Medication info
Simbarol Tablets (Simvastatin)

Simbarol Tablets (Simvastatin)

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

MFDS item code 200300283 · Notified 2003.03.27 · Insurance code 642900890

Summary

Main use
Reduces the risk of cardiovascular disease and improves hyperlipidemia
Who takes it
Adults · Children
Adult dose
Start with a dose of 40 mg once daily as the initial dose. The usual initial dose is 20 mg taken once daily in the evening. Patients with mild to moderate hypercholesterolemia may start with 10 mg. Administer 5 to 40 mg once daily in the evening, adjusting the dosage based on treatment goals and patient response. For certain patient groups, do not exceed 10 mg or 20 mg per day.
Child dose
For pediatric patients aged 10 to 17 years, administer 10 mg once daily in the evening. The recommended dosage range is 10 to 40 mg once daily, with a maximum dose of 40 mg per day. Dosage must be adjusted based on treatment goals.

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

Reduces the risk of cardiovascular disease and improves hyperlipidemia

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

This medication helps reduce the risk of cardiovascular diseases. It lowers the risk of heart disease mortality, myocardial infarction, and stroke in patients with a history of coronary heart disease, diabetes, peripheral vascular disease, and stroke. It also reduces the risk of coronary and non-coronary vascular interventions. When treating hyperlipidemia, it lowers total cholesterol, LDL cholesterol, and apo-B levels, while increasing HDL cholesterol levels, thereby improving blood lipid levels. It is especially effective in controlling cholesterol levels in patients with familial hypercholesterolemia and in pediatric patients when used alongside dietary measures. This medication is used to treat a variety of cardiovascular diseases and hyperlipidemia.

How to take

Adult dose

Start with a dose of 40 mg once daily as the initial dose. The usual initial dose is 20 mg taken once daily in the evening. Patients with mild to moderate hypercholesterolemia may start with 10 mg. Administer 5 to 40 mg once daily in the evening, adjusting the dosage based on treatment goals and patient response. For certain patient groups, do not exceed 10 mg or 20 mg per day.

Child dose

For pediatric patients aged 10 to 17 years, administer 10 mg once daily in the evening. The recommended dosage range is 10 to 40 mg once daily, with a maximum dose of 40 mg per day. Dosage must be adjusted based on treatment goals.

Precautions

This medication can cause muscle-related side effects such as myopathy and rhabdomyolysis; therefore, caution is especially needed when taking high doses. If unexplained muscle pain or muscle weakness occurs during the use of this medication, inform your doctor immediately, and stop taking the medication if necessary. Since this medication is primarily metabolized in the liver, patients with poor liver function or those who consume alcohol heavily should regularly monitor their liver health. Women who are pregnant or may become pregnant, and nursing mothers should not take this medication and must stop if pregnancy is confirmed during treatment. This medication can interact with certain drugs, increasing blood concentration levels and potentially raising the risk of muscle damage; thus, patients should consult with their doctor or pharmacist if they are taking other medications. Elderly patients or those with reduced kidney function, and patients with hypothyroidism need careful monitoring while taking this medication. If liver dysfunction is suspected, liver function tests should be performed, and treatment should be stopped immediately if symptoms of hepatitis or jaundice appear. It is advisable to avoid certain foods such as grapefruit juice while taking this medication, and inform other doctors that you are taking this medication when receiving other treatments. This medication is used with restrictions in children and adolescents, especially not administered to children under 10 years. In case of overdose, seek appropriate treatment at the hospital immediately, and store in a place out of reach of children in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest discomfort, difficulty breathing, cold sweat, pallor, severe allergic reaction, high fever with severe rash, blisters, skin peeling, pain in oral/eye mucous membranes, severe skin atypical reactions, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, liver abnormalities (jaundice), sudden and very severe effects

Mild side effects

Muscle pain, muscle cramps, joint pain, headache, weakness, abdominal pain, constipation, diarrhea, indigestion, bloating, nausea, upper respiratory infection, gastritis, insomnia, dizziness, bronchitis, tonsillitis, eczema, gynecomastia, decreased libido, sexual dysfunction (including erectile dysfunction), progression of cataracts, oculomotor paralysis, anemia, thyroid dysfunction, temporary and mild liver function test abnormalities, increased HbA1c and fasting blood glucose levels, sensory numbness, tingling, cold sensation

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve its effectiveness for a longer period.

Appearance and packaging

Appearance

Brownish yellow oval film-coated tablet

Package unit

30 tablets/bottle - 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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.