Medication info
Atorvastatin Calcium/Ezetimibe Tablet 10/40 mg

Atorvastatin Calcium/Ezetimibe Tablet 10/40 mg

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›43.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)유한양행
Appearance
White, double-convex, rectangular film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202101383 · Approved 2021.02.18 · Insurance code 642105710

Summary

Main use
Reduction of cholesterol and improvement of lipids in hypercholesterolemia (primary, homozygous familial) and dyslipidemia
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 per day, with a recommended starting dose of 10/10 mg or 10/20 mg per day. For patients requiring more significant reduction in LDL cholesterol (by over 55%), a starting dose of 10/40 mg per day is recommended. After initiating treatment or adjusting the dosage, blood lipid levels should be checked at intervals of more than 2 weeks.

Ingredients

Manufacturer
(주)유한양행

Efficacy & effects

Reduction of cholesterol and improvement of lipids in hypercholesterolemia (primary, homozygous familial) and dyslipidemia

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

This medication is used to lower total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels and to increase HDL cholesterol in patients with primary hypercholesterolemia and homozygous familial hypercholesterolemia as an adjunct to dietary measures. It may also be administered alone or in combination with other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. This medication should be used in conjunction with an appropriate diet and secondary causes (such as diabetes and hypothyroidism) should be treated first. Due to a lack of study in special types of dyslipidemia, caution is advised, and it should be administered carefully in patients at high risk for cardiovascular disease. Regular blood lipid tests should be performed to confirm effectiveness during the treatment process. This drug is effectively used for the treatment of 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 per day, with a recommended starting dose of 10/10 mg or 10/20 mg per day. For patients requiring more significant reduction in LDL cholesterol (by over 55%), a starting dose of 10/40 mg per day is recommended. After initiating treatment or adjusting the dosage, blood lipid levels should be checked at intervals of more than 2 weeks.

Precautions

This medication may cause rhabdomyolysis, which is a serious side effect associated with specific muscle diseases. This side effect can lead to muscle destruction and complications with kidney function, so if severe muscle pain or weakness occurs, consult a doctor immediately. This medication should not be administered to patients with allergies to its components or those with severe liver impairment, people with muscle diseases, pregnant or nursing women, or patients taking certain antiviral agents. Patients with a history of alcohol addiction or liver disease, severe liver dysfunction, poor kidney function, hypothyroidism, elderly patients, and others should be especially cautious when using this drug. During the course of treatment with this drug, regular liver function tests and muscle-related tests should be performed, and any symptoms of liver dysfunction or muscle pain or weakness should be reported to a doctor immediately. This drug has many drug interactions, so any other medications being taken should be disclosed to a doctor or pharmacist; caution is particularly needed when combined with certain antibiotics, antiviral agents, immunosuppressants, or fibrate medications. Women of childbearing potential should use appropriate contraception while taking this drug, and if pregnancy is confirmed, the medication should be stopped immediately. Furthermore, nursing mothers are advised to avoid taking this drug. Caution should be taken during driving or operating machinery as symptoms such as dizziness may occur. Safety in children has not been established, therefore it is generally not recommended. In case of overdose, there is no specific antidote, so treatment should be symptomatic and supportive, and the condition should be monitored through liver function and muscle-related tests. This drug should be kept out of the reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in mouth/eye mucous membranes, shortness of breath or difficulty breathing, asthma attack, cough with fever and respiratory distress, jaundice (yellowing of skin or eyes), extreme drowsiness, sudden and severe headaches, lightning headache, seizures, confusion, vision disturbances, paralysis, urinary retention

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • hyperkalemia
  • bronchitis
  • sinusitis
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  • flushing
  • dizziness
  • fatigue
  • headache
  • pharyngitis
  • constipation
  • vomiting
  • belching
  • sore throat
  • muscle fatigue
  • itching
  • rash
  • hair loss
  • thrombocytopenia
  • hepatitis
  • blurred vision
  • tinnitus
  • erectile dysfunction
  • urinary tract infection
  • cystitis
  • hematuria
  • dysuria
  • kidney stones
  • nocturia
  • epididymitis
  • breast fibrocystic changes
  • vaginal bleeding
  • allergic reactions

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

Storage

This medication should be stored in a closed container to protect it from air and moisture. It is best to maintain storage temperatures between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White, double-convex, rectangular film-coated tablet

Package unit

30 tablets/box [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.