on patient education and adherence, healthcare providers can help ensure that individuals receive the maximum benefit from rosuvastatin therapy while minimizing potential risks.

The Role of Pharmacists in Rosuvastatin Management

Pharmacists play a vital role in the management of patients on rosuvastatin. How can pharmacists contribute to optimal rosuvastatin therapy?

• Providing medication counseling and education to patients
• Monitoring for potential drug interactions with rosuvastatin
• Assisting with medication adherence strategies
• Collaborating with physicians to optimize dosing and manage side effects
• Offering guidance on lifestyle modifications to complement statin therapy

By leveraging the expertise of pharmacists, healthcare systems can enhance the safety and effectiveness of rosuvastatin therapy for patients.

Crestor Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very small number of people taking rosuvastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor.

Rarely, statins may cause or worsen diabetes. Talk to your doctor about the benefits and risks.

Tell your doctor right away if this unlikely but serious side effect occurs: foamy urine.

This drug may rarely cause muscle problems (which can rarely lead to very serious conditions called rhabdomyolysis and autoimmune myopathy). Tell your doctor right away if you develop any of these symptoms during treatment and if these symptoms persist after your doctor stops this drug: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), signs of kidney problems (such as change in the amount of urine).

This medication may rarely cause liver problems. If you notice any of the following rare but serious side effects, tell your doctor right away: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

FDA approves first generic Crestor

For Immediate Release:

April 29, 2016

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The U. S. Food and Drug Administration today approved the first generic version of Crestor (rosuvastatin calcium) tablets for the following uses:  

• in combination with diet for the treatment of high triglycerides (hypertriglyceridemia) in adults;
• in combination with diet for treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia), a disorder associated with improper breakdown of cholesterol and triglycerides;
• either alone or in combination with other cholesterol treatment(s) for adult patients with homozygous familial hypercholesterolemia, a disorder associated with high low-density lipoprotein (LDL) cholesterol.

High LDL cholesterol, the so-called “bad cholesterol,” is a known risk factor for heart attacks, strokes, and heart disease. High triglycerides may also increase the risk of heart disease.

“The FDA is working hard to get first-time generic drugs approved as quickly as possible so patients can have increased access to needed treatments,” said Kathleen Uhl, M. D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “The FDA requires that generic drugs meet rigorous scientific and quality standards.”

Generic drugs approved by the FDA have the same quality and strength as brand-name drugs. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs. 

Watson Pharmaceuticals Inc. of Parsippany, New Jersey has received approval to market generic rosuvastatin calcium in multiple strengths.

Rosuvastatin calcium is in a class of drugs called statins, which work by stopping an enzyme called HMG-CoA reductase from making cholesterol. Statins should be used in addition to a diet restricted in saturated fat and cholesterol.

In the clinical trials for Crestor, the most common side effects reported by participants taking Crestor included headache, pain in muscles (myalgia), abdominal pain, abnormal weakness (asthenia), and nausea.

Rosuvastatin calcium should not be used in women who are pregnant or may become pregnant as it may cause fetal harm. Women who require treatment with rosuvastatin should be advised not to nurse their infants.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Related Information

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• Content current as of:

  06/08/2016

Information on Uses, Dosages, Warnings & Recalls

Crestor is part of a family of cholesterol-lowering drugs known as statins that includes Lipitor, Zocor and Lescol. The medication is designed to work with proper diet and exercise to lower bad cholesterol and slow the buildup of fatty deposits in the walls or blood vessels, which may prevent heart attacks and strokes.

Rosuvastatin works in two ways:

1. It reduces the amount of cholesterol the liver produces by blocking a key enzyme.
2. It allows the liver to take in and break down cholesterol already in the blood.

The active ingredient is rosuvastatin calcium. Rosuvastatin has been shown to reduce the risk of heart attack and other heart-related adverse events over 1.9 years of use. But there have been no long-term studies examining the effects of taking it or any other statins for as long as 20 or 30 years, which is the length of time many people will take the medicine.

Crestor is part of a class of drugs called statins.

The U.S. Food and Drug Administration first approved the medication in 2003 for use in adults with high levels of “bad cholesterol” and a history of heart disease. In 2010, the FDA approved the drug for additional uses including prevention of heart attacks, strokes and certain heart-related procedures among fairly healthy people with elevated C-reactive protein (CRP) levels, which is a marker of inflammation.

AstraZeneca manufactures the drug, which is approved for use in more than 115 countries. Generic versions have been available since 2016.

Dosages and Precautions

Crestor comes in tablets that vary in color, shape and size depending on the dosage. Doses range from 5 mg to 40 mg taken once a day at any time, with or without food.

The usual starting dose is 10 mg to 20 mg once daily. But there are notable exceptions.

In March 2004, the FDA required updates to the drug’s package insert to include new dosage instructions for patients with Asian ancestry. The change told doctors to consider starting Asian patients at just 5 mg once daily.

The drug’s label cites studies that have shown rosuvastatin levels twice as great in Asian subjects compared to Caucasian patients who took the same dose. Such elevated levels can increase the risk of muscle damage.

The label warns that people with a known hypersensitivity to ingredients in the drug should not take it. Rosuvastatin is also not recommended for people with active liver disease, women who are pregnant or who may become pregnant, or nursing mothers.

Side Effects and Warnings

The most common side effects of Crestor may include muscle aches, weakness, abdominal pain, nausea and headache. The drug has also been associated with a risk of kidney and liver damage, and a possible increased risk of developing diabetes.

Let your doctor know if you experience unexplained muscle pain or weakness, or if you continue to have muscle problems even after your doctor has told you to stop taking Crestor. You should also alert your doctor if your urine is dark, your skin or eyes are yellowing, your stomach hurts or your appetite has changed. These could be signs of rare but serious skeletal muscle effects such as myopathy or rhabdomyolysis.

The FDA has required AstraZeneca to add warnings to Crestor’s label based on clinical trials and postmarketing surveillance.

Required warnings include:

LIVER ENZYME ABNORMALITITES

Recommends doctors test liver enzymes before prescribing the medication and during treatment if the patient has symptoms of liver problems

BLOOD SUGAR INCREASES

Advises increases in blood sugar levels have been reported with use of statins

PROTEASE INHIBITOR DRUG INTERACTIONS

Cautions taking the drug with HIV or hepatitis C virus medicines called protease inhibitors may raise statin levels in the blood (This increases the risk for muscle injury, including rhabdomyolysis, which can result in kidney failure)

Recall Petition

Public Citizen petitioned the FDA in 2004 and 2005 to recall Crestor. The advocacy organization’s health research group documented cases of patients who developed rhabdomyolysis after taking the drug.

Rhabdomyolysis is a severe form of muscle damage that can lead to permanent kidney damage, coma and sometimes death.

Public Citizen demanded the FDA recall the drug to prevent further incidents of rhabdomyolysis, kidney failure or kidney damage. The FDA denied the petitions, but the agency later required AstraZeneca to add warnings to the drug’s label about a risk of developing rhabdomyolysis with acute renal failure.

EXPAND

In its 2017 annual report, AstraZeneca acknowledged it had faced several Crestor lawsuits over rhabdomyolysis and other injuries.

“In the US, AstraZeneca was defending a number of lawsuits alleging multiple types of injuries caused by the use of Crestor, including diabetes mellitus, various cardiac injuries, rhabdomyolysis, and/or liver and kidney injuries,” the report stated. “AstraZeneca has resolved all active claims with regard to this matter.”

