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

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

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tabletAmlodipine Besylate›13.889mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Pink, biconvex, round film-coated tablet
Packaging
Bottle packaging - 30 tablets/bottle, Bottle packaging - 100 tablets/bottle
Approval status
Active

MFDS item code 202402811 · Approved 2024.11.27 · Insurance code 693903960

Summary

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

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Treatment for improvement of hypertension and dyslipidemia and risk reduction of angina

  • Hypertension
  • fixed closure of coronary artery
  • vasospasm
  • vascular contraction
  • myocardial ischemia
  • primary hypercholesterolemia
  • elevated total cholesterol
  • LDL cholesterol
  • Apo B protein
  • triglycerides
  • non-HDL cholesterol
View approved original text

This medication is used for patients who need to take Amlodipine and Ezetimibe/Rosuvastatin simultaneously. Amlodipine is effective for hypertension and angina, particularly for myocardial ischemia caused by stable angina and variant angina. Furthermore, in patients with confirmed coronary artery disease who do not have heart failure and have a cardiac output of over 40%, it reduces the risk of hospitalization due to angina and the risk of coronary vascular revascularization. Ezetimibe/Rosuvastatin helps to reduce total cholesterol, LDL, Apo B, triglycerides, and non-HDL cholesterol levels while increasing HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. This medication is used to lower the risk of cardiovascular disease and improve dyslipidemia.

How to take

Adult dose

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

Precautions

This medication can cause a rare side effect known as rhabdomyolysis, which can lead to serious muscle problems and may result in the risk of acute kidney dysfunction; therefore, if severe muscle pain or weakness occurs, you should inform your doctor immediately. This medication should not be used by individuals with certain medical conditions or allergies to the medication, by pregnant or breastfeeding women, or by people with severe liver or kidney diseases. Patients with impaired liver function or very low blood pressure, the elderly, those with a history of muscle disorders, or those taking certain medications should use this medication cautiously. During the use of this medication, liver function tests and blood tests should be performed periodically, and if abnormal liver symptoms occur, immediate consultation with healthcare professionals is necessary. Side effects such as muscle pain, fatigue, headaches, dyspepsia, edema, etc. may occur; if symptoms are severe or persistent, consult a physician. This medication may interact with other medications; therefore, if you are taking other medications, be sure to inform your healthcare provider, especially when taken with anticoagulants, some antibiotics, antifungals, or immunosuppressants. Women who are pregnant or may become pregnant should use appropriate contraceptive methods while taking this medication and should not take it during pregnancy. It is not recommended for children and adolescents as the safety and efficacy have not been established. In case of overdose, severe hypotension or cardiac problems may occur, so the prescribed dosage should be adhered to and followed under the guidance of a physician. This medication should be stored out of the reach of children, and transferring it to other containers should be avoided.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, skin peeling, mouth/eye mucosal pain, shortness of breath or difficulty breathing, asthma attacks, breathing difficulties accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme drowsiness, sudden and severe headache, lightning headache, seizures, confusion, vision disturbances, paralysis, coma

Mild side effects

  • Fatigue
  • edema
  • headache
  • dizziness
  • drowsiness
  • abdominal pain
  • nausea
  • diarrhea
  • constipation
  • myalgia
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  • arthralgia
  • muscle cramps
  • itching
  • rash
  • urticaria
  • vasculitis
  • insomnia
  • cough
  • phlegm
  • runny nose
  • chest pain
  • chest discomfort
  • weakness
  • increased frequency of urination
  • urination disorders
  • nocturia
  • weight changes
  • thrombocytopenia
  • leukopenia
  • erectile dysfunction
  • sensory disturbances
  • nausea
  • pruritus
  • alopecia
  • hyperhidrosis
  • skin discoloration
  • hypotension
  • hypertension
  • tremors

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

Storage

This medication may be sensitive to air or moisture, therefore it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius to effectively preserve the drug's efficacy and safety.

Appearance and packaging

Appearance

Pink, biconvex, round film-coated tablet

Package unit

Bottle packaging - 30 tablets/bottle, Bottle packaging - 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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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.