What are the common and serious side effects of simvastatin 20mg tablets. How can patients manage potential risks associated with this cholesterol-lowering medication. What precautions should be taken when using simvastatin.

Understanding Simvastatin: A Powerful Cholesterol-Lowering Medication

Simvastatin is a widely prescribed medication belonging to the statin class of drugs. It’s primarily used to lower cholesterol levels and reduce the risk of cardiovascular events in patients with high cholesterol or heart disease. While simvastatin is generally well-tolerated, it’s important for patients to be aware of potential side effects and how to manage them effectively.

Common Side Effects of Simvastatin 20mg Tablets

Most side effects associated with simvastatin are mild and often resolve on their own as the body adjusts to the medication. However, it’s crucial to be aware of these potential effects:

• Upper respiratory infections
• Headache
• Stomach pain
• Constipation
• Nausea
• Vertigo
• Insomnia
• Muscle pain
• Fluid retention
• Swollen sinuses

Are these side effects a cause for concern? In most cases, these common side effects are not serious and may subside as your body adjusts to the medication. However, if they persist or become bothersome, it’s important to consult your healthcare provider.

Serious Side Effects Requiring Immediate Medical Attention

While rare, some side effects of simvastatin can be serious and require prompt medical attention. Patients should be vigilant for the following symptoms:

• Unexplained muscle pain, tenderness, weakness, or cramps
• Yellowing of the eyes or skin (jaundice)
• Dark urine or pale stools
• Severe stomach pain
• Skin rash with pink-red blotches
• Cough, shortness of breath, and unexplained weight loss
• Signs of a severe allergic reaction (anaphylaxis)

When should you seek emergency medical care? If you experience symptoms of a severe allergic reaction, such as difficulty breathing, swelling of the face or throat, or a severe skin reaction, seek immediate medical attention by calling emergency services or visiting the nearest emergency room.

Cognitive Side Effects: Memory and Confusion Concerns

Some patients taking simvastatin have reported cognitive side effects, including memory problems and confusion. While these effects are not common, they can be concerning for patients.

Is there a link between statins and cognitive decline? Research on the relationship between statins and cognitive function has produced mixed results. Some studies suggest a potential link, while others have found no significant association. If you experience persistent cognitive issues while taking simvastatin, discuss these concerns with your healthcare provider.

Managing Cognitive Side Effects

If you’re experiencing cognitive side effects while taking simvastatin, consider the following steps:

1. Keep a journal of your symptoms and when they occur
2. Discuss your concerns with your healthcare provider
3. Consider cognitive exercises or activities to maintain mental sharpness
4. Explore potential alternative medications or dosage adjustments with your doctor

Myopathy and Rhabdomyolysis: Understanding Muscle-Related Side Effects

One of the most serious potential side effects of simvastatin is myopathy, a condition characterized by muscle weakness and pain. In rare cases, this can progress to rhabdomyolysis, a severe form of muscle damage that can lead to kidney failure.

What factors increase the risk of muscle-related side effects? The risk of myopathy and rhabdomyolysis is higher in patients taking high doses of simvastatin, those with certain genetic predispositions, and individuals taking medications that interact with simvastatin.

Recognizing Signs of Muscle Damage

Be alert for the following symptoms, which may indicate muscle damage:

• Unexplained muscle pain or tenderness
• Muscle weakness, especially in the upper arms, thighs, or hips
• Dark or cola-colored urine
• Fatigue or general weakness
• Fever or feeling unwell

If you experience these symptoms, contact your healthcare provider immediately. Early detection and intervention can prevent the progression to more serious complications.

Gastrointestinal Side Effects: Managing Constipation and Stomach Pain

Gastrointestinal side effects, particularly constipation and stomach pain, are relatively common among simvastatin users. While these effects are usually mild, they can be uncomfortable and impact quality of life.

How can you alleviate gastrointestinal side effects? Several strategies may help manage these symptoms:

• Increase your fiber intake through diet or supplements
• Stay well-hydrated by drinking plenty of water
• Engage in regular physical activity
• Consider taking simvastatin with food (unless otherwise directed by your doctor)
• Discuss the use of over-the-counter remedies with your healthcare provider

If gastrointestinal side effects persist or worsen, consult your healthcare provider. They may recommend adjusting your dosage or exploring alternative medications.

Timeline of Side Effects: What to Expect When Starting Simvastatin

Understanding the typical timeline for side effects can help patients better manage their expectations and identify any concerning symptoms promptly.

