Medication info
Empitorin Tablet 10/20 mg

Empitorin Tablet 10/20 mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
A white to off-white, bilaterally convex, rectangular tablet.
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201600904 · Approved 2016.02.17 · Insurance code 669906620

Summary

Main use
Improvement of cholesterol and lipids in primary hypercholesterolemia (homozygous familial type) and mixed hyperlipidemia.
Who takes it
Adults
Adult dose
This medication is taken once daily in the evening, irrespective of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg per day, and the generally recommended starting dose is 10/20 mg per day. Patients with less need for LDL cholesterol reduction can start at 10/10 mg per day. Dosage adjustments are made after checking blood lipid levels with an interval of more than 4 weeks. Homozygous

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Improvement of cholesterol and lipids in primary hypercholesterolemia (homozygous familial type) and mixed hyperlipidemia.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerotic vascular disease due to hypercholesterolemia.
View approved original text

This medication helps lower total cholesterol, LDL cholesterol, Apo B, and triglycerides while increasing HDL cholesterol in patients with primary hypercholesterolemia. It can be used in combination with dietary therapy for patients with familial hypercholesterolemia, and can be administered as an adjunct or alternative treatment in patients with homozygous familial hypercholesterolemia. This medication is used as a lipid-modifying agent to reduce the risk of atherosclerotic vascular disease due to hypercholesterolemia. Before use, secondary causes such as diabetes or hypothyroidism should be evaluated and treated if necessary. Furthermore, this medication is administered after appropriate dietary control and non-pharmacological management have been attempted, and it is ineffective. Overall, this medication is used to improve cholesterol and lipid levels to reduce the risk of cardiovascular diseases.

How to take

Adult dose

This medication is taken once daily in the evening, irrespective of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg per day, and the generally recommended starting dose is 10/20 mg per day. Patients with less need for LDL cholesterol reduction can start at 10/10 mg per day. Dosage adjustments are made after checking blood lipid levels with an interval of more than 4 weeks. Homozygous

Precautions

This medication can cause muscle problems, so if muscle pain or weakness occurs, consult a doctor immediately. Particular caution is needed when taking high doses as the risk of muscle damage increases. Women who are pregnant or nursing and those with allergies to any ingredients in this medication or with active liver disease should not use this medication. Additionally, drugs that interfere with the metabolism of this medication in the liver, such as certain antifungal agents, antibiotics, and antiviral drugs, should not be taken concurrently. This medication may affect liver function, so patients with a history of liver disease should have regular liver function tests. Elderly patients or those with compromised kidney function should be particularly cautious when taking this medication, and dosage adjustments may be necessary. Patients should report any unexplained muscle pain, weakness, or darkening of urine to healthcare providers immediately while taking this medication. The risk of muscle damage may increase when used in combination with other lipid-lowering agents, so caution is warranted during concurrent administration. Women planning to become pregnant should consult a doctor before taking this medication, and they should discontinue its use immediately if pregnancy is confirmed during treatment. This medication should not be administered to breastfeeding women, and if nursing, breastfeeding should be stopped. In children or adolescents, due to limited safety data, it should be taken only under medical supervision. Patients receiving new prescriptions while taking this medication should inform their healthcare providers about all currently taken medications. There is no specific antidote for overdose, so patients should seek appropriate medical treatment immediately. Taking this medication with grapefruit juice may increase blood concentrations, so avoiding grapefruit juice is recommended.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, anaphylaxis, angioedema, rash, severe allergic reactions, severe skin adverse reactions, mucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), erythema multiforme, shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes).

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory infection
  • muscle pain
  • limb pain
  • fatigue
  • abdominal pain
  • nausea
  • constipation
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  • epigastric pain
  • vomiting
  • chest pain
  • chest discomfort
  • weakness
  • sensory loss
  • cough
  • syncope
  • insomnia
  • gastritis
  • atrophic gastritis
  • dyspepsia
  • mucus stool
  • irritable bowel syndrome
  • sore throat
  • joint pain
  • arthritis
  • itching
  • alopecia
  • skin changes
  • gynecomastia
  • decreased libido
  • erectile dysfunction
  • progression of cataracts
  • dizziness
  • sensory abnormalities

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to keep the storage temperature between 1 and 30 degrees Celsius at room temperature. This will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

A white to off-white, bilaterally convex, rectangular tablet.

Package unit

30 tablets (10 tablets/PTP x 3)

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.