What are the common side effects of simvastatin 5mg. How does simvastatin work to lower cholesterol levels. When should you not take simvastatin. What are the potential interactions with other medications.

Understanding Simvastatin: A Powerful Cholesterol-Lowering Drug

Simvastatin is a widely prescribed medication belonging to the class of drugs known as statins. It is primarily used to manage high cholesterol levels and reduce the risk of cardiovascular diseases. Available as both a brand-name drug (Zocor) and a generic version, simvastatin comes in two forms: oral tablets and oral suspension.

The primary functions of simvastatin include:

• Lowering LDL (bad) cholesterol and triglycerides
• Increasing HDL (good) cholesterol
• Slowing the progression of heart disease
• Reducing the risk of stroke and heart attack

How does simvastatin achieve these benefits? It works by inhibiting HMG-CoA reductase, an enzyme crucial for cholesterol production in the body. By doing so, simvastatin effectively reduces the amount of cholesterol and triglycerides circulating in the bloodstream.

Simvastatin Dosage and Administration

Simvastatin is available in various strengths, with 5mg being one of the lower doses. The appropriate dosage depends on several factors, including the patient’s cholesterol levels, medical history, and response to treatment.

Can simvastatin be taken at any time of day? While it can be taken at any time, it is often recommended to take simvastatin in the evening. This is because the body produces most cholesterol at night, and taking the medication in the evening may enhance its effectiveness.

Proper Administration of Simvastatin

To ensure optimal results and minimize side effects, follow these guidelines when taking simvastatin:

1. Take the medication exactly as prescribed by your healthcare provider
2. Swallow the tablet whole with a glass of water
3. Avoid consuming grapefruit or grapefruit juice while on simvastatin, as it can increase the risk of side effects
4. Inform your doctor of all other medications, supplements, or herbal products you are taking
5. Maintain a healthy lifestyle, including a balanced diet and regular exercise, to complement the medication’s effects

Common Side Effects of Simvastatin 5mg

While simvastatin is generally well-tolerated, some users may experience side effects. It’s important to note that the 5mg dose is relatively low, which may reduce the likelihood of adverse effects compared to higher doses.

What are the most common side effects associated with simvastatin 5mg? The following side effects are typically mild and may resolve on their own:

• Headache
• Nausea
• Stomach pain
• Constipation
• Mild muscle pain or weakness
• Joint pain
• Upper respiratory infections

Is muscle pain a common side effect of simvastatin 5mg? While muscle pain can occur, it is generally less common at lower doses like 5mg. However, if you experience persistent or severe muscle pain, it’s crucial to consult your healthcare provider immediately.

Serious Side Effects and Warnings

Although rare, simvastatin can cause serious side effects, particularly at higher doses or in certain risk groups. It’s essential to be aware of these potential complications and seek immediate medical attention if they occur.

Myopathy and Rhabdomyolysis

One of the most significant concerns with simvastatin and other statins is the risk of myopathy (muscle disease) and rhabdomyolysis (severe muscle breakdown). These conditions can lead to kidney failure in severe cases.

Who is at increased risk for myopathy and rhabdomyolysis when taking simvastatin? The following factors may elevate the risk:

• Advanced age
• Female gender
• Kidney disease
• Low thyroid function
• High doses of simvastatin
• Concurrent use of certain medications

What symptoms should prompt immediate medical attention? If you experience any of the following, contact your healthcare provider right away:

• Unexplained muscle weakness or tenderness
• Persistent muscle pain
• Muscle pain or weakness that persists after discontinuing the medication
• Abdominal pain
• Fever
• Dark-colored urine

Liver Concerns

Simvastatin can potentially cause liver problems, particularly in individuals with pre-existing liver conditions or a history of alcohol abuse. Regular liver function tests may be necessary for patients taking simvastatin.

When should simvastatin be avoided due to liver concerns? People with active liver disease should not use simvastatin. Those with a history of liver problems or alcohol abuse should discuss the risks and benefits with their healthcare provider before starting treatment.

Drug Interactions and Precautions

Simvastatin can interact with various medications, supplements, and even certain foods. These interactions can either reduce the effectiveness of simvastatin or increase the risk of side effects.

Strong CYP3A4 Inhibitors

Certain drugs known as strong CYP3A4 inhibitors can significantly interfere with the metabolism of simvastatin. This interaction can lead to dangerously high levels of simvastatin in the body, increasing the risk of side effects, including rhabdomyolysis.

Which medications should not be used concurrently with simvastatin? Some examples of strong CYP3A4 inhibitors that should be avoided include:

• Certain antifungal medications (e.g., itraconazole, ketoconazole)
• Some antibiotics (e.g., erythromycin, clarithromycin)
• HIV protease inhibitors
• Certain hepatitis C medications

If treatment with these drugs is necessary, simvastatin therapy should be temporarily suspended.