Short-term Side Effects

Some side effects may appear shortly after starting simvastatin:

• Headache: Often occurs within the first few days
• Stomach upset: May begin within the first week
• Muscle aches: Can develop within the first few weeks

Long-term Side Effects

Certain side effects may develop over a longer period:

• Liver function changes: May occur after several months of treatment
• Increased blood sugar levels: Can develop over time, potentially leading to diabetes in some individuals
• Cognitive effects: May appear gradually and be subtle at first

How long should you wait for side effects to subside? Many side effects improve within a few weeks as your body adjusts to the medication. However, if side effects persist or worsen after 4-6 weeks, consult your healthcare provider.

Contraindications and Warnings: When to Avoid Simvastatin

Simvastatin is not suitable for everyone. Certain conditions and factors may increase the risk of side effects or complications.

Absolute Contraindications

Simvastatin should not be used in the following situations:

• Active liver disease or unexplained persistent elevations in liver enzymes
• Pregnancy or breastfeeding
• Known hypersensitivity to simvastatin or any component of the formulation

Relative Contraindications and Warnings

Caution is advised in the following circumstances:

• History of liver disease
• Heavy alcohol consumption
• Kidney impairment
• Hypothyroidism
• Age over 65 years
• Female gender (increased risk of myopathy)

Why is it crucial to inform your healthcare provider about your medical history? Providing a complete medical history allows your doctor to assess the potential risks and benefits of simvastatin treatment and make appropriate recommendations for monitoring and dosage.

Drug Interactions: Medications to Avoid While Taking Simvastatin

Simvastatin can interact with various medications, potentially increasing the risk of side effects or reducing its effectiveness. It’s essential to be aware of these interactions and discuss all medications, including over-the-counter drugs and supplements, with your healthcare provider.

Common Drug Interactions

Be cautious when using simvastatin with the following:

• Strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole)
• Gemfibrozil and other fibrates
• Cyclosporine
• Danazol
• Amiodarone
• Verapamil
• Diltiazem
• Grapefruit juice (large quantities)

How can you minimize the risk of drug interactions? Always inform your healthcare provider and pharmacist about all medications you’re taking, including herbal supplements and over-the-counter drugs. They can help identify potential interactions and adjust your treatment plan accordingly.

Strategies for Minimizing Side Effects of Simvastatin

While side effects can occur with simvastatin use, there are several strategies patients can employ to minimize their risk and severity:

1. Take simvastatin as prescribed, usually in the evening
2. Maintain a healthy lifestyle with a balanced diet and regular exercise
3. Avoid excessive alcohol consumption
4. Stay hydrated
5. Monitor for side effects and report any concerns to your healthcare provider promptly
6. Attend regular check-ups and undergo recommended laboratory tests
7. Consider CoQ10 supplementation (discuss with your doctor first)

Can lifestyle changes help reduce the need for simvastatin? In some cases, adopting a heart-healthy lifestyle may help lower cholesterol levels and potentially reduce the required dose of simvastatin. However, never adjust your medication without consulting your healthcare provider.

Treatment Options for Managing Simvastatin Side Effects

If you experience side effects while taking simvastatin, several treatment options may be available:

Dosage Adjustment

Your healthcare provider may recommend:

• Lowering the dose of simvastatin
• Changing the timing of your dose
• Switching to an alternate-day dosing schedule

Medication Switch

If side effects persist, your doctor might suggest:

• Trying a different statin medication
• Exploring non-statin cholesterol-lowering drugs

Supportive Treatments

Additional measures to manage side effects may include:

• Pain relief medications for muscle aches
• Dietary changes to address gastrointestinal issues
• Cognitive exercises for memory concerns

What should you do if side effects become intolerable? Never stop taking simvastatin abruptly without consulting your healthcare provider. They can help you safely discontinue the medication if necessary and explore alternative treatments for managing your cholesterol levels.

In conclusion, while simvastatin is an effective medication for managing cholesterol levels and reducing cardiovascular risk, it’s essential to be aware of potential side effects and how to manage them. By working closely with your healthcare provider, monitoring for side effects, and adopting healthy lifestyle habits, you can maximize the benefits of simvastatin while minimizing potential risks. Remember, your health is a partnership between you and your medical team, so don’t hesitate to ask questions or voice concerns about your treatment plan.

Side effects of simvastatin – NHS

Common side effects

Like all medicines, simvastatin can cause side effects in some people, but not everybody gets them.

Talk to your doctor or pharmacist if you do get any side effects and they bother you, or do not go away. They may recommend trying a lower dose of simvastatin, or a different statin.

Serious side effects

It happens rarely, but less than 1 in 1,000 people taking simvastatin may have a serious side effect.

