What is Crestor?

Crestor belongs to 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.

Warnings

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 breastfeeding 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 breastfeeding.

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.

Dosing information

Usual Adult Dose for Hyperlipoproteinemia:

Initial dose: 5 mg to 10 mg once a day with or without food
Maintenance dose: 5 mg to 40 mg once a day with or without food

Usual Adult Dose for Hyperlipoproteinemia Type IIa (Elevated LDL):

Initial dose: 5 mg to 10 mg once a day with or without food
Maintenance dose: 5 mg to 40 mg once a day with or without food

Usual Adult Dose for Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL):

Initial dose: 5 mg to 10 mg once a day with or without food
Maintenance dose: 5 mg to 40 mg once a day with or without food

Usual Adult Dose for Hyperlipoproteinemia Type IV (Elevated VLDL):

Initial dose: 5 mg to 10 mg once a day with or without food
Maintenance dose: 5 mg to 40 mg once a day with or without food

Usual Adult Dose for Atherosclerosis:

Initial dose: 5 mg to 10 mg once a day with or without food
Maintenance dose: 5 mg to 40 mg once a day with or without food

Usual Adult Dose for Homozygous Familial Hypercholesterolemia:

Initial dose: 20 mg once a day with or without food
Maintenance dose: 20 mg to 40 mg once a day with or without food

Usual Adult Dose for Prevention of Cardiovascular Disease:

Initial dose: 5 mg to 10 mg once a day with or without food Maintenance dose: 5 mg to 40 mg once a day with or without food

Response to therapy should be estimated from preapheresis LDL-C levels.

Usual Geriatric Dose for Hyperlipidemia:

Initial dose: 5 mg once a day with or without food
Maintenance dose: 5 mg to 20 mg once a day with or without food

Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia:

Pediatric patients 10 to 17 years of age:

Usual dose range: 5 to 20 mg orally once a day with or without food. Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more.

Maximum dose: 20 mg orally once a day

What happens if I miss a dose?

Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

Avoid eating foods high in fat or cholesterol, or Crestor will not be as effective.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Avoid using antacids without your doctor’s advice. Use only the type of antacid your doctor recommends, and do not take it within 2 hours after taking Crestor. Some antacids can make it harder for your body to absorb rosuvastatin.

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.

Crestor side effects

Get emergency medical help if you have any signs of an allergic reaction to Crestor: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• unexplained muscle pain, tenderness, or weakness;
• muscle weakness in your hips, shoulders, neck, and back;
• trouble lifting your arms, trouble climbing or standing;
• confusion, memory problems; or
• liver problems – upper stomach pain, tiredness, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• headache;
• weakness;
• muscle aches; or
• nausea, stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Crestor?

When you start or stop taking Crestor, your doctor may need to adjust the doses of any other medicines you take on a regular basis. Using certain medicines together with rosuvastatin can increase your risk of serious muscle problems. It is very important to tell your doctor about all medicines you use, and those you start or stop using during your treatment with Crestor, especially:

• colchicine;
• cyclosporine;
• another “statin” medicine – atorvastatin, lovastatin, simvastatin, Lipitor, Pravachol, Zocor, Vytorin, and others;
• antiviral medicine to treat HIV or hepatitis C – atazanavir, fosamprenavir, ledipasvir, lopinavir, ritonavir, simeprevir, sofosbuvir, tipranavir, Epclusa, Mavyret, Viekira, Vosevi, and others;
• a blood thinner – warfarin, Coumadin, Jantoven;
• cancer medicine – darolutamide, regorafenib;
• other cholesterol medications – fenofibrate, gemfibrozil; or
• medicines that contain niacin or nicotinic acid – vitamin B3, Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others.

What is atorvastatin?

Atorvastatin is a prescription medicine used to treat high cholesterol and to reduce the risk of heart attack, stroke, angina, and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease.

Atorvastatin helps lower LDL cholesterol (‘bad cholesterol’) and triglyceride levels, and increases HDL cholesterol (‘good cholesterol’) levels, to improve your overall lipid profile.

Atorvastatin calcium belongs to a class of medications called HMG-CoA reductase inhibitors, commonly referred to as statins.

Atrovastatin tablets are taken once daily with or without food. 

How does atorvastatin work?

Atorvastatin works by selectively blocking HMG-CoA reductase, the key enzyme the liver uses to produce cholesterol. By slowing this process, it reduces cholesterol production in the liver and increases the number of LDL receptors on liver cells, which helps remove more LDL (“bad”) cholesterol from the bloodstream. 

