Medication info

Ahn Kook Simvastatin Tablet 20 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
안국약품(주)
Appearance
Oval film-coated tablet of brownish-yellow color
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 200300801 · Notified 2003.07.12

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 the risk of cardiovascular disease and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
The general recommended initial dose is 20 mg once daily in the evening. For patients with mild to moderate hypercholesterolemia, treatment may be started with 10 mg. Administer 5 to 40 mg once daily in the evening, adjusting the dose according to treatment goals and patient response. For adults at high risk of cardiovascular disease, the initial dose is 40 mg daily. For specific patient populations (elderly, renal impairment
Child dose
For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily in the evening. The recommended dosage range is 10 to 40 mg per day, with a maximum dose of

Ingredients

Manufacturer
안국약품(주)

Efficacy & effects

Reduction of the risk of cardiovascular disease and improvement of hyperlipidemia

  • Coronary heart disease
  • diabetes
  • peripheral vascular disease
  • stroke
  • other cerebrovascular diseases
  • hyperlipidemia
  • primary hypercholesterolemia
  • mixed dyslipidemia
  • dysbetalipoproteinemia
  • hypertriglyceridemia
  • heterozygous familial hypercholesterolemia
View approved original text

This medication helps lower the risk of cardiovascular diseases. It reduces the risk of coronary heart disease mortality and non-fatal myocardial infarction and stroke in adult patients with a high risk of cardiovascular events, such as those with coronary heart disease, diabetes, peripheral vascular disease, and stroke. It also helps reduce the risk of complications after vascular surgeries. In patients with hyperlipidemia, it is used to lower elevated total cholesterol, LDL cholesterol, Apo-B protein, and triglycerides, while increasing HDL cholesterol. It is especially effective in genetic dyslipidemias, such as familial hypercholesterolemia, and can be administered to pediatric patients as an adjunct to dietary therapy. This drug is used to improve blood lipid levels and reduce the risk of cardiovascular diseases.

How to take

Adult dose

The general recommended initial dose is 20 mg once daily in the evening. For patients with mild to moderate hypercholesterolemia, treatment may be started with 10 mg. Administer 5 to 40 mg once daily in the evening, adjusting the dose according to treatment goals and patient response. For adults at high risk of cardiovascular disease, the initial dose is 40 mg daily. For specific patient populations (elderly, renal impairment

Child dose

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

Precautions

This drug can cause serious muscle-related side effects such as myopathy and rhabdomyolysis, so caution is necessary, particularly when taking high doses. If symptoms like muscle pain or weakness occur, the doctor should be informed immediately, and if these symptoms persist, the medication should be discontinued. This medication is primarily metabolized in the liver; therefore, patients with liver disease or impaired liver function should not use it. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not take this medication, and women of childbearing potential should use contraception while taking it. There are several medications that can interact with this drug, so if the patient is taking other medications, they must inform their doctor or pharmacist. In particular, the risk of muscle side effects may increase when used with strong CYP3A4 inhibitors, certain antibiotics, antifungals, immunosuppressants, and some heart medications. Elderly patients, those with renal impairment, hypothyroidism, and excessive alcohol consumption are at higher risk for muscle side effects when taking this medication and should be even more cautious. Regular blood tests to monitor liver function and muscle enzyme levels are recommended, and if abnormal findings are noted, the patient should consult their doctor immediately. It is advisable to avoid excessive consumption of grapefruit juice or fruits during treatment. Additionally, the risk of diabetes may increase, so periodic monitoring of blood glucose levels is necessary. Special caution is required for children and adolescents, and it is not recommended for children under 10 years. This drug contains lactose and is not suitable for patients with lactose intolerance. When storing, keep it out of reach of children, and store it sealed in its original container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, fever and severe rash, blisters, skin peeling, mucosal pain in the mouth and eyes, wheezing or difficulty breathing, asthma attack, cough and fever with respiratory abnormalities, jaundice of the skin or eyes, generalized malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output, generalized severe edema, hypertension

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
  • alopecia
  • pruritus
  • nodules
  • discoloration
  • dryness of skin and mucous membranes
  • changes in hair and nails
  • drug rash resembling lichen planus
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataract progression
  • ocular muscle paralysis
  • anemia
  • thyroid dysfunction

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness and safety of the medication for a long time.

Appearance and packaging

Appearance

Oval film-coated tablet of brownish-yellow color

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.