Medication info
Simvastatin Tablet 20 Milligrams (Simvastatin)

Simvastatin Tablet 20 Milligrams (Simvastatin)

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

MFDS item code 200500072 · Notified 2005.09.13 · Insurance code 648502500

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
This medication is administered once daily in the evening. - For adult patients at high risk due to a history of coronary heart disease, diabetes, peripheral vascular disease, stroke, or other cerebrovascular diseases, the initial dosage is recommended to be 40 mg once daily. - For hyperlipidemia patients, it is generally administered as 20 mg once daily in the evening, while mild to moderate hypercholesterolemia patients may start with 10 mg. - The dosage is 5
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), it is recommended to administer 10 mg once daily in the evening. The dosage may be adjusted within the range of 10-40 mg based on treatment goals.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

  • Coronary heart disease
  • diabetes
  • peripheral vascular disease
  • stroke
  • other cerebrovascular diseases
  • hypercholesterolemia
  • dyslipidemia
  • aberrant beta-lipoproteinemia
  • hypertriglyceridemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • early cardiovascular disease.
View approved original text

This medication helps reduce the risk of cardiovascular diseases. It lowers the risk of cardiovascular-related deaths, myocardial infarction, and strokes in adults with a history of coronary heart disease, diabetes, peripheral vascular disease, or stroke. It also reduces risks after coronary and non-coronary vascular surgeries. For patients with hyperlipidemia, it helps to reduce total cholesterol, LDL cholesterol, apolipoprotein B, and triglyceride levels, while increasing good HDL cholesterol levels. Especially for pediatric patients with familial hypercholesterolemia, it is used in conjunction with dietary therapy to effectively manage cholesterol levels. This medication is very effective in treating cardiovascular diseases and hyperlipidemia.

How to take

Adult dose

This medication is administered once daily in the evening. - For adult patients at high risk due to a history of coronary heart disease, diabetes, peripheral vascular disease, stroke, or other cerebrovascular diseases, the initial dosage is recommended to be 40 mg once daily. - For hyperlipidemia patients, it is generally administered as 20 mg once daily in the evening, while mild to moderate hypercholesterolemia patients may start with 10 mg. - The dosage is 5

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), it is recommended to administer 10 mg once daily in the evening. The dosage may be adjusted within the range of 10-40 mg based on treatment goals.

Precautions

This medication primarily acts in the liver to lower blood cholesterol levels and is particularly used in the treatment of hyperlipidemia. Caution is required as muscle-related side effects such as myopathy or rhabdomyolysis may occur when taking this medication. Especially when taking high doses of this medication, the risk of muscle problems may increase, and concomitant use of other medications may heighten this risk due to interactions. Patients with liver function issues or a history of liver disease should avoid taking this medication and should undergo regular liver function tests. Women who are pregnant or may become pregnant and breastfeeding mothers should not use this medication. This medication increases the risk of myopathy when used in conjunction with certain drugs, so if other medications are being taken, patients must inform their doctor or pharmacist. Elderly patients, those with reduced kidney function, and patients with hypothyroidism should be particularly cautious when using this medication, and if symptoms arise, they should consult a healthcare professional immediately. If muscle pain, weakness, or soreness occurs while taking this medication, inform a doctor immediately, and it may be necessary to discontinue this medication. This medication may cause side effects such as liver dysfunction, digestive disturbances, headaches, upper respiratory infections, so if these symptoms persist, consult a healthcare provider. During the course of taking this medication, it is advisable to avoid specific foods or beverages such as grapefruit juice, and to strictly adhere to the cautions provided.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, painful mucous membranes in the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory problems accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, urination changes.

Mild side effects

  • Abdominal pain
  • fatigue
  • 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
  • skin changes
  • lichenoid drug eruption
  • gynecomastia
  • reduced libido
  • sexual dysfunction
  • cataract progression
  • ocular muscle paralysis
  • anemia
  • thyroid dysfunction
  • increased serum creatine kinase
  • temporary liver function test changes.

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

Storage

This medication can be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature. Proper storage can help maintain the medication's effectiveness for a longer time.

Appearance and packaging

Appearance

Brownish-yellow oval film-coated tablets

Package unit

30 tablets/per bottle, 100 tablets/per 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.