Other Important Interactions

What other substances can interact with simvastatin? Be cautious with the following:

• Grapefruit and grapefruit juice
• Other cholesterol-lowering medications (e.g., fibrates, niacin)
• Certain heart medications (e.g., amiodarone, verapamil)
• Cyclosporine
• Warfarin

Always inform your healthcare provider about all medications, supplements, and herbal products you are taking to avoid potential interactions.

Maximizing the Benefits of Simvastatin 5mg

While simvastatin 5mg can effectively lower cholesterol levels, its benefits are best realized when combined with lifestyle modifications. How can you enhance the effectiveness of your simvastatin treatment?

• Follow a heart-healthy diet low in saturated fats and rich in fruits, vegetables, and whole grains
• Engage in regular physical activity, aiming for at least 150 minutes of moderate-intensity exercise per week
• Maintain a healthy weight
• Quit smoking and limit alcohol consumption
• Manage stress through relaxation techniques or mindfulness practices
• Attend regular check-ups and follow your healthcare provider’s recommendations

By combining medication with these lifestyle changes, you can significantly improve your cholesterol profile and reduce your risk of cardiovascular diseases.

Monitoring and Follow-up Care

Regular monitoring is essential when taking simvastatin to ensure its effectiveness and detect any potential side effects early. What should you expect in terms of follow-up care?

• Periodic blood tests to check cholesterol levels and liver function
• Regular check-ups with your healthcare provider to assess your response to treatment
• Adjustment of dosage if necessary, based on your cholesterol levels and any side effects
• Ongoing evaluation of your overall cardiovascular risk

How often should you have your cholesterol levels checked while on simvastatin? Initially, your healthcare provider may recommend checks every 4-6 weeks until your cholesterol levels stabilize. After that, testing may be done every 3-6 months or as advised by your doctor.

When to Seek Medical Attention

While simvastatin 5mg is generally well-tolerated, it’s important to be vigilant about potential side effects. When should you contact your healthcare provider immediately?

• If you experience severe muscle pain, weakness, or tenderness
• If you notice signs of liver problems (e.g., yellowing of the skin or eyes, dark urine, persistent nausea)
• If you develop an allergic reaction (e.g., rash, itching, swelling, difficulty breathing)
• If you experience any unusual or severe side effects

Remember, early intervention can prevent serious complications and ensure the best possible outcomes from your simvastatin treatment.

Side Effects, Dosage, Usage, and More

1. Simvastatin oral tablet is available as a brand-name drug and a generic drug. Brand name: Zocor.
2. Simvastatin comes in two forms: an oral tablet and an oral suspension.
3. Simvastatin oral tablet is used to help lower cholesterol and triglyceride levels. It can also reduce the risk of heart disease.

• Myopathy and rhabdomyolysis warning: Simvastatin and other statin drugs can sometimes cause myopathy (muscle disease) or immune-mediated necrotizing myopathy (IMNM). They can even cause rhabdomyolysis (severe muscle breakdown). Rhabdomyolysis can lead to kidney failure. You have an increased risk of each condition if you:
  • are an older adult
  • are female
  • have kidney disease
  • have low thyroid function
  • take high doses of this drug
  • take this drug with certain other drugs

Tell your doctor right away if you experience:

• unexplained muscle weakness or tenderness
• persistent muscle pain
• muscle pain or weakness that does not go away when this drug is stopped
• abdominal pain
• fever
• dark-colored urine

• Warning for liver disease and alcohol misuse: People with active liver disease should not use simvastatin. People with a history of alcohol abuse or liver disease should discuss the risks of this drug with their doctor. For people with these conditions, simvastatin can increase the risk of serious liver injury.

Simvastatin is a prescription drug. It comes in two forms: a tablet and a suspension. Both forms are taken by mouth.

Simvastatin oral tablet is available as the brand-name drug Zocor. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug.

Why it’s used

Simvastatin oral tablet is used to:

• lower low-density lipoprotein, or LDL (bad) cholesterol and triglycerides in the body
• increase high-density lipoprotein, or HDL (good) cholesterol
• slow the development of heart disease and reduce the risk of stroke

How it works

Simvastatin belongs to the drug class known as HMG-CoA reductase inhibitors, also called statins. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Statins work to reduce the body’s cholesterol production. They also reduce the amount of cholesterol and triglycerides moving through the body. High cholesterol and triglycerides are associated with increased risk of:

• heart disease
• stroke
• heart attack

Statins are usually used in combination with lifestyle changes, such as changes to diet and exercise.

Simvastatin oral tablet doesn’t cause drowsiness, but it can cause other side effects.

