Medication info
Amlojet Tablets 5/5/10 mg (Amlodipine, Rosuvastatin, Ezetimibe)

Amlojet Tablets 5/5/10 mg (Amlodipine, Rosuvastatin, Ezetimibe)

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tabletAmlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Pink, bi-convex, round, film-coated tablet
Packaging
Bottle packaging - 30 tablets/bottle, bottle packaging - 100 tablets/bottle
Approval status
Active

MFDS item code 202402809 · Approved 2024.11.27 · Insurance code 693903940

Summary

Main use
Improvement of hypertension and coronary artery disease (angina), improvement of dyslipidemia
Who takes it
Adults
Adult dose
The usual dose is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). As amlodipine, 5 mg is administered orally once daily, and the dose may be increased up to a maximum of 10 mg per day based on the patient's response. The ezetimibe/rosuvastatin combination should be taken once daily, regardless of meals. The initial recommended dose is 10/5 mg once daily, but may be adjusted as needed.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Improvement of hypertension and coronary artery disease (angina), improvement of dyslipidemia

  • Hypertension
  • fixed coronary occlusion
  • vasospasm
  • vascular constriction
  • myocardial ischemia
  • primary hypercholesterolemia
  • dyslipidemia
  • elevated total cholesterol
  • elevated LDL-cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL-cholesterol
View approved original text

This medication is used for patients who need to take amlodipine and ezetimibe/rosuvastatin simultaneously. Amlodipine helps treat hypertension and improves myocardial ischemia due to stable angina and variant angina. It also reduces the risk of hospitalization for angina and the risk of coronary vascular procedures in patients with coronary heart disease with normal cardiac output and no heart failure. Ezetimibe/rosuvastatin is used to lower total cholesterol, LDL-cholesterol, Apo B, triglycerides, and non-HDL-cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL-cholesterol. This medication improves cardiovascular health by managing both hypertension and dyslipidemia.

How to take

Adult dose

The usual dose is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). As amlodipine, 5 mg is administered orally once daily, and the dose may be increased up to a maximum of 10 mg per day based on the patient's response. The ezetimibe/rosuvastatin combination should be taken once daily, regardless of meals. The initial recommended dose is 10/5 mg once daily, but may be adjusted as needed.

Precautions

This medication has been reported to cause a rare side effect known as rhabdomyolysis, which can lead to severe muscle problems. Therefore, if severe muscle pain or weakness occurs, discontinue use immediately and consult a physician. This medication is contraindicated in certain patients, such as those with allergies to the drug components, pregnant women, and individuals with severe liver or kidney disease. Patients with impaired liver function or specific conditions like hypertension and hypothyroidism should use this medication with caution and have regular liver function tests before and during treatment. This medication may cause side effects such as muscle pain, headache, dyspepsia, and edema, and if any unusual symptoms persist or worsen, notify your doctor. Women who are pregnant or breastfeeding should not use this medication, and women of childbearing age should employ appropriate contraceptive methods while taking it. Elderly patients or those with decreased kidney function are at a higher risk of muscle problems and may require dose adjustments. This medication may interact with other drugs, so inform your doctor or pharmacist about any other medications you are taking. In case of overdose, symptoms such as hypotension and heart problems may occur, so seek appropriate medical treatment immediately. Store this medication out of reach of children and avoid transferring it to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headaches, lightning strike headache, seizures, confusion, vision abnormalities, paralysis, urination

Mild side effects

  • Headache
  • fatigue
  • edema
  • myalgia
  • arthralgia
  • dizziness
  • abdominal pain
  • diarrhea
  • nausea
  • insomnia
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  • pruritus
  • rash
  • cough
  • urinary disorders
  • dyspepsia
  • weakness
  • malaise
  • weight changes
  • thrombocytopenia
  • increased blood pressure
  • sensory abnormalities
  • vomiting
  • constipation
  • weight gain or loss
  • vasculitis
  • taste disturbance
  • tremor
  • increased serum creatinine
  • abdominal distension
  • loss of appetite
  • generalized pain
  • muscle cramps
  • erectile dysfunction
  • urticaria
  • hyperhidrosis
  • skin discoloration

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

Storage

Store this medication in a sealed container to prevent exposure to air and moisture, and maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. Proper storage will ensure the safety and efficacy of the medication.

Appearance and packaging

Appearance

Pink, bi-convex, 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.