Medication info
Lipiduet Tablet 10/10 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Lipiduet Tablet 10/10 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
대우제약(주)
Appearance
A film-coated tablet shaped like a capsule, convex on both sides, white or light yellow.
Packaging
30 tablets/box [10 tablets/Alu-Alu x 3]
Approval status
Active

MFDS item code 202101633 · Approved 2021.02.18 · Insurance code 649606370

Summary

Main use
Reduction of cholesterol and increase of HDL in hypercholesterolemia and dyslipidemia to mitigate the risk of cardiovascular diseases.
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the daily dose range is between 10/10 mg to 10/80 mg, with a recommended initial dose of 10/10 mg or 10/20 mg once daily. For patients requiring a significant reduction in LDL cholesterol, an initial dose of 10/40 mg once daily is recommended. Blood lipid levels should be checked at least two weeks after starting or adjusting the dosage to determine the need for further adjustments.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Reduction of cholesterol and increase of HDL in hypercholesterolemia and dyslipidemia to mitigate the risk of cardiovascular diseases.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated apolipoprotein B
  • elevated triglycerides
  • elevated non-HDL cholesterol.
View approved original text

This medication is used in conjunction with dietary changes to lower total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol in patients with primary hypercholesterolemia, while raising HDL cholesterol. Particularly, patients with homozygous familial hypercholesterolemia are given this drug as an adjunct to other lipid-lowering therapies and may benefit when conventional treatments are inadequate. This drug has not been studied for certain types of dyslipidemia, so caution is needed during treatment. Moreover, for patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia, lipid-modifying medications should be used cautiously considering various risk factors, and it should always be complemented with appropriate dietary measures to be most effective. Before administering this drug, it is crucial to identify and treat other causes of dyslipidemia, such as diabetes and hypothyroidism.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the daily dose range is between 10/10 mg to 10/80 mg, with a recommended initial dose of 10/10 mg or 10/20 mg once daily. For patients requiring a significant reduction in LDL cholesterol, an initial dose of 10/40 mg once daily is recommended. Blood lipid levels should be checked at least two weeks after starting or adjusting the dosage to determine the need for further adjustments.

Precautions

This medication may cause muscle abnormalities, leading to severe muscle pain or weakness, which can risk renal function. Patients at high risk of renal damage due to serious infections, surgery, trauma, metabolic disorders, etc., should temporarily discontinue or stop the medication. Patients with allergies to any components of this drug, liver diseases or significantly elevated liver function tests, muscle disorders, pregnant or breastfeeding women, those taking certain antiviral drugs, and lactose intolerant individuals should not take this medication. Caution is advised for individuals with a history of alcoholism or liver disease, those with severe liver dysfunction, decreased renal function, hypothyroidism, family history of muscle disorders, and patients with muscle toxicity reactions to statins or fibrates, individuals over 70 years old, and those taking other medications that may interact with this drug. This medication may cause side effects such as myalgia, abdominal pain, and elevated liver enzymes, and serious skin reactions or allergic responses may arise, necessitating immediate consultation with a physician if unusual symptoms occur. Liver function tests should be performed before starting this medication and regularly during treatment; if signs of liver damage are present, the administration should be discontinued. This drug is not administered to pregnant women or women who may become pregnant, and those taking it should employ appropriate contraception. Moreover, caution is warranted as dizziness may occur when driving or operating machinery. This medication may interact with other drugs, so it is essential to inform the physician or pharmacist of any other medications being taken. There are no specific antidotes for overdose; symptomatic treatment and supportive care while monitoring liver function and muscle enzyme levels are required. It is not recommended for children due to lack of established safety and efficacy.

Side effects and when to seek care immediately

Serious side effects

Urticaria, serious swelling (including angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, markedly reduced urine output, severe swelling throughout the body with hypertension.

Mild side effects

  • Myalgia
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • vomiting
  • diarrhea
  • arthralgia
  • musculoskeletal pain
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  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • headache
  • constipation
  • bloating
  • nausea
  • pharyngitis
  • upper respiratory infection
  • low back pain
  • muscle weakness
  • muscle cramping
  • itching
  • rash
  • hair loss
  • angioedema
  • urticaria
  • skin rash
  • sweating
  • eczema
  • seborrhea
  • muscle fatigue
  • myositis
  • myopathy
  • muscle rupture
  • immune-related issues.

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

Storage

Store this medication in a tightly closed container to prevent exposure to air or moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius room temperature.

Appearance and packaging

Appearance

A film-coated tablet shaped like a capsule, convex on both sides, white or light yellow.

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.

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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.