More common side effects

The more common side effects that can occur with simvastatin include:

• headache
• nausea
• stomach pain
• constipation
• muscle pain or weakness
• joint pain
• upper respiratory infections

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• rhabdomyolysis (muscle breakdown)
• severe muscle pain or weakness
• muscle pain or weakness that does not go away when this drug is stopped
• muscle spasms
• kidney failure
• liver toxicity
• jaundice (yellowing of the skin)
• severe anemia
• severe allergic reaction, with symptoms such as fever and trouble breathing
• rash of any kind
• extreme sensitivity to the sun
• diarrhea
• feeling weak or very tired
• severe stomach pain
• severe nausea or vomiting
• severe swelling of the hands, feet, and ankles

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we can not guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare professional who knows your medical history.

Simvastatin oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk with your doctor or pharmacist.

Examples of drugs that can cause interactions with simvastatin are listed below.

Strong CYP3A4 Inhibitors

These drugs block your body from breaking down simvastatin. This can lead to very high levels of the drug in your body. It can also increase side effects, including rhabdomyolysis.

These drugs should not be used with simvastatin. If treatment with these drugs is required, the use of simvastatin must be on hold during the course of treatment. Examples of these drugs include:

• ketoconazole
• itraconazole
• voriconazole
• posaconazole
• erythromycin
• clarithromycin
• telithromycin
• cyclosporine
• danazol
• nefazodone
• telaprevir
• ritonavir
• tipranavir
• indinavir
• fosamprenavir
• darunavir
• atazanavir
• nelfinavir
• cobicistat

Other cholesterol-lowering drugs

When used with simvastatin, some cholesterol drugs can increase side effects such as myopathy or rhabdomyolysis. If you use these drugs with simvastatin, your doctor may lower your dosage of simvastatin. Examples of these drugs include:

• gemfibrozil
• fenofibrate
• niacin
• lomitapide

The Food and Drug Administration (FDA) reports that, according to research, with niacin, the incidence of myopathy and rhabdomyolysis is higher when the drug is taken in larger doses and in people of Chinese descent.

Calcium channel blockers and other drugs that increase risk for myopathy or rhabdomyolysis

Using simvastatin with these drugs can increase the risk of myopathy or rhabdomyolysis. Your doctor may discuss other medication options or lower your dosage of simvastatin. Examples of calcium channel blockers include:

• amlodipine
• diltiazem
• verapamil

Do not take more than 10 mg of simvastatin with diltiazem or verapamil, or more than 20 mg of simvastatin with amlodipine.

Other drugs that increase risk of myopathy or rhabdomyolysis include:

• amiodarone
• dronedarone
• ranolazine

Heart drug

Digoxin is used to treat heart failure and arrhythmias. Taking simvastatin with digoxin can increase levels of digoxin in your body. If you’re taking both drugs, your doctor may want to monitor your digoxin level more closely.

Gout drug

Colchicine is a drug used to treat gout. Using simvastatin with colchicine can increase the risk of both myopathy and rhabdomyolysis.

Warfarin (blood thinner)

When taken with warfarin, simvastatin can increase the blood-thinning effects of warfarin. This can lead to an increased risk of bleeding. Your doctor may want to monitor your warfarin level more closely if you’re taking these two drugs at the same time.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we can not guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare professional about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

This drug comes with several warnings.

Alcohol warning

People with a history of alcohol misuse and risk of liver disease should not take this drug. For people with these conditions, simvastatin can increase the risk of serious liver injury.

Food interaction warning

Avoid grapefruit juice while taking simvastatin. Grapefruit juice can increase simvastatin levels in your body and increase the risk of side effects.

Warnings for people with certain health conditions

For people with low thyroid function (hypothyroidism) or diabetes: Simvastatin and other statin drugs can sometimes cause rhabdomyolysis. Having hypothyroidism or diabetes raises your risk for this condition. Other risk factors include:

• being an older adult
• being female
• having kidney disease
• use of drugs that interact with simvastatin

Tell your doctor right away if you experience:

• unexplained muscle weakness or tenderness
• continuous muscle pain
• diarrhea
• fever
• dark-colored urine

For people with liver disease: People with active liver disease, such as cirrhosis or hepatitis, should not use simvastatin.

Warnings for other groups

For pregnant people: In July 2021, the FDA requested that statins no longer be labeled as “contraindicated” in pregnancy. The FDA still recommends that most patients discontinue statins when they become pregnant. The contraindication was removed as the choice to continue a statin should be patient-specific with the pros and cons weighed by both the doctor and the patient. The FDA has requested that manufacturers update their package inserts to reflect the change. As of now, there is no deadline by which all manufacturers must update their package inserts.

Simvastatin blocks the production of cholesterol, which is important for the developing baby.

If you’re pregnant and need treatment for high cholesterol or triglycerides, talk with your doctor. They can discuss other treatment options during pregnancy.

If you become pregnant while taking this drug, call your doctor right away.

