Medication info

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

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
대우제약(주)
Appearance
White or pale yellow, round, film-coated tablet with a biconvex shape
Packaging
30 tablets/box [10 tablets/Alu-Alu x 3]
Approval status
Approval withdrawn

MFDS item code 202101662 · Approved 2021.02.18 · Insurance code 649606000

This product's status changed to Approval withdrawn on 2024.06.03. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of cholesterol levels and increase of HDL through reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is taken once daily, regardless of meals. The dosage range for primary hypercholesterolemia is 10/10 mg to 10/80 mg per day, with a recommended initial dose of 10/10 mg or 10/20 mg per day. For patients requiring significant LDL cholesterol reduction (55% or more), an initial dose of 10/40 mg per day is recommended. After initiation of treatment or dose adjustment, follow-up of lipid levels should be done at intervals of more than 2 weeks.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Improvement of cholesterol levels and increase of HDL through reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia

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

This medication helps improve cholesterol and lipid levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It mainly lowers LDL cholesterol, total cholesterol, Apo B, triglycerides, and non-HDL cholesterol, while increasing good HDL cholesterol. It is used as an adjunctive therapy for patients with homozygous familial hypercholesterolemia either alone or when other lipid-lowering therapies are ineffective. This medication is used in conjunction with diet to reduce the risk of atherosclerotic vascular diseases that may arise due to hypercholesterolemia, and it is administered when the diet alone is insufficient. Prior to treatment, other causes of secondary dyslipidemia should be identified and tested, and those causes treated if necessary. Overall, this medication is used to improve lipid levels in dyslipidemia patients to lower the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

This medication is taken once daily, regardless of meals. The dosage range for primary hypercholesterolemia is 10/10 mg to 10/80 mg per day, with a recommended initial dose of 10/10 mg or 10/20 mg per day. For patients requiring significant LDL cholesterol reduction (55% or more), an initial dose of 10/40 mg per day is recommended. After initiation of treatment or dose adjustment, follow-up of lipid levels should be done at intervals of more than 2 weeks.

Precautions

This medication is a drug that helps lower blood cholesterol levels, with the active ingredients being Ezetimibe and Atorvastatin Calcium. Before taking this medication, if symptoms such as muscle pain, muscle weakness, or muscle cramps occur, inform your doctor immediately. These symptoms can rarely progress to a serious muscle damage condition called rhabdomyolysis, which may lead to kidney problems. In cases of severe infections, hypotension, major surgery, trauma, severe metabolic disorder, or uncontrolled seizures, the use of this medication may need to be temporarily paused or stopped. Patients with a known allergy to any of the ingredients in this medication, those with active liver disease, or those with persistently elevated liver enzyme levels of unknown cause, or patients with muscle diseases should not use this medication. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication, and women of childbearing potential should use appropriate contraception while taking it. This medication may affect liver function, so regular liver function tests should be performed before and during treatment, and if symptoms of liver dysfunction occur, inform your doctor immediately. This medication can interact with other drugs; thus, if you are currently taking any medications, be sure to inform your doctor or pharmacist. Caution is especially needed when taken with certain antibiotics, antiviral agents, antifungals, immunosuppressants, or fibrate medications. Elderly patients or those with diminished kidney function may have an increased risk of developing myopathy, so caution is advised during use. In case of overdose, there is no specific antidote, so treatment should be symptom-based and supportive, and liver function along with muscle enzyme levels should be monitored. Dizziness or fatigue may occur, so caution should be observed when driving or operating machinery. The safety and efficacy of this medication in children have not been established, so it is not recommended for use in pediatric patients. For safe storage, this medication should be kept out of reach of children, and it is advisable not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, cough+fever accompanied breathing abnormalities, yellowing of skin or eyes (jaundice), severe lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual abnormalities, paralysis, urination problems

Mild side effects

  • Muscle pain
  • abdominal pain
  • dizziness
  • headache
  • nausea
  • diarrhea
  • fatigue
  • joint pain
  • muscle weakness
  • musculoskeletal pain
Show 28 more
  • bronchitis
  • sinusitis
  • hyperkalemia
  • flushing
  • pharyngitis
  • constipation
  • dyspepsia
  • vomiting
  • burping
  • pancreatitis
  • sore throat
  • nosebleed
  • insomnia
  • nightmares
  • sensory abnormalities
  • amnesia
  • taste disturbance
  • muscle cramps
  • joint swelling
  • back pain
  • thrombocytopenia
  • hepatitis
  • blurred vision
  • tinnitus
  • itching
  • rash
  • hair loss
  • angioedema

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1°C and 30°C. This helps to preserve the medication's effectiveness and safety for a longer time.

Appearance and packaging

Appearance

White or pale yellow, round, film-coated tablet with a biconvex 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.