International Safety Concerns

While most statins are very similar, Crestor is one of the two most powerful statins at reducing LDL, or “bad” cholesterol, levels. The other is Lipitor.

This increased potency has caused some regulatory bodies outside of the United States to approach Crestor’s approval with caution. Higher doses and stronger statins pose a greater risk of rare but serious side effects, including a potentially life-threatening muscle disease called myopathy.

In June 2004, AstraZeneca released a revised package insert for use in the European Union.

“The changes to the European labeling are in response to postmarketing spontaneous adverse event reports in patients receiving Crestor and highlight certain patient populations who may be at an increased risk for serious muscle toxicity (myopathy) associated with Crestor use, especially at the highest approved dose of 40 mg,” the FDA said in a public health advisory.

Lingering safety concerns prompted Germany, Norway, Poland, Malta and Spain to hold off on approval. While most EU countries approved the drug in 2003 or shortly after, the five holdouts did not grant approval until 2008, according to Reuters.

Germany is the largest national economy in Europe. Winning approval to market the medication there helped the drug’s global sales grow by more than $900 million in following year, according to the company’s 2010 annual report.

Generic Versions

AstraZeneca’s patent on Crestor expired in the United States on July 8, 2016. This allowed other companies to seek FDA approval for generic versions and begin manufacturing the approved ones.

As of February 2020, at least 20 manufacturers had received FDA approval to manufacture generic versions of rosuvastatin calcium. The agency says the generic drugs it approves have the same quality and strength as brand-name versions.

Crestor sales dropped 70 percent from $1.2 billion in 2016 to $373 million in 2017 to $170 million in 2018. However, AstraZeneca noted in its 2017 and 2018 annual reports that the drug had remained one of its top sellers.

In the face of growing generic competition, the drug still generated more than $2.36 billion for the company worldwide in 2017, and $1.43 billion in 2018. But that represented a 30 percent and 39 percent global decline from the previous years.

Please seek the advice of a medical professional before making health care decisions.

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Rosuvastatin: a medicine used to lower cholesterol

Like all medicines, rosuvastatin can cause side effects, although not everyone gets them. Side effects often improve as your body gets used to the medicine.

One rare but serious side effect is unexplained muscle aches and pains, tenderness or weakness. This can happen a few weeks or months after you first start taking this medicine.

Report any unexplained muscle aches and pains, tenderness or weakness to a doctor straight away.

Talk to your doctor or a pharmacist if side effects are bothering you. They may recommend trying an alternative statin.

Common side effects

These side effects happen in more than 1 in 100 people.

Keep taking the medicine, but tell your doctor or pharmacist if these side effects bother you or do not go away:

• feeling sick
• headaches
• stomach pain
• feeling weak or dizzy
• constipation
• protein in your pee (if you’re taking the higher 40mg dose) – your doctor will check for this as there are no symptoms for this side effect

Serious side effects

Serious side effects are rare and happen in less than 1 in 1,000 people.

Stop taking rosuvastatin and call a doctor if you get:

• muscle pain, tenderness, weakness or cramps – these can be signs of muscle breakdown and kidney damage
• yellow skin or the whites of your eyes turn yellow – these can be signs of liver problems
• severe stomach pain – this can be a sign of pancreas problems
• a cough, shortness of breath and weight loss – these can be signs of lung disease

Less than 1 in 10,000 people may experience memory loss.

If you experience problems with your memory, speak to your doctor, as it may be unrelated to rosuvastatin.

Do not stop taking the medicine without talking to your doctor first.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction (anaphylaxis) to rosuvastatin.

These are not all the side effects of rosuvastatin.

For a full list, see the leaflet inside your medicines packet.

Cholesterol-Lowering Drugs: Benefits & Side Effects

What types of drugs are used to lower cholesterol?

Cholesterol is produced in the body by the liver, but is also taken in from food derived from animals (such as meat and dairy products. ) You might have a genetic issue that leads to high blood cholesterol levels, or your cholesterol might be high due to food choices and lack of physical activity. You can improve cholesterol levels with a healthy diet and exercise, but if the cholesterol level doesn’t drop low enough to be healthy, your healthcare provider might prescribe medication.

There are several classes of drugs used to decrease cholesterol. These include:

• Statins.
• PCSK9 inhibitors.
• Fibric acid derivatives (also called fibrates).
• Bile acid sequestrants (also called bile acid resins).
• Nicotinic acid (also called niacin).
• Selective cholesterol absorption inhibitors.
• Omega 3 fatty acids and fatty acid esters.
• Adenosine triphosphate-citrate lyase (ACL) inhibitors.

Your healthcare provider will discuss these options with you and together you can decide which type of medication, if any, would be best for you.

Statins

Statins are one of the better known types of cholesterol-lowering drugs. Statins decrease cholesterol output by blocking the HMG CoA reductase enzyme that the liver uses to make cholesterol. Statins are also called HMG CoA reductase inhibitors.

Statins also:

• Improve the function of the lining of the blood vessels.
• Reduce inflammation (swelling) and damage.
• Reduce the risk of blood clots by stopping platelets from sticking together.
• Make plaques (fatty deposits) less likely to break away and cause damage.

These additional benefits help prevent coronary vascular disease (CVD) in people who have had events like heart attacks and in people who are at risk.

What statins are available to treat high cholesterol?

What are the side effects of statins?

Like any other drugs, statins may produce unwanted side effects. These may include:

• Constipation or nausea.
• Headaches and cold-like symptoms.
• Sore muscles, with or without muscle injury.
• Liver defects.
• Increased blood glucose levels.
• Reversible memory issues.

If you’re unable to take statins because of the side effects, you’re said to be statin-intolerant. If you are taking a statin, you should avoid grapefruit products because they can increase side effects. You should limit the amount of alcohol that you drink because combining alcohol and statin usage can increase your risk of liver damage. You may want to talk with your provider or pharmacist if you are concerned about any other types of interactions.

PCSK9 inhibitors

PCSK9 inhibitors are designed to attach to a particular liver protein, which results in lowered LDL cholesterol. This class of drug can be given with statins and is usually for people at high risk of heart disease who have not been able to lower their cholesterol enough through other means.

What PCSK9 inhibitors are available to treat cholesterol?

What are some possible side effects of PCSK9 inhibitors?

Possible side effects include pain, including muscle pain (myalgia) and back pain, or swelling at the injection site and cold-like symptoms. Another drawback may be cost as these products may be expensive.

Fibric acid derivatives (fibrates)

Fibric acid derivatives make up another class of drugs that reduce blood lipid (fat) levels, especially triglycerides. Triglycerides are fats that come from food that are created when you consume calories that are not spent.

Fibric acid derivatives may also increase the level of HDL, also called the “good” cholesterol, while lowering liver production of LDL, the “bad” cholesterol. People who have severe kidney disease or liver disease should not take fibrates.

What fibrates are available to treat high cholesterol levels?

What are some possible side effects of fibric acid derivatives?

Possible side effects of fibrates include:

• Constipation or diarrhea.
• Weight loss.
• Bloating, belching or vomiting.
• Stomachache, headache or backache.
• Muscle pain and weakness.

Bile acid sequestrants (also called bile acid resins)

This class of drugs works inside the intestine by attaching themselves to bile, a greenish fluid made of cholesterol that is produced by the liver to digest food. The binding process means that less cholesterol is available in the body. Resins decrease LDL cholesterol and give a slight boost to HDL cholesterol levels.

