Medication info
Gentor Tablet 10/20 Milligrams (Ezetimibe, Atorvastatin Calcium Hydrate)

Gentor Tablet 10/20 Milligrams (Ezetimibe, Atorvastatin Calcium Hydrate)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
(주)셀릭스
Appearance
White or whitish rectangular film-coated tablet
Packaging
30 tablets/box[(10 tablets/Alu-Alu×3)]
Approval status
Active

MFDS item code 202101565 · Approved 2021.02.18 · Insurance code 646204280

Summary

Main use
Reduction of cholesterol in primary hypercholesterolemia (homozygous familial) and dyslipidemia, and mitigation of cardiovascular disease risk by increasing HDL.
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is from 10/10mg to 10/80mg per day. The initial dose is recommended to be 10/10mg or 10/20mg once daily. For patients who require more significant reductions in LDL-cholesterol (55% or greater), the recommended initial dose is 10/40mg once daily. After starting therapy or adjusting the dose, lipid levels should be checked after an interval of more than 2 weeks.

Ingredients

Manufacturer
(주)셀릭스

Efficacy & effects

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

  • Primary Hypercholesterolemia
  • Heterozygous Familial Hypercholesterolemia
  • Non-Familial Hypercholesterolemia
  • Mixed Dyslipidemia
  • Homozygous Familial Hypercholesterolemia
  • elevated total cholesterol
  • elevated LDL-cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL-cholesterol
  • dyslipidemia
View approved original text

This medication helps lower elevated total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL-cholesterol levels while increasing HDL-cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It is also used as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia, and may be utilized alone in certain cases. This medication is used alongside dietary therapy and contributes to reducing cardiovascular disease risk associated with dyslipidemia. It is important to check for secondary causes, such as diabetes and hypothyroidism, before treatment and to treat them as necessary. By conducting comprehensive tests and management, this medication finely adjusts the patient’s lipid levels to improve overall vascular health. It is effectively used in the treatment of hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is from 10/10mg to 10/80mg per day. The initial dose is recommended to be 10/10mg or 10/20mg once daily. For patients who require more significant reductions in LDL-cholesterol (55% or greater), the recommended initial dose is 10/40mg once daily. After starting therapy or adjusting the dose, lipid levels should be checked after an interval of more than 2 weeks.

Precautions

This medication is used to lower cholesterol levels for the prevention and treatment of cardiovascular diseases. There is a risk of muscle-related problems with this medication, so if symptoms like muscle pain or weakness occur, it is essential to consult a doctor immediately. Serious conditions such as myopathy or rhabdomyolysis may occur rarely, which can lead to kidney function issues, so caution is needed. Patients with poor liver function or abnormally elevated liver enzyme levels should not take this medication and should undergo regular liver function tests. Pregnant women, women who may become pregnant, and nursing mothers should not use this medication, and women of childbearing age should use appropriate contraceptive methods while taking it. This medication can interact with other drugs, so caution is advised, especially when taken with specific antibiotics, antivirals, immunosuppressants, and fibrates. Side effects such as dizziness, headache, abdominal pain, muscle pain may occur; any unusual or severe symptoms should be reported to a doctor. Elderly individuals are at a higher risk for muscle-related issues and should take this medication with caution; safety for children has not been established and is not recommended. In cases of overdose, there is no specific antidote, so appropriate treatment and supportive therapy are needed according to symptoms, and liver function and muscle enzyme levels should be monitored. This medication should be kept out of reach of children and it is advisable not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucous membranes, severe dermatological reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by coughing and fever, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • diarrhea
  • dizziness
  • headache
  • joint pain
  • musculoskeletal pain
  • fatigue
  • hyperkalemia
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  • bronchitis
  • sinusitis
  • flushing
  • abnormal liver function tests
  • increased serum creatine kinase
  • pharyngitis
  • swelling
  • malaise
  • chest pain
  • discomfort in the chest
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • cough
  • sputum
  • runny nose
  • limb pain
  • diabetes
  • hypoglycemia
  • anemia
  • skin rash
  • itching
  • rash
  • hair loss
  • hives

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a sealed container. It is important to maintain the storage temperature between 1 and 30 degrees Celsius (room temperature) to preserve the drug’s efficacy for a longer period.

Appearance and packaging

Appearance

White or whitish rectangular film-coated tablet

Package unit

30 tablets/box[(10 tablets/Alu-Alu×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.