Medication info
SimvaCo Tablets (Simvastatin)

SimvaCo Tablets (Simvastatin)

Prescription medicationTablet경구
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
Brownish-yellow oval film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200308586 · Notified 2003.11.19 · Insurance code 657302400

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 disease, the daily dose is 40 mg. In the treatment of hyperlipidemia, the typical initial dose is 20 mg once daily in the evening, while patients with mild to moderate hypercholesterolemia can start with 10 mg. Doses are given once daily in the evening and adjusted according to cholesterol levels. Certain patient populations may have dose limitations; for example,
Child dose
The recommended initial dose for pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily in the evening. The recommended dosage range is 10-40 mg per day, with a maximum dose of 40 mg.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

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

This medicine helps lower the risk of cardiovascular diseases. It reduces the risk of cardiovascular events and death in adult patients with a history of coronary heart disease, diabetes, peripheral vascular disease, stroke, or other cerebrovascular diseases. Additionally, it decreases the risk of serious cardiovascular events such as myocardial infarction and stroke, and lowers the risk of vascular surgery. In the treatment of hyperlipidemia, it primarily lowers total cholesterol, LDL cholesterol, Apo-B protein, and triglyceride levels, while increasing good HDL cholesterol levels. It can effectively control cholesterol levels in pediatric patients with familial hypercholesterolemia when used together with dietary therapy. This medicine is used to improve cardiovascular health and reduce the risk of related diseases.

How to take

Adult dose

For reducing the risk of cardiovascular disease, the daily dose is 40 mg. In the treatment of hyperlipidemia, the typical initial dose is 20 mg once daily in the evening, while patients with mild to moderate hypercholesterolemia can start with 10 mg. Doses are given once daily in the evening and adjusted according to cholesterol levels. Certain patient populations may have dose limitations; for example,

Child dose

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

Precautions

This medication may cause myopathy or rhabdomyolysis, which can affect muscles. The risk is particularly increased at high doses, and caution is necessary. Patients with allergies to this medication or liver diseases, as well as women who are pregnant or breastfeeding, should not take this medication. Furthermore, the risk may increase when combined with certain medications; therefore, consultation with a physician is essential. Regular testing is required if there is a history of liver disease or suspected liver dysfunction as this medication can affect liver function. Any unusual symptoms should be reported to healthcare providers immediately. If symptoms such as muscle pain or weakness occur, the medication should be stopped immediately and a physician should be consulted, particularly for elderly patients or those with poor kidney function who need to be more cautious. This medication may interact with other drugs, so patients should inform healthcare providers of its use before starting any new medication. Women of childbearing potential should practice contraception while using this medication, and if pregnancy is confirmed, discontinuation should occur immediately. This medication is not to be used in children under 10 years of age; for adolescents over the age of 10, it should be taken only under a physician's guidance. In case of overdose, immediate medical attention should be sought for appropriate treatment. Store this medication out of the reach of children and it is safest to store it 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 rash with fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, lightning headache, seizures, altered consciousness, vision abnormalities, paralysis, urination.

Mild side effects

Abdominal pain, weakness, constipation, diarrhea, indigestion, bloating, nausea, headache, upper respiratory infection, atrial fibrillation, gastritis, diabetes, muscle pain, insomnia, dizziness, bronchitis, pharyngitis, eczema, urinary tract infection, alopecia, pruritus, various skin changes, lichenoid drug rash, gynecomastia, decreased libido, erectile dysfunction, cataract progression, oculomotor nerve paralysis, anemia, thyroid dysfunction, transient and mild liver function test abnormalities.

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

Storage

This medication must be stored in a tightly sealed container to protect it from air exposure, and it should be kept at room temperature between 1°C and 30°C. Proper storage will maintain the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

Brownish-yellow oval film-coated tablets

Package unit

30 tablets/bottle, 100 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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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.