For people who are nursing: It isn’t known if simvastatin enters breast milk. However, because of the risk of severe side effects, this drug should not be used during nursing. Talk with your doctor about other cholesterol treatment options while nursing.

For people of Chinese descent: The risk of myopathy and rhabdomyolysis is higher when the drug is taken with niacin in larger doses. In addition, the FDA reports that, according to research, the incidence of myopathy is higher in people of Chinese descent. For more information about this higher occurrence, talk with your doctor.

All possible dosages and forms may not be included here. Your dose, form, and how often you take it may depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

Drug forms and strengths

Generic: Simvastatin

• Form: oral tablet
• Strengths: 5 mg, 10 mg, 20 mg, 40 mg, 80 mg

Brand: Zocor

• Form: oral tablet
• Strengths: 5 mg, 10 mg, 20 mg, 40 mg

Dosage for high cholesterol

Adult dosage (ages 18 years and older)

• Typical starting dosage: Simvastatin is often started at 10–20 mg per day. However, the dosage may range from 5 mg to 40 mg per day. You should take this drug once a day in the evening.
• Dosage increases: Your doctor will gradually adjust your dosage if needed.

Child dosage (ages 10–17 years)

• Typical starting dosage: 10 mg per day.
• Note: Doses above 40 mg per day have not been studied in this age group.

Child dosage (ages 4–9 years)

• Typical starting dosage: 5 mg per day.
• Note: Doses above 20 mg per day have not been studied in this age group.

Child dosage (ages 0–4 years)

This medication has not been studied in children below age 4 years.

Dosage for reducing the risk of heart disease and heart attack and stroke in people with heart disease

Adult dosage (ages 18 years and older)

• Typical starting dosage: Simvastatin is often started at 10–20 mg per day. However, the dosage may range from 5 mg to 40 mg per day. You should take this drug once a day in the evening.
• Dosage increases: Your doctor will gradually adjust your dosage if needed.

Child dosage (ages 10–17 years)

• Typical starting dosage: 10 mg per day.
• Note: Doses above 40 mg per day have not been studied in this age group.

Child dosage (ages 0–9 years)

This medication has not been studied in children below age 10 years.

Special dosage considerations

• For people with kidney disease: Having kidney disease may affect your dosage. People with advanced kidney disease usually require a lower dosage. Talk with your doctor about your treatment with simvastatin if you have kidney disease.
• For people with liver disease: If your liver isn’t working well, more of this drug may stay in your body longer. This puts you at increased risk of side effects. If you have active liver problems, you should not use this medication.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we can not guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Simvastatin is used for long-term treatment. It comes with serious risks if you don’t take it as prescribed.

If you don’t take it at all or stop taking it: If you have high cholesterol and don’t take your simvastatin, you risk having increased cholesterol levels, developing heart disease, and having a heart attack or a stroke.

If you don’t take it on schedule: Not taking simvastatin every day, skipping days, or taking doses at different times of the day may also increase your risk for high cholesterol levels, heart attack, or stroke.

If you miss a dose: If you miss a dose, take the next dose as scheduled. Do not double your dose.

How can I tell if the drug is working: Your cholesterol and triglyceride levels should be within healthy levels while taking it.

Keep these considerations in mind if your doctor prescribes simvastatin for you.

General

• You can take simvastatin with or without food. Taking it with food may reduce nausea.
• Take simvastatin in the evening to maximize its effects. Cholesterol production in the body is highest at nighttime.

Storage

• Store the tablets between 41°F and 86°F (5°C to 30°C).
• Keep the tablets in a tightly closed, light-resistant container.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They won’t damage your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Do not put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

While you take simvastatin, your doctor will want to make sure that it isn’t affecting your liver and kidneys. Your doctor may perform a baseline liver function test (an initial liver function test that is repeated in a few months). They may also do additional liver and kidney function tests during treatment.

Are there any alternatives?

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk with your doctor about other drug options that may work for you.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained here is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Side Effects, Dosage, Usage, and More

1. Simvastatin oral tablet is available as a brand-name drug and a generic drug. Brand name: Zocor.
2. Simvastatin comes in two forms: an oral tablet and an oral suspension.
3. Simvastatin oral tablet is used to help lower cholesterol and triglyceride levels. It can also reduce the risk of heart disease.

• Myopathy and rhabdomyolysis warning: Simvastatin and other statin drugs can sometimes cause myopathy (muscle disease) or immune-mediated necrotizing myopathy (IMNM). They can even cause rhabdomyolysis (severe muscle breakdown). Rhabdomyolysis can lead to kidney failure. You have an increased risk of each condition if you:
  • are an older adult
  • are female
  • have kidney disease
  • have low thyroid function
  • take high doses of this drug
  • take this drug with certain other drugs

Tell your doctor right away if you experience:

• unexplained muscle weakness or tenderness
• persistent muscle pain
• muscle pain or weakness that does not go away when this drug is stopped
• abdominal pain
• fever
• dark-colored urine

• Warning for liver disease and alcohol misuse: People with active liver disease should not use simvastatin. People with a history of alcohol abuse or liver disease should discuss the risks of this drug with their doctor. For people with these conditions, simvastatin can increase the risk of serious liver injury.

