Rosuvastatin 20mg Tablets
It is used to lower bad cholesterol (LDL).It is used to lower triglycerides.It is used to slow the progress of heart disease.It is used in some people to lower the chance of heart attack, stroke, and certain heart procedures.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antilipemic Agent
Pharmacologic Class
HMG-CoA Reductase Inhibitor (Statin)
Pregnancy Category
Category X
FDA Approved
Aug 2003
DEA Schedule
Not Controlled
Overview
What is this medicine?
Rosuvastatin is a medication used to lower high cholesterol and triglyceride levels in your blood. It works by reducing the amount of 'bad' cholesterol (LDL) your body makes and increasing the amount of 'good' cholesterol (HDL). Lowering cholesterol helps prevent heart attacks, strokes, and other heart problems.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
You can take your medication with or without food.
If you are taking an antacid that contains aluminum or magnesium, take it at least 2 hours after taking your medication.
Swallow your medication whole with a glass of water or another drink.
Storing and Disposing of Your Medication
To ensure the safety and effectiveness of your medication:
Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Skip the missed dose and take your next dose at the usual time.
* Do not take two doses at the same time or take extra doses to make up for the missed dose.
To get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
You can take your medication with or without food.
If you are taking an antacid that contains aluminum or magnesium, take it at least 2 hours after taking your medication.
Swallow your medication whole with a glass of water or another drink.
Storing and Disposing of Your Medication
To ensure the safety and effectiveness of your medication:
Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Skip the missed dose and take your next dose at the usual time.
* Do not take two doses at the same time or take extra doses to make up for the missed dose.
Lifestyle & Tips
- Take this medication exactly as prescribed, usually once a day, with or without food.
- Continue to follow a cholesterol-lowering diet (low in saturated fat and cholesterol) as recommended by your doctor.
- Engage in regular physical activity.
- Maintain a healthy weight.
- Limit alcohol intake.
- Quit smoking.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Hyperlipidemia: 10 mg orally once daily. Homozygous Familial Hypercholesterolemia (HoFH): 20 mg orally once daily.
Dose Range:
5 - 40 mg
Condition-Specific Dosing:
Hyperlipidemia:
Initial dose 10 mg once daily; may be initiated at 5 mg once daily for patients requiring less aggressive LDL-C reduction or with predisposing factors for myopathy. Max 40 mg once daily.
Homozygous Familial Hypercholesterolemia (HoFH):
Initial dose 20 mg once daily. Max 40 mg once daily.
Primary Dysbetalipoproteinemia:
10-20 mg once daily.
Hypertriglyceridemia:
10-20 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Heterozygous Familial Hypercholesterolemia (HeFH) 8 to <10 years: 5-10 mg orally once daily. HeFH 10 to <17 years: 5-20 mg orally once daily. HoFH 7 to <17 years: 20 mg orally once daily.
Adolescent:
Heterozygous Familial Hypercholesterolemia (HeFH) 10 to <17 years: 5-20 mg orally once daily. HoFH 7 to <17 years: 20 mg orally once daily.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment needed (CrCl âĨ 60 mL/min).
Moderate:
No dosage adjustment needed (CrCl 30-59 mL/min).
Severe:
Initial dose 5 mg once daily; max 10 mg once daily (CrCl < 30 mL/min, not on hemodialysis).
Dialysis:
Initial dose 5 mg once daily; max 10 mg once daily. Administer after hemodialysis.
Hepatic Impairment:
Mild:
No dosage adjustment needed (Child-Pugh A).
Moderate:
No dosage adjustment needed (Child-Pugh B).
Severe:
Contraindicated in active liver disease or unexplained persistent elevations of serum transaminases (Child-Pugh C).
Pharmacology
Mechanism of Action
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. This inhibition leads to a decrease in hepatic cholesterol synthesis, which in turn upregulates the expression of LDL receptors on hepatocyte surfaces, increasing the uptake and catabolism of LDL. It also inhibits hepatic synthesis of VLDL, thereby reducing total cholesterol, LDL-C, ApoB, and triglycerides, and increasing HDL-C.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 20%
Tmax:
3-5 hours
FoodEffect:
Food does not affect bioavailability, but Cmax may be reduced by 20%.
