Medication info

Simvastatin 20 mg (Simvastatin)

Prescription medicationApproval withdrawn
Ingredient · strength
Simvastatin›Strength being verified
Manufacturer / importer
코스맥스파마(주)
Appearance
Brownish-yellow oval film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201900690 · Approved 2019.01.29

This product's status changed to Approval withdrawn on 2023.07.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of the risk of cardiovascular diseases and improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
In adult patients at high risk for coronary heart disease with a history of coronary artery disease, diabetes, peripheral vascular disease, stroke, or other cerebrovascular diseases, 40 mg of Simvastatin is administered daily. For patients with hyperlipidemia, a common starting dose is 20 mg once daily in the evening, while mild to moderate hypercholesterolemia patients may start with 10 mg. Doses can be administered at 5 mg to 40 mg once daily in the evening, and
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dosage is 10 mg once daily in the evening. The recommended dosage range is 10 to 40 mg daily, with a maximum dosage of

Ingredients

Manufacturer
코스맥스파마(주)

Efficacy & effects

Reduction of the risk of cardiovascular diseases and improvement of hyperlipidemia

  • Coronary heart disease
  • diabetes
  • peripheral vascular disease
  • stroke
  • hypercholesterolemia
  • dyslipidemia
  • hypertriglyceridemia
  • heterozygous familial hypercholesterolemia
View approved original text

This medication is used to reduce the risk of cardiovascular diseases. It lowers the risk of death from heart disease, myocardial infarction, and occurrence of stroke in adult patients with a history of coronary heart disease, diabetes, peripheral vascular disease, or stroke, and reduces the related risks of vascular interventions. It also helps patients with hyperlipidemia to lower total cholesterol, LDL-cholesterol, apolipoprotein-B, and triglyceride levels, while increasing HDL-cholesterol levels. It is particularly used alongside diet in patients with familial hypercholesterolemia or mixed dyslipidemia. Additionally, it is used as an adjunct to diet to improve blood lipid levels in young patients with heterozygous familial hypercholesterolemia who meet specific criteria. It is effective for a wide range of cardiovascular diseases and dyslipidemia.

Dosage and Administration

Adult dosage

In adult patients at high risk for coronary heart disease with a history of coronary artery disease, diabetes, peripheral vascular disease, stroke, or other cerebrovascular diseases, 40 mg of Simvastatin is administered daily. For patients with hyperlipidemia, a common starting dose is 20 mg once daily in the evening, while mild to moderate hypercholesterolemia patients may start with 10 mg. Doses can be administered at 5 mg to 40 mg once daily in the evening, and

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dosage is 10 mg once daily in the evening. The recommended dosage range is 10 to 40 mg daily, with a maximum dosage of

Precautions

This medication is primarily used to lower blood cholesterol levels and works in the liver to inhibit cholesterol synthesis. Caution is necessary when taking this medication, as serious muscle-related side effects such as myopathy or rhabdomyolysis may occur. The risk is particularly higher at high doses (80 mg), and if symptoms like muscle pain or weakness occur, you should inform your doctor immediately. It may affect liver function; therefore, patients with liver disease or abnormally elevated liver enzyme levels should not take this medication. Regular liver function tests before and during treatment are important. Women who are pregnant or may become pregnant and those who are breastfeeding should not take this medication and should consult a doctor and use contraception if pregnancy is planned. This medication may interact with certain drugs. Particularly, when taken with strong CYP3A4 inhibitors, gemfibrozil, cyclosporine, danazol, certain calcium channel blockers, or amiodarone, the risk of myopathy increases, so concurrent use or dosage adjustments may be necessary. Elderly patients, women, patients with hypothyroidism, and patients with poor kidney function may be at higher risk for myopathy and should exercise extra caution while taking this medication. This medication may rarely cause side effects such as hepatitis, liver dysfunction, peripheral neuropathy, thrombocytopenia, hypersensitivity reactions, or interstitial lung disease, so you should consult a doctor immediately if any abnormal symptoms arise. During treatment, avoid consuming large amounts of grapefruit juice, and inform any other doctor who prescribes new medications that you are taking this medication. In case of overdose, standard emergency measures should be taken, and it should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), difficulty breathing, severe allergic reactions, fatal liver failure, hepatitis, jaundice, liver abnormalities (jaundice), toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, severe skin adverse reactions, rhabdomyolysis, severe myopathy, acute renal failure, serious neurological symptoms, paralysis, severe edema or urination abnormalities, thrombocytopenia, interstitial lung disease, anaphylaxis, vascular disorders

Mild side effects

  • Abdominal pain
  • malaise
  • constipation
  • diarrhea
  • dyspepsia
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • atrial fibrillation
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  • gastritis
  • diabetes
  • muscle pain
  • insomnia
  • dizziness
  • bronchitis
  • sinusitis
  • eczema
  • urinary tract infection
  • itching
  • alopecia
  • various skin changes
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataract progression
  • anemia
  • thyroid function abnormalities
  • elevated serum creatine kinase
  • insomnia and nightmares
  • depression
  • cognitive impairment
  • anxiety
  • thrombocytopenia

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and it is recommended to be stored at room temperature between 1 degree and 30 degrees Celsius. This method of storage will maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Brownish-yellow oval film-coated tablet

Package unit

30 tablets/bottle, 300 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.