Medication info
Aprogen Simvastatin Tablets 20 mg

Aprogen Simvastatin Tablets 20 mg

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

MFDS item code 200300670 · Notified 2003.07.11 · Insurance code 645201540

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
1. For the reduction of cardiovascular disease risk in adult patients, the recommended initial starting dose is 40 mg once daily in the evening. 2. For adult patients with hyperlipidemia, the recommended initial starting dose is 20 mg once daily in the evening, and patients with mild to moderate hypercholesterolemia may start with 10 mg. 3. In general, a dose of 5 to 40 mg once daily in the evening is recommended, with dose adjustments made after 4 weeks of treatment.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dose is 10 mg once daily in the evening, with a recommended dosage range of 10 to 40 mg daily and a maximum dose of 40 mg daily.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

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

This medication helps reduce the risk of heart disease and stroke in adult patients who are at high risk for cardiovascular diseases such as coronary heart disease, diabetes, peripheral vascular disease, and stroke. Additionally, in patients with hyperlipidemia, it contributes to improving blood lipid levels by lowering total cholesterol, LDL cholesterol, apolipoprotein B, and triglyceride levels while raising HDL cholesterol levels. It is particularly useful in pediatric patients with familial hypercholesterolemia who have difficulty controlling their condition with diet alone. This drug is used to prevent and improve these diseases.

How to take

Adult dose

1. For the reduction of cardiovascular disease risk in adult patients, the recommended initial starting dose is 40 mg once daily in the evening. 2. For adult patients with hyperlipidemia, the recommended initial starting dose is 20 mg once daily in the evening, and patients with mild to moderate hypercholesterolemia may start with 10 mg. 3. In general, a dose of 5 to 40 mg once daily in the evening is recommended, with dose adjustments made after 4 weeks of treatment.

Child dose

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

Precautions

This drug is primarily used to lower cholesterol levels. Serious muscle-related side effects such as myopathy or rhabdomyolysis may occur when taking this medication, so caution is needed. The risk of such side effects is higher, especially when taking a high dose of 80mg, therefore, concomitant medications should be chosen at lower doses or alternatives. Patients with allergies to this medication or its ingredients, those with severely impaired liver function, pregnant or potentially pregnant women, and breastfeeding women should not take this drug. Furthermore, it should also not be administered to patients taking interacting medications such as certain antifungals, antibiotics, or immunosuppressants. Patients with poor liver or kidney function or alcohol abuse should exercise increased caution when taking this medication and should regularly check liver function and muscle condition. If symptoms such as muscle pain or weakness occur during treatment, patients should inform their doctor immediately and may need to stop taking the drug. This medication may affect liver function; hence if symptoms of hepatitis or jaundice appear, it should be discontinued immediately, and medical consultation sought. This medication may increase the risk of muscle side effects when combined with certain drugs, so it is crucial to inform healthcare providers about its use when prescribed other medications. Pregnant women should not take this drug and women planning a pregnancy should consult a doctor beforehand and use appropriate contraception. Breastfeeding women should also cease breastfeeding while taking this medication, and caution is necessary for children and the elderly regarding dosage adjustments. Regular health monitoring including liver function tests and muscle enzyme tests is necessary while taking this medication, and in case of an overdose, immediate medical attention should be sought. Store in a secure place out of reach of children and keep in the original container for safety.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty or shortness of breath, asthma attack, respiratory distress with coughing and fever, skin or eyes turning yellow (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination issues

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
  • dermatitis
  • urinary tract infection
  • alopecia
  • pruritus
  • various skin changes
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataract progression
  • ocular muscle paralysis
  • anemia
  • elevated aminotransferases
  • increased ALP
  • γ-GTP elevation
  • elevated bilirubin levels
  • thyroid dysfunction

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is best to keep it at room temperature below 30 degrees Celsius. Doing so will help maintain the drug's effectiveness and safety for a longer duration.

Appearance and packaging

Appearance

Brownish yellow oval film-coated tablets

Package unit

30, 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.