As a result, it lowers overall LDL levels, decreases the number of LDL particles, and improves the body’s ability to clear cholesterol.

What is atrovastatin used for?

Atorvastatin FDA-approved uses:

To reduce the risk of cardiovascular events in adults with:

• Multiple risk factors for coronary heart disease (CHD), but without established CHD.
  Use: to reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina.
• Type 2 diabetes and multiple risk factors for CHD, without established CHD
  Use: to help reduce the risk of MI and stroke.
• Adults with clinically evident CHD:
  Use: To reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina.

As an adjunct to diet to lower LDL-C:

• Adults with primary hyperlipidemia.
• Adults and pediatric patients (10 years and older) with heterozygous familial hypercholesterolemia (HeFH).

As an adjunct to other LDL-lowering therapies:

• For adults and pediatric patients (10 years and older) with homozygous familial hypercholesterolemia.

As an adjunct to diet for additional lipid disorders in adults:

• Primary dysbetalipoproteinemia.
• Hypertriglyceridemia.

How atorvastatin improves cholesterol and heart health

When cholesterol and fats build up along your artery walls, in a process called atherosclerosis, they narrow the blood vessels and reduce blood and oxygen flow to your heart, brain, and other parts of your body. By slowing cholesterol production, atorvastatin helps prevent this buildup to keep blood flowing more freely to vital organs.

Lowering your blood level of cholesterol and fats with atorvastatin may help prevent heart disease, angina (chest pain), strokes, and heart attacks.

Your healthcare provider will check your blood lipid levels regularly to assess how well your treatment is working. These measurements include:

• LDL-C: Low-density lipoprotein (“bad” cholesterol)
• HDL-C: High-density lipoprotein (“good” cholesterol)
• TG: Triglycerides (a type of blood fat)
• Total-C: Total cholesterol

Warnings

You should not take atrovastatin calcium if you have liver disease or cirrhosis.

Atorvastatin calcium can cause the breakdown of muscle tissue, which can lead 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, or dark urine.

Serious drug interactions can occur when certain medicines are used together with atrovastatin calcium. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Avoid drinking more than 1.2 liters of grapefruit juice each day.

Avoid eating foods that are high in fat or cholesterol. Atrovastatin is often used in conjunction with a cholesterol-lowering diet.

Atorvastatin side effects

Common atorvastatin side effects

Common atorvastatin side effects may include pain in your bones, spine, joints, or muscles, muscle spasms, upset stomach, trouble sleeping, stuffy nose, runny nose, sore throat, diarrhea, nausea, or pain in your arms or legs, urinary tract infection with pain and burning when you urinate, painful urination. 

Serious atorvastatin side effects

Allergic reactions: Get emergency medical help if you have signs of an allergic reaction to atorvastatin (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Myopathy and Rhabdomyolysis: Atorvastatin calcium can cause the breakdown of muscle tissue, which can lead 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, or dark urine. This serious side effect is more likely in older adults and those who have kidney problems, thyroid problems, or take certain other medicines.

Other serious side effects may occur. Call your doctor at once if you have:

• muscle weakness in your hips, shoulders, neck, and back;
• trouble lifting your arms, trouble climbing, or standing;
• liver problems – loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems – swelling, urinating less, feeling tired or short of breath; or
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Warnings

You should not take atorvastatin if you have liver disease or cirrhosis.

Atorvastatin can cause the breakdown of muscle tissue, which can lead 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, or dark urine.

Serious drug interactions can occur when certain medicines are used together with atorvastatin. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

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

Atorvastatin 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 use atorvastatin if you are allergic to it, or if you have liver failure or cirrhosis.

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

• muscle pain or weakness;
• diabetes;
• stroke;
• a thyroid disorder;
• a habit of drinking more than 2 alcoholic beverages per day; or
• kidney disease.

Atorvastatin 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).

Pregnancy

Tell your healthcare professional if you are pregnant, or plan to become pregnant, or become pregnant. Atorvastatin may harm your unborn baby. If you become pregnant, stop taking atorvastatin and call your healthcare provider right away.

Breastfeeding

Tell your healthcare professional if you are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take this medicine or breastfeed. You should not take atorvastatin if you breastfeed. Talk to your healthcare provider about the best way to feed your baby if you take LIPITOR.

How should I take atorvastatin?