Simvastatin is a prescription drug. It comes in two forms: a tablet and a suspension. Both forms are taken by mouth.

Simvastatin oral tablet is available as the brand-name drug Zocor. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug.

Why it’s used

Simvastatin oral tablet is used to:

• lower low-density lipoprotein, or LDL (bad) cholesterol and triglycerides in the body
• increase high-density lipoprotein, or HDL (good) cholesterol
• slow the development of heart disease and reduce the risk of stroke

How it works

Simvastatin belongs to the drug class known as HMG-CoA reductase inhibitors, also called statins. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Statins work to reduce the body’s cholesterol production. They also reduce the amount of cholesterol and triglycerides moving through the body. High cholesterol and triglycerides are associated with increased risk of:

• heart disease
• stroke
• heart attack

Statins are usually used in combination with lifestyle changes, such as changes to diet and exercise.

Simvastatin oral tablet doesn’t cause drowsiness, but it can cause other side effects.

More common side effects

The more common side effects that can occur with simvastatin include:

• headache
• nausea
• stomach pain
• constipation
• muscle pain or weakness
• joint pain
• upper respiratory infections

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• rhabdomyolysis (muscle breakdown)
• severe muscle pain or weakness
• muscle pain or weakness that does not go away when this drug is stopped
• muscle spasms
• kidney failure
• liver toxicity
• jaundice (yellowing of the skin)
• severe anemia
• severe allergic reaction, with symptoms such as fever and trouble breathing
• rash of any kind
• extreme sensitivity to the sun
• diarrhea
• feeling weak or very tired
• severe stomach pain
• severe nausea or vomiting
• severe swelling of the hands, feet, and ankles

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we can not guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare professional who knows your medical history.

Simvastatin oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk with your doctor or pharmacist.

Examples of drugs that can cause interactions with simvastatin are listed below.

Strong CYP3A4 Inhibitors

These drugs block your body from breaking down simvastatin. This can lead to very high levels of the drug in your body. It can also increase side effects, including rhabdomyolysis.

These drugs should not be used with simvastatin. If treatment with these drugs is required, the use of simvastatin must be on hold during the course of treatment. Examples of these drugs include:

• ketoconazole
• itraconazole
• voriconazole
• posaconazole
• erythromycin
• clarithromycin
• telithromycin
• cyclosporine
• danazol
• nefazodone
• telaprevir
• ritonavir
• tipranavir
• indinavir
• fosamprenavir
• darunavir
• atazanavir
• nelfinavir
• cobicistat

Other cholesterol-lowering drugs

When used with simvastatin, some cholesterol drugs can increase side effects such as myopathy or rhabdomyolysis. If you use these drugs with simvastatin, your doctor may lower your dosage of simvastatin. Examples of these drugs include:

• gemfibrozil
• fenofibrate
• niacin
• lomitapide

The Food and Drug Administration (FDA) reports that, according to research, with niacin, the incidence of myopathy and rhabdomyolysis is higher when the drug is taken in larger doses and in people of Chinese descent.

Calcium channel blockers and other drugs that increase risk for myopathy or rhabdomyolysis

Using simvastatin with these drugs can increase the risk of myopathy or rhabdomyolysis. Your doctor may discuss other medication options or lower your dosage of simvastatin. Examples of calcium channel blockers include:

• amlodipine
• diltiazem
• verapamil

Do not take more than 10 mg of simvastatin with diltiazem or verapamil, or more than 20 mg of simvastatin with amlodipine.

Other drugs that increase risk of myopathy or rhabdomyolysis include:

• amiodarone
• dronedarone
• ranolazine

Heart drug

Digoxin is used to treat heart failure and arrhythmias. Taking simvastatin with digoxin can increase levels of digoxin in your body. If you’re taking both drugs, your doctor may want to monitor your digoxin level more closely.

Gout drug

Colchicine is a drug used to treat gout. Using simvastatin with colchicine can increase the risk of both myopathy and rhabdomyolysis.

Warfarin (blood thinner)

When taken with warfarin, simvastatin can increase the blood-thinning effects of warfarin. This can lead to an increased risk of bleeding. Your doctor may want to monitor your warfarin level more closely if you’re taking these two drugs at the same time.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we can not guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare professional about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

This drug comes with several warnings.

Alcohol warning

People with a history of alcohol misuse and risk of liver disease should not take this drug. For people with these conditions, simvastatin can increase the risk of serious liver injury.

