Medication info

Ilyang Bio Simvastatin Tablet

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

MFDS item code 200503786 · Notified 2005.12.30

This product's status changed to Expired on 2024.10.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of cardiovascular disease risk and improvement of dyslipidemia
Who takes it
Adults · Children
Adult dose
1. For reduction of cardiovascular disease risk, administer 40 mg once daily. 2. For treatment of dyslipidemia, generally administer 5 to 40 mg once daily in the evening. - The initial dose is 20 mg or 10 mg for mild to moderate cases. - The dosage should be adjusted based on regular cholesterol level measurements at 4 weeks after starting treatment and thereafter. - Refer to the recommendations for specific patient populations (homozygous familial hypercholesterolemia.
Child dose
For pediatric patients with familial heterozygous hypercholesterolemia (ages 10 to 17) The recommended initial dose is 10 mg once daily in the evening. The recommended dosage range is 10 to 40 mg per day, and the maximum is 40 mg.

Ingredients

Manufacturer
일양바이오팜(주)

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of dyslipidemia

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

This medication helps reduce the risk of cardiovascular diseases. It lowers the risk of cardiac mortality, myocardial infarction, and stroke in adult patients with a history of coronary artery disease, diabetes, peripheral vascular disease, or stroke. It also reduces the risk associated with coronary and non-coronary vascular procedures. In the treatment of dyslipidemia, it controls cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia and improves cardiovascular health by increasing HDL cholesterol. In particular, it is used to improve blood lipids in pediatric patients with familial heterozygous hypercholesterolemia in conjunction with dietary therapy. This medication is effectively used for the prevention of cardiovascular diseases and the treatment of dyslipidemia.

How to take

Adult dose

1. For reduction of cardiovascular disease risk, administer 40 mg once daily. 2. For treatment of dyslipidemia, generally administer 5 to 40 mg once daily in the evening. - The initial dose is 20 mg or 10 mg for mild to moderate cases. - The dosage should be adjusted based on regular cholesterol level measurements at 4 weeks after starting treatment and thereafter. - Refer to the recommendations for specific patient populations (homozygous familial hypercholesterolemia.

Child dose

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

Precautions

This medication may cause muscle-related disorders such as myopathy or rhabdomyolysis. The risk increases especially when taking high doses, so caution is necessary. People with allergies to this medication or its components, those with liver diseases or elevated liver function test results, pregnant women or women with the potential for pregnancy, and nursing mothers should not take this medication. Additionally, when taken with certain potent drugs, the risk of muscle damage may increase, so the dosage should be adjusted to a lower dose or another medication should be substituted if taking drugs that interact with this medication. People who consume large amounts of alcohol, have liver or kidney problems, have a history of hypothyroidism or muscle disorders, the elderly, and women should be particularly cautious when taking this medication. During treatment, if there is unexplained muscle pain, tenderness, or weakness, promptly inform a doctor, and if necessary, discontinue the medication. Regular liver function tests should be conducted before and during treatment, as there may be liver function abnormalities, and if symptoms such as hepatitis or jaundice occur, consult medical personnel immediately. Pregnant women or those planning to become pregnant should not take this medication, and if pregnancy is confirmed during treatment, it should be stopped immediately and a doctor consulted. This medication can be used in children and adolescents, but it should not be administered to children under 10 years of age or to females before menarche. This medication can interact with several other drugs, so individuals taking other medications should inform their doctor or pharmacist, and it is advisable to avoid certain foods such as grapefruit juice. In case of overdose, general emergency measures should be taken, and it should be stored out of the reach of children 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, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), severe general malaise, sudden and very severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination.

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
  • sinusitis
  • eczema
  • urinary tract infection
  • muscle cramps
  • joint pain
  • taste disorder
  • ocular motility disorder
  • facial paresis
  • tremor
  • sensory disorder
  • peripheral neuropathy
  • peripheral nerve paralysis
  • mental disorders
  • anxiety
  • sleep disturbances
  • nightmares
  • depression
  • alopecia
  • pruritus
  • skin changes
  • lichen planus

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. The recommended storage temperature is room temperature between 1°C and 30°C. This helps to maintain the medication's efficacy and safety for a longer time.

Appearance and packaging

Appearance

Brownish-yellow oval film-coated tablets

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.