Take atorvastatin tablet once daily with or without food. Many people ask when to take atorvastatin morning or night? It can be taken any time of the day, but try and take it at the same time each day. 

Take the liquid medicine on an empty stomach, at least 1 hour before a meal or 2 hours after a meal. Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).

Take atorvastatin exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Do not change your dose or stop taking any of your medications without your doctor’s advice.

It may take up to 2 weeks before your cholesterol levels improve, and you may need frequent blood tests. Even if you have no symptoms, tests can help your doctor determine if this medicine is effective.

Your treatment may also include diet, exercise, weight control, and blood tests.

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

Throw away in the trash any unused liquid 60 days after opening the bottle.

Atorvastatin Dosing Information

Recommended Dosage in Adult Patients The recommended starting dosage of Lipitor is 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily. Patients who require a reduction in LDL-C greater than 45% may be started at 40 mg once daily.

Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HeFH The recommended starting dosage of Lipitor is 10 mg once daily. The dosage range is 10 mg to 20 mg once daily. 

Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HoFH The recommended starting dosage of Lipitor is 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily. 

Comments: Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating Lipitor, and adjust the dosage if necessary.

This medicine is available as: atorvastatin 10 mg tablets, atorvastatin 20 mg tablets, atorvastatin 40 mg tablet, 80 mg tablets. 

The original brand name of atorvastatin was Lipitor, and now it is also available as a generic.
Atorvastatin calcium oral suspension is also available as the brand Aorvaliq 20mg/5ml.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking atorvastatin?

Avoid eating foods high in fat or cholesterol, or atorvastatin will not be as effective.

Drinking alcohol may increase your risk of liver damage.

Grapefruit may interact with atorvastatin and cause side effects. Avoid consuming grapefruit products and drinking more than 1.2 liters of grapefruit juice each day.

What other drugs will affect atorvastatin?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which can increase the risk of serious muscle problems or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can interact with atorvastatin, especially:

• other cholesterol-lowering medicines – gemfibrozil, niacin, fenofibrate, fenofibric acid, and others;
• colchicine;
• antibiotic or antifungal medicine – rifampin, erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole;
• birth control pills;
• medicine to prevent organ transplant rejection; or
• antiviral medicine to treat hepatitis C or HIV.

What is Lipitor?

Lipitor is used together with diet, weight loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease.

Lipitor is also used to lower the amount of fatty substances such as low-density lipoprotein (LDL) cholesterol (‘bad cholesterol’) and triglycerides in the blood and to increase the amount of high-density lipoprotein (HDL) cholesterol (‘good cholesterol’) in the blood.

Lipitor may also be used to decrease the amount of cholesterol and other fatty substances in the blood in children and teenagers 10 to 17 years of age who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally).

Lipitor (atorvastatin) belongs to a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats with Lipitor has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks.

Warnings

You should not take Lipitor if you have liver disease or cirrhosis.

Lipitor can cause the breakdown of muscle tissue, which can lead 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, or dark urine.

Serious drug interactions can occur when certain medicines are used together with Lipitor. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

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

Lipitor 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 use Lipitor if you are allergic to atorvastatin, or if you have liver failure or cirrhosis.

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

• muscle pain or weakness;
• diabetes;
• stroke;
• a thyroid disorder;
• a habit of drinking more than 2 alcoholic beverages per day; or
• kidney disease.

Lipitor 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).

Atorvastatin may harm an unborn baby. Tell your doctor if you are pregnant.

Ask a doctor if it is safe to breastfeed while using Lipitor.

How should I take Lipitor?

Take Lipitor exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Do not change your dose or stop taking any of your medications without your doctor’s advice.

Lipitor is usually taken once per day. Follow your doctor’s instructions.

You may take Lipitor tablets with or without food.

It may take up to 2 weeks before your cholesterol levels improve, and you may need frequent blood tests. Even if you have no symptoms, tests can help your doctor determine if Lipitor is effective.

Your treatment may also include diet, exercise, weight control, and blood tests.

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

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Lipitor?

Avoid eating foods high in fat or cholesterol, or Lipitor will not be as effective.

Drinking alcohol may increase your risk of liver damage.

Grapefruit may interact with atorvastatin and cause side effects. Avoid consuming grapefruit products and drinking more than 1.2 liters of grapefruit juice each day.

Lipitor side effects

Get emergency medical help if you have signs of an allergic reaction to Lipitor (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Lipitor can cause the breakdown of muscle tissue, which can lead 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, or dark urine.

