Medication info
Enbizet Tablet 10/40 mg

Enbizet Tablet 10/40 mg

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›43.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
엔비케이제약(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/Alu-Alu[((10 tablets/Alu-Alu x 3))]
Approval status
Active

MFDS item code 202101646 · Approved 2021.02.18 · Insurance code 054801280

Summary

Main use
Improvement of lipid levels through reduction of cholesterol and increase of HDL in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dosage range is from 10/10 mg to 10/80 mg daily. The recommended initial dose is 10/10 mg or 10/20 mg once daily. If a reduction in LDL-cholesterol of more than 55% is required, the recommended initial dose is 10/40 mg once daily. After starting treatment or after dosage adjustments, lipid levels in the blood should be checked at intervals of more than 2 weeks.

Ingredients

Manufacturer
엔비케이제약(주)

Efficacy & effects

Improvement of lipid levels through reduction of cholesterol and increase of HDL in hypercholesterolemia and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
  • hypercholesterolemia
  • increased risk of atherosclerotic vascular disease
View approved original text

This medication is used to lower cholesterol and triglyceride levels in patients with primary hypercholesterolemia, especially heterozygous familial and non-familial types, as well as mixed dyslipidemia. It may also be used in patients with homozygous familial hypercholesterolemia in conjunction with other treatments or as an alternative therapy. This medication reduces the risk of cardiovascular disease, and it is important to use it alongside dietary therapy. Patients with dyslipidemia should identify the exact underlying cause and treat any additional factors if needed. Before starting treatment, total cholesterol, LDL, HDL, and triglyceride levels should be tested, and additional tests are required especially if triglyceride levels exceed 400 mg/dL. It also aids in the rapid assessment and management of lipid levels during acute coronary events. This medication is effective in improving dyslipidemia and its associated complications.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dosage range is from 10/10 mg to 10/80 mg daily. The recommended initial dose is 10/10 mg or 10/20 mg once daily. If a reduction in LDL-cholesterol of more than 55% is required, the recommended initial dose is 10/40 mg once daily. After starting treatment or after dosage adjustments, lipid levels in the blood should be checked at intervals of more than 2 weeks.

Precautions

This medication poses a risk of muscle problems; therefore, if sudden muscle pain or weakness occurs, it is crucial to inform a doctor immediately. In cases of severe infections, surgery, or trauma that may impair kidney function, the use of this medication may need to be temporarily halted. It is not safe for individuals with certain medical conditions to use this medication. For example, those with severe liver dysfunction or persistent unexplained elevation of liver enzymes, individuals with muscle disorders, women who are pregnant or breastfeeding, and those who are allergic to any components of this medication should not take it. Those with a history of alcohol addiction or liver disease, poor kidney function, or hypothyroidism, as well as elderly patients over 70 years of age, who are at higher risk for myopathy should use this medication cautiously, and dosage adjustments or regular monitoring may be necessary as directed by a doctor. During treatment, liver function and muscle status should be monitored regularly, and if liver issues arise, the medication should be discontinued. Additionally, this medication may elevate blood sugar levels, so individuals at risk for diabetes should manage their blood sugar carefully. Interactions may occur when taken with other medications, so it is essential to inform a doctor or pharmacist of any current medications. Especially when taken with drugs that inhibit enzymes in the liver that metabolize medications, there may be an increased risk of muscle damage. Women who are pregnant or may become pregnant should not take this medication, and women of childbearing age should use appropriate contraception methods. It is also recommended that breastfeeding women do not take this medication. Safety and efficacy in children have not been established, therefore it is not recommended for pediatric use. Caution is necessary for elderly patients due to the risk of myopathy, but generally, dosage adjustments are not required. In case of overdose, there is no specific antidote; therefore, appropriate treatment and monitoring according to symptoms are necessary. Finally, this medication should be kept out of reach of children and should not be stored in a different container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), heaviness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever, jaundice (yellowing of the skin or eyes), profound malaise, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination changes

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • diarrhea
  • dizziness
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • hyperkalemia
  • bronchitis
Show 26 more
  • sinusitis
  • flushing
  • increased ALT
  • increased AST
  • fatigue
  • malaise
  • chest pain
  • tiredness
  • fever
  • also pharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • belching
  • pancreatitis
  • throat and larynx pain
  • nasal bleeding
  • insomnia
  • nightmares
  • headache
  • paresthesia
  • sensory loss

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture and kept at room temperature between 1 degree and 30 degrees Celsius. Therefore, it is important to avoid direct sunlight and not to keep it in excessively hot or cold places.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/Alu-Alu[((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.