Medication info
SimvaRoad Tablets 20 mg (Simvastatin)

SimvaRoad Tablets 20 mg (Simvastatin)

Prescription medicationTablet경구
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
(주)종근당
Appearance
Yellowish-brown, rectangular film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200200173 · Notified 2002.05.29 · Insurance code 643301480

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
This medication is taken once daily in the evening. For the purpose of reducing cardiovascular disease risk, the initial starting dose is 40 mg once daily. When treating hyperlipidemia, it is generally administered at 20 mg once daily in the evening, and patients with mild to moderate hypercholesterolemia can start with 10 mg. The dosage should be adjusted within the range of 5 to 40 mg based on the initial LDL cholesterol level and treatment goals,
Child dose
In pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the recommended starting dose is 10 mg once daily in the evening. The recommended dose range is 10 to 40 mg daily, and the maximum dose is daily

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

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

This medication is used to reduce the risk of cardiovascular diseases. It lowers the risk of cardiac death and the incidence of myocardial infarction and stroke in adult patients with a history of vascular diseases such as coronary artery disease, diabetes, peripheral vascular disease, and stroke. Additionally, it reduces the risk of complications after vascular interventions. For patients with hyperlipidemia, it effectively reduces total cholesterol and LDL cholesterol while increasing HDL cholesterol, aiding in the treatment of dyslipidemia. Specifically, it is used as an adjunct to diet in pediatric patients with familial hypercholesterolemia to lower cholesterol levels. Therefore, this drug is very effective for the treatment of cardiovascular diseases and hyperlipidemia.

How to take

Adult dose

This medication is taken once daily in the evening. For the purpose of reducing cardiovascular disease risk, the initial starting dose is 40 mg once daily. When treating hyperlipidemia, it is generally administered at 20 mg once daily in the evening, and patients with mild to moderate hypercholesterolemia can start with 10 mg. The dosage should be adjusted within the range of 5 to 40 mg based on the initial LDL cholesterol level and treatment goals,

Child dose

In pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the recommended starting dose is 10 mg once daily in the evening. The recommended dose range is 10 to 40 mg daily, and the maximum dose is daily

Precautions

This medication can cause serious muscle-related side effects, such as myopathy and rhabdomyolysis. The risk is higher, especially with high doses, so caution is advised when taking 80 mg. This drug should not be used in patients who have allergies to this medication or its components, have liver disease or persistently elevated liver enzyme levels of unknown cause, are pregnant or breastfeeding, are taking strong CYP3A4 inhibitors, are taking certain medications (gemfibrozil, cyclosporine, danazol), or have lactose intolerance. Patients with poor liver function, alcohol dependence, renal impairment, hypothyroidism, hereditary muscle disorders, elderly patients, and women should use this medication with caution, and if muscle-related symptoms occur, they should consult a physician immediately. While taking this medication, it is important to closely monitor for symptoms such as muscle pain, tenderness, and weakness. If these symptoms occur, it is important to stop taking the drug immediately and inform healthcare professionals. Furthermore, this medication is metabolized in the liver, so regular liver function tests are necessary, and the drug should be discontinued if hepatitis or liver dysfunction symptoms occur. This medication may interact with various drugs, so patients taking other medications should inform their healthcare provider, especially when combining it with CYP3A4 inhibitors, certain lipid-lowering agents, calcium channel blockers, nicotinic acid, antibiotics, antifungals, etc. Women who are pregnant or may become pregnant should not use this medication, and if pregnancy occurs during treatment, it must be stopped immediately and a doctor should be consulted. It should also be avoided in breastfeeding women. Children and elderly patients require dose adjustments and caution, especially this medication is not for children under 10 years old. In case of an overdose, patients should immediately seek medical attention for appropriate treatment, and this medication should be kept out of the reach of children. Finally, it is advisable to avoid consuming certain foods like grapefruit juice while taking this medication, and always consult healthcare professionals about other medications being taken or health conditions.

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 high fever, blisters, peeling skin, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary issues.

Mild side effects

  • Abdominal pain
  • weakness
  • constipation
  • diarrhea
  • dyspepsia
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • edema
Show 27 more
  • atrial fibrillation
  • gastritis
  • diabetes
  • myalgia
  • insomnia
  • dizziness
  • bronchitis
  • rhinitis
  • eczema
  • urinary tract infection
  • muscle cramps
  • arthralgia
  • taste disturbance
  • extraocular muscle movement disorder
  • facial partial paralysis
  • tremors
  • sensory abnormalities
  • peripheral neuropathy
  • peripheral nerve paralysis
  • mental disorders
  • anxiety
  • sleep disturbances
  • nightmares
  • depression
  • cataract progression
  • ocular muscle paralysis
  • anemia

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is safe to store at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Yellowish-brown, rectangular film-coated tablets

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

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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.