Medication info

Elvastat Tablet (Simvastatin)

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

MFDS item code 200403292 · Notified 2004.07.15

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 cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
The recommended starting dose for this medication is 40 mg once daily. For the treatment of hyperlipidemia, the typical starting dose is 20 mg once in the evening. Patients with mild to moderate hypercholesterolemia may start with 10 mg. The dosage of 5 to 40 mg is administered once daily in the evening, and the dosage may be adjusted based on treatment goals and patient response. The 80 mg dose should only be used in patients without evidence of muscle toxicity who have been taking 80 mg for more than 12 months (refer to warning in precautions).
Child dose
For pediatric patients (10 to 17 years) with heterozygous familial hypercholesterolemia, the recommended starting dose is 10 mg once daily in the evening. The recommended dosage range is 10 to 40 mg per day, with a maximum dose of 40 mg.

Ingredients

Manufacturer
(주)유영제약

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

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

This medication helps to reduce the risk of cardiac events in adult patients who are at high risk for cardiovascular diseases such as coronary artery disease, diabetes, peripheral vascular disease, and stroke. It can particularly lower the risk of death from coronary artery disease and non-fatal myocardial infarction, stroke, and risks associated with vascular procedures. It is also used to decrease elevated total cholesterol, LDL cholesterol, and triglyceride levels, while increasing HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. Additionally, it is used as an adjunct treatment in patients with hypertriglyceridemia and familial hypercholesterolemia. It assists in lowering cholesterol levels in children aged 10 to 17 years with heterozygous familial hypercholesterolemia, combined with dietary management. Therefore, it is effectively used to reduce the risk of cardiovascular diseases and to treat hyperlipidemia.

How to take

Adult dose

The recommended starting dose for this medication is 40 mg once daily. For the treatment of hyperlipidemia, the typical starting dose is 20 mg once in the evening. Patients with mild to moderate hypercholesterolemia may start with 10 mg. The dosage of 5 to 40 mg is administered once daily in the evening, and the dosage may be adjusted based on treatment goals and patient response. The 80 mg dose should only be used in patients without evidence of muscle toxicity who have been taking 80 mg for more than 12 months (refer to warning in precautions).

Child dose

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

Precautions

This medication is used to lower blood cholesterol levels. Care must be taken as muscle-related symptoms may appear during treatment. If you experience muscle pain or weakness, inform your doctor immediately. This medication may worsen liver function, so it should not be used in patients with liver disease or elevated liver function test results. Women who are pregnant or may become pregnant and breastfeeding mothers should not take this medication. Additionally, if you are taking certain medications such as specific antifungals, antibiotics, or immunosuppressants that interact with this medication, you should avoid using it or require dosage adjustments. Elderly patients and those with kidney problems or hypothyroidism should be particularly cautious when taking this medication. Rarely, side effects such as hepatitis, skin rash, neurological issues, and allergic reactions may occur, so any abnormal symptoms should be reported to medical personnel immediately. Also, consuming large amounts of grapefruit juice while taking this medication may increase drug concentration and the risk of side effects, so it is advisable to avoid grapefruit juice. It should be avoided during pregnancy, and if pregnancy is confirmed while taking the medication, it should be discontinued immediately and the doctor should be consulted. The medication should be used only in limited circumstances for children or adolescents, especially not for those under 10 years old. This medication should be taken according to the prescribed dosage and method, and in case of overdose, immediate medical attention should be sought. Finally, this medication should be stored out of reach of children and should not be transferred to another container.

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 fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty in breathing, asthma attack, respiratory abnormalities with cough and fever, jaundice (yellowing of skin or eyes), generalized malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination issues

Mild side effects

  • Abdominal pain
  • weakness
  • constipation
  • diarrhea
  • dyspepsia
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • atrial fibrillation
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  • gastritis
  • diabetes
  • myalgia
  • insomnia
  • dizziness
  • bronchitis
  • sinusitis
  • eczema
  • urinary infection
  • alopecia
  • itching
  • various skin changes
  • lichenoid drug rash
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • progression of cataracts
  • eye muscle paralysis
  • anemia
  • thyroid dysfunction
  • hypothyroidism
  • thrombocytopenia
  • sensory numbness

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 or moisture. It is best to keep it at room temperature between 1°C and 30°C. Proper storage will maintain the efficacy of the medication and prevent degradation.

Appearance and packaging

Appearance

Orange 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

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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.