Medication info
Simvax Tablets (Simvastatin)

Simvax Tablets (Simvastatin)

Prescription medicationTablet경구
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
(주)바이넥스
Appearance
Yellowish-brown oval film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200402604 · Notified 2004.11.16

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
Reduction of risk for cardiovascular diseases: recommend 40 mg once daily in the evening. For hyperlipidemia: typically, an initial dose of 20 mg; mild to moderate hypercholesterolemia can start at 10 mg, administered 5-40 mg once daily in the evening. Recommended specific dosages: - for homozygous familial hypercholesterolemia: 40 mg daily in the evening; - elderly: 20 mg daily; - for verapamil.
Child dose
Heterozygous familial hypercholesterolemia pediatric patients (10-17 years): administer 10 mg once daily in the evening. Recommended dosage range is 10-40 mg daily, with a maximum of 40 mg. Dose adjustments should be made after at least 4 weeks of initial administration.

Ingredients

Manufacturer
(주)바이넥스

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 helps lower the risk of cardiovascular diseases. It is particularly effective in reducing the risk of death and recurrence from myocardial infarction or stroke in adult patients with a history of coronary heart disease, diabetes, peripheral vascular disease, and stroke. It also helps improve cholesterol and triglyceride levels in patients with hyperlipidemia, maintaining a healthy blood lipid profile. It is used as an adjunct to diet in pediatric patients with familial hypercholesterolemia to help lower harmful lipid levels in the blood. This drug is widely used for the prevention and treatment of hyperlipidemia and cardiovascular complications.

How to take

Adult dose

Reduction of risk for cardiovascular diseases: recommend 40 mg once daily in the evening. For hyperlipidemia: typically, an initial dose of 20 mg; mild to moderate hypercholesterolemia can start at 10 mg, administered 5-40 mg once daily in the evening. Recommended specific dosages: - for homozygous familial hypercholesterolemia: 40 mg daily in the evening; - elderly: 20 mg daily; - for verapamil.

Child dose

Heterozygous familial hypercholesterolemia pediatric patients (10-17 years): administer 10 mg once daily in the evening. Recommended dosage range is 10-40 mg daily, with a maximum of 40 mg. Dose adjustments should be made after at least 4 weeks of initial administration.

Precautions

This medication primarily works in the liver to lower blood cholesterol levels. Patients should be cautious as muscle-related side effects such as myalgia or muscle weakness may occur during treatment. The risk of muscle disease and rhabdomyolysis may increase, especially when taken at high doses or combined with other medications. Therefore, for high doses, the physician may adjust to a lower dose or change medications according to guidance. This medication may affect liver function, and it should not be taken by individuals with liver disease or abnormal liver function tests, and regular liver function tests should be conducted during treatment. Pregnant or breastfeeding women should not take this medication, and women of childbearing age must ensure contraception if there is a possibility of pregnancy. Additionally, the risk of side effects may increase when taken with certain antibiotics, antifungals, and immunosuppressants that inhibit the CYP3A4 enzyme, so consult a doctor if there are any concomitant drugs. Elderly patients, those with kidney disease, and those with hypothyroidism are at higher risk for muscle disease, requiring additional caution. If unexplained muscle pain, tenderness, or weakness occurs during treatment, inform the physician immediately, and the medication may need to be discontinued if symptoms are severe. Taking this medication with grapefruit juice should be avoided as it may increase blood drug concentration and the risk of side effects. This medication is not recommended for children, especially those under 10 years old or pre-menarchal females. If overdose occurs, seek immediate medical attention for proper treatment, typically based on symptoms. Lastly, it is important to store this medication out of reach of children and keep it in its original container, avoiding transfer to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, jaundice (yellowing of the skin or eyes), extreme fatigue, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, change in urine output,

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
  • alopecia
  • itching
  • skin changes
  • drug rash resembling lichen planus
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • progression of cataracts
  • ocular muscle paralysis
  • anemia
  • thyroid dysfunction
  • serum creatine kinase elevation
  • abnormal liver function test results

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

Storage

Store this medication in a tightly closed container that is not exposed to air, preferably at room temperature between 1 and 30 degrees Celsius. This will help maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Yellowish-brown oval film-coated tablets

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.