Medication info

Simbatec Tablet (Simvastatin)

Prescription medicationTablet경구Expired
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
오스틴제약(주)
Appearance
Light yellow oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 200402028 · Notified 2004.09.23

This product's status changed to Expired on 2024.10.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of risk for cardiovascular diseases and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
Patients should adhere to a standard cholesterol-lowering diet before and during medication. 1. Reduction of the risk of cardiovascular diseases For adult patients at high risk of coronary heart disease incidents due to history of coronary heart disease, diabetes, peripheral vascular disease, stroke, or other cerebrovascular diseases, the recommended initial dose of Simvastatin is 40 mg once daily. 2. Hyperlipidemia (1) Reduction of risks in patients with coronary heart disease-related hypercholesterolemia and hyperlipidemia
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dose is 10 mg taken once daily in the evening. The recommended dosage range is 10 to 40 mg daily, with a recommended maximum

Ingredients

Manufacturer
오스틴제약(주)

Efficacy & effects

Reduction of risk for cardiovascular diseases and improvement of hyperlipidemia

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

This medication helps reduce the risk of cardiovascular diseases. In particular, it lowers the risk of death from heart disease and myocardial infarction, as well as stroke in patients with a history of coronary heart disease, diabetes, peripheral vascular disease, or stroke. It also reduces risks associated with vascular surgeries. It plays an important role in treating hyperlipidemia, improving blood cholesterol and triglyceride levels in patients with primary and familial hypercholesterolemia, and increasing HDL cholesterol. In pediatric patients with heterozygous familial hypercholesterolemia, it effectively controls cholesterol levels when used in conjunction with dietary therapy. Therefore, this medication is used to maintain cardiovascular health and treat hyperlipidemia.

How to take

Adult dose

Patients should adhere to a standard cholesterol-lowering diet before and during medication. 1. Reduction of the risk of cardiovascular diseases For adult patients at high risk of coronary heart disease incidents due to history of coronary heart disease, diabetes, peripheral vascular disease, stroke, or other cerebrovascular diseases, the recommended initial dose of Simvastatin is 40 mg once daily. 2. Hyperlipidemia (1) Reduction of risks in patients with coronary heart disease-related hypercholesterolemia and hyperlipidemia

Child dose

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

Precautions

This medication carries a risk of muscle abnormalities, particularly when taken at high doses or in conjunction with certain medications, which can cause muscle damage. It may affect liver function, so patients with liver disease or impaired liver function should avoid using it. Regular liver function tests are recommended. Women who are pregnant or may become pregnant, as well as nursing women, should not take this medication. If pregnancy is confirmed, the medication should be discontinued immediately. This drug may cause interactions if taken with specific other medications, increasing the risk of side effects, especially with some antibiotics, antifungals, immunosuppressants, and calcium channel blockers. Caution is required when prescribing to the elderly, patients with decreased kidney function, or patients with hypothyroidism, and any occurrence of muscle pain or weakness should prompt immediate consultation with a doctor. If unexplained muscle pain, tenderness, or weakness occurs during treatment, it should be reported to a doctor immediately, and if these symptoms worsen or persist, discontinuation may be necessary. During treatment, the intake of certain foods such as grapefruit juice must be limited, and large quantities of grapefruit juice should be avoided. Moreover, when administering this medication to children and adolescents, it should be used cautiously considering age and growth status, and it is not to be used in children under 10 years of age. In case of overdose, seek medical attention immediately for appropriate treatment. Lastly, this medication should be stored out of reach of children and kept safely in its original container.

Side effects and when to seek care immediately

Serious side effects

Myopathy, rhabdomyolysis, severe allergic reactions (rash, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor), severe skin reactions (extensive rash, blistering, skin peeling, mucosal pain in mouth/eyes), respiratory issues (shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever), liver abnormalities (jaundice, yellowing of skin or eyes, severe lethargy), severe neurological

Mild side effects

  • Abdominal pain
  • weakness
  • constipation
  • diarrhea
  • indigestion
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • atrial fibrillation
Show 23 more
  • gastritis
  • diabetes
  • myalgia
  • insomnia
  • dizziness
  • bronchitis
  • rhinitis
  • eczema
  • urinary tract infection
  • alopecia
  • itching
  • various skin changes
  • lichenoid drug eruption
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • progression of cataracts
  • oculomotor paralysis
  • anemia
  • elevated amino transferases
  • ALP
  • γ-GTP
  • bilirubin levels

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

Storage

This medication may be sensitive to air or moisture and should be kept in a tightly closed container. It is essential to maintain a storage temperature between 1 °C and 30 °C.

Appearance and packaging

Appearance

Light yellow oval film-coated tablet

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.