Distribution:
Vd:
Approximately 134 L
ProteinBinding:
Approximately 90% (primarily to plasma proteins)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 19 hours
Clearance:
Not available
ExcretionRoute:
Fecal (approximately 90%), Renal (approximately 5% as unchanged drug)
Unchanged:
Approximately 5% (renal)
Pharmacodynamics
OnsetOfAction:
Within 1 week
PeakEffect:
2-4 weeks
DurationOfAction:
Not available (continuous daily dosing required)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Memory problems or loss
Feeling confused
Blood in the urine
Difficulty passing urine or changes in urine output
Blurred vision, double vision, or other changes in eyesight
Eyelid droop
Muscle-Related Side Effects
This medication may cause muscle pain, tenderness, or weakness, especially if you have low thyroid function, kidney problems, or are taking certain other medications. Your risk may also be higher if you are 65 or older. In rare cases, severe muscle problems can lead to kidney issues, and even death. Contact your doctor immediately if you experience:
Abnormal muscle pain, tenderness, or weakness (with or without fever or feeling unwell)
Muscle problems that persist after stopping the medication
Liver-Related Side Effects
Drugs like this one have been associated with liver problems, which can be fatal. Seek medical help right away if you notice:
Dark urine
Tiredness
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
Headache
Stomach pain
Upset stomach
Constipation
Joint pain
* Weakness
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Memory problems or loss
Feeling confused
Blood in the urine
Difficulty passing urine or changes in urine output
Blurred vision, double vision, or other changes in eyesight
Eyelid droop
Muscle-Related Side Effects
This medication may cause muscle pain, tenderness, or weakness, especially if you have low thyroid function, kidney problems, or are taking certain other medications. Your risk may also be higher if you are 65 or older. In rare cases, severe muscle problems can lead to kidney issues, and even death. Contact your doctor immediately if you experience:
Abnormal muscle pain, tenderness, or weakness (with or without fever or feeling unwell)
Muscle problems that persist after stopping the medication
Liver-Related Side Effects
Drugs like this one have been associated with liver problems, which can be fatal. Seek medical help right away if you notice:
Dark urine
Tiredness
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
Headache
Stomach pain
Upset stomach
Constipation
Joint pain
* Weakness
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine (signs of muscle breakdown).
- Yellowing of the skin or eyes (jaundice), dark urine, light-colored stools, or severe stomach pain (signs of liver problems).
- Unusual tiredness or weakness.
- Swelling in your hands or feet.
- Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have liver disease or elevated liver enzymes.
If you are currently taking any of the following medications: Cyclosporine, gemfibrozil, ledipasvir/sofosbuvir, sofosbuvir/velpatasvir/voxilaprevir, or tafamidis.
If you are pregnant or think you might be pregnant. Note that this medication is not recommended during pregnancy.
* If you are breastfeeding. You should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe for you to take this medication alongside your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have liver disease or elevated liver enzymes.
If you are currently taking any of the following medications: Cyclosporine, gemfibrozil, ledipasvir/sofosbuvir, sofosbuvir/velpatasvir/voxilaprevir, or tafamidis.
If you are pregnant or think you might be pregnant. Note that this medication is not recommended during pregnancy.
* If you are breastfeeding. You should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe for you to take this medication alongside your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
One of the potential side effects of this drug is high blood sugar, which may lead to the development of new-onset diabetes or worsen existing diabetes. To monitor this, follow your doctor's instructions for checking your blood sugar levels regularly. Additionally, adhere to the schedule recommended by your doctor for having blood work done, and discuss the results with your doctor.
To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. It is also crucial to follow the diet and exercise plan outlined by your doctor to ensure safe and effective use of this medication.
Limit your alcohol consumption to no more than 2 drinks per day, as excessive alcohol intake may increase your risk of developing liver disease.
