Medication info
Lipiduet Tablets 10/20 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Lipiduet Tablets 10/20 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.7mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
대우제약(주)
Appearance
White or pale yellow, biconvex film-coated tablets in capsule shape
Packaging
30 tablets/box [(10 tablets/Alu-Alu x 3)]
Approval status
Active

MFDS item code 202101663 · Approved 2021.02.18 · Insurance code 649606020

Summary

Main use
Lipid improvement through reducing cholesterol in hypercholesterolemia and dyslipidemia and increasing HDL.
Who uses it
Adults
Adult dosage
This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/10 mg or 10/20 mg is recommended. For patients requiring a greater reduction in LDL-cholesterol (more than 55%), an initial dose of 10/40 mg is suggested. After starting the treatment or adjusting the dosage, blood lipid levels should be checked at intervals of more than 2 weeks to adjust the dosage accordingly.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Lipid improvement through reducing cholesterol in hypercholesterolemia and dyslipidemia and increasing HDL.

  • 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 to lower total cholesterol, LDL-cholesterol, Apolipoprotein B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia, while raising levels of good cholesterol, HDL-cholesterol. It also aids in controlling cholesterol levels in patients with homozygous familial hypercholesterolemia when used in conjunction with or as an alternative to other treatment methods. Considering various causes of dyslipidemia, it is important to use it along with appropriate dietary management and to identify and treat secondary causes such as diabetes and hypothyroidism as needed. This drug contributes to reducing the risk of cardiovascular diseases and improving patient's health by enhancing blood lipid levels.

Dosage and Administration

Adult dosage

This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/10 mg or 10/20 mg is recommended. For patients requiring a greater reduction in LDL-cholesterol (more than 55%), an initial dose of 10/40 mg is suggested. After starting the treatment or adjusting the dosage, blood lipid levels should be checked at intervals of more than 2 weeks to adjust the dosage accordingly.

Precautions

This medication is used to lower blood cholesterol levels and works by combining two components for effect. Before taking this drug, it is crucial to inform your doctor immediately if there is severe muscle pain or weakness. This can lead to rare but serious muscle damage (rhabdomyolysis). If you have liver function issues or a history of liver disease, taking this drug may worsen liver damage, so caution is necessary. Regular liver function tests before and during treatment are essential. This medication may interact with certain drugs, so if you are currently taking any medications, be sure to inform your healthcare provider. It is particularly important when taken with drugs metabolized by the liver. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication and should use appropriate contraceptive methods while on it. Elderly patients or those with impaired kidney function may have an increased risk of muscle damage, thus they should strictly follow physician instructions during treatment. In the event of an overdose, there is no specific antidote, so treatment should be symptomatic with monitoring of liver function and muscle status. If dizziness, muscle pain, or abdominal pain occurs during treatment, consult your healthcare provider immediately, and if symptoms are severe, discontinue use. This medication is not recommended for children as safety and efficacy have not been established. Store this medication out of reach of children, and it is advisable to avoid transferring it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rashes with high fever, blisters, skin peeling, oral/eye mucosal pain, shortness of breath or trouble breathing, asthma attacks, respiratory distress accompanied by cough + fever, jaundice (skin or eyes turning yellow), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, 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
  • increased ALT
  • increased AST
  • fatigue
  • lethargy
  • chest pain
  • weakness
  • constipation
  • dyspepsia
  • pharyngolaryngeal pain
  • epistaxis
  • insomnia
  • nightmares
  • paresthesia
  • sensory loss
  • taste distortion
  • memory loss
  • peripheral neuropathy
  • thrombocytopenia
  • hepatitis
  • blurred vision

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It is best kept at room temperature between 1 to 30 degrees Celsius, away from excessive heat or cold.

Appearance and packaging

Appearance

White or pale yellow, biconvex film-coated tablets in capsule 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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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.