Muscle problems may be more likely in older adults and those who have kidney problems, thyroid problems, or take certain other medicines.

Also call your doctor at once if you have:

• muscle weakness in your hips, shoulders, neck, and back;
• trouble lifting your arms, trouble climbing or standing;
• liver problems – loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems – swelling, urinating less, feeling tired or short of breath; or
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor.

Common Lipitor side effects may include:

• pain in your bones, spine, joints, or muscles;
• pain and burning when you urinate, painful urination;
• muscle spasms;
• upset stomach;
• trouble with sleeping;
• stuffy nose, runny nose, sore throat;
• diarrhea, nausea; or
• pain in arms or legs (limbs).

What is lovastatin?

Lovastatin 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).

Lovastatin is used to lower the risk of stroke, heart attack, and other heart complications in adults with diabetes, coronary heart disease, or other risk factors.

Lovastatin may also be used for purposes not listed in this medication guide.

Lovastatin side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Lovastatin can cause the breakdown of muscle tissue, which can lead 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, or dark colored urine.

Also call your doctor at once if you have:

• muscle weakness in your hips, shoulders, neck, and back;
• trouble lifting your arms, trouble climbing or standing;
• kidney problems–little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
• liver problems–loss of appetite, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of lovastatin may include:

• infections;
• headache; or
• accidental injury.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA

Warnings

You should not take lovastatin if you have active liver disease, or if you are pregnant or breastfeeding.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Stop taking lovastatin and tell your doctor at once if you become pregnant.

Before taking this medicine

You should not use lovastatin if you are allergic to it, or if:

• you are pregnant or breastfeeding; or
• you have active liver disease.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with lovastatin. Your doctor may change your treatment plan if you also use:

• nefazodone;
• an antibiotic–clarithromycin, erythromycin, telithromycin;
• antifungal medicine–itraconazole, ketoconazole, posaconazole, voriconazole; or
• antiviral medicine to treat HIV or hepatitis C–boceprevir, cobicistat, dasabuvir, elvitegravir, indinavir, lopinavir/ritonavir, nelfinavir, ombitasvir, paritaprevir saquinavir, telaprevir, tipranavir.

Tell your doctor if you have ever had:

• liver disease;
• muscle pain or weakness;
• kidney disease;
• a thyroid disorder; or
• if you drink large amounts of alcohol.

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

Do not use if you are pregnant. This medicine can harm an unborn baby. Use effective birth control to prevent pregnancy. Stop taking this medicine and tell your doctor at once if you become pregnant.

Do not breastfeed while using this medicine.

Lovastatin is not approved for use by anyone younger than 18 years old.

How should I take lovastatin?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Swallow the tablet whole and do not crush, chew, or break it.

It may take up to 4 weeks before your cholesterol levels improve, and you may need frequent blood tests. Even if you have no symptoms, tests can help your doctor determine if lovastatin is effective.

You may need to stop using lovastatin for a short time if you have surgery or a medical emergency. Do not stop taking this medicine unless your doctor tells you to.

Lovastatin is only part of a complete 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.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking lovastatin?

Avoid eating foods high in fat or cholesterol, or lovastatin will not be as effective.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Grapefruit may interact with lovastatin and lead to unwanted side effects. Avoid the use of grapefruit products.

What other drugs will affect lovastatin?

Some drugs can increase your risk of serious muscle problems if you take them together with lovastatin. Your doctor may need to change your treatment plan if you use any of the following drugs:

• cyclosporine;
• danazol;
• gemfibrozil, fenofibric acid, fenofibrate; or
• medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others).

What is pravastatin?

Pravastatin belongs to a group of drugs called HMG CoA reductase inhibitors, or “statins.”

Pravastatin 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).

Pravastatin is also used to lower the risk of stroke, heart attack, and other heart complications in people with or without coronary heart disease or other risk factors.

Pravastatin is used in adults and children who are at least 8 years old.

Warnings

You should not take pravastatin if you have active liver disease, or if you are pregnant or breastfeeding.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Stop taking pravastatin and tell your doctor at once if you become pregnant.

Pravastatin can cause the breakdown of muscle tissue, which can lead 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, or dark urine.

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

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Before taking this medicine

You should not use pravastatin if you are allergic to it, or if:

• you are pregnant or breastfeeding; or
• you have active liver disease.

