Medication info

Simvita Tablet 20 Milligrams (Simvastatin)

Prescription medicationTablet경구Expired
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
(주)라이트팜텍
Appearance
Pale yellow oval-shaped film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle, 500 tablets/bottle
Approval status
Expired

MFDS item code 202002293 · Approved 2020.04.02

This product's status changed to Expired on 2025.04.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
For adult patients, to reduce the risk of cardiovascular diseases, a dose of 40 mg once daily is administered. In typical treatment for hyperlipidemia, the general initial starting dose is 20 mg taken once in the evening, while patients with mild to moderate hypercholesterolemia may start at 10 mg. The dose of 5 to 40 mg is given once daily in the evening, and prior to initiation of treatment, the initial LDL-cholesterol level, target treatment level, and patient’s
Child dose
For pediatric patients aged 10 to 17 years, the recommended initial dose is 10 mg once daily in the evening. The recommended dosage range is 10 to 40 mg per day, with a maximum dose of 40 mg per day.

Ingredients

Manufacturer
(주)라이트팜텍

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

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

This medication reduces the risk of cardiovascular diseases. It lowers the risk of mortality from coronary artery disease, non-fatal myocardial infarction, and stroke in adults with a history of coronary artery disease, diabetes, peripheral vascular disease, or stroke. It also has the effect of reducing the risk associated with vascular bypass surgery. In patients with hyperlipidemia, it helps to lower high cholesterol and triglyceride levels and increase good cholesterol (HDL). It is also used as an adjunct to diet for pediatric patients with heterozygous familial hypercholesterolemia to improve blood lipid levels. Overall, it is used to protect cardiovascular health and manage dyslipidemia.

How to take

Adult dose

For adult patients, to reduce the risk of cardiovascular diseases, a dose of 40 mg once daily is administered. In typical treatment for hyperlipidemia, the general initial starting dose is 20 mg taken once in the evening, while patients with mild to moderate hypercholesterolemia may start at 10 mg. The dose of 5 to 40 mg is given once daily in the evening, and prior to initiation of treatment, the initial LDL-cholesterol level, target treatment level, and patient’s

Child dose

For pediatric patients aged 10 to 17 years, the recommended initial dose is 10 mg once daily in the evening. The recommended dosage range is 10 to 40 mg per day, with a maximum dose of 40 mg per day.

Precautions

This drug is primarily used to lower cholesterol levels in the blood and reduce the risk of cardiovascular diseases. This drug can cause muscle abnormalities, so if symptoms of muscle pain or weakness occur, you should inform your doctor immediately. Particularly, the risk of myopathy increases when taking high doses or certain other medications together. As this drug is metabolized in the liver, caution is necessary for patients with poor liver function or those who consume a lot of alcohol. If liver function test results are abnormal, administration should be avoided or done according to the doctor's guidance. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this drug, and if pregnancy is confirmed during treatment, it should be immediately discontinued. This drug interacts with many specific drugs; co-administration can increase the risk of side effects, so if other medications are being taken, you must inform your doctor or pharmacist. Particularly, caution is needed when taking in conjunction with potent CYP3A4 inhibitors, some antifungals, antibiotics, immunosuppressants, and certain heart medications. Elderly patients or those with impaired kidney function, as well as patients with hypothyroidism, have a higher risk of muscle problems when using this drug, thus careful monitoring is essential. If you experience unexplained muscle pain, tenderness, or weakness that persists or worsens during treatment, consult with healthcare personnel immediately, and if necessary, blood tests should be conducted to check for muscle damage. This medication may rarely cause side effects such as liver dysfunction, allergic reactions, skin rashes, dyspepsia, headache, etc., so if any unusual symptoms arise, consult a doctor. When storing this medication, keep it out of the reach of children, store it in its original container, and do not transfer it to another container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, consciousness confusion, visual disturbances, paralysis, s

Mild side effects

Abdominal pain, weakness, constipation, diarrhea, dyspepsia, bloating, nausea, headache, upper respiratory infections, atrial fibrillation, gastritis, diabetes, myalgia, insomnia, dizziness, bronchitis, sinusitis, eczema, urinary tract infections, alopecia, itching, various skin changes, lichenoid drug eruption, gynecomastia, decreased libido, sexual dysfunction, progression of cataracts, ocular muscle paralysis, anemia, thyroid dysfunction, transient and mild liver function test abnormalities, H

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

Storage

This medication should be stored in a tightly closed container to prevent contact with air or moisture, and ideally kept at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Pale yellow oval-shaped film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle, 500 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.

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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.