Medication info
Simvastatin Tablets 20 mg (Simvastatin)

Simvastatin Tablets 20 mg (Simvastatin)

Prescription medicationTablet경구
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
미래바이오제약(주)
Appearance
Brownish-orange oval film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200402567 · Notified 2004.11.16 · Insurance code 657500690

Summary

Main use
Reduces the risk of cardiovascular disease and improves hyperlipidemia
Who takes it
Adults · Children
Adult dose
For adults at risk of cardiovascular disease with a history of coronary artery disease, diabetes, peripheral vascular disease, stroke, or other cerebrovascular conditions, administer an initial dosage of 40 mg once daily. For the treatment of hyperlipidemia, it is generally recommended to take 20 mg once daily in the evening. Patients with mild to moderate hypercholesterolemia may start at 10 mg, with allowances for doses between 5 and 40 mg.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), administer 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
미래바이오제약(주)

Efficacy & effects

Reduces the risk of cardiovascular disease and improves 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 is primarily used to reduce the risk of cardiovascular disease. In particular, it lowers the risk of death associated with coronary events, myocardial infarction, and strokes in high-risk adult patients with a history of coronary artery disease, diabetes, peripheral vascular disease, and stroke. It also helps in the treatment of hyperlipidemia, lowering total cholesterol and LDL cholesterol, while increasing HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia in conjunction with dietary changes. The medication is effective in improving cholesterol levels in pediatric patients with heterozygous familial hypercholesterolemia when diet alone is insufficient. Thus, it is widely used for the prevention of cardiovascular disease and management of hyperlipidemia.

How to take

Adult dose

For adults at risk of cardiovascular disease with a history of coronary artery disease, diabetes, peripheral vascular disease, stroke, or other cerebrovascular conditions, administer an initial dosage of 40 mg once daily. For the treatment of hyperlipidemia, it is generally recommended to take 20 mg once daily in the evening. Patients with mild to moderate hypercholesterolemia may start at 10 mg, with allowances for doses between 5 and 40 mg.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), administer 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 medication may cause serious side effects such as myopathy and rhabdomyolysis that can result in muscle abnormalities. The risk is especially heightened when taking a high dose of 80 mg; therefore, caution is required. Patients with known allergies to this drug or its components, those with severe hepatic impairment, and pregnant or nursing women should not take this medication. It is also important to inform the healthcare provider if you are taking other specific medications, as the risk may increase. Individuals with impaired liver or kidney function, as well as those with a history of hypothyroidism or muscle-related diseases, should use this medication with caution. Elderly patients and women are also at a higher risk for muscle abnormalities, necessitating vigilance. Symptoms such as muscle pain, weakness, and tenderness should be reported to healthcare providers immediately, and treatment should be stopped if these symptoms are severe. Regular liver function tests are recommended as liver function abnormalities may occur. This medication can interact with other drugs, so it is essential to disclose any new medications being taken. Women of childbearing potential must use contraception while taking this medication, and if pregnancy is confirmed, the medication should be discontinued immediately. Nursing women are advised to discontinue breastfeeding while on this medication. This drug should not be used in children under 10 years of age or in females before menarche. In case of overdose, standard treatment should be pursued, and the medication should be kept out of reach of children. It is advised not to consume excessive grapefruit juice while taking this medication, as the risk of muscle abnormalities may increase when used with certain medications.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, fever with severe rash, blisters, skin peeling, oral/eye mucosal pain, shortness of breath or difficulty breathing, asthmatic attacks, respiratory problems accompanied by coughing and fever, yellowing of skin or eyes (jaundice), extreme malaise, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Abdominal pain, weakness, constipation, diarrhea, indigestion, bloating, nausea, headache, upper respiratory infection, atrial fibrillation, gastritis, diabetes, myalgia, insomnia, dizziness, bronchitis, rhinitis, dermatitis, urinary tract infection, alopecia, pruritus, various skin changes, lichenoid drug rash, gynecomastia, decreased libido, sexual dysfunction, cataract progression, ocular muscle paralysis, anemia, thyroid dysfunction, transient mild liver function test abnormalities, H

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 is important to maintain a storage temperature between 1 to 30 degrees Celsius. Proper storage will help ensure the medication's effectiveness.

Appearance and packaging

Appearance

Brownish-orange 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.