Medication info
Simvastatin 20 mg Tablets

Simvastatin 20 mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
아주약품(주)
Appearance
Yellowish-brown oval film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200400724 · Notified 2004.05.29 · Insurance code 654000580

Summary

Main use
Reduction of the risk of cardiovascular disease and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
Administer 5–40 mg once daily in the evening. The initial starting dose is 20 mg, and in high-risk adults, 40 mg is administered once daily. Patients with homozygous familial hypercholesterolemia receive 40 mg once daily in the evening. There are dose restrictions when used with certain drugs, and for patients with severe renal impairment, the initial dose is 5 mg.
Child dose
For pediatric patients aged 10-17 years, administer 10 mg once daily in the evening, with a maximum dose of 40 mg per day. Dosage adjustments should be made appropriately according to treatment goals with an interval of 4 weeks.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

Reduction of the risk of cardiovascular disease and improvement of hyperlipidemia

  • Coronary heart disease
  • diabetes
  • peripheral vascular disease
  • stroke
  • other cerebrovascular diseases
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • hypertriglyceridemia
  • heterozygous familial hypercholesterolemia
View approved original text

This medication is used to reduce the risk of cardiovascular diseases. It decreases the risk of death and non-fatal myocardial infarction and stroke due to coronary heart disease in adult patients with a history of various cardiovascular diseases including coronary heart disease, diabetes, peripheral vascular disease, and stroke. It also reduces the risks after coronary and non-coronary vascular surgery, thereby protecting cardiovascular health. It is effective in the treatment of hyperlipidemia, helping to lower cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia. Particularly, it is effective as an adjunct to diet therapy in pediatric patients with heterozygous familial hypercholesterolemia, reducing total cholesterol and LDL cholesterol levels. Therefore, it is widely used to improve cardiovascular diseases and dyslipidemia.

How to take

Adult dose

Administer 5–40 mg once daily in the evening. The initial starting dose is 20 mg, and in high-risk adults, 40 mg is administered once daily. Patients with homozygous familial hypercholesterolemia receive 40 mg once daily in the evening. There are dose restrictions when used with certain drugs, and for patients with severe renal impairment, the initial dose is 5 mg.

Child dose

For pediatric patients aged 10-17 years, administer 10 mg once daily in the evening, with a maximum dose of 40 mg per day. Dosage adjustments should be made appropriately according to treatment goals with an interval of 4 weeks.

Precautions

This medication carries a risk of muscle problems, so if muscle pain or weakness occurs, especially when taking a high dose, inform your doctor immediately. This medication may affect liver function, so patients with liver disease or abnormal liver function tests should not take it. Pregnant women, women who may become pregnant, and nursing mothers should not take this medication. If taken with certain other medications, the risk of muscle damage may increase, so it is essential to inform your doctor or pharmacist if you are taking other medications. Excessive alcohol consumption or a history of liver or kidney disease requires careful use of this medication, and regular monitoring may be necessary. Elderly patients and women are at a higher risk of developing muscle problems, so caution is needed. It is advisable to regularly check liver function and muscle condition while taking this medication. Some patients may experience side effects such as headaches, dyspepsia, constipation, nausea, or other symptoms, and if symptoms persist, consult your doctor. It is recommended to avoid taking this medication with grapefruit juice, as grapefruit juice can increase the drug’s blood concentration and the risk of side effects. Avoid taking this medication during pregnancy or nursing, and women planning to become pregnant should consult their doctor before taking it. Inform your doctor if you are starting any new medications while taking this drug. In case of overdose, seek medical attention immediately for appropriate treatment. This medication should be kept out of reach of children and stored in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, skin peeling, oral/eye mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes, profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine volume

Mild side effects

Abdominal pain, weakness, constipation, diarrhea, dyspepsia, bloating, nausea, headache, upper respiratory infection, atrial fibrillation, gastritis, diabetes, muscle pain, insomnia, dizziness, bronchitis, stenosis, eczema, urinary tract infection, alopecia, itching, skin changes, flat lichen drug rash, gynecomastia, decreased libido, sexual dysfunction, cataract progression, eye muscle paralysis, anemia, thyroid dysfunction, transient liver function test abnormalities, HbA1c and fasting blood

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a sealed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This way, the drug's effectiveness and safety can be well preserved.

Appearance and packaging

Appearance

Yellowish-brown oval film-coated tablet

Package unit

30 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.