Stop taking simvastatin and call a doctor or contact 111 if:

• you get unexplained muscle pain, tenderness, weakness or cramps (this is more likely if you’re taking a higher dose of simvastatin, and it can happen a few weeks or months after you first start taking this medicine) – this can be signs of muscle breakdown and kidney damage
• the whites of your eyes turn yellow, or your skin turns yellow (although this may be less obvious on brown or black skin), or if you have pale poo and dark pee – this can be signs of liver problems
• you get a skin rash with pink-red blotches, especially on the palms of your hands or soles of your feet – this could be a sign of the skin reaction, erythema multiforme
• you have severe stomach pain – this can be a sign of acute pancreatitis
• you have a cough, feel short of breath, and have lost weight – this can be a sign of lung disease

Go to 111. nhs.uk or call 111.

Serious allergic reaction

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

Immediate action required: Call 999 or go to A&E now if:

• you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
• you’re wheezing
• you get tightness in the chest or throat
• you have trouble breathing or talking
• your mouth, face, lips, tongue or throat start swelling

You could be having a serious allergic reaction and may need immediate treatment in hospital.

Other side effects

These are not all the side effects of simvastatin. For a full list see the leaflet inside your medicines packet.

Information:

You can report any suspected side effect using the Yellow Card safety scheme.

Visit Yellow Card for further information.

Page last reviewed: 4 February 2022

Next review due: 4 February 2025

Simvastatin side effects and how to avoid them

Common simvastatin side effects | Serious side effects | Cognitive side effects | Myopathy | Constipation | Side effects timeline | Contraindications | Warnings | Interactions | How to avoid side effects | How to treat side effects

Simvastatin—also prescribed as brand-name Zocor—is a generic prescription drug used to reduce total cholesterol, low-density lipoprotein cholesterol (LDL), and triglycerides (fats) in the bloodstream. 

Simvastatin treatment is most appropriate for people with high LDL cholesterol, high triglyceride levels, or hereditary high cholesterol. It’s also FDA approved to help prevent heart attack, stroke, and death in people with heart disease, blood vessel disease, or diabetes as well as people who have risk factors for cardiovascular disease. Statins are common prescription drugs. They block an enzyme—HMG-CoA reductase—responsible for the body’s synthesis of cholesterol. Healthcare professionals sometimes call them HMG-CoA reductase inhibitors, but it’s easier just to call them statins. Like other statins, simvastatin has a variety of possible side effects, including pain, liver problems, kidney problems, and raised blood sugar. In general, though, many people will find long-term treatment with simvastatin to be relatively problem-free.

Upper respiratory infections are the most common complaint among simvastatin users. In clinical trials, the incidence was close to 1 in 10 participants. In order of likelihood, side effects may include:

• Upper respiratory infections
• Headache
• Stomach pain
• Constipation
• Atrial fibrillation
• Nausea
• Gastritis
• Vertigo
• Insomnia
• Muscle pain
• Fluid retention
• Swollen sinuses
• Liver problems
• Memory problems and amnesia
• Confusion

Serious side effects of simvastatin

The most serious side effects of simvastatin include:

• Atrial fibrillation
• Liver damage
• Kidney failure
• Muscle damage (rhabdomyolysis)
• Tendon rupture
• Blood disorders
• Swollen pancreas
• Diabetes
• Lung disease
• Lupus-like symptoms
• Severe allergic reactions
• Serious skin conditions

Can simvastatin cause sleep problems?

In simvastatin’s initial clinical trials, about 4% of participants reported problems with sleep. However, that was nearly the same incidence as participants who were given a placebo, indicating the drug may have little to do with the problem. A review of sleep studies concerning statins concluded that statins have no significant effect on falling asleep or staying asleep. Sleeplessness has many causes. If it’s a problem when taking simvastatin, ask the prescribing healthcare provider for medical advice. 

Cognitive side effects of simvastatin

Cognitive side effects, like memory problems and confusion, may be an issue with simvastatin and related drugs. The estimated incidence is that 1% of patients will experience memory impairment, 1% will experience amnesia (memory loss), and 1% will feel confused at times when taking simvastatin. These problems may be dose-related, meaning there is a greater risk at higher doses. Confusion and memory problems may significantly impair daily living. If this becomes a concern when taking simvastatin, report it to the prescribing healthcare provider. These problems usually improve when the drug is stopped.

Myopathy

Statins such as simvastatin are associated with muscle complaints, including damage, inflammation, and pain. People experiencing statin-induced myopathy report problems such as muscle pain, tenderness, cramping, weakness, and tendon problems. The exact incidence is unknown. Some estimate the incidence to be as high as 25%, but simvastatin’s clinical trials suggest the number may be closer to 4%. No one knows for certain why statins harm muscles in some people, but there may be higher risk due to age, genetics, medical conditions, and drug interactions. If simvastatin treatment is causing problems, talk to the prescribing healthcare provider. The dose may be reduced, or stopped if there is severe muscle damage.

