Medication info
New Simvastatin Tablet (Simvastatin)

New Simvastatin Tablet (Simvastatin)

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

MFDS item code 201800820 · Approved 2018.02.14

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
The recommended initial starting dose for this medication is 40 mg of Simvastatin once daily. For patients with hyperlipidemia, the general recommended initial starting dose is 20 mg taken once daily in the evening. Patients with mild to moderate hypercholesterolemia may start with 10 mg. It is recommended to take 5 to 40 mg once daily in the evening, adjusting the dose according to treatment goals and patient response. Specific
Child dose
The recommended initial dose for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 10 mg taken once daily in the evening. The recommended dosage range is 10 to 40 mg per day, with a maximum recommended dose of

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

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

This medication is used to reduce the risk of cardiovascular diseases and improve blood lipid levels in patients with hyperlipidemia and familial hypercholesterolemia. It particularly helps to reduce the nonfatal risks of cardiac death, myocardial infarction, and stroke in high-risk adult patients associated with coronary artery heart disease, diabetes, peripheral vascular disease, and stroke. It also lowers total cholesterol and LDL cholesterol while increasing HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia, serving as an adjunct to dietary therapy. It effectively controls blood lipid levels in pediatric patients with heterozygous familial hypercholesterolemia aged 10 to 17 years. Overall, this medication is utilized to improve the risk of cardiovascular diseases and treat dyslipidemia.

How to take

Adult dose

The recommended initial starting dose for this medication is 40 mg of Simvastatin once daily. For patients with hyperlipidemia, the general recommended initial starting dose is 20 mg taken once daily in the evening. Patients with mild to moderate hypercholesterolemia may start with 10 mg. It is recommended to take 5 to 40 mg once daily in the evening, adjusting the dose according to treatment goals and patient response. Specific

Child dose

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

Precautions

This medication can cause serious muscle-related diseases, such as myopathy and rhabdomyolysis. The risk is particularly higher when taking high doses, necessitating caution. Patients who are allergic to this medication, have liver diseases, are pregnant or breastfeeding, and those taking certain medications should not use this medication. Patients with liver and kidney problems, hypothyroidism, a family history of muscle diseases, elderly patients, and women should use this medication with extra caution. While taking this medication, if symptoms such as muscle pain or weakness occur, please inform your doctor immediately, and if these symptoms worsen, discontinue the medication. This medication may affect liver function, requiring regular liver function tests. If abnormalities are found, appropriate measures should be taken. Additionally, this medication may interact with several other medications; thus, if you are taking other medications, you must inform your doctor or pharmacist. Pregnant women or those who may become pregnant should not take this medication, and if pregnancy is confirmed while taking it, they should discontinue it immediately. Breastfeeding women must also discontinue breastfeeding if they take this medication, and special care is needed when prescribing it to children and the elderly. In case of overdose, seek medical attention immediately for appropriate treatment, and store this medication out of the reach of children. During the course of taking this medication, muscle pain, liver function abnormalities, allergic reactions, and neurological symptoms may occur; if any abnormal symptoms arise, contact medical personnel immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, difficulty breathing, dyspnea, toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, purpura, thrombocytopenia, leukopenia, hemolytic anemia, hepatitis, liver failure, cholestatic jaundice, liver cirrhosis, fulminant liver necrosis, liver cancer, severe swelling, severe allergic reaction, severe skin reaction, severe edema, confusion, visual disturbances, paralysis, seizures, sudden and

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
  • hair loss
  • itching
  • skin/mucous membrane dryness
  • changes in hair/nails
  • drug rash resembling lichen planus
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataract progression
  • oculomotor paralysis
  • anemia
  • thyroid dysfunction
  • transient and mild symptoms

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

Storage

This medication should be stored in a sealed container to prevent air or moisture from entering and kept at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the medication's efficacy and prevent degradation.

Appearance and packaging

Appearance

Brownish-yellow 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.