Medication info
Enpitolyn Tablet 10/10mg

Enpitolyn Tablet 10/10mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
A white to light yellow, double-convex, rectangular tablet
Packaging
30 tablets (10 tablets/PTP×3)
Approval status
Active

MFDS item code 201601726 · Approved 2016.03.31 · Insurance code 669906750

Summary

Main use
Improvement of lipids through reduction of LDL cholesterol and increase of HDL cholesterol in primary hypercholesterolemia (homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily in the evening, regardless of meals. The dosage for patients with primary hypercholesterolemia ranges from 10/10mg to 10/40mg daily, with the generally recommended initial dose being 10/20mg daily. For patients requiring less LDL cholesterol reduction, treatment may begin at 10/10mg daily. After starting treatment or adjusting the dose, lipid levels should be checked at intervals of at least 4 weeks.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Improvement of lipids through reduction of LDL cholesterol and increase of HDL cholesterol in primary hypercholesterolemia (homozygous familial) and mixed hyperlipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
  • diabetes
  • hypothyroidism
  • obstructive liver disease
  • chronic renal failure
View approved original text

This medication helps lower elevated total cholesterol and LDL cholesterol levels in patients with primary hypercholesterolemia and mixed hyperlipidemia, reduces ApoB and triglyceride levels, and increases HDL cholesterol. In patients with homozygous familial hypercholesterolemia, it is used in combination with or as an alternative to other lipid-lowering treatments. This medication must be administered alongside appropriate dietary measures and is used as an adjunct when diet alone proves insufficient. It is important to identify and address secondary causes such as diabetes or hypothyroidism before commencing treatment. The efficacy of treatment is monitored through regular tests of total cholesterol, LDL, HDL, and triglycerides. Through this process, the medication effectively improves hypercholesterolemia.

How to take

Adult dose

This medication is administered once daily in the evening, regardless of meals. The dosage for patients with primary hypercholesterolemia ranges from 10/10mg to 10/40mg daily, with the generally recommended initial dose being 10/20mg daily. For patients requiring less LDL cholesterol reduction, treatment may begin at 10/10mg daily. After starting treatment or adjusting the dose, lipid levels should be checked at intervals of at least 4 weeks.

Precautions

This medication is primarily used to lower cholesterol. Serious muscle-related side effects, such as myopathy and rhabdomyolysis, may occur, so if muscle pain or weakness appears, you should immediately inform your physician. The risk of these side effects increases especially with high doses; therefore, dosage adjustment is crucial. Patients with hypersensitivity to this medication, active liver disease, and pregnant or breastfeeding women should not take it. Additionally, the risk of muscle damage increases when used in combination with certain potent drugs, so you must inform your doctor or pharmacist of any other medications you are taking. Patients with muscle weakness or ocular muscle weakness must use the medication cautiously and discontinue use if these symptoms worsen. Patients with liver dysfunction should undergo regular liver function tests, and should discontinue use immediately if signs of liver damage occur. Some patients may experience side effects such as headaches, diarrhea, cold symptoms, muscle pain, limb pain, fatigue, nausea, abdominal pain, constipation, upper abdominal pain, vomiting, chest pain, chest discomfort, weakness, sensory loss, cough, edema, thirst, facial swelling, fainting, insomnia, gastritis, atrophic gastritis, dyspepsia, mucus in stool, irritable bowel syndrome, sore throat, nocturia, hematuria, itching, weight loss, dizziness, sensory abnormalities, depression, cholelithiasis, cholecystitis, alopecia.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pale skin, severe rash with fever, blisters, skin peeling, pain in the oral/eye mucosa, breathlessness or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizure, confusion of consciousness, visual abnormalities, paralysis, significant decrease in urine output

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • muscle pain
  • limb pain
  • fatigue
  • nausea
  • abdominal pain
  • constipation
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  • upper abdominal pain
  • vomiting
  • chest pain
  • chest discomfort
  • weakness
  • sensory loss
  • cough
  • edema
  • thirst
  • facial swelling
  • fainting
  • insomnia
  • gastritis
  • atrophic gastritis
  • dyspepsia
  • mucus in stool
  • irritable bowel syndrome
  • sore throat
  • nocturia
  • hematuria
  • itching
  • weight loss
  • dizziness
  • sensory abnormalities
  • depression
  • cholelithiasis
  • cholecystitis
  • alopecia

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

Storage

This medication is sensitive to air and moisture; therefore, it must be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees. This will help keep the medication effective for a longer period.

Appearance and packaging

Appearance

A white to light yellow, double-convex, rectangular tablet

Package unit

30 tablets (10 tablets/PTP×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.