Constipation

Constipation is a common side effect of simvastatin. Initial clinical trials put the incidence at about 2%, but the real-world incidence may be more than 6%. If constipation occurs when taking any drug, the best advice is to consult with the prescribing healthcare provider.  

How soon do simvastatin side effects start?

Simvastatin’s peak concentration in the bloodstream occurs in about four hours. Some mild and serious side effects can occur early in treatment, while others take several weeks or months of treatment to become problematic. 

How long do simvastatin side effects last?

Some simvastatin side effects may improve over time. Others, including memory loss, cognitive impairment, and muscle pain, are reversible once the drug has been stopped. With a half-life of four to five hours, simvastatin levels fall to less than 10% of their peak in 10 hours. Typically, problems like headaches and nausea will resolve by then. Some problems, such as muscle damage, liver damage, or kidney damage may take longer to get better.

What are the long-term side effects of simvastatin?

Most healthcare professionals consider simvastatin a safe drug for long-term use. Many of the most publicized and severe side effects such as muscle problems, liver problems, kidney problems, and cognitive problems are typically delayed effects, so they are more likely to occur as simvastatin treatment persists or if doses go up.

Simvastatin contraindications

Because simvastatin’s side effects could worsen some conditions, simvastatin is never prescribed to people with:

• Muscle disease
• Liver failure or advanced cirrhosis
• Allergy to statin drugs

Pregnancy

Simvastatin should not be used during pregnancy, though the FDA does allow for its use in some individuals at high risk of complications from lipid disease. Simvastatin can harm the fetus, and statin treatment is usually not necessary during pregnancy.

Breastfeeding

Breastfeeding is not recommended for women who are taking simvastatin. Risks and benefits for individuals should be discussed with a healthcare provider.

Children

Simvastatin is FDA approved to treat children 10 years of age and older for congenital high cholesterol (hypercholesterolemia). Because cholesterol is important for development, the use of statins in very young children is discouraged.

Seniors

People older than 65 have an increased risk of muscle problems when taking simvastatin. In addition, simvastatin levels in the blood are higher in older people, so healthcare providers are urged to use doses that are as low as possible. Liver function as measured by blood tests will need to be regularly performed.

Simvastatin warnings

Although statins such as simvastatin are generally safe to take, some people may have problems requiring extra caution or monitoring.

Cautions

Because of simvastatin’s side effects and its effects on the liver, it’s used with caution in people with:

• Liver problems
• Chronic alcohol abuse
• Kidney disease
• Diabetes
• Underactive thyroid
• People who may become pregnant

People of Chinese descent have an increased risk of developing muscle problems when taking simvastatin. Extra monitoring may be required. 

Abuse and dependence

Simvastatin is not a drug that has a high potential for abuse. There is no known risk for physical dependence. Although discontinuing simvastatin will not cause unpleasant withdrawal effects, anytime a statin is stopped, cholesterol levels may rise.

Overdose

Call a poison control center or get medical attention if too much simvastatin is taken. Most people are prescribed 20–80 mg per day; the absolute maximum is 80 mg per day. Although there may not be immediate issues when exceeding the prescribed dose, repeated overdoses increase the risk of muscle or liver damage.

Simvastatin interactions

Because of potentially hazardous drug interactions, simvastatin is never prescribed with certain prescription drugs, including:

• The macrolide antibiotics clarithromycin and erythromycin
• The azole antifungals ketoconazole, itraconazole, voriconazole, posaconazole, and levoketoconazole
• Some HIV/AIDS drugs including saquinavir, ritonavir, atazanavir, nelfinavir, darunavir, and the antiviral booster cobicistat
• Some cancer drugs
• The cholesterol medication gemfibrozil
• The antidepressant nefazodone
• The immune suppressant cyclosporine
• The testosterone drug danazol
• Mifepristone

Most (but not all) of these drugs block the liver enzyme that breaks down simvastatin. The result is a hazardous increase in simvastatin serum levels, raising the risk of serious side effects such as muscle damage and liver damage. These contraindicated drugs are so good at blocking this enzyme that they can’t be safely taken with simvastatin. Other drugs also block this enzyme but not so powerfully. They can be used with simvastatin, but side effects must be monitored, and doses may need adjusting. These include:

• Some macrolide antibiotics
• Some quinolone antibiotics
• Some azole antifungals
• Calcium channel blockers (blood pressure drugs such as verapamil and diltiazem)
• Some heart rhythm drugs
• Niacin
• Grapefruit and grapefruit juice
• Cranberries and cranberry juice

Some drugs do the opposite: they speed up the body’s metabolism of simvastatin, reducing the ability of simvastatin to lower cholesterol and fats. These drugs include:

• Anticonvulsants
• Benzodiazepines
• Barbiturates
• The tuberculosis antibiotic rifampin
• St. John’s wort

Finally, healthcare providers are wary about combining simvastatin, a drug that can damage muscles, with other drugs that can damage muscles. These include fibrate cholesterol drugs like fenofibrate, corticosteroids, some malaria drugs, and alcohol.

