Medication info
Amlojet Tablets 10/20/10 mg (Amlodipine, Rosuvastatin, Ezetimibe)

Amlojet Tablets 10/20/10 mg (Amlodipine, Rosuvastatin, Ezetimibe)

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium›20.8mg / 1 tabletAmlodipine Besylate›13.889mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Pink, biconvex, round film-coated tablets
Packaging
Bottle packaged - 30 tablets/bottle, Bottle packaged - 100 tablets/bottle
Approval status
Active

MFDS item code 202402806 · Approved 2024.11.27

Summary

Main use
Treatment of hypertension and angina (myocardial ischemia) and improvement of dyslipidemia
Who takes it
Adults
Adult dose
This medication is taken as one tablet once a day with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning) when possible. Amlodipine is administered orally at a dose of 5 mg once daily and can be increased to a maximum of 10 mg per day based on the patient's response. The Ezetimibe/Rosuvastatin combination should be taken once a day regardless of meals. For primary hypercholesterolemia, the dosage range is 10/

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Treatment of hypertension and angina (myocardial ischemia) and improvement of dyslipidemia

  • Hypertension
  • fixed occlusion of coronary arteries
  • vascular spasms
  • vasoconstriction
  • myocardial ischemia
  • primary hypercholesterolemia
  • elevated total cholesterol
  • LDL cholesterol
  • Apo B proteins
  • triglycerides
  • and non-HDL cholesterol
View approved original text

This medication is used for patients who need to take Amlodipine and Ezetimibe/Rosuvastatin together. Amlodipine is used to treat hypertension and stable or variant angina due to myocardial ischemia, and it helps reduce the risk of hospitalization due to angina and the risk of coronary angioplasty. Ezetimibe/Rosuvastatin is used to lower total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol while increasing HDL cholesterol levels in patients with primary hypercholesterolemia and heterozygous familial or non-familial dyslipidemia, thus improving blood lipid concentrations. Therefore, this medication is effective in improving cardiovascular health and reducing the risk of related diseases.

How to take

Adult dose

This medication is taken as one tablet once a day with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning) when possible. Amlodipine is administered orally at a dose of 5 mg once daily and can be increased to a maximum of 10 mg per day based on the patient's response. The Ezetimibe/Rosuvastatin combination should be taken once a day regardless of meals. For primary hypercholesterolemia, the dosage range is 10/

Precautions

This medication may rarely cause rhabdomyolysis due to the Rosuvastatin component, leading to a risk of acute renal failure. Therefore, patients exhibiting serious myopathy symptoms or those with risk factors such as severe infections, hypotension, major surgery, trauma, endocrine and electrolyte disorders, or uncontrolled seizures should temporarily discontinue or stop using this medication. Patients with allergies to this medication's ingredients or similar medications, pregnant or potentially pregnant women, nursing mothers, patients with severe liver dysfunction, active liver disease, severe aortic stenosis, muscle disorder patients, those taking cyclosporine, and patients with severe kidney impairment should not use this medication. Patients at high risk for myopathy or rhabdomyolysis, such as those with moderate to severe kidney impairment, hypothyroidism, a history of genetic muscle disease, a history of muscle toxicity due to statins or fibrates, alcohol dependence, and patients of Asian descent should use this medication with caution, and muscle-related tests should be conducted as necessary. This medication can affect liver function, thus regular liver function tests should be performed before and during treatment, and if liver damage symptoms appear, use should be immediately discontinued. Symptoms such as muscle pain, muscle cramping, or muscle weakness may occur; if these symptoms develop, consult a physician immediately. This medication should not be used during pregnancy or breastfeeding, and women of childbearing potential should use appropriate contraception. Elderly patients or those with kidney impairment should be monitored closely due to a higher risk of myopathy. This medication may interact with several other medications; therefore, if taking other medications, it is essential to inform the doctor or pharmacist, particularly when used in conjunction with fibrates, cyclosporine, warfarin, certain antibiotics, etc. In case of overdose, symptoms such as low blood pressure or decreased cardiac function may occur; immediate medical attention should be sought.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing → severe allergic reaction. Severe skin reaction with high fever and rash, blisters, peeling skin, pain in mucous membranes of mouth/eyes → severe skin abnormal reaction. Shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough + fever → respiratory problems. Yellowing of skin or eyes (jaundice), extreme fatigue → liver problems (jaundice). Sudden and very severe headache,

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • fatigue
  • swelling
  • abdominal pain
  • nausea
  • diarrhea
  • myalgia
  • malaise
Show 28 more
  • thrombocytopenia
  • weakness
  • insomnia
  • itching
  • rash
  • urticaria
  • hair loss
  • increased serum creatinine
  • sensory disturbances
  • chest discomfort
  • vomiting
  • abdominal bloating
  • loss of appetite
  • constipation
  • increased blood pressure
  • pain
  • muscle cramps
  • generalized pain
  • joint pain
  • limb pain
  • chest pain
  • congestion
  • upper respiratory tract infection
  • cough
  • thrombocytopenia
  • rhinitis
  • nocturia
  • erectile dysfunction

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. Additionally, it is best to store the medicine at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a longer time.

Appearance and packaging

Appearance

Pink, biconvex, round film-coated tablets

Package unit

Bottle packaged - 30 tablets/bottle, Bottle packaged - 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

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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.