Medication info
Simvastatin 20mg Tablets

Simvastatin 20mg Tablets

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

MFDS item code 201901722 · Approved 2019.03.22 · Insurance code 658502110

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
The recommended initial starting dose is 40 mg of simvastatin per day. The usual initial starting dose is recommended to be 20 mg taken once daily at bedtime. For patients with mild to moderate hypercholesterolemia, starting with 10 mg may be appropriate. It is recommended to administer 5 to 40 mg once daily at bedtime. Prior to initiation of therapy, the initial LDL-cholesterol level needs to be considered.
Child dose
The recommended initial dosage for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 10 mg once daily at bedtime. The recommended dosage range is 10 to 40 mg daily with a maximum recommended dosage of 40 mg.

Ingredients

Manufacturer
익수제약(주)

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

  • Coronary heart disease
  • diabetes
  • peripheral vascular disease
  • stroke
  • hyperlipidemia
  • primary hypercholesterolemia
  • mixed dyslipidemia
  • primary dysbetalipoproteinemia
  • hypertriglyceridemia
  • secondary hyperlipidemia
  • heterozygous familial hypercholesterolemia
View approved original text

This medication helps to reduce hyperlipidemia and the risk of cardiovascular disease. It is particularly used in adults with a history of coronary heart disease, diabetes, peripheral vascular disease, or cerebral vascular disease to reduce the risk of coronary events, myocardial infarction, stroke, and vascular revascularization. It also helps lower cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia and increases levels of good cholesterol (HDL). In children, it is used as an adjunct to effectively lower cholesterol levels when dietary management alone is insufficient for familial hypercholesterolemia. Overall, this medicine is used to improve heart health and reduce the risk of vascular diseases.

How to take

Adult dose

The recommended initial starting dose is 40 mg of simvastatin per day. The usual initial starting dose is recommended to be 20 mg taken once daily at bedtime. For patients with mild to moderate hypercholesterolemia, starting with 10 mg may be appropriate. It is recommended to administer 5 to 40 mg once daily at bedtime. Prior to initiation of therapy, the initial LDL-cholesterol level needs to be considered.

Child dose

The recommended initial dosage for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 10 mg once daily at bedtime. The recommended dosage range is 10 to 40 mg daily with a maximum recommended dosage of 40 mg.

Precautions

This medication is used to lower cholesterol levels in the blood. Caution is advised while taking this medication as there is a risk of muscle-related issues. Especially when taking high doses or concomitant medications, serious muscle damage such as myopathy or rhabdomyolysis may occur. If symptoms such as muscle pain, weakness, or tenderness occur, consultation with a doctor is essential. Additionally, this medication may impact liver function, so patients with liver disease or elevated liver enzymes should not take it. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication. It may interact with specific antifungals, antibiotics, and immunosuppressants, increasing the risk of side effects; therefore, it is essential to inform the doctor about any other medications being taken. Elderly patients and women are at a higher risk of developing myopathy, and extra caution is advised during usage. Regular blood tests for monitoring liver function and muscle status are recommended while on this medication. In case of overdose, seek immediate hospital care for appropriate treatment. Lastly, this medication should be kept out of reach of children and should be stored in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, severe skin reaction, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, jaundice, extreme lethargy throughout the body, liver dysfunction (jaundice), sudden

Mild side effects

  • Abdominal pain
  • weakness
  • constipation
  • diarrhea
  • dyspepsia
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • atrial fibrillation
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  • gastritis
  • diabetes
  • myalgia
  • insomnia
  • dizziness
  • bronchitis
  • urethritis
  • eczema
  • urinary tract infection
  • hair loss
  • itching
  • skin changes
  • flat skin lesions resembling drug rashes
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataract progression
  • ocular muscle paralysis
  • anemia
  • increases in aminotransferases
  • ALP
  • γ-GTP
  • bilirubin levels
  • thyroid function

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 exposure to air or moisture, and it is safe to store at room temperature between 1°C and 30°C. Therefore, it should be kept in a cool and dry place until use, avoiding direct sunlight or high temperatures.

Appearance and packaging

Appearance

Brownish yellow oval film-coated tablet

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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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.