Simvastatin

Part of a group of medicines known as statins, Simvastatin is commonly used to treat coronary heart disease, inherited homozygous high blood cholesterol, and high cholesterol.

Overview

Simvastatin belongs to a group of medicines known as HMG CoA reductase inhibitors - which are known more popularly as 'statins'. They work to bring down a patient's levels of 'bad' cholesterol (technically referred to as 'low-density lipoprotein', or LDL) and triglycerides (fats) in the bloodstream, while boosting their levels of 'good' cholesterol (or 'high-density lipoprotein', or HDL).

By treating cholesterol and triglycerides, Simvastatin also works to reduce a patient's risk of heart attack, stroke, and multiple complications that may come from having coronary heart disease, diabetes, and other conditions that pose a risk of heart problems. Often prescribed in combination with advice on dietary changes and exercise to bring down a patient's cholesterol levels, Simvastatin is typically given to adults or children over the age of 10.

Simvastatin works to limit the amount of cholesterol in the bloodstream by preventing the action of an enzyme that produces cholesterol. Available only on prescription from a qualified physician, Simvastatin may be otherwise known under the brand name Zocor. Patients may be prescribed a course of tablets, medicine in suspension (as a liquid), or via disintegrating or soluble tablets.

Conditions Treated

  • Increased cholesterol and triglycerides in the blood
  • Hardening of the arteries from plaque layering
  • High cholesterol
  • Inherited homozygous high blood cholesterol
  • High levels of triglyceride
  • Preventing a transient ischemic attack
  • Preventing a heart attack
  • Excessive fat levels in the blood
  • Slowing the progression of coronary artery disease
  • Preventing a stroke.

Type of Medicine

  • HMG CoA reductase inhibitor, or 'statin'.

Side Effects

As with any type of medication, some unwanted effects may occur alongside their intended outcomes. Patients may experience no side effects at all, a single side effect, or more than one at a time. Some side effects may require medical attention. Patients should consult their physician or doctor for advice.

Patients should seek medical advice if they experience any of the following side effects at the same time as taking Simvastatin:

More common:

  • Fainting
  • Dizziness
  • Irregular or fast heart rhythm

Less common:

  • Pain in the bladder
  • Cloudy or bloody urine
  • Blurred vision
  • Pain, aches or chills in the body
  • Coughing
  • Abnormally dark urine
  • Painful, burning or difficult urination
  • Breathing difficulties
  • Difficulties moving
  • Ear congestion
  • Dry mouth
  • Dry, flushed skin
  • Fever or high temperature
  • Increased need to urinate
  • Headache
  • Increased hunger or thirst
  • Increased urination
  • Painful joints
  • Side or lower back pain
  • Nasal congestion
  • Loss of consciousness
  • Cramping muscles, stiffness or spasms
  • Tender, painful, weak or wasting muscles
  • Unusually runny nose
  • Nausea or vomiting
  • Excess sneezing
  • Tender or sore throat
  • Pain in the stomach
  • Swelling
  • Excessive sweating
  • Swelling around the joints
  • Sudden weight loss
  • Unusual fatigue or weakness.

Incidence unknown:

  • Peeling, blistering or loosening of the skin
  • Pins and needles, tingling, itching, numbness, prickling, burning or crawling feelings across the skin
  • Diarrhea
  • Constipation
  • Bloating
  • Difficulty swallowing food or liquids
  • General weakness and fatigue
  • Protruding, large hive swellings on the eyelids, tongue, lips, throat, legs, hands, feet, face, or genitals
  • Indigestion
  • Pale-colored stools
  • Pain in the abdomen, including the side, stomach and lower back
  • Pallid-looking skin
  • Swelling around the eyelids, face, lips, tongue or eyes
  • Red lesions on the skin, particularly with a purple center
  • Irritated eyes
  • Itching, hives or a skin rash
  • Mouth ulcers, sores or spots
  • Sores or white spots on the lips
  • Feeling of tightness in the chest
  • Difficulty breathing during exercise or exertion
  • New bruising or bleeding
  • Pain in the upper right-hand side of the abdomen, or general stomach pain
  • Weakness in the limbs
  • Yellowing skin or eyes.