What bile acid resins are available to treat cholesterol?

Available bile acid resins Generic name (Brand name)	Dosages
Cholestyramine (Questran®)	4 – 16 g/day (once or twice daily). The dose of 4 grams one to two times per day should be increased gradually over about one month intervals to 8-16 g/day divided into two doses. The maximum dose is 24 g/day taken in divided doses.
Colestipol (Colestid®)	Granule formulation: 5 g once or twice a day increase by 5 g every 1 to 2 months if needed. Maintenance dose: 5 to 30 g/day once daily or in divided doses. Tablet formulation: 2 g once or twice a day increase by 2 g once or twice daily every 1 to 2 months if needed. Maintenance dose: 2 to 16 g/day once daily or in divided doses.
Colesevelam (Welchol®)	3.75 g/day in one to two divided doses. Product comes in tablet or powder form.

What are the possible side effects of bile acid resins?

Possible side effects of bile acid sequestrants include:

• Sore throat, stuffy nose.
• Constipation, diarrhea.
• Weight loss.
• Belching, bloating.
• Nausea, vomiting, stomach pain.

If your medication is a powder, never take it dry. It must always be mixed with at least three to four ounces of liquid such as water, juice or a noncarbonated beverage.

If you take other medications besides these, make sure you take the other drugs one hour before or four hours after taking the bile acid resin.

Selective cholesterol absorption inhibitors

This class of medication works in the intestine to stop the body from absorbing cholesterol. These inhibitors reduce LDL cholesterol, but may also help with triglycerides and HDL cholesterol. They can be combined with statins.

There is one product of this class currently available: ezetimibe (Zetia®). The usual dose is 10 mg/day. Possible side effects include diarrhea, fatigue and joint pain.

Nicotinic acid

Nicotinic acid, also called niacin, is a B-complex vitamin. You can get over-the-counter versions of this, but some versions are prescription only. Niacin decreases LDL cholesterol and triglycerides and increases HDL. If you have gout or severe liver disease, you should not take niacin.

What nicotinic acid products are available to treat cholesterol levels?

What are possible side effects of niacin?

The main side effect of niacin is flushing of the face and upper body, which might be lessened if you take it with meals. You might have less flushing if you take aspirin about 30 minutes before taking niacin.

Other side effects include:

• Skin issues, such as itching or tingling.
• Headache.
• Stomach upset.
• Can lead to increased blood sugars.
• Coughing.

Omega-3 fatty acid esters and polyunsaturated fatty acids (PUFAs)

These kinds of drugs, used to lower triglycerides, are commonly called fish oils. Some products are available as OTC items, while others are prescription only. Here are two things to consider: Fish oils might interfere with other medications, and some people are allergic to fish and shellfish.

What omega-3 products are available to treat cholesterol levels?

What are the possible side effects of omega 3 products?

Possible side effects of omega-3 products include:

• Belching.
• Skin issues like rash or itching.
• Gas.
• Fishy taste.
• Increased bleeding time.

Adenosine triphosphate-citric lyase (ACL) inhibitors

The FDA has approved bempedoic acid (Nexletol™) to lower cholesterol. Bempedoic acid works in the liver to slow down cholesterol production. The medication comes in 180-mg tablets taken once per day with or without food. It should be taken with statin medications, but there are dosage limitations if taken with simvastatin or pravastatin.

What are the possible side effects of bempedoic acid?

Some possible side effects of bempedoic acid include:

• Upper respiratory infection.
• Stomach, back or muscle pain.
• Increased levels of uric acid.
• Tendon injury.

What about using red rice yeast or plant stanols (phytosterols) instead of prescription drugs to lower cholesterol?

Many people say they prefer to take ‘natural’ medicines over prescription drugs. However, just because something is natural doesn’t mean that it’s safe. In the U.S., supplements are not regulated as closely as medicines. Supplements can also interfere in dangerous ways with medications that you already take.

However, red rice yeast extract does contain lovastatin, which is the same chemical that is in Mevacor. In some cases, you and your healthcare provider might agree that you should try the supplement with monitoring.

Plant stanols are another nonprescription choice for lowering cholesterol. Plant stanols work by stopping the body from absorbing cholesterol in the intestines. One brand is CholestOff® capsules, while plant stanols are also available in margarine substitutes like Benecol®.

How to take your cholesterol-lowering medicines

When you are taking medicines, it is important to follow your healthcare provider’s advice carefully. If you don’t take medicines exactly as prescribed, they can harm you. For example, you could unknowingly counteract one medicine by taking it with another one. Medicines can make you feel sick or dizzy if not taken properly.

Taking your medicine

Medicine can only help you reduce cholesterol if you take it correctly. You should take all medicines as advised by your provider. Don’t hesitate to let them know if you don’t think the medication is working or if you have side effects that concern you. Fill your prescriptions regularly, and don’t wait till you are out of something to get a refill.

You can ask your healthcare provider or pharmacist any questions you have. Let them know if you have problems getting to the pharmacy to pick up your medicines or if the instructions are too complicated. If you have trouble understanding your provider or pharmacist, ask a friend or family member to be with you when you ask questions. You need to know what medicines you take and what they are for.

Don’t decrease your medicine dosage to save money. You must take the full amount to get the full benefits. If your medicines are too expensive, ask your provider or pharmacist about finding financial assistance. Some companies provide discounts for certain medications.

There are now many ways to keep track of medication schedules. It might help to have a routine of taking your medicines at the same time every day. You can have a pillbox marked with the days of the week that you fill at the start of the week. Some people keep a medication calendar or journal, marking down the time and date and dose. Make use of smart phone apps and pillboxes with alarms you can set.

If you forget to take a dose, take it as soon as you remember. However, if it’s almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Don’t take two doses to make up for the dose you missed.

When traveling, keep your medicines with you so you can take them as scheduled. On longer trips, take an extra week’s supply of medicines and copies of your prescriptions, in case you need to get a refill.

Always discuss any new medication with your provider, including over-the-counter drugs, herbal or dietary supplements. Your cholesterol medicine dose might have to be adjusted. Make sure you tell your dentist and other providers what medications you are taking, especially before having surgery with a general anesthetic.

All of your medicines to lower cholesterol will be more effective if you continue to follow a low cholesterol diet. Your healthcare provider may be able to refer you to a dietitian for help in designing a diet especially for you and encouraging you to stay with it.

A note from Cleveland Clinic

You may need medications to improve your cholesterol numbers. There are several options, but any of them will work better if you eat healthy and exercise. Remember to discuss any new medication with your provider. This includes over-the-counter products like herbs or dietary supplements.

Crestor 5mg film-coated tablets – Patient Information Leaflet (PIL)

Crestor^® 5 mg film-coated tablets

Crestor^® 10 mg film-coated tablets

Crestor^® 20 mg film-coated tablets

Crestor^® 40 mg film-coated tablets

rosuvastatin

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1) What Crestor is and what it is used for

2) What you need to know before you take Crestor

3) How to take Crestor

4) Possible side effects

5) How to store Crestor

6) Contents of the pack and other information

Crestor belongs to a group of medicines called statins.

• You have a high cholesterol level. This means you are at risk from a heart attack or stroke. Crestor is used in adults, adolescents and children 6 years or older to treat high cholesterol.
• You have been advised to take a statin, because changing your diet and doing more exercise were not enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while you are taking Crestor.

