Medication info

Colestin Tablets (Simvastatin)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
대화제약(주)
Appearance
Brownish-yellow round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 200201767 · Notified 2002.10.15

This product's status changed to Approval withdrawn on 2024.11.29. 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 hyperlipidemia
Who takes it
Adults · Children
Adult dose
The recommended initial starting dose for adult patients with a high risk of coronary heart disease events due to a history of coronary artery disease, diabetes, peripheral vascular disease, stroke, or other cerebrovascular diseases is 40 mg of simvastatin once daily. For patients with hyperlipidemia, the usual starting dose is 20 mg once daily in the evening, and mild to moderate hypercholesterolemic patients may start with 10 mg.
Child dose
The recommended initial dosage for pediatric patients (ages 10 to 17) with familial hypercholesterolemia is 10 mg once daily in the evening. The recommended dosing range is 10 to 40 mg per day, with a maximum recommended dose.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

  • Coronary artery disease
  • diabetes
  • peripheral vascular disease
  • stroke
  • other cerebrovascular diseases
  • non-fatal myocardial infarction
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • hypertriglyceridemia
  • familial hypercholesterolemia of the heterozygous type
View approved original text

This medication is highly effective in reducing the risk of cardiovascular diseases. It can reduce the risk of coronary events and cardiovascular mortality in adult patients with a history of coronary heart disease, diabetes, peripheral vascular disease, stroke, or other cerebrovascular diseases, and lower the risk of non-fatal myocardial infarction and stroke. It also decreases the risk of complications that may occur after coronary and non-coronary vascular procedures. Additionally, this drug is helpful in treating hyperlipidemia, effectively lowering total cholesterol and LDL cholesterol levels in patients with primary and mixed dyslipidemia, while increasing good HDL cholesterol. It is especially an important treatment option for patients with familial hypercholesterolemia and can be used in conjunction with or as an alternative to other therapies, and is used as a dietary supplement in pediatric patients. This medication helps improve cardiovascular health and manage hyperlipidemia.

How to take

Adult dose

The recommended initial starting dose for adult patients with a high risk of coronary heart disease events due to a history of coronary artery disease, diabetes, peripheral vascular disease, stroke, or other cerebrovascular diseases is 40 mg of simvastatin once daily. For patients with hyperlipidemia, the usual starting dose is 20 mg once daily in the evening, and mild to moderate hypercholesterolemic patients may start with 10 mg.

Child dose

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

Precautions

This medication can cause serious muscle-related side effects such as myopathy and rhabdomyolysis. The risk of these side effects is particularly higher when taken in high doses. Patients should be cautious. This drug can affect liver function; it should not be taken by patients with liver disease or elevated liver enzyme levels. Women who are pregnant or may become pregnant, as well as nursing women, should also avoid using this medication. The risk of myopathy increases when taken with strong CYP3A4 inhibitors or certain drugs. Patients taking these medications should not use this drug. Patients with a history of alcohol abuse, liver or kidney disease, hypothyroidism, elderly individuals, and women should be particularly cautious when using this medication, and if any muscle pain or weakness occurs, they should consult a physician immediately. This drug can trigger a variety of adverse reactions, particularly muscle pain, gastrointestinal symptoms, headache, and upper respiratory infections. If any adverse reactions are severe or persistent, notify a doctor. Regular monitoring of liver function and muscle condition is recommended during treatment, especially when taken at high doses. As many drugs interact with this medication, medical professionals should be informed of its use when being prescribed new medications. Women who are pregnant or planning to become pregnant should avoid using this medication, and if pregnancy is confirmed while taking it, discontinue use and consult a doctor immediately. It is only to be used in children and adolescents under certain limited circumstances and should not be administered to children under 10 years of age. In case of overdose, seek medical attention immediately for appropriate treatment. This drug should be kept out of reach of children and stored in its original container; avoid transferring it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory distress with cough+fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, urination issues

Mild side effects

Muscle pain, muscle cramps, joint pain, headache, weakness, constipation, diarrhea, dyspepsia, bloating, nausea, upper respiratory infection, abdominal pain, insomnia, dizziness, sensory abnormalities, peripheral neuropathy, peripheral nerve paralysis, mental disorders, anxiety, nightmares, depression, bronchitis, sinusitis, eczema, urinary tract infection, alopecia, pruritus, skin changes (nodules, pigmentation, skin/mucosa dryness, hair/nail changes), lichen planus-like drug rash, gynecomastia, decreased libido

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°C and 30°C. Proper storage maintains the drug's effectiveness and prevents degradation.

Appearance and packaging

Appearance

Brownish-yellow round film-coated tablet

Package unit

30 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.