If you are of Asian descent, exercise caution when taking this drug, as you may be more susceptible to side effects. Similarly, if you are 65 years or older, use this medication with caution due to the potential for increased side effects.
This drug may pose a risk to an unborn baby. If you are pregnant or may become pregnant, it is essential to use birth control while taking this medication. If you become pregnant, notify your doctor immediately.
One of the potential side effects of this drug is high blood sugar, which may lead to the development of new-onset diabetes or worsen existing diabetes. To monitor this, follow your doctor's instructions for checking your blood sugar levels regularly. Additionally, adhere to the schedule recommended by your doctor for having blood work done, and discuss the results with your doctor.
To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. It is also crucial to follow the diet and exercise plan outlined by your doctor to ensure safe and effective use of this medication.
Limit your alcohol consumption to no more than 2 drinks per day, as excessive alcohol intake may increase your risk of developing liver disease.
If you are of Asian descent, exercise caution when taking this drug, as you may be more susceptible to side effects. Similarly, if you are 65 years or older, use this medication with caution due to the potential for increased side effects.
This drug may pose a risk to an unborn baby. If you are pregnant or may become pregnant, it is essential to use birth control while taking this medication. If you become pregnant, notify your doctor immediately.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported. The most likely adverse effects would be an exaggeration of known side effects, such as muscle pain or liver enzyme elevations.
What to Do:
There is no specific antidote for rosuvastatin overdose. Treatment should be symptomatic and supportive. Hemodialysis is unlikely to be of benefit. Call 1-800-222-1222 (Poison Control Center) immediately for advice.
Drug Interactions
Contraindicated Interactions
- Cyclosporine (significantly increases rosuvastatin exposure)
- Co-administration with gemfibrozil (increases rosuvastatin exposure)
Major Interactions
- Antacids (aluminum and magnesium hydroxide) - administer rosuvastatin 2 hours after antacid
- Coumarin anticoagulants (e.g., Warfarin) - monitor INR
- Protease inhibitors (e.g., Atazanavir/Ritonavir, Lopinavir/Ritonavir, Tipranavir/Ritonavir) - significant increase in rosuvastatin exposure, dose adjustment needed
- Regorafenib (increases rosuvastatin exposure)
- Fibrates (e.g., Fenofibrate) - increased risk of myopathy/rhabdomyolysis
- Niacin (lipid-lowering doses âĨ1 g/day) - increased risk of myopathy/rhabdomyolysis
- Colchicine - increased risk of myopathy/rhabdomyolysis
Moderate Interactions
- Ezetimibe - increased risk of myopathy/rhabdomyolysis
- Erythromycin - decreases rosuvastatin exposure
- Oral contraceptives - increases ethinyl estradiol and norgestrel levels
- Fusidic acid (systemic) - increased risk of myopathy/rhabdomyolysis (avoid co-administration)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Rationale: To establish baseline lipid levels and assess treatment efficacy.
Timing: Before initiating therapy.
Liver Function Tests (ALT, AST)
Rationale: To establish baseline liver enzyme levels and monitor for drug-induced hepatotoxicity.
Timing: Before initiating therapy.
Creatine Kinase (CK)
Rationale: To establish baseline CK levels, especially in patients with predisposing factors for myopathy (e.g., renal impairment, hypothyroidism, history of muscle toxicity with other statins).
Timing: Before initiating therapy (if indicated).
Routine Monitoring
Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Frequency: 4-12 weeks after initiation or dose titration, then every 3-12 months or as clinically indicated.
Target: Individualized based on patient risk and guideline recommendations (e.g., LDL-C reduction goals).
Action Threshold: If lipid goals are not met, consider dose titration or alternative therapy. If lipid levels are excessively low, consider dose reduction.
Liver Function Tests (ALT, AST)
Frequency: Periodically as clinically indicated. Routine periodic monitoring of liver enzymes is no longer recommended unless clinically indicated (e.g., symptoms of liver injury).
Target: Within normal limits.
Action Threshold: If ALT or AST persistently exceed 3 times the upper limit of normal (ULN), discontinue rosuvastatin. If elevations are less than 3x ULN, monitor closely or consider dose reduction/discontinuation.