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

• kidney disease;
• abnormal liver function tests;
• muscle pain or weakness;
• a thyroid disorder; or
• if you drink more than 2 alcoholic beverages daily.

Pravastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Do not use if you are pregnant. This medicine can harm an unborn baby. Use effective birth control to prevent pregnancy. Stop taking this medicine and tell your doctor at once if you become pregnant.

Do not breastfeed while using this medicine.

How should I take pravastatin?

Take pravastatin exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Take the medicine at the same time each day, with or without food.

Pravastatin doses are based on age, and are lower in children and teenagers. People taking this medicine during childhood or adolescence may need a different dose as adults.

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; or
• surgery or a medical emergency.

It may take up to 4 weeks before your cholesterol levels improve, and you may need frequent blood tests. Even if you have no symptoms, tests can help your doctor determine if this medicine is effective.

Pravastatin is only part of a complete 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. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid eating foods high in fat or cholesterol, or pravastatin will not be as effective.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Grapefruit may interact with pravastatin and lead to unwanted side effects. Avoid the use of grapefruit products.

Pravastatin side effects

Get emergency medical help if you have signs of an allergic reaction to pravastatin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, pravastatin 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, or dark colored urine.

Call your doctor right away if you have:

• muscle weakness in your hips, shoulders, neck, and back;
• trouble lifting your arms, trouble climbing or standing; or
• liver problems – loss of appetite, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes).

Common pravastatin side effects may include:

• muscle or joint pain;
• nausea, vomiting, diarrhea;
• headache; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

What is rosuvastatin?

Rosuvastatin (Crestor, Ezallor Sprinkle) is a prescription medication used to treat high cholesterol and prevent heart attacks and strokes.

Rosuvastatin belongs to a class of drugs called statins. It works in two ways. Rosuvastatin works by blocking an enzyme in the liver called HMG-CoA reductase, which leads to the liver making less cholesterol. It also works by increasing the liver’s uptake of cholesterol from your blood and its breakdown.

Rosuvastatin comes as a tablet and a capsule. The tablet formulation for rosuvastatin was first approved by the US Food and Drug Administration (FDA) in 2003 under the brand name Crestor. Many generic versions of rosuvastatin tablets have since been approved.

Rosuvastatin is also available as a capsule, which was approved in 2018 under the brand name Ezallor Sprinkle. Adults who can’t easily swallow a tablet or capsule can open the capsules and sprinkle the granules onto soft food and eat it. A generic version of the capsules has not been approved.

What is rosuvastatin used for?

Rosuvastatin tablets are used along with diet to:

• lower the level of your “bad” cholesterol (low-density lipoprotein, LDL)
• increase the level of your “good” cholesterol (high-density lipoprotein, HDL)
• lower the level of fat in your blood (triglycerides)
• slow the buildup of fatty deposits (plaque) in the walls of blood vessels

Rosuvastatin tablets are used:

• to treat adults who cannot control their cholesterol levels by diet and exercise alone.
• to treat children 8 to 17 years of age with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL). Rosuvastatin tablets are not approved for use in children with heterozygous familial hypercholesterolemia younger than 8 years of age.
• to treat children 7 to 17 years of age with homozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL). Rosuvastatin tablets are not approved for use in children with homozygous familial hypercholesterolemia younger than 7 years of age.
• to reduce the risk of heart attacks and strokes in men 50 years of age and older and women 60 years of age and older who do not have known heart disease but do have certain additional risk factors.

Only Crestor tablets are approved for use in children. Generic versions of rosuvastatin tablets and rosuvastatin capsules are not approved for use in children due to the marketer of Crestor tablets currently having exclusive marketing rights for use of rosuvastatin in this age group.

Rosuvastatin capsules are used in adults along with diet to:

• lower the level of your “bad” cholesterol (LDL).
• lower the level of fat in your blood (triglycerides).

It is not known if rosuvastatin is safe and effective in people who have Fredrickson Type I and V dyslipidemias.

Who should not take rosuvastatin?

Do not take rosuvastatin if you:

• are allergic to rosuvastatin calcium or any of the ingredients in your rosuvastatin tablet or capsule. See below for a complete list of ingredients.
• have liver problems.

What should I tell my doctor before taking rosuvastatin?

Before taking rosuvastatin, tell your healthcare provider about all or your medical conditions, including if you:

• have unexplained muscle aches or weakness
• have or have had kidney problems
• have or have had liver problems
• drink more than 2 glasses of alcohol daily
• have thyroid problems

Also tell your healthcare provider if you are 65 years of age or older or are of Asian descent.