Or

• You have other factors that increase your risk of having a heart attack, stroke or related health problems.

Heart attack, stroke and other problems can be caused by a disease called atherosclerosis.

Atherosclerosis is due to build-up of fatty deposits in your arteries.

Crestor is used to correct the levels of fatty substances in the blood called lipids, the most common of which is cholesterol.

There are different types of cholesterol found in the blood – ‘bad’ cholesterol (LDL-C) and ‘good’ cholesterol (HDL-C).

• Crestor can reduce the ‘bad’ cholesterol and increase the ‘good’ cholesterol.
• It works by helping to block your body’s production of ‘bad’ cholesterol. It also improves your body’s ability to remove it from your blood.

For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is left untreated, fatty deposits can build up in the walls of your blood vessels causing them to narrow.

Sometimes, these narrowed blood vessels can get blocked which can cut off the blood supply to the heart or brain leading to a heart attack or a stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, a stroke or related health problems.

You need to keep taking Crestor, even if it has got your cholesterol to the right level, because it prevents your cholesterol levels from creeping up again and causing build-up of fatty deposits. However, you should stop if your doctor tells you to do so, or you have become pregnant.

Do not take Crestor:

• If you have ever had an allergic reaction to Crestor, or to any of its ingredients.
• If you are pregnant or breast-feeding. If you become pregnant while taking Crestor stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Crestor by using suitable contraception.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle aches or pains.
• If you take a drug combination of sofosbuvir/velpatasvir/voxilaprevir (used for viral infection of the liver called hepatitis C).
• If you take a drug called ciclosporin (used, for example, after organ transplants).

If any of the above applies to you (or you are in doubt), please go back and see your doctor.

• If you have moderate kidney problems (if in doubt, please ask your doctor).
• If your thyroid gland is not working properly.
• If you have had any repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines.
• If you regularly drink large amounts of alcohol.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
• If you take other medicines called fibrates to lower your cholesterol.

If any of the above applies to you (or you are in doubt), please go back and see your doctor.

Talk to your doctor or pharmacist before taking Crestor.

• If you have problems with your kidneys.
• If you have problems with your liver.
• If you have had repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines. Tell your doctor immediately if you have unexplained muscle aches or pains, especially if you feel unwell or have a fever. Also, tell your doctor or pharmacist if you have a muscle weakness that is constant.
• If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Crestor or other related medicines.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland is not working properly.
• If you take other medicines called fibrates to lower your cholesterol. Please read this leaflet carefully, even if you have taken other medicines for high cholesterol before.
• If you take medicines used to treat the HIV infection e.g. ritonavir with lopinavir and/or atazanavir, please see “Other medicines and Crestor”.
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infection), orally or by injection. The combination of fusidic acid and Crestor can lead to serious muscle problems (rhabdomyolysis), please see “Other medicines and Crestor”.
• If you are over 70 (as your doctor needs to choose the right start dose of Crestor to suit you)
• If you have severe respiratory failure.
• If you are of Asian origin – that is Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. Your doctor needs to choose the right start dose of Crestor to suit you.

If any of the above applies to you (or if you are not sure):

• Do not take Crestor 40 mg (the highest dose) and check with your doctor or pharmacist before you actually start taking any dose of Crestor.

Serious skin reactions including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with Crestor treatment. Stop using Crestor and seek medical attention immediately if you notice any of the symptoms described in section 4.

In a small number of people, statins can affect the liver. This is identified by a simple test which looks for increased levels of liver enzymes in the blood. For this reason, your doctor will usually carry out this blood test (liver function test) before and during treatment with Crestor.

While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.

• If the patient is under 6 years old: Crestor should not be given to children younger than 6 years.
• If the patient is below 18 years of age: The Crestor 40 mg tablet is not suitable for use in children and adolescents below 18 years of age.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines

Tell your doctor if you are taking any of the following:

• ciclosporin (used for example, after organ transplants),
• warfarin or clopidogrel (or any other drug used for thinning the blood),
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe),
• indigestion remedies (used to neutralise acid in your stomach),
• erythromycin (an antibiotic), fusidic acid (an antibiotic – please see below and Warnings and precautions),
• an oral contraceptive (the pill),
• regorafenib (used to treat cancer),
• darolutamide (used to treat cancer),
• hormone replacement therapy,
• any of the following drugs used to treat viral infections, including HIV or hepatitis C infection, alone or in combination (please see Warnings and precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medicines could be changed by Crestor or they could change the effect of Crestor.

If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Crestor. Taking Crestor with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in Section 4.

Do not take Crestor if you are pregnant or breast-feeding. If you become pregnant while taking Crestor stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Crestor by using suitable contraception.

Ask your doctor or pharmacist for advice before taking any medicine.

Most people can drive a car and operate machinery while using Crestor – it will not affect their ability. However, some people feel dizzy during treatment with Crestor. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Crestor contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars (lactose or milk sugar), contact your doctor before taking Crestor.

For a full list of ingredients, please see Contents of the pack and other information.

Always take this medicine as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

If you are taking Crestor for high cholesterol:

Starting dose

Your treatment with Crestor must start with the 5 mg or the 10 mg dose, even if you have taken a higher dose of a different statin before. The choice of your start dose will depend upon:

• Your cholesterol levels.
• The level of risk you have of experiencing a heart attack or stroke.
• Whether you have a factor that may make you more sensitive to possible side effects.

Please check with your doctor or pharmacist which start dose of Crestor will best suit you.

Your doctor may decide to give you the lowest dose (5 mg) if:

• You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
• You are over 70 years of age.
• You have moderate kidney problems.
• You are at risk of muscle aches and pains (myopathy).

Increasing the dose and maximum daily dose

Your doctor may decide to increase your dose. This is so that you are taking the amount of Crestor that is right for you. If you started with a 5 mg dose, your doctor may decide to double this to 10 mg, then 20 mg and then 40 mg if necessary. If you started on 10 mg, your doctor may decide to double this to 20 mg and then 40 mg if necessary. There will be a gap of four weeks between every dose adjustment.

The maximum daily dose of Crestor is 40 mg. It is only for patients with high cholesterol levels and a high risk of heart attacks or stroke whose cholesterol levels are not lowered enough with 20 mg.

If you are taking Crestor to reduce your risk of having a heart attack, stroke or related health problems:

The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.

The dose range in children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual start dose is 5 mg per day, and your doctor may gradually increase your dose to find the right amount of Crestor for you. The maximum daily dose of Crestor is 10 or 20 mg for children aged 6 to 17 years depending on your underlying condition being treated. Take your dose once a day. Crestor 40 mg tablet should not be used by children.

Swallow each tablet whole with a drink of water.

Take Crestor once daily. You can take it at any time of the day with or without food.

Try to take your tablet at the same time every day to help you to remember it.

It is important to go back to your doctor for regular cholesterol checks, to make sure your cholesterol has reached and is staying at the correct level.

Your doctor may decide to increase your dose so that you are taking the amount of Crestor that is right for you.

Contact your doctor or nearest hospital for advice.

If you go into hospital or receive treatment for another condition, tell the medical staff that you’re taking Crestor.

Don’t worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.

Talk to your doctor if you want to stop taking Crestor. Your cholesterol levels might increase again if you stop taking Crestor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

It is important that you are aware of what these side effects may be. They are usually mild and disappear after a short time.

