Medication info
Ilsung Ezetimibe Atorvastatin Calcium Trihydrate Tablet 10/10 mg

Ilsung Ezetimibe Atorvastatin Calcium Trihydrate Tablet 10/10 mg

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
일성아이에스(주)
Appearance
White or off-white oblong film-coated tablet
Packaging
Alu-Alu - 30 tablets/box [(10 tablets/Alu-Alu*3)]
Approval status
Active

MFDS item code 202101655 · Approved 2021.02.18 · Insurance code 655404170

Summary

Main use
Improvement of lipids by reducing cholesterol and increasing HDL in hypercholesterolemia and dyslipidemia.
Who uses it
Adults
Adult dosage
This drug is administered once daily regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg daily. A starting dose of 10/10 mg or 10/20 mg daily is recommended. For patients requiring a higher reduction in LDL cholesterol (55% or more), a starting dose of 10/40 mg daily is recommended. After administration begins or dosage adjustments, monitor lipid levels at intervals of not less than 2 weeks.

Ingredients

Manufacturer
일성아이에스(주)

Efficacy & effects

Improvement of lipids by reducing cholesterol and increasing HDL in hypercholesterolemia and dyslipidemia.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
  • hypercholesterolemia
  • atherosclerotic vascular disease
View approved original text

This drug is used to improve cholesterol and triglyceride levels in patients with hypercholesterolemia and dyslipidemia. It is administered as an adjunct to dietary therapy to reduce total cholesterol, LDL cholesterol, apo B, triglycerides, and non-HDL cholesterol, and to increase HDL cholesterol, particularly in patients with primary hypercholesterolemia. It is used as an adjunctive therapy in patients with homozygous familial hypercholesterolemia when other treatments are ineffective. This drug should be used with appropriate dietary therapy considering various risk factors, and it is important to identify and treat secondary causes of dyslipidemia. It is effective in reducing the risk of cardiovascular disease and improving cholesterol control.

Dosage and Administration

Adult dosage

This drug is administered once daily regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg daily. A starting dose of 10/10 mg or 10/20 mg daily is recommended. For patients requiring a higher reduction in LDL cholesterol (55% or more), a starting dose of 10/40 mg daily is recommended. After administration begins or dosage adjustments, monitor lipid levels at intervals of not less than 2 weeks.

Precautions

This drug helps reduce blood cholesterol levels by inhibiting cholesterol production in the liver. Muscle problems may arise, so if symptoms such as muscle pain, muscle weakness, or muscle cramps occur, patients should immediately inform their doctor. Particularly, patients at risk for severe myopathy or rhabdomyolysis should discontinue or temporarily pause the use of this drug. Since it may affect liver function, patients should undergo liver function tests before administration and regularly monitor liver function during treatment. If symptoms of liver damage such as jaundice, nausea, vomiting, or fatigue occur, patients should consult healthcare professionals immediately. This drug is not to be administered to patients with certain liver diseases or those with abnormally high liver enzyme levels. Women who are pregnant or may become pregnant, and nursing mothers should not take this drug. Appropriate contraception should be used, and if pregnancy is confirmed, the drug should be discontinued immediately. Elderly patients, those with impaired kidney function, patients with hypothyroidism, and those with a history of muscle disease should use this drug cautiously. This drug may interact with various other medications, especially those metabolized in the liver or those that may cause muscle toxicity, so caution is necessary if taken in conjunction. Patients must inform their doctor or pharmacist of any currently taken medications. During treatment, side effects such as dizziness, headaches, indigestion, abdominal pain, and diarrhea may occur, so it is important to monitor bodily condition closely. In cases of overdose, as there is no specific antidote, patients should receive appropriate treatment and supportive care based on symptoms, and liver function and muscle enzyme tests should be conducted. Safety and efficacy in children have not been established, thus use is not recommended. This drug should be stored out of the reach of children and should not be transferred to other containers.

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/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headaches, thunderclap headaches, seizures, confusion, vision abnormalities, paralysis, urination changes

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
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  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • elevated ALT
  • elevated AST
  • fatigue
  • headache
  • constipation
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • indigestion
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • paresthesia
  • sensory loss
  • taste disturbance
  • memory loss
  • peripheral neuropathy

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

Storage

This drug should be stored in a sealed container to prevent exposure to air and moisture, and it is safe to store at room temperature between 1 to 30 degrees Celsius. Storing it this way preserves the drug's effectiveness and prevents degradation.

Appearance and packaging

Appearance

White or off-white oblong film-coated tablet

Package unit

Alu-Alu - 30 tablets/box [(10 tablets/Alu-Alu*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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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.