Medication info
Entisimba Tablet 20 mg (Simvastatin)

Entisimba Tablet 20 mg (Simvastatin)

Prescription medicationTablet경구
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
한국신텍스제약(주)
Appearance
Pale yellowish oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201907577 · Approved 2019.10.30 · Insurance code 623006210

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
For adult patients, a dose of 40 mg per day is given to reduce the risk of cardiovascular disease. The typical starting dose for hyperlipidemia treatment is 20 mg given once in the evening, while patients with mild to moderate hypercholesterolemia may start at 10 mg. The dosage can be adjusted according to treatment response with administration of 5 to 40 mg once daily in the evening. For specific patient groups, dosage limits are as follows
Child dose
The recommended initial dose for pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia is 10 mg once daily in the evening with a recommended dosage range of 10 to 40 mg per day and a maximum dose of 40 mg per day.

Ingredients

Manufacturer
한국신텍스제약(주)

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

  • Coronary 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 reduces the risk of death from coronary heart disease in adults at high risk for cardiovascular disease, lowers the likelihood of non-fatal myocardial infarction and stroke, and decreases risks associated with vascular regeneration procedures. Additionally, it is used as an adjunct to dietary therapy to effectively lower total cholesterol, LDL cholesterol, and triglyceride levels, while increasing HDL cholesterol in patients with hyperlipidemia. It is especially useful in managing various types of hyperlipidemia, including primary dyslipidemia and familial hypercholesterolemia. It also helps improve total cholesterol and LDL cholesterol levels in pediatric patients with heterozygous familial hypercholesterolemia when combined with dietary control. This medication acts effectively to maintain cardiovascular health and improve hyperlipidemia.

How to take

Adult dose

For adult patients, a dose of 40 mg per day is given to reduce the risk of cardiovascular disease. The typical starting dose for hyperlipidemia treatment is 20 mg given once in the evening, while patients with mild to moderate hypercholesterolemia may start at 10 mg. The dosage can be adjusted according to treatment response with administration of 5 to 40 mg once daily in the evening. For specific patient groups, dosage limits are as follows

Child dose

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

Precautions

This medication is primarily used to lower blood cholesterol levels. When taking this medication, symptoms such as muscle pain or weakness may occur, so any such symptoms should be promptly reported to a physician. Especially when taking high doses or certain other medications together, the risk of muscle problems may increase. Patients with liver dysfunction or a history of liver disease should not take this medication and should have regular liver function tests. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication, and if pregnancy occurs during treatment, it should be stopped immediately. This medication may increase blood concentrations and the risk of side effects when taken with certain enzyme-inhibiting medications, so it is important to inform the physician or pharmacist of any other medications being taken. Elderly patients, patients with reduced kidney function, or patients with hypothyroidism should use this medication with caution, and regular testing is required. It is advisable to avoid certain foods, such as grapefruit juice, during the course of this medication. When receiving a new prescription from another physician while taking this medication, it is essential to inform them about this medication. In case of an overdose, general treatment is required, and the medication should be stored out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme fatigue, sudden and very severe headaches, lightning pains, seizures, confusion, visual disturbances, paralysis, urination problems

Mild side effects

Abdominal pain, fatigue, constipation, diarrhea, indigestion, bloating, nausea, headache, upper respiratory infection, atrial fibrillation, gastritis, diabetes, muscle pain, insomnia, dizziness, bronchitis, eczema, urinary tract infection, alopecia, itching, various skin changes, drug rash resembling lichen planus, gynecomastia, decreased libido, sexual dysfunction, cataract progression, ocular muscle paralysis, anemia, temporary and mild elevations in liver function tests, thyroid function abnormalities, fasting blood sugar

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best to maintain storage temperatures between 1 and 30 degrees Celsius to preserve the drug's effectiveness over time.

Appearance and packaging

Appearance

Pale yellowish 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.