How should I take rosuvastatin?

How should I take rosuvastatin tablets:

• Take the tablets exactly as your doctor tells you to take it.
• Take the tablets by mouth, 1 time each day. Swallow the tablet whole.
• The tablets can be taken at any time of day, with or without food.
• Do not change your dose or stop this medication without talking to your doctor, even if you are feeling well.
• Your doctor may do blood tests to check your cholesterol levels before and during your treatment with rosuvastatin. Your doctor may change your dose of it if needed.
• Your doctor may start you on a cholesterol lowering diet before giving you rosuvastatin. Stay on this diet when you take this medication.
• Wait at least 2 hours after taking rosuvastatin tablets to take an antacid that contains a combination of aluminum and magnesium hydroxide.

How should I take rosuvastatin capsules:

• Take the capsules exactly as your doctor tells you to take it.
• Take the capsules by mouth, 1 time each day. Swallow the capsules whole.
• Do not crush or chew the capsules.
• The capsules can be taken at any time of day, with or without food.
• Taking rosuvastatin capsules with soft food
  If you have trouble swallowing a whole capsule, you can open the capsule and take the contents with soft food (applesauce, or chocolate- or vanilla-flavored pudding). See the “Instructions for Use” that come with your medication for instructions on how to take the capsules with soft food (applesauce, or chocolate- or vanilla-flavored pudding).
  • Carefully open the capsules.
  • Sprinkle the granules filled in the capsules on 1 teaspoonful of soft food (such as applesauce, or chocolate- or vanilla-flavored pudding.
  • Swallow the granules-soft food mixture within 60 minutes. Do not chew the granules.
  • Do not save the granules-soft food mixture for later use. Throw away any remaining granules-soft food mixture.
• Taking rosuvastatin capsules through a nasogastric tube
  See the “Instructions for Use” that come with your medication for instructions on how to mix and give the capsules through a nasogastric tube 16 French or larger.
  • Remove the plunger from 60 mL catheter tipped syringe.
  • Carefully open the capsules and empty the granules into catheter tipped syringe barrel.
  • Add 40 mL of water to the granules that are inside of the catheter tipped syringe barrel. Do not use other liquids.
  • Replace the plunger and shake the catheter tipped syringe well for 15 seconds.
  • Attach the catheter tipped syringe to a nasogastric tube (≥16-French).
  • Give the mixture right away through the nasogastric tube into the stomach. Do not save the mixture for later use. Throw away any remaining mixture.
  • After giving the mixture, the nasogastric tube should be flushed with 20 mL of additional water.
• Do not change your dose or stop this medication without talking to your doctor
• Your doctor may do blood tests to check your cholesterol levels before and during your treatment with rosuvastatin. Your doctor may change your dose of it if needed.
• Your doctor may start you on a cholesterol lowering diet before giving you rosuvastatin. Stay on this diet when you take this medication.
• Wait at least 2 hours after taking rosuvastatin tablets to take an antacid that contains a combination of aluminum and magnesium hydroxide.

What happens if I miss a dose?

If you miss a dose of rosuvastatin, take it as soon as you remember. However, do not take 2 doses within 12 hours of each other.

What happens if I overdose?

If you take too much rosuvastain or overdose, call your doctor or go to the nearest hospital emergency room right away.

Dosing information

Rosuvastatin tablets:

• Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL cholesterol goal with 20 mg.
• Adults with homozygous familial hypercholesterolemia: Starting dose 20 mg/day.
• Pediatric patients with homozygous familial hypercholesterolemia: 20 mg/day for patients 7 to 17 years of age.
• Pediatric patients with heterozygous familial hypercholesterolemia: 5 to 10 mg/day for patients 8 to less than 10 years of age, and 5 to 20 mg/day for patients 10 to 17 years of age.

Rosuvastatin capsules:

• Dose range: 5 mg to 40 mg once daily. Use 40 mg dose only for patients not reaching LDL cholesterol goal with 20 mg.
• Adults with homozygous familial hypercholesterolemia: Starting dose 20 mg/day.

What are the side effects of rosuvastatin?

