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Why it's used

Simvastatin is used to decrease the level of low-density lipoproteins, high-density lipoproteins, and triglycerides in the blood. It also decreases the amount of cholesterol and other fatty substances in the blood in children and teenagers who have familial heterozygous and homozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). It is a prescription medicine. This medicine works by slowing down the production of bad cholesterol in the body. This medicine prevents the blockage of the blood flow to the major organs such as the heart and brain. Simvastatin is also used to reduce the risk of fatal (coronary heart disease) and non-fatal heart diseases (heart attack and stroke). It is also used to reduce the risk of heart diseases in patients who undergo revascularization procedure to restore the flow of blood to the blocked arteries of heart.
When not to use
Simvastatin will not work to treat the abnormal increase in the level of chylomicrons, which are used for transport of lipids (hyperlipidemia Fredrickson types I and V).
HMG-CoA Reductase Inhibitor
Simvastatin belongs to a class of medicines called HMG-CoA Reductase Inhibitor. HMG-CoA Reductase Inhibitors are a class of lipid-lowering medications, effective at lowering high cholesterol levels. These medicines also reduce the risk of having a heart attack or stroke or developing angina.

How to use

Read the medicine guide provided by your pharmacist, your doctor, or the medicine company. If you have any questions related to Simvastatin, ask your doctor or pharmacist. Use Simvastatin as per the instructions provided by your doctor.
Simvastatin is eaten with food. Treatment with Simvastatin can be started along with diet. Simvastatin is eaten usually in the evening.
The typical dose of Simvastatin for adults is 5-80 mg once daily in the evening. The usual dose for children is 10-40 mg once daily. The maximum dose for adult patients of Simvastatin is 80 mg/day as a single dose in the evening per day. Simvastatin is commonly used at the same time every day. This medicine is not known to be addictive or habit-forming.
This medicine is to be used for longer periods of time. Simvastatin should be used as directed by the doctor even if you feel well, or even if you think that there is no need for you to use your medicine.
Discuss with your doctor if you develop new symptoms. If you have any kidney disease, Necessary precautions are to be taken when Simvastatin is given to the patients with severe kidney damage. Treatment should begin with a starting dose of 5 mg/day. If you have issues with the health of your liver, Use of Simvastatin is not recommended in patients with liver disease due to the increased levels of liver enzymes.
Your doctor may prescribe a lower starting dose of this medicine to understand the impact on the body. Please follow your doctor's recommendations. Taking a higher dose of this medicine may increase the risk of side-effects. Older patients may see an increase in the incidence of side-effects. As a result, a lower dose may be recommended for older patients.
If you are giving Simvastatin to a child, be sure to use a product that is for use in children. Use the child's weight or age to find the right dose from the product package or medicine label. If there is no information specified, consult with your doctor and follow their recommendation on pediatric dosage.
If using the orally-disintegrating form of this medicine, make sure you do not consume any food or fluid 5 minutes before or after taking this medicine. Before taking the medicine out of the package, wash your hands thoroughly. Place the medicine on the tongue. Make sure you do not chew or swallow the medicine. You do not need to drink water after consuming the medicine. In certain cases, the medicine can taste slightly bitter. Also, ensure that you do not break or split the medicine.
If using the liquid form of this medicine, measure the dose using the provided measuring cup, spoon, or dropper. Before pouring the medicine into the measuring device, you should check the measurement markings carefully. Then, pour the dose amount into the device. After use, clean and store the measuring device in a safe place for your next use. You should not use a tablespoon or teaspoon as the dose measuring devices since it can result in an incorrect dose. If indicated on the product package, shake the medicine before use.
Consult with your doctor on the consumption of alcohol with Simvastatin. Avoid grapefruit juice while using Simvastatin. Grapefruit juice may affect the functioning of Simvastatin in the body.
Your doctor may request that specific lab tests be performed before you start using Simvastatin. Your doctor may ask you to undergo Liver Panel test. The patients who are being treated with Simvastatin have been found to have an increased level of liver enzymes which may result in fatal or non-fatal liver damage. Therefore, it is recommended to perform a liver function test before starting the therapy. Your doctor may request prothrombin-time test. Simvastatin may enhance the effect of anticoagulants, which are used to prevent clotting when used in combination. Prothrombin time, which is the time taken by blood to clot, is found to increase in patients receiving both Simvastatin and anticoagulants. Your doctor may request Creatine Kinase test. High creatine kinase values may cause risk of myopathy which may be exhibited as muscle pain and weakness. It may also lead to kidney damage due to the release of a chemical during muscle breakdown (rhabdomyolysis).
Medicines may be recommended for uses other than those listed in the medicine guide. You should not use Simvastatin for conditions or symptoms for which it was not prescribed. Do not give Simvastatin to other people, even if they have the same conditions or symptoms that you have. The use of this medicine without the advice of a doctor may cause harm.
Follow storage instructions on the product package if available. Store Simvastatin 5°C-30°C (41°F-86°F), and away from moisture. Store this medicine away from children and pets.