Patients may experience other side effects that usually do not require medical assistance. They may lessen or go away completely as a patient's body adapts to the new medicine. Patients should, however, consult a healthcare professional if they find their side effects particularly troublesome, long-lasting or worrying.

Less common:

  • Sour stomach or acid reflux
  • Excessive belching
  • Burning sensation in the stomach or chest
  • Lightheadedness or dizziness
  • Excess gas in the intestines or stomach
  • Giddy feeling of constant movement
  • Feeling overly full
  • Heartburn or indigestion
  • Weakness or loss of strength
  • Pain under the cheekbones or around the eyes
  • Unusual levels of passing gas
  • Spinning sensation
  • Rashes, including scaly, encrusted or oozing sores
  • Upset stomach, stomach discomfort, or pain
  • Tender stomach and abdomen
  • Difficulty sleeping.

Incidence unknown:

  • Poor short-term memory
  • Depression
  • Skin discoloration
  • Thinning or hair loss
  • Erectile dysfunction
  • Loss of libido, sexual performance or drive.

Dosage

Recommended dosages vary by the specific condition being treated, the age and history of the patient, and any potential drug interactions.

To prevent Cardiovascular Disease in adults

Typical doses range from 5 to 40mg taken orally once a day before bedtime.

Patients with - or at high risk of developing - CHD may be prescribed an initial dose of 10 to 20mg once daily, to be taken in the evening, alongside advice on dietary changes and exercise.

Patients who are deemed at high risk of having a cardiovascular 'event' due to their existing cardiovascular disease, peripheral vascular disease, diabetes, previous strokes, or other cerebrovascular diseases may be given a dose of 40mg to be taken once a day in the evening.

For cardiovascular risk reduction in adult patients

A typical dose should fall within the range of 5 to 40mg, to be taken once a day in the evening before bed.

Patients with cardiovascular disease or at high risk of developing cardiovascular disease are typically prescribed an initial dose of between 10 to 20mg, once a day in the evening. This is usually in combination with changes to a patient's diet and exercise regime.

Patients who are thought to be at a high risk of experiencing a cardiovascular 'event', due to their existing cardiovascular disease, peripheral vascular disease, stroke history, diabetes, or other cerebrovascular diseases may be prescribed 40mg once a day, to be taken in the evening.

Treating adults with homozygous familial hypercholesterolemia

An initial recommended dose is typically 40mg once per day, to be taken before bed. When treating homozygous familial hypercholesterolemia, physicians usually prescribe Simvastatin alongside other lipid-lowering medicines, but it may also be given alone if other treatments are unavailable.

Treating heterozygous familial hypercholesterolemia in children (pediatric care)

Simvastatin is not recommended for use with children under the age of 10.

For children over the age of 10, a typical initial dose is 10mg taken orally once per day in the evening. A maintenance dose, once any initial dose has been established, usually falls within the range of 10 to 40mg once daily in the evening. In children, the maximum recommended dose of Simvastatin is 40mg orally, taken once a day in the evening. Doses will vary by the age and goals of therapy, as decided by a qualified physician. Doses will not normally be changed within four weeks. As with adults, physicians will advise patients on maintaining a low cholesterol diet, which should continue after the use of statins has stopped.

Interactions

Certain medicines should never be used together, but other medicines may be used in combination even if an interaction is possible or likely. Where this is a risk, a patient's physician may review the dosage, or recommend other precautions. Patients should give a full history and tell their doctor about any substances they are taking, including over the counter drugs, herbal remedies, and narcotics. The interactions below are particularly significant - but this may not include all possible interactions with Simvastatin.

Simvastatin is not recommended for use with any of the following medicines, as they may cause problems. Physicians may choose to avoid these medicines entirely or alter the other medicines a patient is taking to minimize the risk.

  • Amprenavir
  • Atazanavir
  • Boceprevir
  • Clarithromycin
  • Cobicistat
  • Cyclosporine
  • Danazol
  • Darunavir
  • Erythromycin
  • Fosamprenavir
  • Gemfibrozil
  • Idelalisib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Mibefradil
  • Mifepristone
  • Nefazodone
  • Nelfinavir
  • Paritaprevir
  • Posaconazole
  • Ritonavir
  • Saquinavir
  • Telaprevir
  • Telithromycin
  • Tipranavir
  • Voriconazole

The following list of medicines are not recommended for use alongside Simvastatin usually but may be necessary in some circumstances. A patient's physician may choose to alter the dose or when other medicines are used to mitigate the risks.

