Medication info
Gontojet Tablet 10/20mg (Ezetimibe/Atorvastatin Calcium Trihydrate)

Gontojet Tablet 10/20mg (Ezetimibe/Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
건일바이오팜주식회사
Appearance
White or off-white oval film-coated tablet
Packaging
30 tablets/box [10 tablets/Alu-Alu x 3]
Approval status
Active

MFDS item code 202101441 · Approved 2021.02.18

Summary

Main use
Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and improvement of lipids through cholesterol reduction and HDL increase
Who uses it
Adults
Adult dosage
This medication is administered once daily without regard to meals. For primary hypercholesterolemia, the dosage range is 10/10mg to 10/80mg daily. The recommended initial doses are 10/10mg or 10/20mg daily. If greater LDL cholesterol reduction is needed, an initial dose of 10/40mg daily is recommended. After administration, serum lipid levels should be checked and dosage adjusted at intervals of more than 2 weeks.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and improvement of lipids through cholesterol reduction and HDL increase

  • Primary hypercholesterolemia
  • elevated total cholesterol
  • LDL cholesterol
  • Apo B protein
  • triglycerides
  • non-HDL cholesterol
  • homozygous familial hypercholesterolemia
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication is used as an adjunct to diet for patients with primary hypercholesterolemia, particularly in those with heterozygous familial and non-familial cases, to lower elevated total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels while increasing HDL cholesterol. It may also be used as an adjunct or alternative to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. This medication enhances therapeutic effects in patients at high risk of atherosclerotic vascular disease associated with dyslipidemia in conjunction with appropriate dietary controls, and treatment of other secondary causes may be necessary. As a medication that assists in effective treatment while considering various risk factors in dyslipidemia management, it contributes to improving lipid levels and reducing the risk of cardiovascular disease.

Dosage and Administration

Adult dosage

This medication is administered once daily without regard to meals. For primary hypercholesterolemia, the dosage range is 10/10mg to 10/80mg daily. The recommended initial doses are 10/10mg or 10/20mg daily. If greater LDL cholesterol reduction is needed, an initial dose of 10/40mg daily is recommended. After administration, serum lipid levels should be checked and dosage adjusted at intervals of more than 2 weeks.

Precautions

This medication may affect muscles; report to your doctor immediately if symptoms such as muscle pain, muscle cramps, or muscle weakness occur. If severe muscle pain or weakness accompanies these symptoms, a blood test may be required to check for muscle damage, and discontinuation of therapy may be necessary. This medication may affect liver function; therefore, liver function tests should be performed before treatment, and regular monitoring of liver function status should continue during therapy. If symptoms of liver dysfunction (e.g., fatigue, jaundice, nausea, vomiting) occur, consult your doctor immediately. Pregnant women or those who may become pregnant, as well as breastfeeding women, should not use this medication, and women of childbearing age should use appropriate contraception. Patients with excessive alcohol consumption history or liver disease should use this medication with caution. Patients with poor kidney function or muscle diseases also need to be careful when taking this medication. Interactions may occur when taking this medication with other drugs; inform your doctor or pharmacist about all medications being taken. The risk of muscle damage may increase, especially when combined with certain antibiotics, antivirals, antifungals, immunosuppressants, and some lipid-lowering agents. Side effects such as dizziness, headache, indigestion, abdominal pain, and diarrhea may occur during the use of this medication; consult a healthcare professional if symptoms are severe. Safety and efficacy in children have not been established, so it is not recommended for use. Caution is needed in the elderly due to a higher risk of muscle-related abnormalities, but separate dosage adjustments are usually not required. There is no specific antidote in case of overdose; therefore, appropriate treatment and observation should be undertaken based on symptoms. This medication should be stored out of reach of children and should not be transferred to other containers. Caution is needed when driving or operating machinery if symptoms such as dizziness occur.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucosas, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual abnormalities, paralysis, urination

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • headache
  • dizziness
  • fatigue
  • malaise
  • chest pain
  • weakness
  • thrombocytopenia
Show 27 more
  • rash
  • itching
  • hair loss
  • urticaria
  • eczema
  • dry skin
  • bronchitis
  • sinusitis
  • cough
  • low back pain
  • joint pain
  • muscle weakness
  • flushing
  • diarrhea
  • constipation
  • loss of appetite
  • vomiting
  • belching
  • indigestion
  • pharyngitis
  • nosebleed
  • nightmares
  • tinnitus
  • blurred vision
  • increased serum creatinine
  • elevated blood pressure
  • increased blood urea

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

Storage

This medication may be sensitive to air and moisture, thus it should be stored in a tightly sealed container. Additionally, it is best to store it at room temperature between 1 °C and 30 °C. Proper storage will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

White or off-white oval 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.