Stop taking Crestor and seek medical help immediately if you have any of the following allergic reactions:

• Difficulty in breathing, with or without swelling of the face, lips, tongue and/or throat.
• Swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing.
• Severe itching of the skin (with raised lumps).
• Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

• If you have any unusual aches or pains in your muscles which go on for longer than you might expect. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects and rarely these have gone on to become a potentially life threatening muscle damage known as rhabdomyolysis.
• If you experience muscle rupture.
• If you have lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).

Common possible side effects (these may affect between 1 in 10 and 1 in 100 patients):

• Headache, stomach pain, constipation, feeling sick, muscle pain, feeling weak, dizziness.
• An increase in the amount of protein in the urine – this usually returns to normal on its own without having to stop taking your Crestor tablets (only Crestor 40 mg).
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Uncommon possible side effects (these may affect between 1 in 100 and 1 in 1,000 patients):

• Rash, itching or other skin reactions.
• An increase in the amount of protein in the urine – this usually returns to normal on its own without having to stop taking your Crestor tablets (only Crestor 5 mg, 10 mg and 20 mg).

Rare possible side effects (these may affect between 1 in 1,000 and 1 in 10,000 patients):

• Severe allergic reaction – signs include swelling of the face, lips, tongue and/or throat, difficulty in swallowing and breathing, a severe itching of the skin (with raised lumps). If you think you are having an allergic reaction, then stop taking Crestor and seek medical help immediately.
• Muscle damage in adults – as a precaution, stop taking Crestor and talk to your doctor immediately if you have any unusual aches or pains in your muscles which go on for longer than expected.
• A severe stomach pain (inflamed pancreas).
• Increase in liver enzymes in the blood.
• Bleeding or bruising more easily than normal due to low level of blood platelets.
• Lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).

Very rare possible side effects (these may affect less than 1 in 10,000 patients):

• Jaundice (yellowing of the skin and eyes), hepatitis (an inflamed liver), traces of blood in your urine, damage to the nerves of your legs and arms (such as numbness), joint pain, memory loss and breast enlargement in men (gynaecomastia).

Side effects of unknown frequency may include:

• Diarrhoea (loose stools), cough, shortness of breath, oedema (swelling), sleep disturbances, including insomnia and nightmares, sexual difficulties, depression, breathing problems, including persistent cough and/or shortness of breath or fever, tendon injury and muscle weakness that is constant.

If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance in Crestor is rosuvastatin. Crestor film-coated tablets contain rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin. The other ingredients are: lactose monohydrate, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171). Crestor 10 mg, 20 mg and 40 mg film-coated tablets also contain red iron oxide (E172). Crestor 5 mg film-coated tablets also contain yellow iron oxide (E172).

Crestor comes in blister packs containing 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98 and 100 tablets and plastic containers with 30 and 100 tablets (Not all packs are available in every country).

Crestor comes in four tablet strengths:

Crestor 5 mg film-coated tablets are yellow, round and marked with ZD4522 and 5 on one side and plain on the reverse.

Crestor 10 mg film-coated tablets are pink, round and marked with ZD4522 and 10 on one side and plain on the reverse.

Crestor 20 mg film-coated tablets are pink, round and marked with ZD4522 and 20 on one side and plain on the reverse.

Crestor 40 mg film-coated tablets are pink, oval and marked with ZD4522 on one side and 40 on the reverse.

The Marketing Authorisations for Crestor are held by

AstraZeneca UK Ltd
600 Capability Green
Luton
LU1 3LU
UK

Manufacturers responsible for batch release:

AstraZeneca UK Ltd.
Silk Road Business Park Macclesfield
Cheshire
SK10 2NA
UK

Telephone: +44 1625 582828

This product is authorised in the Member States of the EEA under the following name(s): Crestor 5 mg, 10 mg, 20 mg and 40 mg (NL, AT, BE, DK, GR, FI, IC, IE, IT, LU, NO, MT, PL, PT, SE, UK), and 5 mg, 10 mg and 20 mg (DE, ES, FR).

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Reference number

Crestor 5 mg Film-coated Tablets 17901/0243

Crestor 10 mg Film-coated Tablets 17901/0201

Crestor 20 mg Film-coated Tablets 17901/0202

Crestor 40 mg Film-coated Tablets 17901/0203

This is a service provided by the Royal National Institute of Blind People.

For more information about Cholesterol and health contact HEART UK The Cholesterol Charity

Sandoz launches generic version of Crestor®

Princeton, New Jersey, July 21, 2016– Sandoz today announced the U.S. market introduction of rosuvastatin calcium tablets, a generic version of Crestor® by AstraZeneca Pharmaceuticals LP¹.

“The U.S. launch of rosuvastatin calcium is a strategic addition to the broad portfolio of generic medicines that Sandoz offers to improve cardiovascular health in adults,” said Peter Goldschmidt, President of Sandoz Inc. “As a leader in the generics market, Sandoz strives to constantly find new, differentiated ways to deliver affordable, high-quality healthcare solutions to the people who need them.”

In adults, rosuvastatin calcium tablets are used along with diet to lower the level of “bad” cholesterol (LDL), increase the level of “good” cholesterol (HDL), and/or lower the level of fat in blood (triglycerides).  Rosuvastatin calcium tablets are used to treat adults who cannot control their cholesterol levels by diet and exercise alone. It is not known if rosuvastatin calcium tablets are safe and effective in people who have Fredrickson Type I and V dyslipidemias.

According to IMS Health, US sales for Crestor were approximately $6.7billion for the 12 months ending in May 2016. Sandoz will market rosuvastatin calcium tablets in the 5mg, 10mg, 20mg and 40mg strengths.

Important Safety Information

Full prescribing information² is available at http://dailymed.nlm.nih.gov.

Contraindications

Rosuvastatin calcium is contraindicated in the following conditions:

Known hypersensitivity to product components

Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels

Pregnancy

Lactation

Warnings and Precautions

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (≥65), hypothyroidism, renal impairment, and combination use with cyclosporine, atazanavir/ ritonavir, lopinavir/ritonavir, or simeprevir. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness and discontinue rosuvastatin if signs or symptoms appear.

Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Perform liver enzyme tests before initiating therapy and as clinically indicated thereafter.

Most frequent adverse reactions (rate ≥ 2%) are headache, myalgia, abdominal pain, asthenia and nausea.

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by words such as “launches,” “introduction,” “launch,” “strategic,” “strives,” “will,” or similar terms, or by express or implied discussions regarding potential future product approvals, or regarding potential revenues from rosuvastatin calcium. You should not place undue reliance on these statements.  Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any potential new products will receive regulatory approval in the future, or that rosuvastatin calcium or any such potential new products will be commercially successful in the future. In particular, management’s expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; competition in general, including potential approval of additional versions of rosuvastatin calcium for sale either before or after the end of Sandoz expected 180-day exclusivity period; government, industry and general public pricing pressures; unexpected patent litigation outcomes; unexpected manufacturing issues; general economic and industry conditions, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Sandoz

Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of over 1000 molecules, covering all major therapeutic areas, accounted for 2015 sales of USD 10.1 billion. In 2015, our products reached over 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.

###

For further information:

Sandoz US Communications

Leslie Pott

+1 609-627-5287

[email protected]

Sandoz Global Communications

Duncan Cantor

+49 8024 476 2597

[email protected]

Footnotes:

¹ CRESTOR is a registered trademark of the AstraZeneca group of companies.

