Medication info
Dongsung Simvastatin Tablets

Dongsung Simvastatin Tablets

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

MFDS item code 200200720 · Notified 2002.10.15 · Insurance code 643200170

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
Administer once daily in the evening. The initial starting dose is 40 mg, with patients with hyperlipidemia generally starting at 20 mg. Patients with mild to moderate hypercholesterolemia may start with 10 mg. The dosage can be adjusted within the range of 5 to 40 mg once daily in the evening. Dosage adjustments are required for specific patient groups and in combination therapy (e.g., elderly patients may start at 20 mg, while for those taking verapamil or diltiazem, appropriate adjustments are needed).
Child dose
For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, with a recommended dosage range of 10 to 40 mg. The maximum dose is 40 mg daily.

Ingredients

Manufacturer
동성제약(주)

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

  • Coronary artery heart disease
  • diabetes
  • peripheral artery disease
  • stroke
  • cerebrovascular disease
  • hypercholesterolemia
  • dyslipidemia
  • dysbetalipoproteinemia
  • hypertriglyceridemia
  • familial hypercholesterolemia
  • early cardiovascular disease
View approved original text

This medication helps reduce the risk of cardiovascular disease. It decreases the risk of death from coronary heart disease and the occurrence of non-fatal myocardial infarction and stroke in adult patients with a history of coronary artery heart disease, diabetes, peripheral artery disease, or stroke. It also reduces the risks that may occur after coronary and non-coronary vascular interventions. In patients with hyperlipidemia, it lowers total cholesterol, LDL cholesterol, Apo-B protein, and triglyceride levels while increasing HDL cholesterol levels. This medication can be used in conjunction with diet to improve cholesterol levels in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. This medication is used to improve cardiovascular health and treat hyperlipidemia.

How to take

Adult dose

Administer once daily in the evening. The initial starting dose is 40 mg, with patients with hyperlipidemia generally starting at 20 mg. Patients with mild to moderate hypercholesterolemia may start with 10 mg. The dosage can be adjusted within the range of 5 to 40 mg once daily in the evening. Dosage adjustments are required for specific patient groups and in combination therapy (e.g., elderly patients may start at 20 mg, while for those taking verapamil or diltiazem, appropriate adjustments are needed).

Child dose

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, with a recommended dosage range of 10 to 40 mg. The maximum dose is 40 mg daily.

Precautions

This medication is designed to lower blood cholesterol levels and help reduce the risk of cardiovascular diseases. When taking this medication, muscle pain or weakness may occur, and if such symptoms arise, you should immediately inform your doctor. Caution is particularly required when taking a high dosage (80 mg), as the risk of muscle-related side effects increases. Because it may affect liver function, patients with liver disease or abnormal liver function test results should not take this medication or must follow their doctor's instructions. Pregnant or potentially pregnant women, as well as breastfeeding women, should not take this medication. This medication may increase the risk of side effects when taken with certain antibiotics, antifungals, and some cardiac drugs, so if you are taking other medications, be sure to inform your doctor or pharmacist. Patients who consume excessive alcohol or have liver or kidney function issues must be more cautious while taking this medication. Elderly individuals and women may experience muscle side effects more frequently and should be careful when taking this medication. It is advisable to regularly check liver function and muscle enzyme levels through blood tests while taking this medication. If any unexplained muscle pain, tenderness, or weakness occurs while taking the medication, you should consult your healthcare provider immediately. This medication contains lactose, so patients with lactose intolerance should not take it. Additionally, this medication may raise blood sugar levels in some patients, so patients at risk of diabetes should periodically check their blood sugar levels. When taking this medication, it is best to avoid certain foods like grapefruit juice, and if a new medication is prescribed during the course of treatment, you must inform the prescriber about this medication. Children, especially those under 10 years of age or pre-menarchal, should not be administered this medication. Finally, store this medication out of reach of children and keep it in its original container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, mucosal pain in mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination issues

Mild side effects

Abdominal pain, weakness, constipation, diarrhea, indigestion, bloating, nausea, headache, upper respiratory infection, atrial fibrillation, gastritis, diabetes, myalgia, insomnia, dizziness, bronchitis, sinusitis, eczema, urinary tract infection, alopecia, itching, skin changes, flat atrophy-like drug rash, gynecomastia, decreased libido, sexual dysfunction (including erectile dysfunction), progression of cataracts, ocular muscle 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 should be stored in a tightly sealed container to prevent air ingress and kept at a temperature between 1 to 30 degrees Celsius in a room. Storing it this way will help maintain its effectiveness.

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.