How to avoid simvastatin side effects

Though generally without problems, statin use can cause side effects. Sometimes side effects can be avoided. Here are a few tips to lower the risk.

1. Take simvastatin as directed

The best way to maximize the benefits and minimize side effects is to follow the instructions when taking this medicine. Above all, don’t take too much. If a dose is missed, it can be taken when remembered, unless it’s almost time for the next dose. In that case, skip the missed dose and take the next dose as scheduled to avoid taking too much at one time.

2. Take simvastatin in the evening

To maximize the benefits of taking this drug, take each dose in the evening. This may help with side effects, too.

3. Inform the prescriber about all medical problems

Besides taking the medicine correctly, another sure way to avoid the side effects of statins is to make sure the prescribing healthcare provider has a complete picture of your health conditions. For simvastatin, the prescriber will particularly need to know about:

• Kidney disease
• Liver disease
• Diabetes
• Hypothyroidism
• Muscle pain or muscle weakness
• Pregnancy or plans on getting pregnant
• Breastfeeding or breastfeeding plans

4. Inform the prescriber about any drugs being taken

Drug interactions are another perennial source of side effects. Unfortunately, the list of drugs, supplements, and foods that cause problems with simvastatin is long. The best advice is to tell the prescriber about all over-the-counter and prescription drugs, supplements, and herbal remedies being taken.

5. Avoid alcohol

Drinking too much alcohol is not safe when taking simvastatin because it increases the risk that simvastatin will cause serious liver damage. Every once in a while is okay, but try to avoid overdoing it.

6. Avoid grapefruit

Believe it or not, grapefruit and grapefruit juice can increase the risk of simvastatin side effects. Healthcare professionals generally advise it be taken out of the diet. Cranberries and cranberry juice could also cause the same problem. So do niacin supplements, so talk to the prescriber if niacin or vitamin B3 supplements are part of the daily routine. 

7. Keep all follow-up appointments 

To avoid serious side effects, follow-up appointments are necessary. Regular blood tests, for instance, help detect problems with the muscles or liver before they blow up into serious medical conditions.

How to treat side effects of simvastatin

Most simvastatin side effects can be managed at home. Many will get better over time. Some side effects, though, will require the help of a healthcare professional.

Muscle problems

Stop taking simvastatin and contact a healthcare professional if muscles start to hurt or become weak. If simvastatin is affecting the muscles, it may become hard to lift your arms or climb stairs. A healthcare professional may need to perform a blood test to confirm that muscles are being damaged.

Memory problems

If things are easily forgotten, or you start feeling confused or disoriented, talk to the prescribing healthcare provider. Reduced doses may help, but some people may need to switch to a different statin or a different type of cholesterol drug.

Liver problems

If simvastatin starts affecting the liver, it may not be evident. Blood tests are usually required. Stop the drug and see a healthcare provider if any of these signs of liver problems are noticed:

• Dark urine
• Pale stools
• Appetite loss
• Throwing up
• Tiredness
• Yellowing of the skin or eyes

Sources

• Simvastatin, Epocrates
• Simvastatin drug summary, Prescriber’s Digital Reference
• Simvastatin tablet prescribing information, U. S. National Library of Medicine
• Sleep changes following statin therapy: a systematic review and meta-analysis of randomized placebo-controlled polysomnographic trials, Archives of Medical Science
• Statin-associated adverse cognitive effects: survey results from 171 patients, Pharmacotherapy
• Statin-induced myopathy, BMJ
• The role of statins in both cognitive impairment and protection against dementia: a tale of two mechanisms, Translational Neurodegeneration

Simvastatin-Teva film-coated tablets 20 mg blister #30

Simvastatin-Teva tablets are indicated for the treatment of hypercholesterolemia and for cardiovascular prevention.

Composition

Active ingredient: simvastatin;

1 film-coated tablet contains 20 mg or 40 mg of simvastatin;

Excipients: actose; corn starch; cellulose microcrystalline citric acid monohydrate ascorbic acid; butylhydroxyanisole (E 320) magnesium stearate.