² Full prescribing information is available at:  https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=861f5730-9b6a-4d8a-9258-dee552dc3fc0

90,000 Egg or life: myths and the truth about cholesterol

MOSCOW, May 20 – PRIME, Ekaterina Shokhina. Everyone has heard that foods high in cholesterol and fat are harmful to health – they raise the level of cholesterol in the blood and thereby increase the risk of cardiovascular diseases. Someone has never attached importance to this, while someone is trying to follow an “anti-cholesterol” diet – they eat eggs only for Easter, instead of butter they use vegetable oil, and they don’t even look at bacon and sausage.

However, until today, no real evidence of the benefits of such a diet has been provided, and the “horror stories” about cholesterol, as the results of investigations have shown, were created by American scientists with the participation of pharmacists and manufacturers of soy products. The former intimidated people and sold them anti-cholesterol drugs, while the latter did a billion dollar business on soy products – “meat substitutes”.

IN THE NAME OF SOY

The theory that the cause of atherosclerosis and myocardial infarction is the consumption of animal food containing cholesterol appeared in the second half of the 20th century in America.Many millions of dollars have been thrown into the furnace of fruitless scientific research in order to confirm the “culpability” of animal fats in the occurrence of atherosclerosis and myocardial infarction.

“At that time, the Americans launched a real anti-cholesterol campaign and began to replace conventional food with soy, which led to a disruption in the synthesis of steroid hormones in the body and to colossal mass obesity,” says doctor of the highest category, surgeon Leonid Elkin. The game was worth the candle – the soy industry generated $ 41 billion in revenue for the state annually.

The American Heart Association (AHA) has recommended a dietary intake of no more than 300 mg of cholesterol per day.

This meant that only two eggs were already exceeding the recommended daily allowance. One large egg contains about 186 mg of cholesterol.

It was also recommended to limit the consumption of the liver and products from it. 100 grams of liver contains 100 to 270 mg of cholesterol. “It is recommended to exclude this product from the diet of hypertensive patients and people with high cholesterol levels,” the experts said.The “ban” included cheese, sausage, confectionery and much more.

However, independent experts soon began to refute these myths. And in 2013, the AHA and the American College of Cardiology said there was not enough scientific evidence to say that restricting dietary cholesterol intake lowers blood cholesterol. Cholesterol in food and in blood are two different things. The effect of cholesterol-rich foods on blood cholesterol is weak and insignificant.

“If you refuse eggs, the yolks of which really contain a lot of cholesterol, then you will not receive it … by 10 percent,” says Irina Zhegulina, a geneticist at the Atlas biomedical holding. in fact, our body is designed so that 80-90% of cholesterol is synthesized in the liver – regardless of whether you eat butter or carrots. That is, the diet, of course, can slightly adjust the level of this substance in the body, but it is completely insignificant – only by those 10-20% ”.

BIG FARMA GOALS

The myth that animal products are harmful to health is closely related to another myth – that high blood cholesterol leads to dire consequences – diabetes, heart attack and stroke.

Scientists and doctors began to talk about the dangers of cholesterol in the body at a time when giant pharmaceutical companies launched anti-cholesterol drugs – statins.

Statins were discovered in the early 70s by the Japanese Akira Endo, who was looking for new antibiotics.For his discovery, Endo did not receive a dime: all the money went to corporations like Merck and Pfizer, which each developed their own synthetic statin. The first to hit the market was Pfizer’s Lipitor, and by 2002, prescription revenues exceeded $ 10 billion in the US alone. Almost at the same time, the Zokor of the firm “Merck, Sharp and Dome” (MSD) went on sale, it was sold for $ 9 billion. Firm “AstraZeneca” with some delay began production of Crestor, but by this time there were persistent signs of adverse reactions from the action of these drugs, and their mass release on the medical market somewhat slowed down.

Doctors began to recommend taking statins not only to lower cholesterol levels in the blood, but also for prophylaxis as vitamins to everyone and even children. However, several years after their creation, publications began to appear, noting the “dubious” benefits of these drugs. In March 2013, a renowned French physician, Professor Bernard Debre published a book in which he argued that medications containing statins are at best useless, at worst toxic and have side effects.

Doctors all over the world began to say that there is no need to fight cholesterol – its lack is more dangerous than an excess.

They began to recall the German scientist Rudolf Virchow, who in the middle of the 19th century wrote that cholesterol cannot be the cause of atherosclerosis, but appears only at the final stage of damage to the arteries. Cholesterol comes to “heal the wound,” but never caused the “wound,” the scientist argued. Elevated cholesterol levels are only a sign of inflammation in the body, not the cause.Many factors damage the walls of arteries. For example, elevated blood glucose and insulin levels. In the United States in the early 2000s, a study was published that showed that half of people who had myocardial infarction had normal cholesterol levels. Conversely, people with low cholesterol have twice the death rate.

A recent study by scientists from the Norwegian University of Science and Technology found that women with high cholesterol live longer and are less likely to suffer from heart attacks and strokes than those with lower numbers.The researchers examined 52,087 people between the ages of 20 and 74. After adjusting for factors such as age, smoking, and blood pressure, the researchers found that women with high cholesterol had a 28% lower risk of death than women with low cholesterol. The risk of developing heart disease, cardiogenic shock, or stroke decreased in parallel with the increase in cholesterol levels.

As Elkin notes, cholesterol is a material for building cell walls, which is absolutely necessary for the production of vitamin D, various steroid hormones, including sex hormones: estrogens, progesterone, testosterone, and bile acids.Among other things, it also plays an important role in the functioning of the nervous and immune systems. Cholesterol is synthesized in the liver, enters the body with food, and then “binds” to proteins, and the result is a lipoprotein complex.

MAGNESIUM, NOT CHOLESTEROL

In recent years, scientific works of physicians from the United States began to appear, which claim: the amount of magnesium in the blood indicates a high risk of heart attack and stroke in a person much more accurately than the level of cholesterol.

Researchers prove that it is a low level of magnesium, not cholesterol, that is associated with all risk factors and symptoms of heart disease: hypertension, diabetes, high cholesterol, cardiac arrhythmias, angina pectoris.

“There are no harmful and healthy foods. It all depends on the quantity. Large portions of vegetables, and other healthy foods, can harm the body. The main thing in the so-called healthy diet is balance. Even ketchup and popcorn may not be harmful, but useful if consume them in small quantities, not to mention meat, cheese, butter and eggs “, – sums up nutritionist Anton Selin.Doctor of the highest category, nutritionist-gastroenterologist Svetlana Berezhnaya agrees with him. According to her, eggs are a unique product that has no equal in useful properties.

“Chicken eggs are the only product that is absorbed by our body by 97-98%, while leaving no toxins in the intestines. One egg contains about 70-75 kcal, and pure protein, that is, protein – 6-6.5 grams. It is known that up to 20 grams of protein is absorbed by the body in one meal, which means that pure protein from two eggs will be absorbed completely and will benefit the muscles, bones and blood vessels, “the specialist says.

How to connect Instagram to Creator Studio?

How to connect Instagram to Creator Studio?

You can post content to Instagram, manage posts and view statistics on your computer by linking your Instagram and Creator Studio accounts.

