Medication info
Simvastatin 20 mg Tablet

Simvastatin 20 mg Tablet

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

MFDS item code 201601571 · Approved 2016.03.18

Summary

Main use
Reduction of risk for cardiovascular diseases and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
1. The recommended initial dosage for reducing the risk of cardiovascular diseases is 40 mg once daily. 2. For treating hyperlipidemia, the general recommended initial dosage is 20 mg administered once daily in the evening. Mild to moderate hypercholesterolemia patients may start with 10 mg. Administer once daily in the evening, adjusting the dosage between 5 and 40 mg according to treatment response. Specific patient groups
Child dose
For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, administer 10 mg once daily in the evening, the recommended dosage range is 10 to 40 mg daily. Dosage should be adjusted according to treatment goals.

Ingredients

Manufacturer
아이큐어(주)

Efficacy & effects

Reduction of risk for cardiovascular diseases and improvement of hyperlipidemia

  • Coronary heart disease
  • diabetes
  • peripheral vascular disease
  • stroke
  • other cerebrovascular diseases
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • hypertriglyceridemia
  • familial hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • early cardiovascular disease risk factors
View approved original text

This medication helps reduce the risk of cardiovascular diseases. It lowers the risk of major cardiovascular events such as coronary heart disease and stroke, and it is effective in patients with diabetes and peripheral vascular disease. Additionally, it reduces the risk of complications that may occur after coronary and non-coronary vascular interventions. It is also used in the treatment of hyperlipidemia, contributing to the reduction of total cholesterol, LDL cholesterol, Apo-B protein, and triglyceride levels, while increasing HDL cholesterol. In particular, it aids in lipid control for patients with familial dyslipidemia and is used in the treatment of children with heterozygous familial hypercholesterolemia. In summary, this drug is effectively used for the prevention of cardiovascular diseases and the management of hyperlipidemia.

How to take

Adult dose

1. The recommended initial dosage for reducing the risk of cardiovascular diseases is 40 mg once daily. 2. For treating hyperlipidemia, the general recommended initial dosage is 20 mg administered once daily in the evening. Mild to moderate hypercholesterolemia patients may start with 10 mg. Administer once daily in the evening, adjusting the dosage between 5 and 40 mg according to treatment response. Specific patient groups

Child dose

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, administer 10 mg once daily in the evening, the recommended dosage range is 10 to 40 mg daily. Dosage should be adjusted according to treatment goals.

Precautions

This drug is primarily used to lower cholesterol levels. Muscle problems may occur during treatment, such as muscle pain or weakness, and in severe cases, it may lead to rhabdomyolysis, a serious muscle injury. These muscle issues may occur more frequently as the drug dosage increases, so caution is especially needed when taking high doses. Additionally, as this drug is metabolized in the liver, patients with poor liver function should not take it and should have regular liver function tests. Pregnant or breastfeeding women should not take this drug, and women of childbearing age must use contraception before taking it. The risk of muscle injury can increase when taken with certain medications, so patients should inform their doctor or pharmacist if they are taking other drugs. Particular caution is needed when combined with strong CYP3A4 inhibitors, fibrate medications, certain antibiotics, calcium channel blockers, and others. If unexplained muscle pain, tenderness, or weakness occurs during treatment, immediately inform a healthcare professional. Elderly patients, women, those with hypothyroidism, and patients with impaired kidney function are at a higher risk for muscle issues when taking this drug and should be monitored closely. This drug can rarely cause various adverse reactions such as hepatitis, jaundice, skin rash, and thrombocytopenia; if any unusual symptoms occur, immediate consultation with a physician is necessary. Additionally, grapefruit juice can elevate drug concentrations and increase the risk of side effects, so it should be avoided during treatment. This drug is not used in children, especially those under 10 years of age or pre-pubertal females, as its safety has not been established. There is no specific treatment for overdose, but general emergency care should be administered, and the medical institution should be visited immediately. Finally, this drug should be stored in its original container and kept away from children's reach.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blistering, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headaches, lightning-like headaches, seizures, confusion, visual disturbances, paralysis

Mild side effects

  • Abdominal pain
  • weakness
  • constipation
  • diarrhea
  • dyspepsia
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • atrial fibrillation
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  • gastritis
  • diabetes
  • muscle pain
  • insomnia
  • dizziness
  • bronchitis
  • furunculosis
  • eczema
  • urinary tract infection
  • alopecia
  • itching
  • various skin changes
  • lichenoid drug rash
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataract progression
  • ocular muscle paralysis
  • anemia
  • elevated aminotransferases
  • elevated ALP
  • elevated γ-GTP
  • bilirubin

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

Storage

This drug is sensitive to air and moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Light yellow oval film-coated tablet

Package unit

30 tablets, 100 tablets

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.