  • Acenocoumarol
  • Amiodarone
  • Amlodipine
  • Azithromycin
  • Bezafibrate
  • Carbamazepine
  • Ceritinib
  • Ciprofibrate
  • Ciprofloxacin
  • Clofibrate
  • Colchicine
  • Conivaptan
  • Dalfopristin
  • Daptomycin
  • Delavirdine
  • Diltiazem
  • Eltrombopag
  • Eslicarbazepine Acetate
  • Fenofibrate
  • Fenofibric Acid
  • Fluconazole
  • Fusidic Acid
  • Lomitapide
  • Lumacaftor
  • Niacin
  • Pazopanib
  • Quinupristin
  • Ranolazine
  • Risperidone
  • Simeprevir
  • Tadalafil
  • Verapamil
  • Warfarin

The following medicines may pose an increased risk of specific side effects when taken at the same time as Simvastatin - but a physician may decide that the combination is in the patient's best interests. When prescribed together, a physician may alter the dose or frequency of one or more medicines.

  • Albiglutide
  • Alitretinoin
  • Bosentan
  • Clopidogrel
  • Dasatinib
  • Digoxin
  • Dronedarone
  • Efavirenz
  • Fosphenytoin
  • Interferon Beta
  • Levothyroxine
  • Oat Bran
  • Oxcarbazepine
  • Pectin
  • Phenytoin
  • Rifampin
  • St John's Wort
  • Ticagrelor

Other interactions with Simvastatin

Some medicines should not be taken at mealtimes or with specific types of food to avoid additional adverse effects. Drinking alcohol or using tobacco may also affect specific medicines, causing interactions or additional side effects to occur. Again, the following information about food interactions with Simvastatin reflects the most significant factors - and is by no means fully inclusive.

Physicians usually do not recommend drinking the following while a patient is taking Simvastatin, but in some cases where it is unavoidable, they may alter the dose or frequency of use, or advise the patient on ways to use food, alcohol or tobacco in ways that lessen the risks of interaction.

Cranberry juice and grapefruit juice may prevent statins from working - making them counterproductive to patients. This may be dangerous if a patient is at high risk of a cardiovascular 'event', such as a stroke or heart attack.

Patients who have other medical problems may also experience issues from taking Simvastatin. Patients should give a full medical history before receiving any prescription - but should make their physician aware of the following medical problems and factors in particular:

  • Alcoholism (historic or current)
  • Chinese ancestry
  • Diabetes
  • Hypothyroidism (an underactive thyroid) - particularly if it is poorly controlled
  • Liver disease (historic or current) - which may cause excessive side effects
  • Severe electrolyte disorders
  • Severe endocrine disorders
  • Poorly controlled epilepsy (seizures)
  • Hypotension (low blood pressure)
  • Severe kidney disease
  • Severe metabolic disorders
  • Sepsis (a severe infection) - which may lead to muscle or kidney problems
  • Hypercholesterolemia (high blood cholesterol levels) or familial homozygous - a physician may choose to alter the dosage in these cases
  • Active liver disease
  • Elevated liver enzyme levels.

Warnings

A physician should review the patient's condition at regular intervals. This allows them to check whether the Simvastatin is working correctly and look for any side effects or drug interactions that may develop. They may take blood tests as part of this review process.

Simvastatin should not be taken by pregnant women as studies have shown a risk of harm to unborn fetuses. Women taking Simvastatin may be asked about birth control methods to ensure they do not become pregnant. Patients who think they may be pregnant while taking statins should inform their physician immediately.

Certain medicines will also pose a heightened risk of developing muscle injury or kidney problems when taken with Simvastatin. These include products containing cobicistat (such as Stribild®), cyclosporine (including Neoral®, Gengraf®, and Sandimmune®), boceprevir (such as Victrelis®), nefazodone (such as Serzone®), gemfibrozil (such as Lopid®), and telaprevir (such as Incivek®). They also include specific antibiotics, such as itraconazole, clarithromycin, ketoconazole, Nizoral®, erythromycin, posaconazole, voriconazole, and telithromycin. Medicines used in the treatment of HIV and AIDs may also pose a significant risk of muscle and kidney damage, including indinavir, Lexiva®, Prezista®, atazanavir, ritonavir, Crixivan®, Norvir®, Kaletra®, Reyataz®, saquinavir, and nelfinavir.