Before you start

Connect an Instagram account in Creator Studio that is not linked to the Facebook Page

To manage Instagram content that is not linked to the Facebook Page and get statistics on your computer:

1. Open Creator Studio.
2. Click the icon next to at the top of the screen.
3. Follow the onscreen instructions to log into Creator Studio using your Instagram username and password.
4. If you cannot connect your Instagram account in Creator Studio, you will be prompted to link this account to the Facebook Page. If so, do one of the following:

   • Log out of your Facebook profile and log in to Creator Studio using your Instagram username and password.

   • Open Creator Studio in your browser in Safe Mode or Incognito Mode and log in using your Instagram username and password.

Connect the Instagram account linked to the Facebook Page in Creator Studio

To manage the Instagram content linked to the Facebook Page and get statistics on your computer:

1. Open Creator Studio.
2. Click the icon next to the icon at the top of the screen.
3. What happens next depends on the link between your Instagram account and the Facebook Page.

   • If you are managing a Facebook Page associated with the Instagram account you want to use in Creator Studio, click on that Page to connect to it.

   • If your Instagram account is not linked to a Facebook Page, click Connect to Instagram . Then follow the instructions to sign in to the desired Instagram account.

   • If you are managing a Facebook Page linked to an Instagram account, but you need to use a different account that is not on the list, click Connect another Instagram account and follow the instructions.

   • If you have multiple Instagram accounts linked to your Facebook Page or Pages and need to manage them in Creator Studio, click Continue with linked accounts .

Instagram accounts linked to Facebook Pages can be managed by all users with the appropriate role on the Pages. Learn more about what happens when you link your Instagram account to your Facebook Page.

After connecting an Instagram account in Creator Studio, all users who have the corresponding roles on the connected Facebook Page will have access to it in the “Instagram” section of Creator Studio.What information they see and what actions they can take depends on the role.

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💊 Crestor instructions for use

Mechanism of action

Rosuvastatin is a selective, competitive inhibitor of HMG-CoA reductase, an enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a cholesterol precursor. The main target of rosuvastatin is the liver, where cholesterol (CS) synthesis and low-density lipoprotein (LDL) catabolism are carried out.

Rosuvastatin increases the number of “hepatic” LDL receptors on the cell surface, increasing the uptake and catabolism of LDL, which in turn leads to inhibition of the synthesis of very low density lipoproteins (VLDL), thereby reducing the total amount of LDL and VLDL.

Pharmacodynamics

Crestor® reduces elevated concentrations of LDL cholesterol (LDL-C), total cholesterol, triglycerides (TG), increases the concentration of high-density lipoprotein cholesterol (HDL-C), and also reduces the concentration of apolipoprotein B (ApoB) Cholesterol-non-HDL, cholesterol-VLDL, TG-VLDL and increases the concentration of apolipoprotein A-I (ApoA-I) (see.Tables 1 and 2), reduces the ratio of cholesterol-LDL / cholesterol-HDL, total cholesterol / HDL cholesterol and cholesterol-non-HDL / HDL cholesterol and the ratio of ApoB / ApoA-I.

The therapeutic effect develops within one week after the start of therapy with Crestor®, after 2 weeks of treatment it reaches 90% of the maximum possible effect. The maximum therapeutic effect is usually achieved by the 4th week of therapy and is maintained with regular intake of the drug.

Table 1. Dose-dependent effect in patients with primary hypercholesterolemia (Fredrickson type IIa and IIb) (mean adjusted percentage change from baseline) – seeinstructions.

Table 2. Dose-dependent effect in patients with hypertriglyceridemia (Fredrickson type IIb and IV) (mean percentage change from baseline). – see instructions.

Clinical efficacy

Crestor® is effective in adult patients with hypercholesterolemia with or without hypertriglyceridemia, regardless of race, gender or age, including in patients with diabetes mellitus and familial hypercholesterolemia.

In 80% of patients with Fredrickson type IIa and IIb hypercholesterolemia (average initial concentration of LDL-C about 4.8 mmol / L) while taking the drug at a dose of 10 mg, the concentration of LDL-C reaches values ​​less than 3 mmol / L.

In patients with heterozygous familial hypercholesterolemia, receiving Crestor® at a dose of 20-80 mg, there is a positive trend in the

lipid profile (a study involving 435 patients). After titration to a daily dose of 40 mg (12 weeks of therapy), there is a decrease in the concentration of LDL-C by 53%. In 33% of patients, an LDL-C concentration of less than 3 mmol / l is achieved.

In patients with homozygous familial hypercholesterolemia, taking Crestor® at a dose of 20 mg and 40 mg, the average decrease in the concentration of LDL-C is 22%.

In patients with hypertriglyceridemia with an initial TG concentration of 273 to 817 mg / dL, who received Crestor® at a dose of 5 mg to 40 mg once a day for 6 weeks, the concentration of TG in the blood plasma significantly decreased (see. Table 2).

An additive effect is observed in combination with fenofibrate in relation to the concentration of triglycerides and with nicotinic acid in lipid-lowering doses in relation to the concentration of HDL-C (see also the section “Special instructions”).

In the METEOR study involving 984 patients aged 45 – 70 years with a low risk of coronary heart disease (CHD) (10-year risk on the Framingham scale less than 10%), an average LDL-C concentration of 4.0 mmol / L (154 , 5 mg / dl) and subclinical atherosclerosis (which was assessed by the thickness of the intima-media complex of the carotid arteries – TCIM), the effect of rosuvastatin on the thickness of the intima-media complex was studied.

Patients received rosuvastatin 40 mg / day or placebo for 2 years. Rosuvastatin therapy significantly slowed the rate of progression of the maximum IMT for 12 carotid artery segments compared with placebo with a difference of –0.0145 mm / yr [95% CI, –0.0196 to –0.0093; R

The results of the JUPITER study (Rationale for the use of statins for primary prevention: an interventional study evaluating rosuvastatin) in 17,802 patients showed that rosuvastatin significantly reduced the risk of cardiovascular complications (252 in the placebo group versus 142 in the rosuvastatin group) (p

Medicines in Turkey – buying advice, manufacturers and prices for analogues of Russian medicines

I watch our tourists in Turkey and see the following picture: earlier they brought from Turkey leather, furs, gold, silver, high-quality textiles (whatever you say, in Turkey it is really excellent), sweets, and, of course, the eternal attribute – souvenirs.Now they carry mainly medicines. Lived))) …

The harsh reality changes and puts everything in its place: the primary needs, namely health, come to the fore. Without textiles, gold and leather, you can live, but without health – nowhere. So our citizens are being transported in sacks …

So who buys analogues of Russian medicines in Turkey? Usually the most ingenious, who, as they say, are “in the subject”: doctors, pharmacists, representatives of pharmaceutical companies, who come here in droves for various conferences and sessions, and then, in the same crowds, are “bought” in the nearest pharmacies.Yes, these are the people in Russia who prescribe well-known pills to us, sell them to us or “distribute” on behalf of the company in which they work. A friend of mine is a medical representative for such a farm. a very large and well-known company.

And here’s what I noticed: as a rule, those who work with medicines themselves have long been “addicted” to their use, with or without reason. Every year, when my friend comes to Antalya for her conference, I buy a ton of analogs of Russian medicines in advance on her order, probably for a whole year.To be honest, I was like that when I worked in Russia as a pharmacist. Probably this is the specificity of the profession, but it’s a pity for patients who, wanting to receive real help from a doctor, receive only a prescription for the next pills. But this is already a topic for another article …

Why buy medicines in Turkey

There are at least 4 pros to buy and bring the medicine you need from Turkey:

1. Compared to the prices for well-known import brands in Russia, in Turkey similar drugs are much cheaper and if you don’t see this difference, then you bought or are buying the necessary tablets in Russia at the “old” price of the drug imported before crisis.Everyone knows that imported drugs are purchased for foreign currency and their price in Russian pharmacies depends on the exchange rate.

