Medication info
SimvaRoad Tablets 40 mg (Simvastatin)

SimvaRoad Tablets 40 mg (Simvastatin)

Prescription medicationTablet경구
Ingredient · strength
Simvastatin›40mg / 1 tablet
Manufacturer / importer
(주)종근당
Appearance
Red brick-colored rectangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200400121 · Notified 2004.09.03 · Insurance code 643301490

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
Patients undergoing treatment with this medication must adhere to a standard cholesterol-lowering diet before and during treatment. 1. To reduce the risk of cardiovascular disease for adult patients at high risk of coronary heart disease due to a history of coronary heart disease, diabetes, peripheral vascular disease, stroke, or other cerebrovascular diseases, the initial dosage should be 40 mg once daily. 2. For the treatment of hyperlipidemia, the typical starting dose...
Child dose
Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) should receive 10 mg once daily in the evening, with a recommended dosage range of 10 to 40 mg per day. The maximum dosage is 40 mg per day.

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

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

This medication is used to reduce the risk of cardiovascular disease. It is administered to adult patients at high risk for coronary events due to coronary heart disease, diabetes, peripheral vascular disease, or stroke, reducing the risk of mortality from coronary heart disease as well as the risks of non-fatal myocardial infarction and stroke. Additionally, it effectively lowers the risk of complications after vascular revascularization. As a treatment for hyperlipidemia, it lowers cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia while increasing the levels of good cholesterol, HDL. Furthermore, it is beneficial for pediatric patients with heterozygous familial hypercholesterolemia who have difficulties managing lipid levels through diet alone.

How to take

Adult dose

Patients undergoing treatment with this medication must adhere to a standard cholesterol-lowering diet before and during treatment. 1. To reduce the risk of cardiovascular disease for adult patients at high risk of coronary heart disease due to a history of coronary heart disease, diabetes, peripheral vascular disease, stroke, or other cerebrovascular diseases, the initial dosage should be 40 mg once daily. 2. For the treatment of hyperlipidemia, the typical starting dose...

Child dose

Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) should receive 10 mg once daily in the evening, with a recommended dosage range of 10 to 40 mg per day. The maximum dosage is 40 mg per day.

Precautions

This medication can cause serious side effects such as myopathy or rhabdomyolysis, leading to muscle abnormalities. The risk is particularly higher with high doses, so patients taking high doses should be cautious of drug interactions. This medication should not be taken by patients with a known allergy to this drug or its components, severe liver dysfunction, or by women who are pregnant or breastfeeding. Additionally, it is contraindicated to use in combination with certain strong hepatic enzyme inhibitors and some other medications. Patients with liver dysfunction or those who consume large amounts of alcohol, individuals with poor kidney function, hypothyroidism, a history of muscle diseases, older adults, and women should use this medication with caution. If unexplained muscle pain or weakness occurs while taking this medication, the physician should be informed immediately, and the medication should be discontinued if necessary. It is vital to perform regular liver function tests before and during treatment as this medication can cause liver dysfunction. Moreover, this medication can interact with multiple drugs, potentially increasing blood concentration, therefore consulting a physician or pharmacist about other medications taken concurrently is essential. It should be avoided during pregnancy, and women of childbearing age should use contraception while taking this medication. Nursing mothers should discontinue breastfeeding if they take this medication. It is recommended not to prescribe this medication to children or adolescents, especially those under 10 years old or females before menarche. Older adults may experience higher blood concentration of this drug, hence dosage adjustment and careful monitoring is necessary. During treatment, symptoms related to muscles, liver function, allergic reactions, gastrointestinal symptoms, etc., should be closely observed, and if any abnormal symptoms occur, medical personnel must be notified immediately. In case of overdose, emergency care is required. Lastly, this medication should be kept out of the reach of children and stored safely in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, oral/conjunctival mucosa pain, shortness of breath or respiratory distress, asthmatic attack, respiratory issues with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, reduced urine output

Mild side effects

Abdominal pain, weakness, constipation, diarrhea, indigestion, bloating, nausea, headache, upper respiratory infection, edema, atrial fibrillation, gastritis, diabetes, myalgia, insomnia, dizziness, bronchitis, sinusitis, eczema, urinary tract infection, alopecia, pruritus, various skin changes, lichenoid drug rash, gynecomastia, decreased libido, sexual dysfunction, cataract progression, ocular muscle paralysis, anemia, thyroid dysfunction, and transient mild liver function abnormalities

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the medication's effectiveness and safety over time.

Appearance and packaging

Appearance

Red brick-colored rectangular 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.

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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.