Food interaction warning

Avoid grapefruit juice while taking simvastatin. Grapefruit juice can increase simvastatin levels in your body and increase the risk of side effects.

Warnings for people with certain health conditions

For people with low thyroid function (hypothyroidism) or diabetes: Simvastatin and other statin drugs can sometimes cause rhabdomyolysis. Having hypothyroidism or diabetes raises your risk for this condition. Other risk factors include:

• being an older adult
• being female
• having kidney disease
• use of drugs that interact with simvastatin

Tell your doctor right away if you experience:

• unexplained muscle weakness or tenderness
• continuous muscle pain
• diarrhea
• fever
• dark-colored urine

For people with liver disease: People with active liver disease, such as cirrhosis or hepatitis, should not use simvastatin.

Warnings for other groups

For pregnant people: In July 2021, the FDA requested that statins no longer be labeled as “contraindicated” in pregnancy. The FDA still recommends that most patients discontinue statins when they become pregnant. The contraindication was removed as the choice to continue a statin should be patient-specific with the pros and cons weighed by both the doctor and the patient. The FDA has requested that manufacturers update their package inserts to reflect the change. As of now, there is no deadline by which all manufacturers must update their package inserts.

Simvastatin blocks the production of cholesterol, which is important for the developing baby.

If you’re pregnant and need treatment for high cholesterol or triglycerides, talk with your doctor. They can discuss other treatment options during pregnancy.

If you become pregnant while taking this drug, call your doctor right away.

For people who are nursing: It isn’t known if simvastatin enters breast milk. However, because of the risk of severe side effects, this drug should not be used during nursing. Talk with your doctor about other cholesterol treatment options while nursing.

For people of Chinese descent: The risk of myopathy and rhabdomyolysis is higher when the drug is taken with niacin in larger doses. In addition, the FDA reports that, according to research, the incidence of myopathy is higher in people of Chinese descent. For more information about this higher occurrence, talk with your doctor.

All possible dosages and forms may not be included here. Your dose, form, and how often you take it may depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

Drug forms and strengths

Generic: Simvastatin

• Form: oral tablet
• Strengths: 5 mg, 10 mg, 20 mg, 40 mg, 80 mg

Brand: Zocor

• Form: oral tablet
• Strengths: 5 mg, 10 mg, 20 mg, 40 mg

Dosage for high cholesterol

Adult dosage (ages 18 years and older)

• Typical starting dosage: Simvastatin is often started at 10–20 mg per day. However, the dosage may range from 5 mg to 40 mg per day. You should take this drug once a day in the evening.
• Dosage increases: Your doctor will gradually adjust your dosage if needed.

Child dosage (ages 10–17 years)

• Typical starting dosage: 10 mg per day.
• Note: Doses above 40 mg per day have not been studied in this age group.

Child dosage (ages 4–9 years)

• Typical starting dosage: 5 mg per day.
• Note: Doses above 20 mg per day have not been studied in this age group.

Child dosage (ages 0–4 years)

This medication has not been studied in children below age 4 years.

Dosage for reducing the risk of heart disease and heart attack and stroke in people with heart disease

Adult dosage (ages 18 years and older)

• Typical starting dosage: Simvastatin is often started at 10–20 mg per day. However, the dosage may range from 5 mg to 40 mg per day. You should take this drug once a day in the evening.
• Dosage increases: Your doctor will gradually adjust your dosage if needed.

Child dosage (ages 10–17 years)

• Typical starting dosage: 10 mg per day.
• Note: Doses above 40 mg per day have not been studied in this age group.

Child dosage (ages 0–9 years)

This medication has not been studied in children below age 10 years.

Special dosage considerations

• For people with kidney disease: Having kidney disease may affect your dosage. People with advanced kidney disease usually require a lower dosage. Talk with your doctor about your treatment with simvastatin if you have kidney disease.
• For people with liver disease: If your liver isn’t working well, more of this drug may stay in your body longer. This puts you at increased risk of side effects. If you have active liver problems, you should not use this medication.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we can not guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Simvastatin is used for long-term treatment. It comes with serious risks if you don’t take it as prescribed.

If you don’t take it at all or stop taking it: If you have high cholesterol and don’t take your simvastatin, you risk having increased cholesterol levels, developing heart disease, and having a heart attack or a stroke.

If you don’t take it on schedule: Not taking simvastatin every day, skipping days, or taking doses at different times of the day may also increase your risk for high cholesterol levels, heart attack, or stroke.

If you miss a dose: If you miss a dose, take the next dose as scheduled. Do not double your dose.

How can I tell if the drug is working: Your cholesterol and triglyceride levels should be within healthy levels while taking it.

Keep these considerations in mind if your doctor prescribes simvastatin for you.