Even domestic drugs have risen in price (or will rise in price in the near future) and it is clear why: substances for drugs are mainly produced in the world only by India and China, and they are bought for the same currency.

2. In Turkey, there is a very strict punishment for counterfeiting drugs and, apparently, there are absolutely no conditions for counterfeiting. Which is a little surprising, since, for example, fake brands of clothing, shoes, perfumes, alcohol, sports equipment and bags are put on stream, but there are no fakes of drugs at all!

T.That is, when you come to a pharmacy, you can be 100% sure that the medicines there are genuine.

3. Almost all known foreign drug formulas are registered in Turkey. I am telling you this, as a pharmacist and a person who has been living in Antalya for 8 years and who has thoroughly analyzed this moment. I often come across even the fact that there are modern drugs that are not yet available in Russia.

4. The prices of medicines in Turkey are strictly regulated. Pharmacies cannot cheat as much as they want, the prices for medicines in Turkish pharmacies are fixed.Where can I see them? In the Internet. This can and should be done in order to avoid further deception on the part of staff in pharmacies. Greedy people are everywhere.

A little about Turkish pharmaceuticals

Turkish medicine from the very beginning of its formation was based on European and American schools and its medical school and, accordingly, its developments of lek. she had no drugs. But on the other hand, she succeeded in using foreign drugs that are so popular all over the world today.Therefore, if the doctor advised you a medicine that is not yet available in Russia, it is possible that it has been used in Turkey for a long time.

In Russia, the medical school has always been strong, but many of the medicines developed by our scientists, and to which we are accustomed, are completely unknown in other countries, incl. and in Turkey. You will not find here, for example, such neurological drugs as succinic acid, cortexin and various extracts from the brains of cattle, valerian extract (valerian in Russian), glycine.Preparations from Far Eastern adaptogens, such as tincture of ginseng and eleucterococcus, etc.

But drug manufacturers in Turkey are very flexible in responding to demand, incl. and Russian-speaking citizens and tourists who are “used” to their pills. I remember how, having moved to Turkey, I tried in vain to find bifidumbacterin here. It just wasn’t there! And now, please, you can buy it under the trademarks “Maflor” or “Bifiform” of local Turkish manufacturers, and you will be offered different, even intravaginal, forms of release!

Recommendations for buying medicines in Turkey

And now, as promised, there is a clear step-by-step instruction on how to properly buy the Turkish analogue of the medicinal substance you need.

For example, you want to buy the Prestarium so popular in Russia – I know that many people use it to lower and maintain blood pressure.

1. First of all, we look at the packaging and look for an international name under the brand name: Perindopril – this name on all drug packages in the world will be the same, but brand (trade names) in each country may be different. For example, in Turkey the Prestarium is called COVERSYL

2. Then go to your favorite Internet search engine (Yandex or Google) and write the international name Perindopril in the address bar and next to the magic word fiyatı (which in Turkish means “price”).If you don’t write it, the search engine can start looking for you both Russian and English-language sites. And we need exactly Turkish ones in order to clearly understand that this drug is registered in Turkey.

3. Next, let’s see what we got: sites in Turkish came out with approximately the following content (see the picture)

This means that there is a drug in Turkey and its brand name will be immediately displayed to you. Since we have written a price in a search engine query, it means that in the selected sites they will also present you with a price in Turkish lira.You can recalculate this price in rubles (there is a currency counter on our website) and decide whether it is profitable for you to buy at that price or not.

4. You come to Turkey, go to any decent pharmacy and submit a list of the drugs you need, prescribed already from by the brand name , registered in Turkey. You can, of course, write international names, but be prepared for the fact that pharmacy workers who come here (but not always) even with a higher pharmaceutical education do not know international names and formulas at all and will look at you “like a sheep at a new gate.” …

They will immediately run with your piece of paper to their computer and will frantically try to find the medicine you need there. And not the fact that they will find it. Therefore, if you are ready and write them the already existing Turkish brand name of the drug, then you will make your life easier and save a lot of time.

Pharmacy communication tips

In conclusion, I will give some important tips that will greatly simplify the process of communicating with pharmacists in pharmacies.

1. In Antalya pharmacies, as in many ordinary stores, you can pay not only in Turkish lira, but also in the most popular currency: dollars or euros.If you take a large number of drugs, you can easily demand a discount (in Turkey, all pharmacies are private and market laws also work here), but remember that you still have to go through customs, where the question may arise: why are you carrying so many drugs.
2. In Turkey, brand (trade names) lek. drugs may coincide with those in Russia, for example, the now popular drug for lowering cholesterol Crestor is also called here – Crestor (in English transcription) or the legendary antidepressant Prozac in Turkey, also sounds like Prozac.But do not try to pronounce the names of medicines out loud when buying – the pharmacist may not understand you, because even with the same spelling, the names of drugs can sound completely different (I’ve come across this many times). It is better to provide it as written on paper.
3. If you did not find the Turkish corporate name, then write what it is – the international name and submit it in writing. Do not try to pronounce to the pharmacist something like “phenolphthalein propionate” – you will not see anything except misunderstanding on his part)), write better.
4. It is important to know that sometimes a preparation contains more than one active ingredient. These drugs are called combination drugs. The brand names of such drugs in Russia and Turkey often differ, and the international names on the packaging itself may not be indicated, as, for example, for the Maltofer drug. What to do? We look at the international name in the instructions, which is necessarily indicated there (in this case, ferrum hidroksydum komlex + folici asidi), and show it to the pharmacist.
5. Be sure to pay attention to the doses: the dosages prescribed by your doctor may simply not be produced in Turkey.
6. The technology of medicines does not stand still and offers us various prolonged-release forms for ease of use (in order to drink less pills per day or take once a day, instead of 3-4). If a medicine is prolonged, this is necessarily indicated in the name (forte or Long), so if the medicine you need does not have this “additive” in the name, then you should buy Turkish without it.Be careful not to overdose.

Medicinal plants

There are very few medicinal herbs in the pharmacy and usually in the form of ready-made preparations, for example, for coughs or colds (usually this is the lot of shops called kuruyemiş or sağılık bitkiler). As you can imagine, asking for the names of medicinal plants by their Latin name is useless, local pharmacists do not know them. Therefore, if you need to buy some medicinal plant that is not in Russian pharmacies, then you need to prepare in advance: find it on the Internet by its Latin name, and then – as I described above, find the Turkish name, just go to buy not at the pharmacy, but to the respective stores.

Another option is to find this lek. a plant in the composition of dietary supplements that pharmacies offer in a large assortment. The dietary supplements are sold here certified – from the world’s best manufacturers. They are very popular in Turkey, but this is a topic for a separate article.

Despite all the advantages of buying medicines in Turkish pharmacies, I want to remind you that medicines have not cured anyone in the world (not even antibiotics), but mortality from a drug disease (complications from taking medicine) is in third place in the world.Be healthy and buy only those medicines that you really need!

Author: Evgeniya

Great for Vagetarians – Dentistry “Ludent” in Soligorsk

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Far far away, behind the word mountains, far from the countries Vokalia and Consonantia, there live the blind texts. -Philip Katlar

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