Medication info
Simvastatin 20 mg Tablets (Simvastatin)

Simvastatin 20 mg Tablets (Simvastatin)

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

MFDS item code 200403258 · Notified 2004.05.11 · Insurance code 654700360

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
Patients receiving this medication should strictly follow a standard cholesterol-lowering diet before and during treatment. 1. Reduction of risk for cardiovascular disease - The recommended initial dose of Simvastatin is 40 mg once daily. 2. Hyperlipidemia - For usual starting dosage, 20 mg is recommended once daily in the evening. - For patients with mild to moderate hypercholesterolemia, it may start at 10 mg.
Child dose
For pediatric patients (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

Ingredients

Manufacturer
케이엠에스제약(주)

Efficacy & effects

Reduction of cardiovascular disease risk 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 is used to lower the risk of cardiovascular diseases. In particular, it reduces the risk of cardiac events in adult patients with a history of coronary heart disease, stroke, or peripheral vascular disease. It also helps to improve cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia. In pediatric patients with heterozygous familial hypercholesterolemia, it is used as an adjunct to diet to lower cholesterol levels. This medication plays an important role in protecting and improving heart and vascular health.

How to take

Adult dose

Patients receiving this medication should strictly follow a standard cholesterol-lowering diet before and during treatment. 1. Reduction of risk for cardiovascular disease - The recommended initial dose of Simvastatin is 40 mg once daily. 2. Hyperlipidemia - For usual starting dosage, 20 mg is recommended once daily in the evening. - For patients with mild to moderate hypercholesterolemia, it may start at 10 mg.

Child dose

For pediatric patients (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

Precautions

This medication may cause muscle-related side effects such as myopathy or rhabdomyolysis, especially at high doses. Therefore, if muscle pain or weakness occurs while taking a high dose, you should immediately consult your physician. Patients with a known allergy to this medication or those with liver disease, pregnant or nursing women, or those taking certain medications should not use this medication. Patients with liver or kidney issues, alcohol dependence, or a history of hypothyroidism should use this medication with caution. Regular liver function and muscle-related tests are recommended during therapy, and any unusual symptoms should be reported to healthcare professionals immediately. This medication can interact with many other drugs, so if you are taking other medications, you must inform your physician or pharmacist. Special caution is needed when being taken with CYP3A4 inhibitors, certain antibiotics, calcium channel blockers, and fibrate drugs. Pregnant women should avoid this medication, and women who may become pregnant should ensure effective contraception while taking it. Nursing mothers are also advised to stop breastfeeding while on this medication. Elderly patients and pediatric patients should also use caution, particularly in elderly patients, where the risk of muscle-related side effects may be higher. In case of overdose, you should immediately visit a medical facility for appropriate treatment. This medication should be stored away from direct sunlight and kept out of reach of children, preferably 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, paleness, severe rash with fever, blisters, skin peeling, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attack, cough with fever accompanied respiratory abnormalities, jaundice (yellowing of skin or eyes), general malaise, sudden and severe headache, lightning-like headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Abdominal pain
  • weakness
  • constipation
  • diarrhea
  • dyspepsia
  • 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
  • various skin changes
  • drug rash resembling lichen planus
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • progression of cataracts
  • ocular muscle paralysis
  • anemia
  • elevated aminotransferases
  • increased ALP
  • increased γ-GTP
  • bili

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

Storage

Keep this medication in a tightly sealed container to prevent exposure to air and store at room temperature between 1°C and 30°C. Proper storage helps maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Brown-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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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.