General

• You can take simvastatin with or without food. Taking it with food may reduce nausea.
• Take simvastatin in the evening to maximize its effects. Cholesterol production in the body is highest at nighttime.

Storage

• Store the tablets between 41°F and 86°F (5°C to 30°C).
• Keep the tablets in a tightly closed, light-resistant container.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They won’t damage your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Do not put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

While you take simvastatin, your doctor will want to make sure that it isn’t affecting your liver and kidneys. Your doctor may perform a baseline liver function test (an initial liver function test that is repeated in a few months). They may also do additional liver and kidney function tests during treatment.

Are there any alternatives?

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk with your doctor about other drug options that may work for you.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained here is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Simvastatin – description of the substance, pharmacology, use, contraindications, formula

Contents

• Structural formula

• Russian name

• English name

• Latin name

• chemical name

• Gross formula

• Pharmacological group of the substance Simvastatin

• Nosological classification

• CAS code

• pharmachologic effect

• Characteristic

• Pharmacology

• The use of the substance Simvastatin

• Contraindications

• Use during pregnancy and lactation

• Side effects of simvastatin

• Interaction

• Dosage and administration

• Precautionary measures

• Trade names with the active ingredient Simvastatin

Structural formula

Russian name

Simvastatin

English name

Simvastatin

Latin name

Simvastatinum (born 90 060 Simvastatini)

Chemical name

1,2,3,7,8,8a- Hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl-2,2-dimethylbutanoate

Gross formula

C ₂₅ H ₃₈ O ₅

Pharmacological group of the substance Simvastatin

Statins

Nosological classification

ICD-10 code list

• E78. 0 Pure hypercholesterolemia

• E78.2 Mixed hyperlipidemia

• I25 Chronic ischemic heart disease

• I70 Atherosclerosis

CAS code

79902-63-9

Pharmacological action

Pharmacological action –

hypocholesterolemic .

Characteristics

White or almost white crystalline powder. Non-hygroscopic. Practically insoluble in water, freely soluble in chloroform, methanol and ethanol.

Pharmacology

When taken orally, it is hydrolyzed to form an active metabolite that inhibits 3-hydroxy-3-methyl-glutaryl-CoA reductase (catalyses the rate-limiting step in cholesterol synthesis). Reduces both elevated and normal cholesterol levels, the concentration of LDL and VLDL. As a result, the ratio of HDL to LDL increases and cholesterol/HDL decreases. Increases the content of HDL and reduces the concentration of triglycerides. In hereditary absence of LDL receptors (homozygous familial hypercholesterolemia), simvastatin is ineffective. A reliable clinical result is obtained 2 weeks after the start of treatment, the maximum – after 4-6 weeks. Long-term use of 20–40 mg/day increases the survival rate of patients with hypercholesterolemia and coronary artery disease, reduces the progression of atherosclerotic lesions of the coronary arteries. It is active with the ineffectiveness of diet therapy and other non-drug methods of treatment.

After oral administration, the concentration of simvastatin and its metabolites (formed mainly in the liver) reaches a maximum after 4 hours and decreases by 90% after 12 hours. Both simvastatin and its plasma biotransformation products are 95% bound to proteins. Hypocholesterolemic activity is retained by 6′-hydroxy-, 6′-hydroxymethyl- and 6′-exomethylene derivatives. Excreted as metabolites in bile (60%) and urine (13%).

The use of the substance Simvastatin

Hypercholesterolemia in the absence of the effect of diet therapy, combined hypercholesterolemia and triglyceridemia, coronary artery disease, prevention of myocardial infarction and stroke, atherosclerosis.

Contraindications

Hypersensitivity, acute liver dysfunction, severe renal failure, pregnancy, breast-feeding, childhood.

Use in pregnancy and lactation

FDA category of action on the fetus – X.

Side effects of the substance Simvastatin

Dyspepsia, diarrhea, flatulence, nausea, exacerbation of pancreatitis and hepatitis, increased transaminase levels , CNS disorders ( headache, paresthesia, convulsions), myalgia, asthenia, myopathy, rhabdomyolysis, photosensitivity, allergic reactions (vasculitis, urticaria, arthralgia, thrombocytopenia, eosinophilia, angioedema, symptoms similar to lupus erythematosus).

Interactions

Immunosuppressive therapy, high doses of nicotinic acid, azole antifungals (ketoconazole, itraconazole) increase the risk of myopathy and rhabdomyolysis. Enhances the effects of indirect anticoagulants, hepatotoxicity of alcohol and drugs that adversely affect the liver.

Method of administration and doses

Inside: at the beginning of the course once at a dose of 5-10 mg / day, if necessary, up to 40 mg per day, depending on the content of cholesterol and lipoproteins in the blood. With IHD, the initial dose is 20 mg / day once.

Precautions

Monitoring of liver function is recommended before and during treatment and should be used with caution in abnormalities.

