Medication info
Myungmoon Simvastatin Tablet

Myungmoon Simvastatin Tablet

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

MFDS item code 200403243 · Notified 2004.09.30 · Insurance code 649801210

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
This medication is taken once daily in the evening. - The initial starting dose for adults at high risk for coronary heart disease is 40 mg per day. - The typical initial starting dose for patients with hyperlipidemia is 20 mg, while patients with mild to moderate hypercholesterolemia may start at 10 mg. - The dosage should be within the range of 5 to 40 mg per day, and cholesterol levels should be measured regularly at 4 weeks and thereafter to adjust the dosage.
Child dose
The recommended initial dose for pediatric patients (10 to 17 years old) with heterozygous familial hypercholesterolemia is 10 mg taken once daily in the evening. The recommended dosage range is 10 to 40 mg per day, with a maximum dose of

Ingredients

Manufacturer
명문제약(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
  • abnormal beta-lipoproteinemia
  • high triglyceridemia
  • heterozygous familial hypercholesterolemia
View approved original text

This medication reduces the risk of death from coronary heart disease, non-fatal myocardial infarction, and stroke in adult patients with a high risk of cardiovascular diseases, including coronary heart disease, diabetes, peripheral vascular disease, and stroke. Additionally, it lowers total cholesterol, bad LDL cholesterol, Apo-B protein, and triglyceride levels while increasing good HDL cholesterol levels in patients with primary hypercholesterolemia and dyslipidemia, thereby improving blood lipid levels. This medication is particularly effective in controlling cholesterol levels in pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia who have insufficient control with diet alone. Therefore, it is useful for reducing cardiovascular disease risks and managing hyperlipidemia.

How to take

Adult dose

This medication is taken once daily in the evening. - The initial starting dose for adults at high risk for coronary heart disease is 40 mg per day. - The typical initial starting dose for patients with hyperlipidemia is 20 mg, while patients with mild to moderate hypercholesterolemia may start at 10 mg. - The dosage should be within the range of 5 to 40 mg per day, and cholesterol levels should be measured regularly at 4 weeks and thereafter to adjust the dosage.

Child dose

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

Precautions

This medication helps lower blood cholesterol levels. However, caution is required as there may be abnormalities in the muscles while taking this medication. The risk of muscle damage can increase, especially when taking high doses or in combination with certain medications. If symptoms such as muscle pain, tenderness, or weakness occur, notify a doctor immediately. Since this medication is primarily metabolized in the liver, patients with poor liver function or liver disease should not take it. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not take this medication. Additionally, this medication may be dangerous when taken with other drugs that act on the liver, such as certain antifungals, antibiotics, and immunosuppressants, so it is necessary to inform your doctor or pharmacist. Elderly patients, patients with reduced kidney function, and those with hypothyroidism should also exercise caution when taking this medication. Regular monitoring of liver function and muscle status is recommended while on this medication. Patients with a history of excessive alcohol use or liver disease should be especially careful. Rarely, side effects such as hepatitis, skin rashes, and thrombocytopenia may occur, so if any unusual symptoms arise, consult medical personnel immediately. Moreover, it is advisable to avoid certain beverages such as grapefruit juice while taking this medication. This medication can also be used in children and adolescents, but dosages and precautions vary depending on age and condition, so consultation with a specialist is necessary. Always inform medical personnel when starting any new medications while taking this medication, and do not discontinue or change it without consulting your doctor. Finally, keep this medication out of reach of children and store it in its original container.

Side effects and when to seek care immediately

Serious side effects

Myopathy, rhabdomyolysis, severe allergic reactions (hives, severe swelling, angioedema, chest tightness, difficulty breathing, breathlessness, cold sweat, pallor), severe skin reactions (severe rash, blisters, skin peeling, oral/ocular mucosal pain, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme), liver abnormalities (hepatitis, jaundice, liver failure, abnormal liver function, pancreatitis, fatal liver failure

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
  • hair loss
  • pruritus
  • skin changes
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • progression of cataracts
  • oculomotor paralysis
  • anemia
  • abnormal thyroid function
  • hyperbilirubinemia
  • mild liver function test abnormalities
  • HbA1c and fasting blood sugar levels

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

Storage

Store this medication in a tightly sealed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius. Storing it this way will help ensure the medication's effectiveness.

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.