Creatine Kinase (CK)
Frequency: As clinically indicated (e.g., if patient reports muscle pain, tenderness, or weakness). Routine monitoring is not recommended.
Target: Within normal limits.
Action Threshold: If CK levels are significantly elevated (>10 times ULN) or if muscle symptoms are severe, discontinue rosuvastatin immediately. If CK is elevated but <10x ULN and symptoms are mild, monitor closely.
Symptom Monitoring
- Unexplained muscle pain, tenderness, or weakness (myopathy/rhabdomyolysis)
- Dark urine (rhabdomyolysis)
- Fever (rhabdomyolysis)
- Unusual fatigue or weakness
- Loss of appetite
- Upper right abdominal pain
- Nausea, vomiting
- Yellowing of skin or eyes (jaundice)
- Flu-like symptoms
Special Patient Groups
Pregnancy
Rosuvastatin is contraindicated in pregnancy. Cholesterol and its derivatives are essential for fetal development. Statins may cause fetal harm. If a patient becomes pregnant while taking this drug, discontinue treatment immediately and advise the patient of the potential hazard to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity due to interference with cholesterol synthesis, which is critical for fetal development.
Second Trimester:
Continued risk of fetal harm.
Third Trimester:
Continued risk of fetal harm.
Lactation
Rosuvastatin is contraindicated during breastfeeding. It is unknown if rosuvastatin is excreted in human milk, but other statins are. Due to the potential for serious adverse reactions in breastfed infants, women should not breastfeed while taking rosuvastatin.
Infant Risk:
High risk of serious adverse effects due to potential for interference with infant lipid metabolism and development.
Pediatric Use
Rosuvastatin is indicated for pediatric patients 7 years and older with homozygous familial hypercholesterolemia (HoFH) and for pediatric patients 8 years and older with heterozygous familial hypercholesterolemia (HeFH) if, after an adequate trial of diet therapy, the following findings are present: LDL-C > 190 mg/dL or LDL-C > 160 mg/dL and there is a positive family history of premature cardiovascular disease or two or more other CVD risk factors are present in the pediatric patient. Dosing varies by age and condition. Safety and efficacy have not been established in patients younger than 7 years.
Geriatric Use
No overall differences in effectiveness or safety were observed between geriatric patients (âĨ65 years) and younger patients. However, due to increased predisposition to myopathy and other adverse effects in the elderly, caution should be exercised, and the lowest effective dose should be considered. Renal function should be monitored.
Clinical Information
Clinical Pearls
- Rosuvastatin is a potent statin; a 5 mg dose of rosuvastatin is roughly equivalent in LDL-C lowering to 10 mg of atorvastatin.
- Administer rosuvastatin at any time of day, with or without food, as its absorption is not significantly affected by food and its long half-life allows for flexible dosing.
- Counsel patients to report any unexplained muscle pain, tenderness, or weakness immediately, as this could be a sign of myopathy or rhabdomyolysis.
- Avoid grapefruit juice with rosuvastatin, although the interaction is less pronounced than with some other statins (e.g., simvastatin, lovastatin).
- For patients of Asian descent, consider an initial dose of 5 mg due to higher systemic exposure to rosuvastatin.
- Ensure patients understand the importance of lifestyle modifications (diet, exercise) in conjunction with medication for optimal lipid management.
Alternative Therapies
- Other HMG-CoA reductase inhibitors (Statins): Atorvastatin, Simvastatin, Pravastatin, Lovastatin, Fluvastatin, Pitavastatin
- Cholesterol Absorption Inhibitors: Ezetimibe
- PCSK9 Inhibitors: Alirocumab, Evolocumab
- Fibrates: Gemfibrozil, Fenofibrate
- Niacin (Nicotinic Acid)
- Bile Acid Sequestrants: Cholestyramine, Colestipol, Colesevelam
- Omega-3 Fatty Acid Esters: Icosapent ethyl, Omega-3-acid ethyl esters
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.