Trade names with the active substance Simvastatin

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Manufacturer
All manufacturers AVVA RUS JSC ALKALOID AD Skopje ALSI Pharma JSC ALSI Pharma CJSC Akrikhin JSC Active ingredient CJSC Alkaloid Artemis Biotek (Department of Themis Medicare Limited) Borisov Plant of Medical Preparations JSC (JSC “BZMP”) VERTEKS JSC Valenta Pharmaceutics JSC (JSC “Valenta Pharm” ) J. Umphrey Laboratories Zentiva c.s ZiO-Health Ipka Laboratories Ltd. Krka Krka-Rus Merck Sharp and Dome Micro Labs Limited Renewal of PFC JSC Ozon OOO Ozon Pharm OOO Polpharma S.A., Poland Ranbaxy Laboratories Limited STI-MED-SORB Salutas Pharma GmbH Sun Pharmaceutical Industries Ltd. Sandoz Group Saglik Urunleri Ilachlari Sanai ve Tijaret A.Sh. Pharmstandard-Leksredstva Hemofarm Hetero Labs Limited Zhejiang Haisan Pharmaceutical Co. Zhejiang Jiangbei Pharmaceutical Co. Ltd. Shangyu Jingxin Pharmaceutical Co. Shin Pung Pharmaceutical Co.

Department of Medicines – Simvastatin: restriction of medical use.

Simvastatin: restricted medical use.

The Center for Expertise for Drug Safety (CEBLS) reminds you that the use of certain drugs may be associated with the risk of developing serious, life-threatening complications of pharmacotherapy, such as myopathies and rhabdomyolysis. It is known that the prescription of drugs (drugs) from the group of statins (Simvastatin, Lovastatin, Pravastatin, Atorvastatin, Rosuvastatin) may be associated with the risk of developing in patients a serious, life-threatening adverse reaction (ADR) – myopathy. Clinically, myopathy is manifested by weakness, muscle pain and an increase in the level of creatine kinase in the blood plasma. One of the most severe complications is rhabdomyolysis, a syndrome that develops as a result of damage to skeletal muscles, resulting in the appearance of free myoglobin in the blood (myoglobinemia). At the onset of the disease, pain, muscle weakness, swelling of the muscles, and darkening of the urine are possible. Often rhabdomyolysis led to the development of renal failure and death.
Risk factors for the development of rhabdomyolysis are:
• Patient’s age over 65;
• Hypothyroidism;
• Presence of kidney pathology.
In the recent SEARCH study, rhabdomyolysis was significantly more common (52 cases) in the simvastatin 80 mg daily dose group than in the 20 mg simvastatin group (1 case).
Based on the information received, the US Food and Drug Administration (US FDA) decided to make a number of additions to the instructions for medical use of Simvastatin regarding its dosages and interactions with other drugs, which are presented below.
Additions made by the FDA to the instructions for medical use of Simvastatin dated 08/06/2011.
• It is recommended to use simvastatin in the dose range of 5 to 40 mg/day.
• The usual starting dose of simvastatin is 10 to 20 mg given once daily in the evening.
• In patients with coronary artery disease (CHD) or at high risk of developing complications from CAD, it is recommended to start simvastatin therapy in conjunction with a therapeutic diet.
• In patients with coronary artery disease who have additional risk factors for cardiovascular complications, such as diabetes mellitus, peripheral vascular disease, cerebrovascular disease, or a history of stroke, the recommended initial daily dose of simvastatin is 40 mg/day.
• In patients suffering from homozygous hereditary hypercholesterolemia, it is recommended to use simvastatin at a daily dose of 40 mg, in the evening, in addition to other methods of treating hypercholesterolemia, for example, low-density lipoprotein apheresis, or if they are not possible.
• In adolescents 10-17 years of age, the initial daily dose is 10 mg once a day, in the evening. It is not recommended to prescribe Simvastatin in a daily dose of more than 40 mg in this category of patients. If necessary, correction of ongoing therapy is recommended every 4 weeks.
• In patients with impaired renal function, dose adjustment is not necessary due to the fact that the drug is slightly excreted in the urine, however, in patients with severe kidney damage, the recommended initial daily dose of Simvastatin is 5 mg / day under the control of renal function.
• Routine determination of plasma lipid levels should begin after 4 weeks of treatment.

Limitations of simvastatin 80 mg daily:
• It is not recommended to initiate treatment with simvastatin 80 mg daily.
• The use of Simvastatin at a daily dose of 80 mg is possible only in patients taking the drug at this dosage for a long time (more than a year) without signs of damage to muscle tissue.
• If patients taking simvastatin 80 mg need to use other drugs for which administrative decisions have been made (the list of drugs is presented below), it is recommended to replace simvastatin with another drug from the statin group.