Medication info
Simvastatin 20 mg Tablets (Simvastatin)

Simvastatin 20 mg Tablets (Simvastatin)

Prescription medicationTablet경구
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
Yellow-brown oval film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200404707 · Notified 2004.03.25 · Insurance code 671700660

Summary

Main use
Reduces the risk of cardiovascular diseases and improves hyperlipidemia
Who takes it
Adults · Children
Adult dose
Adults should take 5 mg to 40 mg once daily in the evening. The initial starting dose is 20 mg, and patients with mild to moderate hypercholesterolemia may start with 10 mg. For patients with homozygous familial hypercholesterolemia, the dose is 40 mg once daily in the evening. Elderly patients may achieve maximum reduction with a daily dose of 20 mg.
Child dose
Pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia should start with 10 mg once daily in the evening. The recommended dosage range is 10 mg to 40 mg per day.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Reduces the risk of cardiovascular diseases and improves hyperlipidemia

  • Coronary heart disease
  • diabetes
  • peripheral artery disease
  • stroke
  • other cerebrovascular diseases
  • primary hypercholesterolemia
  • mixed dyslipidemia
  • primary dysbetalipoproteinemia
  • severe hypertriglyceridemia
  • heterozygous familial hypercholesterolemia
View approved original text

This medication helps reduce the risk of cardiovascular diseases and decreases the risk of coronary events, myocardial infarction, stroke, and vascular surgeries in adult patients with a history of coronary heart disease, diabetes, peripheral artery disease, and stroke. It is also effective in treating hyperlipidemia, lowering cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol. It is particularly used in patients with familial hypercholesterolemia or severe hypertriglyceridemia. In pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, it is used alongside dietary therapy to lower total cholesterol and LDL cholesterol levels. This drug is used to improve cardiovascular health and significantly reduce the risk of heart disease.

How to take

Adult dose

Adults should take 5 mg to 40 mg once daily in the evening. The initial starting dose is 20 mg, and patients with mild to moderate hypercholesterolemia may start with 10 mg. For patients with homozygous familial hypercholesterolemia, the dose is 40 mg once daily in the evening. Elderly patients may achieve maximum reduction with a daily dose of 20 mg.

Child dose

Pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia should start with 10 mg once daily in the evening. The recommended dosage range is 10 mg to 40 mg per day.

Precautions

This medication is primarily used to lower serum cholesterol levels. If any muscle-related symptoms such as myalgia or weakness occur while taking this medication, it is important to inform a doctor immediately. There is an increased risk of serious muscle problems such as myopathy or rhabdomyolysis, especially when taking high doses or certain medications. Individuals with liver dysfunction or active liver disease should not take this medication. Pregnant women or women who may become pregnant, as well as breastfeeding women, should not use this medication. The risk of side effects is increased when taken with certain strong medications, so it's essential to discuss any concurrent medications with a doctor. Caution is also advised for those consuming alcohol excessively or having issues with liver, kidney, or thyroid function. Elderly patients and women are at higher risk for myopathy, and careful monitoring is necessary. Regular liver function tests and muscle-related tests should be conducted, and any unusual symptoms should be reported to healthcare professionals immediately. Additionally, the intake of certain foods such as grapefruit juice should be limited during treatment, and any new medications should be reported to healthcare providers. If planning pregnancy or if pregnant, do not take this medication and consult healthcare professionals.

Side effects and when to seek care immediately

Serious side effects

Myopathy, rhabdomyolysis, anaphylaxis, angioedema, toxic epidermal necrolysis (Lyell syndrome), Stevens-Johnson syndrome, erythema multiforme, hepatitis, chronic active hepatitis, liver failure, pancreatitis, cholestatic jaundice, liver cirrhosis, fulminant liver necrosis, liver cancer, severe muscle weakness, ocular muscle weakness, anemia, thrombocytopenia, leukopenia, hemolytic anemia, hypersensitivity reactions (including lupus-like syndrome and vasculitis)

Mild side effects

Abdominal pain, asthenia, constipation, diarrhea, dyspepsia, bloating, nausea, headache, upper respiratory infection, atrial fibrillation, gastritis, diabetes, myalgia, insomnia, dizziness, bronchitis, sinusitis, eczema, urinary tract infection, alopecia, pruritus, skin changes (nodules, pigmentation, skin/mucosal dryness, hair/nail changes), lichenoid drug rash, gynecomastia, decreased libido, sexual dysfunction (including erectile dysfunction), cataract progression, ocular muscle paralysis, anemia

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

Storage

Store this medication in a tightly sealed container to protect it from air and moisture. It should be kept at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow-brown oval film-coated tablets

Package unit

30 tablets/bottle, 100 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.