Contraindications

Hypersensitivity to simvastatin or any other component of the formulation. Liver disease in the acute stage or a persistent increase in the level of transaminases in the blood serum of unknown origin. Concomitant use of potent CYP3A4 inhibitors (drugs that increase AUC by about 5 times or more) such as itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors (eg nelfinavir), boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, and nefazodone. Concomitant use of gemfibrozil, cyclosporine or danazol. During pregnancy and breastfeeding.

Method of administration

Daily doses of the drug – from 5 mg (use the dosage form with the appropriate dosage) to 80 mg orally 1 time per day in the evening. Dose selection should be made at intervals of at least 4 weeks up to a maximum daily dose of 80 mg taken once a day in the evening. The 80 mg dose is only recommended for patients with severe hypercholesterolemia and a high risk of cardiovascular complications who have not reached the goal of treatment with low doses and when the benefits are expected to outweigh the potential risks.

Application features

Pregnant women

Contraindicated.

Children

From 10 years old.

Drivers

Refrain from driving or using machines.

Overdose

Currently, there are several cases of overdose, the maximum dose taken was 3.6 g, while one of the patients did not show specific symptoms. All patients recovered without complications. In case of overdose, symptomatic and supportive measures should be taken, since there is no specific treatment.

Side effects

Severe hypersensitivity syndrome has been reported, including some of the following: angioedema, lupus-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, thrombocytopenia, eosinophilia, increased erythrocyte sedimentation rate (ESR), arthritis and arthralgia, urticaria , photosensitivity, fever, hot flashes, shortness of breath and malaise.

Interactions

Concomitant use of strong CYP3A4 inhibitors (drugs that increase AUC by about 5 times or more), such as itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors (eg nelfinavir), boceprevir, telaprevir, erythromycin, clarithromycin , telithromycin and nefazodone.

Storage conditions

Store below 25°C in original packaging.

Keep out of reach of children.

Shelf life – 2 years.

Simvastatin :: Instructions :: Price :: Description of the drug

Simvastatin (Simvastatin)

1 film-coated tablet, Simvastatin 10 contains:
Simvastatin – 10 mg;
Excipients including lactose monohydrate.

1 film-coated tablet, Simvastatin 20 contains:
Simvastatin – 20 mg;
Excipients including lactose monohydrate.

1 film-coated tablet, Simvastatin 40 contains:
Simvastatin 40 mg;
Excipients including lactose monohydrate.

Simvastatin is a drug from the group of HMG-CoA reductase inhibitors that has a hypolipidemic effect. Simvastatin – a substance obtained by synthesis from the fermentation products of Aspergillus terreus, simvastatin is metabolized in the body to form a pharmacologically active derivative. The drug inhibits the activity of 3-hydroxy-3-methyl-glutaryl-CoA reductase, an enzyme involved in the initial reaction of converting HMG-CoA to mevalonate. This reaction is the initial step in the synthesis of cholesterol, thus, simvastatin, by inhibiting the synthesis of mevalonate, helps to reduce the level of potentially toxic sterols in the body.
HMG-CoA is metabolized to acetyl-CoA, a substance involved in a number of biochemical processes in the body.

When taking simvastatin, there is a decrease in plasma levels of low and very low density lipoproteins, apolipoprotein B, triglycerides and total cholesterol (including in patients with mixed hyperlipidemia, familial heterozygous and non-familial form of hypercholesterolemia).
There has been some increase in high-density lipoprotein when taking simvastatin. In addition, when taking the drug, the ratio of total cholesterol and high-density lipoproteins, as well as low-density lipoproteins and high-density lipoproteins, decreases.
The therapeutic effect develops within 2 weeks after the start of treatment, the maximum effect – within 4-6 weeks. After stopping therapy, the cholesterol level gradually returns to the level that it was before the start of treatment.

Simvastatin is well absorbed in the intestine, peak plasma concentrations are reached within 1.3-2.4 hours. Within 12 hours, plasma levels of simvastatin are reduced by 90%. Approximately 95% of simvastatin binds to plasma proteins.
During the first pass through the liver, the active metabolite of simvastatin is formed. In addition, during the metabolism of simvastatin in the liver, a number of other active and inactive substances are formed.
The half-life of simvastatin metabolites reaches 1.9 hours.
About 60% is excreted by the intestines, about 10-15% is excreted in the inactive form by the kidneys.

Simvastatin is indicated for the treatment of patients with hypercholesterolemia.
In particular, simvastatin is indicated in patients with primary hypercholesterolemia or mixed dyslipidaemia as a medical therapy when other treatments (diet and exercise) have failed.
Simvastatin is used in the treatment of patients with homozygous hereditary hypercholesterolemia as an adjunct to diet and exercise, and when lipid-lowering interventions such as low-density lipoprotein apheresis are not available.
Simvastatin can be used prophylactically in patients with diabetes mellitus and coronary heart disease to prevent the development of cardiovascular complications.

