Medication info

Mitojet Tablets 10/10 Milligrams

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
미래바이오제약(주)
Appearance
White or light yellow, bilaterally convex film-coated tablet shaped like a capsule.
Packaging
30 tablets/box [10 tablets/Alu-Alu X 3]
Approval status
Active

MFDS item code 202104834 · Approved 2021.06.24

Summary

Main use
Improvement of cholesterol and LDL reduction, HDL increase in hypercholesterolemia (primary, homozygous familial) and dyslipidemia.
Who uses it
Adults
Adult dosage
This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is from 10/10mg to 10/80mg per day. The initial dose recommended is 10/10mg or 10/20mg once daily, while patients requiring a greater reduction in LDL cholesterol (more than 55%) should start with 10/40mg once daily. Dosage adjustments should occur with at least 2 weeks between checks of lipid levels.

Ingredients

Manufacturer
미래바이오제약(주)

Efficacy & effects

Improvement of cholesterol and LDL reduction, HDL increase in hypercholesterolemia (primary, homozygous familial) and dyslipidemia.

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

This medication is used in conjunction with dietary therapy to improve high cholesterol and triglyceride levels in patients primarily with primary hypercholesterolemia and mixed dyslipidemia. It effectively reduces total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol, while increasing HDL cholesterol, known as good cholesterol. Additionally, it helps lower blood cholesterol levels in patients with homozygous familial hypercholesterolemia, either alongside or as an alternative to other lipid-lowering treatments. This medication is used when dietary and non-drug therapies are insufficient, and secondary causes, such as diabetes and hypothyroidism, must be confirmed before use. Regular blood lipid tests are recommended for accurate treatment and safe use. Overall, this medication is effectively used for the treatment of hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is from 10/10mg to 10/80mg per day. The initial dose recommended is 10/10mg or 10/20mg once daily, while patients requiring a greater reduction in LDL cholesterol (more than 55%) should start with 10/40mg once daily. Dosage adjustments should occur with at least 2 weeks between checks of lipid levels.

Precautions

This medication may pose the risk of a rare side effect known as rhabdomyolysis, which can cause serious muscle problems. Patients with severe infections, low blood pressure, major surgery or trauma, or metabolic disorders may need to temporarily discontinue or stop this medication. Patients allergic to any component of this medication or those with active liver disease or muscle disorders should not use it. Furthermore, women who are pregnant, potentially pregnant, or breastfeeding should not take this medication. Patients sensitive to lactose, which is included in this medication, should also avoid administration. Patients with alcohol dependence, poor liver function, reduced kidney function, or hypothyroidism should use this medication with caution. Special care is needed for elderly patients over 70 years old, those with previous muscle problems, and those taking specific medications. While taking this medication, side effects such as muscle pain, abdominal pain, and liver function abnormalities may occur, and if these symptoms are severe, consultation with a doctor is advised. Regular liver function test and muscle enzyme (CPK) assessments should be conducted, and treatment should be stopped immediately if abnormalities are found. This medication may affect liver function, so patients with liver disease or elevated liver enzyme levels must undergo testing before use. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should practice appropriate contraception while using it. Safety and efficacy in children have not been established, and caution is necessary for elderly patients due to a higher likelihood of muscle issues. This medication may interact with other drugs, especially those affecting liver metabolism or muscles, so patients should inform their doctor and be closely monitored. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and liver function and muscle enzymes should be monitored. This medication should be kept out of the reach of children and should not be transferred to another container.

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 high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory irregularities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme tiredness, sudden and very severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urine changes.

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • hyperkalemia
Show 28 more
  • bronchitis
  • sinusitis
  • flushing
  • diarrhea
  • vomiting
  • headache
  • fatigue
  • constipation
  • hyperglycemia
  • hypoglycemia
  • loss of appetite
  • pharyngitis
  • edema
  • asthenia
  • chest pain
  • lethargy
  • chest discomfort
  • increased blood pressure
  • low back pain
  • muscle cramps
  • muscle fatigue
  • blurred vision
  • tinnitus
  • itching
  • rash
  • hair loss
  • hives
  • sweating

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. The recommended storage temperature is room temperature between 1 degree to 30 degrees Celsius. Keeping it this way helps maintain the medication's efficacy over time.

Appearance and packaging

Appearance

White or light yellow, bilaterally convex film-coated tablet shaped like a capsule.

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.