How to take Simvastatin

Your dose may depend on several personal factors. You should consult with your doctor to find out the dose that is best for you. The dose of Simvastatin depends on the following factors:
  • patient's age
  • gender
  • patient's health
  • the health of the patient's liver
  • the health of the patient's kidneys
  • medicines recommended by your doctor
  • any other medicines in use
  • herbal supplements consumed
  • response to treatment

Simvastatin Dosage

Dosage for the patients at high risk of fatalities associated with existing heart diseases (coronary heart disease)

Adult
  • Recommended: 20-40 mg/day given as a single dose in the evening
  • Initial: 10-20 mg once a day in the evening
  • Maximum: 80 mg/day given as a single dose in the evening

Dosage for patients with heritary high cholesterol (homozygous familial hypercholesterolemia)

Adult
  • Recommended: 40 mg/day in the evening
  • Maximum: 80 mg/day divided into three doses

Dosage for children and adults with high cholesterol levels (heterozygous familial hypercholesterolemia)

Adult (10-17 years)
  • Recommended: 10-40 mg/day
  • Initial: 10 mg/day in the evening
  • Maximum: 40 mg/day

Dosage for patients with high levels of cholesterol in the blood (hypercholesterolaemia)

Adult
  • Initial: 10-20 mg/day given as a single dose in the evening

Dosage for patients with high lipid levels

Adult
  • Initial: 10 mg in the evening
  • Maximum: 80 mg

Minimum Age

10 years

Forms

Tablet
Strength: 5 mg, 10 mg, 20 mg, 40 mg and 80 mg
Oral suspension
Strength: 20 mg/5 ml, 40 mg/5 ml
Tablet, coated
Strength: 5 mg, 10 mg, 20 mg, 40 mg, 80 mg
Tablet, film coated
Strength: 5 mg, 10 mg, 20 mg, 40 mg, 80 mg
Tablet, orally disintegrating
Strength: 10 mg, 20 mg, 40 mg, 80 mg

Missed Dose

A missed dose should be taken as early as you remember it. However, if the time for the next dose is almost there, then the missed dose should be skipped, and the regular dosing schedule should be continued. Avoid taking a repeated dose to make up for a missed dose.

Overdose

What to do if you overdose on Simvastatin?
As no specific treatment is available for an overdose of Simvastatin, so treatment according to the symptoms and supportive measures should be undertaken in case of overdose with Simvastatin.
If you think you have overdosed on Simvastatin, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Simvastatin