Simvastatin is for oral use. The tablet is recommended to be taken in the evening, without violating the integrity of the shell. The daily dose, as a rule, is prescribed for 1 dose. Before starting simvastatin, lipid levels should be adjusted as much as possible through exercise and diet; Simvastatin is prescribed only if non-drug methods are ineffective. The duration of the course of taking and dose of simvastatin is determined by the doctor, taking into account the initial level of cholesterol and the effectiveness of non-drug methods.
The average daily dose of simvastatin is 5 to 80 mg.
Dose adjustment is recommended no earlier than 4 weeks after the start of treatment or the next dose increase.

The maximum dose (80 mg of simvastatin per day) is usually required in patients with severe hypercholesterolemia and a high risk of developing cardiovascular complications.
Hypercholesterolemia is usually treated with simvastatin at an initial dose of 10-20 mg per day. If it is necessary to significantly reduce low-density lipoprotein cholesterol (by more than 45%), the initial dose may be 20-40 mg per day. 4 weeks after the start of therapy, cholesterol levels are monitored and, if necessary, the dose of simvastatin is increased.
In homozygous hereditary hypercholesterolemia, as a rule, simvastatin is prescribed at an initial dose of 40 mg per day. Perhaps the appointment of simvastatin in a daily dose of 80 mg, which should be divided into 3 doses: twice 20 mg and 40 mg in the evening.

For the prevention of cardiovascular complications in patients with coronary heart disease and diabetes mellitus, as a rule, simvastatin is prescribed at a dose of 20-40 mg per day. 4 weeks after the start of therapy, the dose of simvastatin is adjusted depending on the effect achieved.
Patients with severe renal insufficiency (with creatinine clearance less than 30 ml / min) should adjust the dose of simvastatin. Doses greater than 10 mg/day of simvastatin should be used with caution in these patients.
Patients with impaired thyroid function, as well as some kidney diseases with an increase in cholesterol levels, should first be treated with the underlying disease, if elevated cholesterol levels persist, lipid-lowering therapy with simvastatin is performed.
If a dose of simvastatin is missed, it should be taken as soon as possible, but the dose should not be doubled.

When taking Simvastatin, patients may develop the following adverse reactions:
From the digestive tract: flatulence, pain in the epigastric and abdominal region, stool disorders, pancreatitis, vomiting, increased activity of liver enzymes, creatine phosphokinase and alkaline phosphokinase. In addition, the development of hepatitis cannot be excluded.
From the sensory organs and the nervous system: decreased visual acuity, changes in taste, insomnia, headache, asthenic syndrome, dizziness, convulsions, paresthesia and peripheral neuropathy.
From the musculoskeletal system: myalgia, myasthenia gravis, myopathy. In rare cases, when taking simvastatin, the development of rhabdomyolysis was noted.

Allergic reactions: hyperemia of the skin, polymyalgia rheumatica, photosensitivity, vasculitis, fever, urticaria, lupus-like syndrome, dermatomyositis, angioedema.
Others: arthritis, increased erythrocyte sedimentation rate, thrombocytopenia, dyspnea, eosinophilia, alopecia, anemia, erectile dysfunction, acute renal failure.
At the beginning of therapy, as well as with an increase in the dose of simvastatin, the risk of developing myopathy is highest, with the development of muscle pain, lethargy and muscle weakness, which are accompanied by fever and malaise, you should immediately consult a doctor. Cancellation of the drug Simvastatin is necessary both for diagnosed myopathy and for suspected myopathy. For early diagnosis of myopathy, it is recommended to regularly monitor the level of CPK, the drug should be discontinued when the level of CPK increases by more than 10 times relative to the upper limit of normal.

An increase in CPK due to simvastatin should be considered in the differential diagnosis of chest pain.
At the beginning of therapy, a transient increase in liver enzymes may develop. It is recommended to monitor the level of liver enzymes throughout therapy, with a persistent and pronounced increase in the level of transaminases, simvastatin is canceled.

Simvastatin should not be given to patients with a history of hypersensitivity to simvastatin, statin-type medicines, or additional tablet components.
Film-coated tablets, Simvastatin should not be administered to patients with a rare form of lactose intolerance (including lactase deficiency, galactosemia and glucose-galactose malabsorption syndrome).
Simvastatin is not used in the treatment of patients suffering from myopathy, active liver disease, and a persistent increase in plasma transaminase levels.
Simvastatin is not used in pediatric practice.

