Medication info
BIEL Simvastatin 20 mg Tablet

BIEL Simvastatin 20 mg Tablet

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

MFDS item code 201804346 · Approved 2018.10.31 · Insurance code 647205310

Summary

Main use
Reduction of the risk of cardiovascular disease and improvement of dyslipidemia
Who takes it
Adults · Children
Adult dose
The recommended initial dose for reducing the risk of cardiovascular disease is 40 mg once daily. For the treatment of dyslipidemia, the typical initial dose is 20 mg once in the evening, and patients with mild to moderate hypercholesterolemia may start with 10 mg. Administer a dose of 5 to 40 mg once daily in the evening; the dosage should be adjusted based on the initial LDL cholesterol levels and therapeutic goals before starting treatment.
Child dose
For pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once in the evening, with a recommended dosage range of 10 to 40 mg per day. The recommended maximum dose

Ingredients

Manufacturer
한국코러스(주)

Efficacy & effects

Reduction of the risk of cardiovascular disease and improvement of dyslipidemia

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

This medication is particularly effective in adult patients with a history of cardiovascular diseases such as coronary heart disease, diabetes, peripheral vascular disease, and stroke. It reduces the risk of fatal coronary heart disease and lowers the risk of non-fatal myocardial infarction and stroke. It also helps reduce the risk of coronary and non-coronary vascular interventions. For patients with dyslipidemia, it is used as an adjunct to diet to lower total cholesterol, LDL cholesterol, and triglyceride levels while increasing HDL cholesterol. It is also used in conjunction with diet to reduce total cholesterol and LDL cholesterol in pediatric patients with heterozygous familial hypercholesterolemia. Therefore, this medication is effectively used for the reduction of cardiovascular disease risk and improvement of dyslipidemia.

How to take

Adult dose

The recommended initial dose for reducing the risk of cardiovascular disease is 40 mg once daily. For the treatment of dyslipidemia, the typical initial dose is 20 mg once in the evening, and patients with mild to moderate hypercholesterolemia may start with 10 mg. Administer a dose of 5 to 40 mg once daily in the evening; the dosage should be adjusted based on the initial LDL cholesterol levels and therapeutic goals before starting treatment.

Child dose

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

Precautions

This medication is used to lower blood cholesterol levels. There is a risk of muscle problems with this medication, particularly at high doses or when taken with certain drugs. If symptoms such as muscle pain, muscle weakness, or muscle tenderness occur, you must inform your doctor immediately. This medication is metabolized in the liver, so patients with liver function issues or liver disease should not take it. Women who are pregnant or may become pregnant, as well as those who are breastfeeding, should not take this medication. There are many drug interactions; concomitant use with certain antibiotics, antifungals, immunosuppressants, etc., may increase the risk of muscle damage. During the use of this medication, it is important to refrain from consuming alcohol and to regularly check liver function and muscle condition. Extra caution is needed for children, elderly individuals, patients with impaired kidney function, and those with hypothyroidism when using this medication. This medication may rarely cause liver function abnormalities, allergic reactions, neurological disorders, skin rashes, etc., so if any unusual symptoms occur, you must visit a hospital immediately. This medication cannot be given to patients with certain genetic lactose metabolism abnormalities, so if you have lactose intolerance, be sure to inform your healthcare provider. It is also advisable to avoid certain foods like grapefruit juice during treatment and to inform other doctors that you are taking this medication when prescribed other drugs. Dose adjustments and reviews of concomitant medications should be discussed with a specialist, and you should not stop or change the dosage on your own.

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 a fever, blisters, skin peeling, pain in oral or ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual impairment, paralysis, urination issues

Mild side effects

Abdominal pain, weakness, constipation, diarrhea, indigestion, bloating, nausea, headache, upper respiratory infections, atrial fibrillation, gastritis, diabetes, myalgia, insomnia, dizziness, bronchitis, sinusitis, eczema, urinary tract infections, alopecia, itching, various skin changes, drug rash resembling lichen planus, gynecomastia, decreased libido, sexual dysfunction, cataract progression, ocular muscle paralysis, anemia, thyroid dysfunction, temporary and mild liver function test abnormalities, none

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

Storage

This medication should be stored in a tightly sealed container that is air-tight and kept at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain its effectiveness for a longer time.

Appearance and packaging

Appearance

Brownish-yellow oval film-coated tablets

Package unit

30 tablets, 300 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.