Before you use Simvastatin, tell your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information.
Before you use Simvastatin, tell your doctor of your medical history including liver problems, kidney damage, abnormal absorption of glucose and galactose (Lapp lactase deficiency), muscular disorders, muscular damage due to medicines (statin or fibrate), alcohol abuse, thyroid problems, high blood pressure, or severe lung disease. Before having any surgery when using Simvastatin, tell your doctor and dentist about all the medicinal products you use including prescription and non-prescription medicines, and any herbal supplements.
The use of this medicine may change liver enzymes (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase). The use of Simvastatin may increase the level of liver enzymes in the blood which may further lead to liver problems.
The use of Simvastatin may change creatine kinase. The use of Simvastatin may increase the level of creatine kinase which may further lead to risk of muscle diseases (myopathy).
The use of this medicine may change prothrombin time. An increase in prothrombin time has been found when Simvastatin is given in combination with anticoagulants.
Consult with your doctor on the consumption of alcohol with Simvastatin. Drinking alcohol may cause may increase risk of muscle breakdown.
Simvastatin is not for use by women and hence pregnant women should not use this medicine. The use of Simvastatin may cause harm to the fetus due to decreased production of cholesterol in pregnant women. Simvastatin is not safe for use in women who are breastfeeding. If you are breastfeeding, discuss with your doctor if you should either discontinue breastfeeding or stop using this medicine while breastfeeding. Women taking Simvastatin should not breastfeed their children as there is a risk for severe side effects in nursing infants. The use of Simvastatin is not recommended in women who are attempting to conceive due to risk to fetus development.
Simvastatin can make you feel sleepy. Be careful while driving, using machinery, or doing any other activity that needs you to be alert. The consumption of alcohol with Simvastatin can make you feel more sleepy.
This medicine may increase your sensitivity to sunlight. If this happens, limit your time outdoors and do not tan to prevent sunburns. Cover your skin when you are outdoors or use a sunscreen. In case you get a sunburn, consult with your doctor.
Simvastatin may increase side-effects in older patients. Elderly patients may see an increased risk of muscle pain (myopathy).

Simvastatin Side-effects

The following side-effects may commonly occur when using Simvastatin. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
The following side-effects may commonly occur in older patients on the use of Simvastatin. Discuss with your doctor if any of these side-effects last for a long time or are severe:
Rarely, the use of Simvastatin may cause the following side-effects:
  • abnormal accumulation of fluid within the body
  • burning sensation in the parts of the body
  • changes to hair/nails
  • chills
  • difficulty in erection (erectile dysfunction)
  • discoloration
  • dizziness (vertigo)
  • dryness of skin/mucous membrane
  • feeling of discomfort
  • gas formation
  • growth of abnormal tissue (nodules)
  • hair loss
  • hives
  • indigestion
  • inflammation of the joints (arthritis)
  • insomnia
  • joint pain
  • memory loss caused by brain damage (amnesia)
  • muscle cramps
  • muscle pain
  • muscle pain and stiffness
  • muscle weakness and skin rash (dermatomyositis)
  • physical weakness
  • purple or red discolored spots on the skin
  • reddening of the skin, especially around the face, neck, or chest (flushing)
  • redness of the skin by increased blood flow (erythematous-like syndrome)
  • weakness, swelling, pain, and inflammation in muscles (myopathy including myositis)
The following severe side-effects may also occur when using Simvastatin:
  • endocrine disorders
    Symptoms: high blood glucose levels (diabetes mellitus)
  • skin and subcutaneous tissue disorders
    Symptoms: itchy inflammation of the skin (eczema), severe skin reactions, increased sensitivity to sunlight (photosensitivity), severe skin reactions, a serious, life-threatening allergic reaction (anaphylaxis) red colored rashes on the skin (erythema multiforme)
  • stomach and intestinal disorders
    Symptoms: inflammation of the pancreas (pancreatitis), vomiting, inflammation of the lining of the stomach (gastritis), vomiting diarrhea
    The patient should discontinue the use of this medicine.
  • psychiatric disorders
  • blood and lymphatic system disorders
    Symptoms: decrease in amount of red blood cells (anemia), inflammation of blood vessels (vasculitis), low levels of thrombocytes, decrease in the number of white blood cells, abnormal breakdown of red blood cells (hemolytic anemia) an increase in the number of eosinophils in the blood (eosinophilia)
  • heart disorders
    Symptoms: irregular heart rate (atrial fibrillation)
  • respiratory system disorders
    Symptoms: inflammation of the airways of the lungs (bronchitis), inflammation of the nasal passages (sinusitis), shortness of breath damage of the lung tissues (interstitial lung disease)
    Discontinue the use of this medicine in severe lung diseases.
  • urinary and genital disorders
  • musculoskeletal and connective tissue disorders
    Symptoms: breakdown of damaged skeletal muscles (rhabdomyolysis)
    Discontinue the use of Simvastatin in such patients.
  • nervous system disorders
    Symptoms: pain, weakness, and loss of sensation associated with nerve damage usually in the hands and feet (peripheral neuropathy)
Your doctor has prescribed Simvastatin because they judge that the benefit is greater than the risk posed by side-effects. Many people using this medicine do not have serious side-effects. This page does not list all possible side-effects of Simvastatin.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Warnings

