Medication info
Atorvastatin/Ezetimibe Tablet 10/10 mg

Atorvastatin/Ezetimibe Tablet 10/10 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
에이치엘비제약(주)
Appearance
White or whitish film-coated tablet in an elongated shape
Packaging
30 tablets/box [10 tablets/Alu-Alu x 3]
Approval status
Active

MFDS item code 202101521 · Approved 2021.02.18 · Insurance code 647303990

Summary

Main use
Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and improvement of lipids by increasing HDL.
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg once daily, with an initial dose of either 10/10 mg or 10/20 mg recommended. In cases where a greater reduction in LDL cholesterol is required, an initial dose of 10/40 mg is recommended. After starting treatment or adjusting dosage, lipid levels in the blood should be checked at intervals of more than 2 weeks.

Ingredients

Manufacturer
에이치엘비제약(주)

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and improvement of lipids by increasing HDL.

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

This medication helps reduce total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol. It is particularly used as an adjunct when other lipid-lowering therapies are insufficient in patients with homozygous familial hypercholesterolemia. This drug should be administered alongside dietary therapy for dyslipidemia, considering various risk factors of the patient for appropriate usage. Additionally, it is important to check if there are other diseases or conditions causing dyslipidemia and to undertake necessary treatments. Therefore, this drug is effectively used for the treatment of hypercholesterolemia and related dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg once daily, with an initial dose of either 10/10 mg or 10/20 mg recommended. In cases where a greater reduction in LDL cholesterol is required, an initial dose of 10/40 mg is recommended. After starting treatment or adjusting dosage, lipid levels in the blood should be checked at intervals of more than 2 weeks.

Precautions

This medication may lead to serious muscle problems; therefore, if symptoms such as sudden muscle pain, muscle weakness, or high fever occur, inform a doctor immediately. Patients at risk for renal function impairment due to severe infections, hypotension, major surgery, trauma, or severe metabolic abnormalities should temporarily discontinue or stop taking this medication. Patients with allergies to this drug's components, severely impaired liver function, muscle disorders, pregnant women, or nursing mothers should not take this drug. Additionally, patients on certain antiviral medications or with lactose intolerance should also avoid this medication. Patients with alcohol dependence or a history of liver disease, impaired renal function, hypothyroidism, or a family history of muscle disorder, as well as those over 70 years of age, should use this drug with caution. Careful monitoring is needed when taken in conjunction with fibrate-class drugs due to increased risk of muscle issues. During treatment with this medication, side effects such as liver function abnormalities, muscle pain, abdominal pain, and dizziness may occur; if symptoms worsen, consult a doctor. Liver enzyme levels should be regularly monitored, and if signs of liver damage appear, use should be discontinued. Women who are pregnant or planning to become pregnant should not use this medication and should use appropriate contraception while on it. Dizziness may occur, so caution is necessary when driving or operating machinery. This medication has many drug interactions, so if other medications are being taken, it is essential to inform a doctor or pharmacist, and dose adjustments may be required when taken with drugs affecting liver metabolism. In the case of overdose, treatment should be based on symptoms, and liver function and muscle condition should be monitored. This medication has not established safety and efficacy in children, so it is not recommended for use. No specific dose adjustment is needed for elderly patients, but careful observation is required due to an increased risk of muscle problems. Patients with active liver disease or persistent unexplained elevations in liver enzymes should not take this drug. Patients with impaired renal function should be regularly checked for the risk of muscle issues. Symptoms such as muscle pain, fatigue, or fever during treatment with this drug should be reported to healthcare personnel immediately, and blood tests may be necessary to check for muscle damage.

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 high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities with cough+fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and very severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • hyperkalemia
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  • bronchitis
  • sinusitis
  • flushing
  • diarrhea
  • constipation
  • insomnia
  • nightmares
  • sensory loss
  • taste disorder
  • memory loss
  • peripheral neuropathy
  • thrombocytopenia
  • hepatitis
  • blurred vision
  • tinnitus
  • itching
  • skin rash
  • hair loss
  • angioedema
  • gynecomastia
  • urinary tract infection
  • frequent urination
  • cystitis
  • kidney stones
  • hypoglycemia

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

Storage

Store this medication in a tightly closed container to keep it away from air and moisture. It is best to store it between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White or whitish film-coated tablet in an elongated shape

Package unit

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