Medication info

Samsung Simvastatin Tablet 20 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
Yellow-brown oval film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle.
Approval status
Expired

MFDS item code 201805363 · Approved 2018.12.28

This product's status changed to Expired on 2023.12.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

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

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

  • Coronary heart disease
  • diabetes
  • peripheral vascular diseases
  • stroke
  • other cerebrovascular diseases
  • non-fatal myocardial infarction
  • hyperlipidemia
  • primary hypercholesterolemia
  • dyslipidemia
  • primary hyper-beta-lipoproteinemia
  • hypertriglyceridemia
  • heterozygous familial hypercholesterolemia
View approved original text

This medication is used to reduce various risks associated with cardiovascular diseases. It decreases the risk of cardiac-related mortality, myocardial infarction, and stroke in adult patients with a history of coronary heart disease, diabetes, peripheral vascular diseases, stroke, and other cerebrovascular diseases. It also helps maintain cardiovascular health by lowering the risks associated with vascular interventions. In hyperlipidemic patients, it improves cholesterol and triglyceride levels and increases HDL-cholesterol to support the management of dyslipidemia. Especially in pediatric patients with familial hypercholesterolemia, it aids in controlling blood lipid levels when used in conjunction with dietary measures. It is thus utilized to reduce the risks of various cardiovascular diseases and improve blood lipid status.

How to take

Adult dose

In adult patients at high risk of coronary heart disease due to a history of coronary heart disease, diabetes, peripheral vascular diseases, stroke, or other cerebrovascular diseases, a daily dose of 40 mg of Simvastatin is recommended. For hyperlipidemic patients, generally, 20 mg is administered once daily in the evening, while mild to moderately hypercholesterolemic patients may start with 10 mg. The initial dose of 5-40 mg may be administered once daily in the evening.

Child dose

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

Precautions

This medication helps lower blood cholesterol levels. Care should be taken when taking this medication as it may lead to muscle problems. This is particularly true if taken in high doses or in conjunction with certain medications, which may result in muscle pain or weakness. Patients allergic to this medication or those with liver dysfunction, as well as women who are pregnant or breastfeeding, should not take it. Additionally, concomitant use with certain antifungal or antibiotic medications and immunosuppressants may increase the risk of muscle problems, so it is essential to consult a physician. Those with compromised liver function or who consume alcohol excessively should undergo liver function testing before taking this medication and should be closely monitored. While being treated, if unexplained muscle pain or weakness occurs, it should be reported to a physician immediately, and medication may need to be discontinued if necessary. This medication may affect the fetus during pregnancy, so it should be discontinued immediately upon confirmation of pregnancy and a physician should be consulted. In breastfeeding cases, this medication can pass into breast milk and affect the baby, so breastfeeding should be discontinued while taking this medication. Elderly patients or those with reduced kidney function are at higher risk of muscle problems when taking this medication, and therefore should exercise additional caution. It is advisable to undergo regular liver function tests and muscle function tests during the course of treatment. Avoid medications or foods that interact with this drug, and specifically, limiting grapefruit juice intake is recommended for safety. Finally, when storing this medication, keep it out of reach of children and store it in its original container.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • shortness of breath
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • erythema multiforme
  • pancreatitis
  • hepatitis
  • liver failure
  • cholestatic jaundice
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  • fulminant hepatic necrosis
  • liver cancer
  • acute renal failure
  • rhabdomyolysis
  • muscle weakness
  • visual disturbances
  • paralysis
  • thrombocytopenia
  • leukopenia
  • hemolytic anemia
  • decreased platelets
  • liver dysfunction
  • jaundice
  • confusion
  • seizures
  • altered consciousness
  • severe edema
  • increased blood pressure
  • severe allergies

Mild side effects

  • Abdominal pain
  • weakness
  • constipation
  • diarrhea
  • dyspepsia
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • atrial fibrillation
Show 26 more
  • gastritis
  • diabetes
  • myalgia
  • insomnia
  • dizziness
  • bronchitis
  • rhinitis
  • eczema
  • urinary tract infection
  • muscle cramp
  • arthralgia
  • taste disturbance
  • eye movement disorder
  • facial nerve palsy
  • tremor
  • sensory disturbance
  • peripheral neuropathy
  • peripheral nerve paralysis
  • mental disorder
  • anxiety
  • sleep disturbances
  • nightmares
  • depression
  • cognitive impairment
  • interstitial lung disease
  • alopecia

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

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage helps to maintain the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Yellow-brown oval film-coated tablet

Package unit

30 tablets/bottle, 300 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.