Medication info
Amijet Tablet 10/10 Milligrams

Amijet Tablet 10/10 Milligrams

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
대원바이오텍주식회사
Appearance
White, rectangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202101625 · Approved 2021.02.18 · Insurance code 057600860

Summary

Main use
Improvement of lipids through reduction of cholesterol and LDL, and increase of HDL in high cholesterol blood (primary, homozygous familial) and dyslipidemia.
Who uses it
Adults
Adult dosage
This drug is administered once daily, regardless of meals. For primary hypercholesterolemia, it is administered in the range of 10/10mg to 10/80mg once daily, with an initial dose of 10/10mg or 10/20mg recommended. For patients requiring more significant reduction in LDL-cholesterol (more than 55%), an initial dose of 10/40mg once daily is recommended. After starting or adjusting the dosage, check lipid levels with an interval of more than 2 weeks.

Ingredients

Manufacturer
대원바이오텍주식회사

Efficacy & effects

Improvement of lipids through reduction of cholesterol and LDL, and increase of HDL in high cholesterol blood (primary, homozygous familial) and dyslipidemia.

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

This drug is used as an adjunct to diet in patients with primary hypercholesterolemia or mixed dyslipidemia to lower elevated total cholesterol and LDL-cholesterol, apo B, triglycerides, non-HDL cholesterol, and to raise good cholesterol HDL-cholesterol. It is also administered as an adjunct in patients with homozygous familial hypercholesterolemia when other lipid-lowering therapies are ineffective. However, there is currently no established evidence that this drug significantly reduces the incidence and mortality of cardiovascular disease. This drug should be used when there is insufficient response to appropriate non-drug treatment for certain types of dyslipidemia, as research is lacking. Prior to administration, it is important to check for other secondary causes such as diabetes, hypothyroidism, and chronic renal failure and treat as necessary. Additionally, measuring lipid levels to guide treatment is crucial. This drug helps reduce the risk of atherosclerotic vascular disease due to hypercholesterolemia.

Dosage and Administration

Adult dosage

This drug is administered once daily, regardless of meals. For primary hypercholesterolemia, it is administered in the range of 10/10mg to 10/80mg once daily, with an initial dose of 10/10mg or 10/20mg recommended. For patients requiring more significant reduction in LDL-cholesterol (more than 55%), an initial dose of 10/40mg once daily is recommended. After starting or adjusting the dosage, check lipid levels with an interval of more than 2 weeks.

Precautions

This drug can cause a rare side effect called rhabdomyolysis, which can lead to serious muscle problems. There is a risk of rapid deterioration of kidney function, so if severe muscle pain or weakness occurs, inform your doctor immediately. This drug should not be administered to certain patients. For example, those allergic to drug components, with active liver disease, muscle disorders, women who are pregnant or breastfeeding, and patients taking certain other medications should not use this drug. While using this drug, periodic assessments of liver and muscle status are necessary. Special caution is needed for individuals with poor liver function or a high risk of myopathy. Alcoholics or the elderly should also exercise caution when using this drug. This drug can interact with several medications; therefore, if taking other medicines, be sure to inform your doctor or pharmacist. Especially when using with certain antibiotics, antivirals, immunosuppressants, dosage adjustment or monitoring may be necessary. Women who are pregnant or may become pregnant should not take this drug, and women of childbearing age should use appropriate contraception while taking this medication. Additionally, it is safest for nursing women to avoid this drug. During treatment, if symptoms such as muscle pain, weakness, fatigue, fever, or other signs of liver dysfunction (e.g., nausea, vomiting, jaundice) appear, treatment should be stopped and a doctor notified immediately. This drug is not recommended for children as safety and efficacy have not been established. In case of overdose, there is no specific antidote; therefore, appropriate measures should be taken based on symptoms along with tests of liver and muscle function.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), tightness in the chest, 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 attack, respiratory abnormalities accompanied by coughing and fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination abnormalities.

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
Show 25 more
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • malaise
  • chest pain
  • discomfort in the chest
  • edema
  • asthenia
  • general edema
  • headache
  • insomnia
  • nightmares
  • sensory loss
  • taste abnormalities
  • memory loss
  • peripheral neuropathy
  • urticaria
  • skin rash
  • itching
  • hair loss
  • angioedema
  • blurred vision
  • visual disturbance

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

Storage

Store this drug in a tightly sealed container to protect it from air and moisture, at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a longer duration.

Appearance and packaging

Appearance

White, rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

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.