Muscle diseases/Breakdown of damaged skeletal muscles (Myopathy/Rhabdomyolysis)

Elderly patients, females, the patients with a thyroid problem (uncontrolled hypothyroidism), history of muscular disorders, muscle damage due to the use of medicines, kidney damage and patients who drink alcohol are at an increased risk when using this medicine. Such patients may have an increased risk of muscle pain, muscle tenderness or weakness with or without kidney damage and rarely fatality. Treatment with Simvastatin should be discontinued if such symptoms appear.

Abnormal functioning of the liver

The patients with increased levels of liver enzymes (transaminases) and patients with liver disease are at an increased risk to develop liver damage. Such patients are at an increased risk to develop fatal and non-fatal liver failure. If severe liver damage or yellow discoloration of the skin (jaundice) occurs during the treatment, then discontinue the use of Simvastatin.

Endocrine function

The levels of glycated red blood cells (HbA1c) as well as glucose are found to increase in the patients on treatment with Simvastatin.

Lung disease

The patients on long-term treatment with Simvastatin are at an increased risk when using this medicine. Such patients may develop symptoms such as shortness of breath, cough, fatigue, weight loss, and muscle weakness. If the patients develop these symptoms, treatment with Simvastatin should be discontinued.

High blood glucose (diabetes mellitus)

The patients on treatment with Simvastatin are at risk to develop future diabetes as Simvastatin may increase the level of glucose in the blood. Such patients may develop high levels of blood glucose (hyperglycemia). The patients on treatment with Simvastatin should be carefully monitored for high glucose risk.

Reduced transport proteins function

Patients with reduced function of liver transport proteins are at an increased risk when using this medicine. Such patients are at an increased risk of developing muscle diseases with the breakdown of damaged skeletal muscles. Use of high dose should be avoided in those who carry the genes for the transport of proteins.

Patients with family problems of galactose intolerance, the Lapp lactase deficiency

Such patients with inherited family problems are at an increased risk when using this medicine. Avoid the use of this medicine in such patients.

