Medication info
Simvast Tablets 20 mg (Simvastatin)

Simvast Tablets 20 mg (Simvastatin)

Prescription medicationTablet경구
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Yellowish brown oval film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200202205 · Notified 2002.07.20 · Insurance code 643501460

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
For reducing the risk of cardiovascular diseases, the initial dose is 40 mg once daily. For treating hyperlipidemia, it is generally administered as 20 mg once daily in the evening. Patients with mild to moderate hypercholesterolemia may start with 10 mg. The dose can be adjusted from 5 - 40 mg daily, and cholesterol levels should be checked regularly after 4 weeks of starting treatment for adjustments. For specific patient populations...
Child dose
The recommended initial dose for pediatric patients (10 - 17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a recommended dosage range of 10 - 40 mg daily. The maximum recommended dose is 40 mg daily.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

  • Coronary heart disease
  • diabetes
  • peripheral vascular disease
  • stroke
  • other cerebrovascular diseases
  • hyperlipidemia
  • primary hypercholesterolemia
  • mixed dyslipidemia
  • primary abetalipoproteinemia
  • 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 due to heart disease, myocardial infarction, stroke, and risks associated with vascular procedures in adult patients with a history of coronary heart disease, diabetes, peripheral vascular disease, or stroke. It also helps lower blood lipid levels such as total cholesterol, LDL-cholesterol, and triglycerides while increasing HDL-cholesterol in patients with hyperlipidemia. For patients with familial hypercholesterolemia or dyslipidemia, it can be used alone or in combination with other treatments to manage blood lipids. In young pediatric patients with a family history or those in high-risk groups, it is used as an adjunct to a dietary regimen to lower cholesterol levels. Thus, this medication is effectively used for reducing the risk of cardiovascular diseases and improving hyperlipidemia.

How to take

Adult dose

For reducing the risk of cardiovascular diseases, the initial dose is 40 mg once daily. For treating hyperlipidemia, it is generally administered as 20 mg once daily in the evening. Patients with mild to moderate hypercholesterolemia may start with 10 mg. The dose can be adjusted from 5 - 40 mg daily, and cholesterol levels should be checked regularly after 4 weeks of starting treatment for adjustments. For specific patient populations...

Child dose

The recommended initial dose for pediatric patients (10 - 17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a recommended dosage range of 10 - 40 mg daily. The maximum recommended dose is 40 mg daily.

Precautions

This medication carries a risk of causing myopathy and rhabdomyolysis that may affect the muscles. This risk can increase, especially when taken at high doses or in conjunction with certain medications. This medication should not be used in patients who are allergic to its ingredients, have severely impaired liver function, are pregnant, breastfeeding women, or those taking certain potent medications. Patients with impaired liver or kidney function, hypothyroidism, or severe myasthenia gravis should use this medication cautiously, and precautions are necessary for elderly patients and women. While taking this medication, any symptoms such as muscle pain, weakness, or tenderness should be reported to a healthcare professional immediately, and if severe unusual symptoms occur, medication should be discontinued. Due to the possibility of liver function abnormalities, it is important to have regular liver function tests. If symptoms of hepatitis, jaundice, etc., occur, treatment should be stopped immediately. This medication can interact with several drugs, so inform your healthcare provider if you are taking other medications, especially when combined with certain antifungals, antibiotics, immunosuppressants, or calcium channel blockers. It should be avoided during pregnancy, and women of childbearing potential should ensure adequate contraception during treatment. If breastfeeding, this medication should not be taken. For pediatric patients, it should be used restrictively for those over 10 years, particularly between the ages of 10 and 17, monitoring its impact on growth and maturation is essential. Elderly patients may be more sensitive to the effects and side effects of this medication, necessitating dose adjustment and careful monitoring. In case of overdose, standard emergency first aid should be performed, as there is no specific antidote, following the instructions of healthcare professionals is crucial. Store this medication out of reach of children in its original container; transferring to another container might lead to quality degradation or misuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, high fever with severe rash, blisters, peeling skin, pain in mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory symptoms with cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy, sudden and severe headaches, lightning headaches, seizures, confusion, visual disturbances, paralysis, urination changes

Mild side effects

  • Abdominal pain
  • weakness
  • constipation
  • diarrhea
  • indigestion
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • atrial fibrillation
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  • gastritis
  • diabetes
  • myalgia
  • insomnia
  • dizziness
  • bronchitis
  • rhinitis
  • eczema
  • urinary tract infection
  • alopecia
  • itching
  • various skin changes
  • drug rash resembling lichen planus
  • gynecomastia
  • decreased libido
  • erectile dysfunction
  • cataract progression
  • ocular muscle paralysis
  • anemia
  • elevated aminotransferases
  • ALP
  • γ-GTP
  • bilirubin levels

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 air or moisture from getting in, and it should be kept at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain its effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Yellowish brown oval film-coated tablets

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.

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.