Patients receiving strong inhibitors of CYP3 A4 should not be treated with simvastatin.
With caution, Simvastatin is prescribed to patients suffering from chronic alcoholism, as well as conditions that increase the risk of developing acute renal failure, including arterial hypotension, severe forms of infectious diseases, metabolic and endocrine system disorders.
Simvastatin should be used with caution in patients undergoing surgery, as well as in patients who have undergone organ transplantation and are receiving immunosuppressant therapy.
Caution should be exercised when taking simvastatin after injury.

In patients with epilepsy, impaired skeletal muscle tone and a history of liver disease, Simvastatin should only be prescribed under strict medical supervision.
Simvastatin is not indicated for the treatment of patients with type I, IV or V hypertriglyceridemia.
In patients with renal disease, simvastatin should only be used if renal function is monitored closely.
Simvastatin can cause dizziness, so drive vehicles and work with potentially unsafe machinery during drug therapy should be used with extreme caution.

Simvastatin is contraindicated during pregnancy. There are data on the development of anomalies in children whose mothers received simvastatin therapy. Women of childbearing age should use effective contraception while taking simvastatin.
If pregnancy occurs during therapy, immediately stop taking the drug and warn the woman about possible complications.
No data on the penetration of simvastatin into breast milk. To prevent possible risks before starting therapy with simvastatin, it is recommended to stop breastfeeding.

Simvastatin is not prescribed in combination with CYP3 A4 inhibitors due to an increased risk of myopathy. The simultaneous use of simvastatin with itraconazole, HIV protease inhibitors, ketoconazole, clarithromycin, erythromycin, nefazodone and telithromycin is strictly prohibited. With caution, simvastatin is prescribed simultaneously with cyclosporine, diltiazem, verapamil and amiodarone (if the combined use of these drugs cannot be avoided, the daily dose of simvastatin should not exceed 20 mg).
Do not drink grapefruit juice during therapy with simvastatin (when drinking more than 1 liter of juice, there is a pronounced inhibition of CYP3 A4 and an increase in plasma concentrations of simvastatin).
Simvastatin should be used with caution in combination with coumarin anticoagulants (prothrombin time should be regularly monitored and the dose of anticoagulant adjusted if necessary).

There may be an increased risk of myopathy when simvastatin is used concomitantly with other lipid-lowering drugs.
Simvastatin, when used simultaneously, increases plasma concentrations of digoxin.
There is a decrease in the bioavailability of simvastatin when combined with cholestyramine and colestipol (an interval of at least 4 hours between taking these drugs should be observed).
Simvastatin should be used with caution in combination with potentially nephrotoxic and hepatotoxic drugs.
When simvastatin is co-administered with bile acid sequestrants, Simvastatin should be taken 2 hours or 4 hours after bile acid sequestrants.

When taking high doses of simvastatin, including chronic overdose, there is an increased risk of development and an increase in the severity of undesirable effects characteristic of the drug. In severe cases, myopathy with rhabdomyolysis and hyperkalemia may develop.
No specific antidote. It is necessary to monitor the patient’s condition, as well as to monitor the function of the kidneys and liver, as well as the level of creatine phosphokinase in the blood plasma. In case of an overdose, measures are taken to reduce the absorption of simvastatin, in particular, gastric lavage and the intake of enterosorbent agents. If necessary, prescribe therapy aimed at eliminating the symptoms of an overdose.

In the case of myopathy with rhabdomyolysis, as well as in acute renal failure, the withdrawal of Simvastatin, the appointment of diuretics and the infusion of sodium bicarbonate are indicated. With the development of hyperkalemia, calcium preparations (calcium gluconate or calcium chloride) are administered intravenously, and glucose infusion with insulin is also prescribed. With hyperkalemia, potassium ion-exchange sorbents can also be prescribed.
Hemodialysis may be given to lower plasma levels of simvastatin.

Tablets for oral use, film-coated, Simvastatin, containing 10 mg, 20 mg or 40 mg of the active substance, 14 pieces in blister packs, 2 blister packs are included in a carton box.

Simvastatin should be stored in rooms where the temperature is maintained between 15 and 25 degrees Celsius.
Simvastatin tablets are good for 3 years if stored properly.

Avestatin, Vasilip, Vabadin, Simvahexal, Simvakol, Simvor, Zorstat, Simvalimit, Simlo, Aktalipid, Aterostat.
See also the list of analogues of the drug Simvastatin.

The instruction was compiled by a team of authors and editors of the Piluli website. The list of authors of the drug reference book is presented on the site editorial page: Site editors.

References to used sources of information.

Attention!
The description of the drug “ Simvastatin ” on this page is a simplified and supplemented version of the official instructions for use.