Patients with Chinese ancestry are also at an increased risk of developing muscle injury, particularly if they are taking more than 1 gram or 1000 milligrams daily of niacin in combination with any dose of Simvastatin. Patients with Chinese ancestry who take niacin (also known as Niaspan® and Niacor®) should fully inform their physician. Their doses may need to be closely supervised and altered to mitigate the risks.

Any patients on Simvastatin should contact a qualified physician as soon as they experience unusual tenderness, weakness or muscular pain - particularly if they also have unexplained fatigue or a fever. Together, these could be the symptoms of more serious muscle problems, including immune-mediated necrotizing myopathy (IMNM) or myopathy. Larger doses of Simvastatin (up to 80mg) make myopathy more likely in patients, but some patients, unfortunately, experience it even at low doses.

Patients should also be advised to call a physician immediately if they experience dark-colored urine, fever, muscle spasms and cramps, diarrhea, stiffness or muscle pain, or unexplained fatigue and weakness. Together, these represent the symptoms of a muscle problem known as rhabdomyolysis - which could cause serious kidney problems.

A physician should also be consulted immediately if patients experience stomach pains, nausea, and vomiting, headaches, dark-colored urine, appetite loss, weight loss, fatigue and weakness, light-colored stools, or yellowing skin or eyes. These are collectively the symptoms of liver damage.

When consulting any healthcare professional (including doctors and dentists), patients should make it clear that they are using Simvastatin before any other treatment. They may be required to stop taking statins before significant surgery, during a major injury, or if they develop other health issues.

Patients should always be clearly asked about their physical history and any other substances they are taking, including prescription, non-prescription (otherwise known as 'over the counter'), herbal remedies, vitamin supplements, and narcotics.

Storage

Simvastatin, like all oral medicines, should be tightly sealed in its original packaging and kept out of the reach of children and vulnerable adults. It should be stored at room temperature, away from excess moisture and heat (so not in a bathroom cupboard).

Despite any child-resistant cap, it is essential to keep all medicines out of the reach and sight of children. Protect children from poisoning by always securing the cap back on immediately after use and place it back in a high and out of reach location.

Patients who are left with a surplus of Simvastatin should dispose of it in a responsible way that ensures children, pets, and other people cannot use them. Do not flush any medicines down the toilet. The FDA recommends using a take-back program to dispose of unwanted excess medicines. Patients should inquire at their local pharmacy or garbage department to find out about the availability of take-back programs in their communities.

Summary

Simvastatin - a member of a group of medicines known as 'statins' - is used in combination with dietary and exercise changes to reduce the risk of stroke and heart attack in certain patients with an elevated risk of a cardiovascular 'event'. It is also used to bring down the chances of heart surgery in patients who have a history of cardiovascular disease or a high risk of developing cardiovascular disease. It works to decrease the levels of 'bad' cholesterol (known as low-density lipoprotein (LDL)) and fatty triglycerides in the bloodstream and boost levels of 'good' cholesterol (known as high-density lipoprotein (HDL)). Simvastatin may also be prescribed for pediatric patients aged between 10 and 17 who have an inherited condition known as familial heterozygous hypercholesterolemia (where cholesterol cannot be normally ejected from the body). By reducing the production of cholesterol in the body, it works to reduce the amount of cholesterol that can build up on the walls of arteries, which can pose cardiovascular problems in the heart, brain, and other regions of the body.

Fatty deposits and the accumulation of cholesterol on the walls of a patient's arteries (otherwise known as atherosclerosis) prevents blood flow and can go on to limit the supply of oxygen to the brain, heart and other areas of the body. By lowering blood cholesterol levels and other lipids, Simvastatin has been statistically shown to reduce the risk of angina (or chest pain), cardiovascular disease, heart attacks, and strokes.

 

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Last Reviewed:
January 30, 2018
Last Updated:
January 27, 2018