Medication info
Ebejett Tablets 10/10 mg (Ezetimibe, Atorvastatin)

Ebejett Tablets 10/10 mg (Ezetimibe, Atorvastatin)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
(주)이든파마
Appearance
White, biconvex, film-coated rectangular tablets
Packaging
30 tablets/box [(10 tablets/PTP)x3]
Approval status
Active

MFDS item code 202101432 · Approved 2021.02.18 · Insurance code 628901970

Summary

Main use
Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and prevention of cardiovascular disease risk by increasing HDL
Who uses it
Adults
Adult dosage
This medication is to be taken once daily, regardless of meals. The dosing range for primary hypercholesterolemia is 10/10 mg to 10/80 mg daily, with a recommended starting dose of 10/10 mg or 10/20 mg daily. For patients requiring more significant reductions in LDL cholesterol, a starting dose of 10/40 mg daily is recommended. After administration, lipid levels should be monitored after an interval of at least two weeks to adjust the dosage.

Ingredients

Manufacturer
(주)이든파마

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and prevention of cardiovascular disease risk by increasing HDL

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

This drug is used as an adjunct to diet to lower elevated total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to increase levels of good cholesterol, HDL cholesterol. It is also used as an adjunct therapy in patients with homozygous familial hypercholesterolemia or when other therapies are ineffective. Additionally, it should be administered cautiously in patients at increased risk of atherosclerotic vascular disease due to hypercholesterolemia, considering other risk factors, and should be used in conjunction with appropriate dietary measures. Prior to medication, the lipid status and potential secondary causes should be verified, and secondary causes should be treated if necessary. This drug helps treat dyslipidemia to control cholesterol levels and reduce the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

This medication is to be taken once daily, regardless of meals. The dosing range for primary hypercholesterolemia is 10/10 mg to 10/80 mg daily, with a recommended starting dose of 10/10 mg or 10/20 mg daily. For patients requiring more significant reductions in LDL cholesterol, a starting dose of 10/40 mg daily is recommended. After administration, lipid levels should be monitored after an interval of at least two weeks to adjust the dosage.

Precautions

This drug has been reported to cause a rare side effect called rhabdomyolysis, which can lead to serious muscle damage. Patients who develop severe muscle disorder symptoms or have kidney function issues should temporarily stop or discontinue this medication. It should not be administered to patients with allergies to specific components, those with severely impaired liver function, patients with muscle diseases, pregnant or breastfeeding women, or patients taking certain antiviral medications. Caution is advised for patients with alcohol dependence, a history of liver disease, moderate to severe liver dysfunction, or elderly patients with risk factors for myopathy. This drug may cause side effects such as muscle pain, abdominal pain, increased liver enzymes, etc., so if any abnormal symptoms occur, consultation with a physician should occur immediately. Regular monitoring of liver function and muscle status is important before and during treatment, particularly reporting symptoms such as muscle pain, malaise, or fever promptly. There may be interactions with other medications, so any concurrent medications should be disclosed, and caution is needed when used with some antibiotics, antiviral agents, or fibrates. Women of childbearing age should use appropriate contraceptive methods while taking this drug and should discontinue use immediately if pregnancy is confirmed. Symptoms such as dizziness may occur, so caution is needed when driving or operating machinery. Additionally, this drug has not been established to be safe or effective in children and is not recommended. In case of overdose, there are no specific antidotes; treatment and supportive care should be provided based on symptoms. This drug should be kept out of the reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, mouth/eye mucosal pain, severe skin adverse reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme), shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanied respiratory abnormalities, jaundice (yellowing of skin or eyes), general malaise

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • diarrhea
  • dizziness
  • fatigue
  • headache
  • joint pain
  • muscle weakness
  • musculoskeletal pain
Show 25 more
  • bronchitis
  • sinusitis
  • flushing
  • hyperkalemia
  • anemia
  • hernia
  • depression
  • bronchiolitis
  • dental abscess
  • vestibular neuritis
  • bradycardia
  • hypotension
  • urticaria
  • itching
  • rash
  • hair loss
  • thrombocytopenia
  • hepatitis
  • cholestasis
  • blurred vision
  • tinnitus
  • hearing loss
  • gynecomastia
  • increased serum creatine kinase
  • forgetfulness

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. Additionally, it should be stored at room temperature, specifically between 1 degree and 30 degrees Celsius, and not in excessively hot or cold conditions.

Appearance and packaging

Appearance

White, biconvex, film-coated rectangular tablets

Package unit

30 tablets/box [(10 tablets/PTP)x3]

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.