Medication info
Simvastatin Tablets (Simvastatin)

Simvastatin Tablets (Simvastatin)

Prescription medicationTablet경구
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
영풍제약(주)
Appearance
Pale yellow oval film-coated tablets
Packaging
For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle, For domestic use - 500 tablets/bottle, For export - 30 tablets/box [(10 tablets/PTP × 3)]
Approval status
Active

MFDS item code 200402946 · Notified 2004.02.16 · Insurance code 661900760

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
High-risk adult patients for cardiovascular disease are recommended to take 40 mg of simvastatin once daily. General hyperlipidemia patients are administered 20 mg once daily in the evening, and mild to moderate hypercholesterolemia may start with 10 mg. The dosage can be adjusted within the range of 5 to 40 mg once daily, and cholesterol levels should be regularly checked four weeks after starting treatment and adjusted accordingly. In cases of homozygous familial hypercholesterolemia, the initial recommended dose is 40 mg administered in the evening.
Child dose
Pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17) are administered 10 mg once daily in the evening. The recommended dosage range is 10 to 40 mg per day, with a maximum of 40 mg daily.

Ingredients

Manufacturer
영풍제약(주)

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

  • Coronary artery disease
  • diabetes
  • peripheral vascular disease
  • stroke
  • other cerebrovascular diseases
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • hypertriglyceridemia
  • hypercholesterolemia
  • early cardiovascular disease
View approved original text

This medication is used to reduce the risk of cardiovascular diseases. It decreases the risk of cardiac events and mortality in adult patients with a history of coronary heart disease, diabetes, peripheral vascular disease, or stroke. Furthermore, it aids in the treatment of hyperlipidemia by lowering total cholesterol, LDL cholesterol, Apo-B protein, and triglyceride levels, while increasing HDL cholesterol levels. It also helps pediatric patients with familial hypercholesterolemia in managing cholesterol levels when used in conjunction with dietary therapy. Thus, it is effectively used to protect heart health and improve risk factors.

How to take

Adult dose

High-risk adult patients for cardiovascular disease are recommended to take 40 mg of simvastatin once daily. General hyperlipidemia patients are administered 20 mg once daily in the evening, and mild to moderate hypercholesterolemia may start with 10 mg. The dosage can be adjusted within the range of 5 to 40 mg once daily, and cholesterol levels should be regularly checked four weeks after starting treatment and adjusted accordingly. In cases of homozygous familial hypercholesterolemia, the initial recommended dose is 40 mg administered in the evening.

Child dose

Pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17) are administered 10 mg once daily in the evening. The recommended dosage range is 10 to 40 mg per day, with a maximum of 40 mg daily.

Precautions

This medication primarily acts in the liver to lower blood cholesterol levels. Myopathy, such as muscle pain or weakness, may occur during treatment, and in severe cases, rhabdomyolysis, which is the destruction of muscle tissue, may develop. The risk of these muscle problems increases with high doses, so caution is especially needed for patients taking 80mg. Taking this medication in conjunction with certain drugs that interact can increase the risk of myopathy, so patients should inform their doctor or pharmacist about any other medications they are taking. Patients with impaired liver function or liver disease should not take this medication, nor should it be used by pregnant or potentially pregnant women or nursing women. Patients with alcohol dependence, impaired kidney function, hypothyroidism, elderly patients, and women should use this medication with extra caution, and regular checks and monitoring by a physician are necessary. If unexplained muscle pain, tenderness, or weakness occurs while taking this medication, the patient should immediately notify a doctor and discontinue the medication. Additionally, various side effects can occur, such as liver dysfunction, indigestion, headache, constipation, skin rash, so medical consultation is needed if symptoms arise. This medication is not recommended for use during pregnancy, and women planning for pregnancy should consult with a doctor before taking it. Nursing women should discontinue breastfeeding while taking this medication, and it should not be used in children or patients under 10 years old. Elderly patients may have higher blood levels of this medication, so dose adjustment and regular monitoring are required. Taking this medication with drugs that inhibit specific enzymes can increase its blood concentration, leading to a greater risk of side effects, so caution should be exercised with co-administration of other medications. In case of overdose, general emergency measures should be performed, and immediate medical assistance should be obtained. Keep the medication out of reach of children, and store it in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain of oral/ocular mucosa, shortness of breath or respiratory difficulties, asthma attacks, cough with fever accompanied by respiratory abnormalities, yellowing of skin or eyes (jaundice), extreme lethargy, sudden severe headaches, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination

Mild side effects

  • Abdominal pain
  • weakness
  • constipation
  • diarrhea
  • indigestion
  • bloating
  • nausea
  • headache
  • upper respiratory tract infections
  • atrial fibrillation
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  • gastritis
  • diabetes
  • myalgia
  • insomnia
  • dizziness
  • bronchitis
  • eczema
  • urinary tract infections
  • muscle cramps
  • joint pain
  • taste disturbances
  • ocular motility disorders
  • facial nerve palsy
  • tremors
  • sensory disturbances
  • peripheral neuropathy
  • peripheral nerve palsy
  • psychological disorders
  • anxiety
  • sleep disorders
  • depression
  • cataract progression
  • ocular muscle paralysis
  • anemia
  • alopecia
  • itching

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius. This will help to ensure the medication's effectiveness.

Appearance and packaging

Appearance

Pale yellow oval film-coated tablets

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle, For domestic use - 500 tablets/bottle, For export - 30 tablets/box [(10 tablets/PTP × 3)]

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.