Interactions with Simvastatin

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
Simvastatin interacts with HIV-protease inhibitors e.g.nelfinavir, boceprevir, telaprevir, and cobicistat which are used to treat viral diseases. The patients using CYP3A4 inhibitors with Simvastatin may increase the risk of muscle diseases and breakdown of damaged skeletal muscles (rhabdomyolysis) by increasing the inhibitory activity of HMG-CoA reductase enzyme in the blood. The combined use of Simvastatin with protease inhibitors is not recommended.
There may be an interaction of Simvastatin with Strong CYP3A4 inhibitors such as (erythromycin, clarithromycin, telithromycin), which are used to treat bacterial infections in the lungs, throat, and ear. When these strong cytochrome inhibitors are used with Simvastatin may lead to an increase in the risk of breakdown of damaged skeletal muscles by increasing the inhibitory activity of HMG-CoA reductase enzyme in the blood. The combined use of Simvastatin with cytochrome inhibitors is not recommended. In case, if this combination is unavoidable, then follow the use of other alternative statins.
Simvastatin may interact with Strong CYP3A4 inhibitors such as (itraconazole, ketoconazole, posaconazole, voriconazole, fluconazole), which are used to treat fungal infections. The patients using CYP3A4 inhibitors with Simvastatin may increase the risk of muscle diseases and breakdown of damaged skeletal muscles (rhabdomyolysis) by increasing the inhibitory activity of HMG-CoA reductase enzyme in the blood. Use of voriconazole with Simvastatin may lead to inhibition of metabolism of #NAME, so in that case, proper adjustment of the Simvastatin dose may be needed to reduce the risk of muscle diseases, including the breakdown of damaged skeletal muscles (rhabdomyolysis).
Your doctor's guidelines may need to be followed while taking this medicine along with Nefazodone, which is used to treat depression, aggressive behavior, and panic disorders. Nefazodone prevents the metabolic pathway of cytochrome P450 isoform 3A4 which can raise the levels of Simvastatin in the blood and may increase the risk of muscle diseases. The combined use of Simvastatin with nefazodone should be avoided.
Special instructions need to be followed while taking this medicine along with CYP3A4 inhibitors such as (cyclosporine and danazol) which is used to prevent organ transplant rejection and to treat the hormonal disturbances in the body. The risk of muscle diseases, including muscular weakness and breakdown of damaged skeletal muscles (rhabdomyolysis), is increased when Simvastatin is taken with cyclosporine or danazol. The combined use of Simvastatin with gemfibrozil, cyclosporine, or danazol is not recommended.
Your doctor's guidelines may need to be followed while taking this medicine along with Coumarin anticoagulants, which are used to prevent blood clot formation. When Simvastatin is used in combination with coumarin anticoagulants, may lead to an increase in prothrombin time. Before starting the treatment with Simvastatin, the prothrombin time should be monitored carefully.
Special instructions need to be followed while taking this medicine along with Colchicine, which is used to treat gout. When Simvastatin is taken with colchicine, cases of myopathy, including rhabdomyolysis have been reported. Close clinical monitoring of such patients is advisable in this combination of Simvastatin with colchicine.
Simvastatin interacts with Niacin, which is used to fulfill vitamin B3 deficiency and to treat high cholesterol levels. Rare cases of muscle diseases have been found to be increased when the dose of niacin should be given more than 1 g per day. Take necessary precautions while treating Chinese patients with the exceeding dose (20 mg per day) of Simvastatin when used in combination with niacin-containing products.
There may be an interaction of Simvastatin with Lipid-lowering drugs such as fibrates, Lomitapide, and gemfibrozil. Use of gemfibrozil with Simvastatin may lead to an increase in the metabolism of Simvastatin by 1.9-fold, possibly due to inhibition of the drug metabolism (glucuronidation) pathway. The combined use of lipid-lowering drugs with Simvastatin should be avoided.
Simvastatin may interact with Amiodarone, Ranolazine and Amlodipine, which are used to treat heart disorders and high blood pressure. Use of these medicines with Simvastatin may increase the risk of muscle diseases, including muscular weakness and breakdown of damaged skeletal muscles (rhabdomyolysis). The dosage of Simvastatin should not be exceeded more than 20 mg daily.
Simvastatin interacts with Fusidic acid, which is used as topical medicine to treat skin infections. When fusidic acid is used in combination with Simvastatin may increase the risk of myopathy and rhabdomyolysis. Discontinue the use of Simvastatin throughout the treatment procedure of fusidic acid.
There may be an interaction of Simvastatin with Grapefruit juice, which is used for weight loss, asthma, high cholesterol. When grapefruit juice and Simvastatin (over 1 litre daily) is taken together, it resulted in a 7-fold increase in the absorption of Simvastatin. Avoid the consumption of grapefruit juice during the treatment period of Simvastatin.
Simvastatin may interact with Rifampicin, which is used to treat bacterial infections. The patients having long-term rifampicin therapy may undergo loss of efficacy of Simvastatin.
This page does not contain all the possible interactions of Simvastatin. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Traveling With Medication

  • Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
  • While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country's embassy or website.
  • Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
  • If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Simvastatin is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

  • If there are disposal instructions on the package, please follow the instructions.
  • If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
  • If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
  • If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.