Serious side effects of rosuvastatin include:

• Muscle pain, tenderness and weakness (myopathy). Muscle problems, including muscle breakdown, can be serious in some people and rarely cause kidney damage that can lead to death. Tell your doctor right away if:
  • you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take this medication.
  • you have muscle problems that do not go away even after your doctor has told you to stop taking this medication. Your doctor may do further tests to diagnose the cause of your muscle problems.
    
    Your chances of getting muscle problems are higher if you:
  • are taking certain other medicines while you take rosuvastatin
  • are 65 years of age or older
  • have thyroid problems (hypothyroidism) that are not controlled
  • have kidney problems
  • are taking higher doses of this medication
• Liver problems. Your doctor should do blood tests to check your liver before you start taking this medication and if you have symptoms of liver problems while you taking it. Call your doctor right away if you have any of the following symptoms of liver problems:
  • feel unusually tired or weak
  • loss of appetite
  • upper belly pain
  • dark urine
  • yellowing of your skin or the whites of your eyes

The most common side effects of rosuvastain may include:

• headache
• muscle aches and pains
• abdominal pain
• weakness
• nausea

Additional side effects that have been reported with rosuvastatin include memory loss and confusion.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

Interactions

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Talk to your doctor before you start taking any new medicines.

Taking rosuvastatin with certain other medicines may affect each other causing side effects.

Especially tell your doctor if you take:

• cyclosporine (a medicine for your immune system)
• gemfibrozil (a fibric acid medicine for lowering cholesterol)
• darolutamide (a medicine for the treatment of prostate cancer)
• regorafenib (a medicine used to treat cancer of the colon and rectum)
• anti‑viral medicines including certain HIV or hepatitis C virus drugs such as:
  • lopinavir, ritonavir, fosamprenavir, tipranavir, atazanavir, simeprevir
  • combination of:
    • sofosbuvir/velpatasvir/voxilaprevir
    • dasabuvir/ombitasvir/paritaprevir/ritonavir
    • elbasvir/grazoprevir
    • sofosbuvir/velpatasvir
    • glecaprevir/pibrentasvir and
  • all other combinations with ledipasvir including ledipasvir/sofosbuvir
• certain anti-fungal medicines (such as itraconazole, ketoconazole and fluconazole)
• coumarin anticoagulants (medicines that prevent blood clots, such as warfarin)
• niacin or nicotinic acid
• fibric acid derivatives (such as fenofibrate)
• colchicine (a medicine used to treat gout)

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know all of the medicines you take. Keep a list of them to show your doctor and pharmacist when you get new medicine.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or think you may be pregnant, or are planning to become pregnant. Rosuvastatin may harm your unborn baby. If you become pregnant, stop taking rosuvastatin and call your doctor right away. If you are not planning to become pregnant you should use effective birth control (contraception) while you are taking this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed. Medicines like rosuvastatin can pass into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take this medication.

Storage

• Store rosuvastain at room temperature, between 68°F to 77°F (20°C to 25°C).
• Store in a dry place.
• Safely throw away medicine that is out of date or no longer needed.

Keep this and all medicines out of the reach of children.

What are the ingredients in rosuvastatin?

Active ingredient: rosuvastatin calcium

Inactive ingredients:

Crestor tablets: microcrystalline cellulose NF, lactose monohydrate NF, tribasic calcium phosphate NF, crospovidone NF, magnesium stearate NF, hypromellose NF, triacetin NF, titanium dioxide USP, yellow ferric oxide, and red ferric oxide NF.

Generic versions of rosuvastain tablets may contain different inactive ingredients to those listed above. Check the product label for your particular formulation for a complete list of ingredients.

Ezallor Sprinkle capsules: microcrystalline cellulose, crospovidone, mannitol, magnesium oxide, ferric oxide, sodium citrate, hypromellose, polyethylene glycol 4000, and silicon dioxide.

Capsule shell: gelatin, titanium dioxide, water, sodium lauryl sulfate and the following colorants: FD & C Red 40 (5 mg), FD & C Blue 1 (5 mg, 10 mg, 20 mg), D & C Red 28 (5 mg, 10 mg), FD & C Red 3 (20 mg), and FD & C Green 3 (40 mg).The imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, purified water, and potassium hydroxide.

The Crestor brand of rosuvastatin tablets are distributed by AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 under license from Shionogi & Co., LTD., Oska, Japan. Generic versions are also manufactured by a number of other companies.

Ezallor Sprinkle, the only available form of rosuvastatin capsules, is manufactured by Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India and distributed by Sun Pharmaceutical Industries, Inc, Cranbury, NJ 08512.