Medication info
Guntojet Tablets 10/10 mg (Ezetimibe/Atorvastatin Calcium Trihydrate)

Guntojet Tablets 10/10 mg (Ezetimibe/Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
건일바이오팜주식회사
Appearance
Oblong film-coated tablets, white or off-white
Packaging
30 tablets/box [(10 tablets/Alu-Alu x 3)]
Approval status
Active

MFDS item code 202101442 · Approved 2021.02.18 · Insurance code 073001640

Summary

Main use
Reduces cholesterol and increases HDL to alleviate the risk of cardiovascular disease in hypercholesterolemia (primary, homozygous familial) and dyslipidemia.
Who uses it
Adults
Adult dosage
Take this medication once daily, regardless of meals. For primary hypercholesterolemia, the dosage is 10/10mg to 10/80mg daily, with an initial recommended dose of 10/10mg or 10/20mg. For patients requiring greater LDL cholesterol reduction, an initial dose of 10/40mg is recommended. After starting treatment or adjusting dosage, check lipid levels in the blood after an interval of more than two weeks.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

Reduces cholesterol and increases HDL to alleviate the risk of cardiovascular disease in hypercholesterolemia (primary, homozygous familial) and dyslipidemia.

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

This medication is used as an adjunct to dietary therapy to improve blood lipid levels, including low HDL cholesterol and high LDL cholesterol, total cholesterol, and triglycerides in patients with primary hypercholesterolemia and mixed dyslipidemia. It is also administered as an adjunct when other lipid-lowering therapies are insufficient in patients with homozygous familial hypercholesterolemia. It is important to use this medication in conjunction with dietary therapy after thoroughly identifying the causes and risk factors of the patient's dyslipidemia. It effectively helps regulate blood lipids in patients with dyslipidemia, thereby reducing the risk of cardiovascular disease.

Dosage and Administration

Adult dosage

Take this medication once daily, regardless of meals. For primary hypercholesterolemia, the dosage is 10/10mg to 10/80mg daily, with an initial recommended dose of 10/10mg or 10/20mg. For patients requiring greater LDL cholesterol reduction, an initial dose of 10/40mg is recommended. After starting treatment or adjusting dosage, check lipid levels in the blood after an interval of more than two weeks.

Precautions

This medication is used to lower blood cholesterol levels and contains two active ingredients. While taking this medication, muscle-related problems may occur; therefore, you should inform your doctor immediately if you experience severe muscle pain or muscle weakness. Especially in cases of severe infection, hypotension, major surgery or trauma, or electrolyte abnormalities, you may need to temporarily discontinue or stop taking this medication. Patients with poor liver function or liver disease may be at risk when taking this medication, so consultation with a physician is essential. This medication is not administered to individuals with allergies to specific ingredients or muscle diseases, women who are pregnant or may become pregnant, or nursing mothers. Moreover, patients taking certain antiviral drugs or with lactose intolerance should not use this medication. Elderly patients, alcoholics, and those with hypothyroidism or impaired kidney function, who are at higher risk for myopathy, should use this medication with caution. When taking this medication with other lipid-lowering agents, such as fibrates, the risk of muscle damage may increase, so care is needed. Regular liver function tests and muscle-related examinations (CPK) should be conducted while on this medication, and if any abnormal signs arise, medical personnel must be notified immediately. Pregnant or nursing women should not take this medication, and women of childbearing potential should use appropriate contraceptive methods. Safety and efficacy in children have not been established, and it is not recommended for use. In cases of overdose, there is no specific antidote, so treatment and supportive care must be provided according to the symptoms, including monitoring liver function and muscle condition. This medication may interact with other drugs, so it is crucial to inform your physician or pharmacist about any other medications you are taking. Lastly, this medication should be kept out of reach of children and not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucous membranes, wheezing or difficulty breathing, asthma attacks, breathing issues associated with cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, numbness, urinary issues.

Mild side effects

  • Muscle pain
  • abdominal pain
  • dizziness
  • nausea
  • diarrhea
  • hyperkalemia
  • joint pain
  • musculoskeletal pain
  • fatigue
  • headache
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  • pharyngitis
  • sinusitis
  • cough
  • constipation
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • throat and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • sensory disturbances
  • numbness
  • taste disturbances
  • memory loss
  • peripheral neuropathy
  • muscle weakness
  • muscle cramps
  • joint swelling
  • back pain
  • neck pain
  • muscle fatigue
  • lupus-like syndrome
  • allergic reactions.

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. Additionally, it should be kept at a temperature between 1°C and 30°C, avoiding extremely hot or cold environments.

Appearance and packaging

Appearance

Oblong film-coated tablets, white or off-white

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.