Medication info
Gentojet Tablet 10/40 mg (Ezetimibe/Atorvastatin Calcium Hydrate)

Gentojet Tablet 10/40 mg (Ezetimibe/Atorvastatin Calcium Hydrate)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
건일바이오팜주식회사
Appearance
White or near-white oblong film-coated tablet
Packaging
30 tablets/box [10 tablets/Alu-Alu x 3]
Approval status
Active

MFDS item code 202101440 · Approved 2021.02.18

Summary

Main use
Reduction of cholesterol and increase of HDL in patients with hypercholesterolemia (primary, homozygous familial) and dyslipidemia to mitigate cardiovascular disease risk
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meal timing. For primary hypercholesterolemia, the dosage range is 10/10mg to 10/80mg per day. Starting with a dose of 10/10mg or 10/20mg per day is recommended, while patients who require a significant decrease in LDL cholesterol are advised to take 10/40mg per day. Blood lipid levels should be monitored at intervals of more than 2 weeks after starting treatment or after dose adjustments.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

Reduction of cholesterol and increase of HDL in patients with hypercholesterolemia (primary, homozygous familial) and dyslipidemia to mitigate cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
View approved original text

This drug is used to improve blood cholesterol and related lipid levels in patients with primary hypercholesterolemia and mixed dyslipidemia. Taking this medication results in a decrease in total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol, with an increase in HDL cholesterol. Additionally, it can be used in patients with homozygous familial hypercholesterolemia in conjunction with or as an alternative to other lipid-lowering treatments. In particular, this drug is administered with dietary therapy during the treatment of dyslipidemia, and if there are secondary causes, these should be treated first. Moreover, patients with acute coronary events can also start treatment early. Overall, this drug is effective in lowering the risk associated with hypercholesterolemia and improving blood lipid management.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meal timing. For primary hypercholesterolemia, the dosage range is 10/10mg to 10/80mg per day. Starting with a dose of 10/10mg or 10/20mg per day is recommended, while patients who require a significant decrease in LDL cholesterol are advised to take 10/40mg per day. Blood lipid levels should be monitored at intervals of more than 2 weeks after starting treatment or after dose adjustments.

Precautions

This medication is a drug that lowers blood cholesterol levels and helps prevent cardiovascular disease. Before taking this drug, there may be symptoms of muscle pain or weakness, so if these symptoms occur, you should immediately notify your physician. Particularly, serious muscle damage known as rhabdomyolysis has been reported rarely, so caution is necessary if muscle pain is accompanied by fever or malaise. It may affect liver function, so liver function tests should be carried out before starting this medication, and liver function should be monitored regularly during treatment. If symptoms of liver dysfunction occur, drug administration should be discontinued. This medication is not administered to patients with certain liver diseases, muscle disorders, women who are pregnant or may become pregnant, nursing mothers, or patients taking specific medications. Caution should be exercised for alcoholics, patients with poor liver function, the elderly, patients with hypothyroidism, and those with decreased kidney function; dosage adjustments or monitoring according to a physician's instructions may be necessary. There are many drug interactions, especially with medications that may increase the risk of muscle damage, so consultation with a physician is essential before co-administration. During the use of this medication, appropriate contraception should be utilized and it should not be taken during pregnancy. Side effects such as dizziness or muscle pain may occur, so caution is necessary when driving or operating machinery. In case of overdose, since there is no specific antidote, immediate medical attention should be sought for appropriate treatment and to check liver function and muscle enzyme levels. Store this medication in a place out of reach of children and do not transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), profound fatigue, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Muscle pain
  • abdominal pain
  • headache
  • diarrhea
  • nausea
  • cough
  • dizziness
  • fatigue
  • musculoskeletal pain
  • joint pain
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  • muscle weakness
  • vomiting
  • constipation
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • dry mouth
  • loss of appetite
  • insomnia
  • nightmares
  • blurred vision
  • tinnitus
  • hair loss
  • itching
  • rash
  • urticaria
  • angioedema
  • sweating
  • acne
  • eczema
  • skin ulcer
  • anemia
  • thrombocytopenia
  • sensory disturbances
  • immune reactions
  • abnormal liver function tests

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

Storage

This medication can be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius to safely preserve the drug's efficacy.

Appearance and packaging

Appearance

White or near-white oblong film-coated tablet

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.