Medication info

Yuhan Simvastatin Tablet 20 mg

Prescription medicationTablet경구Approval withdrawn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Approval withdrawn

MFDS item code 200200478 · Notified 2002.11.08

This product's status changed to Approval withdrawn on 2025.03.27. 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
Patients should adhere to a standard cholesterol-lowering diet before and during treatment with this medication. 1. Reduction of risk for cardiovascular diseases - The recommended starting dose of simvastatin is 40 mg once daily. 2. Hyperlipidemia - The typical starting dose is recommended to be 20 mg once daily in the evening. - For patients with mild to moderate hypercholesterolemia, the dose can begin at 10 mg.
Child dose
Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17): - Recommended initial dose is 10 mg once daily in the evening - Recommended dosage range is 10 to 40 mg once daily - Maximum dose is 40 mg once daily

Ingredients

Manufacturer
(주)유한양행

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

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

This medicine helps reduce the risk of cardiovascular disease. It lowers the risk of heart attacks and strokes in adults with a history of coronary artery disease, diabetes, peripheral vascular disease, or stroke, and reduces the risk of complications from coronary and other vascular procedures. It is also used to treat hyperlipidemia, lowering total cholesterol, LDL cholesterol, Apo-B protein, and triglyceride levels while raising HDL cholesterol. It is effective for patients with genetic dyslipidemia, such as familial hypercholesterolemia, and is also used in pediatric patients when diet alone is insufficient. This drug is widely used in the prevention of cardiovascular diseases and the improvement of dyslipidemia.

How to take

Adult dose

Patients should adhere to a standard cholesterol-lowering diet before and during treatment with this medication. 1. Reduction of risk for cardiovascular diseases - The recommended starting dose of simvastatin is 40 mg once daily. 2. Hyperlipidemia - The typical starting dose is recommended to be 20 mg once daily in the evening. - For patients with mild to moderate hypercholesterolemia, the dose can begin at 10 mg.

Child dose

Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17): - Recommended initial dose is 10 mg once daily in the evening - Recommended dosage range is 10 to 40 mg once daily - Maximum dose is 40 mg once daily

Precautions

This drug is primarily used to lower blood cholesterol levels by acting in the liver to inhibit cholesterol synthesis. When taking this medication, muscle problems may occur; therefore, if symptoms like muscle pain or weakness appear, consult a doctor immediately. Particularly, the risk of myopathy and rhabdomyolysis increases when taking high doses (80mg), so caution is required at high doses. Patients with poor liver function or liver disease should not take this drug and should undergo regular liver function testing. Women who are pregnant or may become pregnant, or who are breastfeeding, should not take this drug and must discontinue it immediately if pregnancy is confirmed while being treated. This drug can interact with certain medications, so if you are taking other medicines, you must inform your doctor or pharmacist. Elderly individuals, patients with reduced kidney function, and those with hypothyroidism should be monitored more closely when taking this drug. During treatment, it is advisable to avoid certain foods like grapefruit juice, which can increase the blood concentration of this drug and raise the risk of side effects. This drug may slightly increase blood sugar levels, so patients at risk for diabetes should monitor their blood sugar regularly. In children and adolescents, this drug should not be used in those under 10 years old or in females before menarche, and adolescents aged 10 to 17 should take it under a doctor's guidance. Various side effects, such as liver function abnormalities, blood test abnormalities, allergic reactions, and skin rashes can occur during treatment, so if any abnormal symptoms arise, consult healthcare professionals immediately. In case of overdose, visit a medical facility immediately for appropriate treatment, and keep this drug out of the reach of children. If receiving treatment from another physician while taking this drug, you must inform them that you are taking it.

Side effects and when to seek care immediately

Serious side effects

Myopathy/rhabdomyolysis, severe allergic reactions (hives, angioedema, difficulty breathing), severe skin reactions (toxic epidermal necrolysis, mucous membrane syndrome, Stevens-Johnson syndrome), liver abnormalities (jaundice, hepatitis, liver failure, abnormal liver function, fulminant liver necrosis), severe neurological symptoms (cranial nerve dysfunction, facial partial paralysis, seizures, confusion), serious edema or urination abnormalities (severe swelling throughout the body, elevated blood pressure,

Mild side effects

Abdominal pain, fatigue, constipation, diarrhea, indigestion, bloating, nausea, headache, upper respiratory infection, atrial fibrillation, gastritis, diabetes, muscle pain, insomnia, dizziness, bronchitis, sinusitis, eczema, urinary tract infection, alopecia, itching, skin changes, lichenoid drug rash, gynecomastia, decreased libido, sexual dysfunction, cataract progression, ophthalmoplegia, anemia, thyroid function abnormalities, transient and mild liver function test abnormalities, HbA1c

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 tightly sealed container. Additionally, it is advisable to store it at room temperature between 1°C and 30°C, avoiding areas that are too hot or too cold. This helps maintain the drug's effectiveness over time.

Appearance and packaging

Appearance

Brownish yellow 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.

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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.