Medication info
Amozartan XQ Tablet 5/100/20/10 Milligrams

Amozartan XQ Tablet 5/100/20/10 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Losartan Potassium›100mg / 1 tabletEzetimibe›10mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tabletRosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Brownish-red oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP×3]
Approval status
Active

MFDS item code 202007695 · Approved 2020.11.09 · Insurance code 643508380

Summary

Main use
Adjunctive treatment for hypertension and dyslipidemia (hypercholesterolemia)
Who takes it
Adults
Adult dose
This medication is to be administered only to adults, and the dosage should be individualized based on each patient. The recommended dosage is 1 tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). The tablet should not be chewed, divided, or crushed; it must be taken whole. For the combination of amlodipine/losartan, the recommended dosage is 1 tablet once daily. If blood pressure control is insufficient, the dosage may be increased.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Adjunctive treatment for hypertension and dyslipidemia (hypercholesterolemia)

  • Essential hypertension
  • Stage 2 hypertension
  • primary hypercholesterolemia
  • familial heterozygous hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed 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 treat both hypertension and dyslipidemia simultaneously. Amlodipine and losartan combination is administered as initial combination therapy for patients with essential hypertension who have difficulty controlling blood pressure with monotherapy or for Stage 2 hypertension patients. Additionally, the rosuvastatin and ezetimibe combination improves cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, helping to increase good cholesterol (HDL-C). This medication is used alongside appropriate dietary measures and is administered considering various risk factors among patients needing lipid control. Furthermore, before administering the combination therapy, it is crucial to thoroughly identify the underlying causes of dyslipidemia and treat if necessary. For these reasons, this medication is used for effective management of hypertension and dyslipidemia.

How to take

Adult dose

This medication is to be administered only to adults, and the dosage should be individualized based on each patient. The recommended dosage is 1 tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). The tablet should not be chewed, divided, or crushed; it must be taken whole. For the combination of amlodipine/losartan, the recommended dosage is 1 tablet once daily. If blood pressure control is insufficient, the dosage may be increased.

Precautions

This medication may cause serious harm to the fetus and newborn if administered to pregnant women; therefore, it should be discontinued immediately upon confirmation of pregnancy. When first administered to patients with reduced blood volume, blood pressure may drop rapidly, so this condition should be treated before use. Rare adverse effects can lead to severe muscle complications, so patients at high risk of muscle damage from acute infections or decreased kidney function should temporarily discontinue or stop taking this medication. Patients allergic to any components contained in this medication, those with certain hereditary diseases, women who are pregnant or may become pregnant, and patients with severe liver or kidney dysfunction should not use this medication. Elderly patients, those with low blood pressure, high potassium levels, heart valve disease, or renal artery stenosis should use this medication cautiously, as it may lead to excessively low blood pressure or worsening kidney function. If symptoms like myalgia or muscle weakness appear, inform a doctor immediately, and if required, check for muscle damage through blood tests. This medication may affect liver function; therefore, patients with a history of liver disease or abnormal liver function test results should undergo regular liver function tests before and during treatment. Due to the blood pressure-lowering effect, dizziness or drowsiness may occur, requiring caution when driving or operating machinery. Interactions may occur when taken with other medications, so patients should inform their doctor or pharmacist of any other medications being taken. During treatment with this medication, regular blood tests and physical examinations to monitor for adverse reactions are important.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough + fever, breathing problems, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe reactions.

Mild side effects

  • Increased ALT
  • increased AST
  • dermatitis
  • orthostatic dizziness
  • syncope
  • musculoskeletal disorders
  • pancreatitis
  • dizziness
  • somnolence
  • neurodegenerative disorders
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  • migraine
  • diabetes
  • depression
  • bronchitis
  • rhinitis
  • cystitis
  • onychomycosis
  • soft tissue inflammation
  • hepatic steatosis
  • liver dysfunction
  • hepatotoxicity
  • acute hepatitis
  • toxic hepatitis
  • increased gamma-glutamyl transferase
  • increased blood cholesterol
  • increased blood alkaline phosphatase.

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

Storage

Store this medication in a tightly sealed container to protect it from air and moisture, and maintain at room temperature between 1 degree and 30 degrees Celsius. This storage method will help preserve the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Brownish-red oval film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP×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.