Medication info
Xoneal Tablet 5/160/2.5 Milligrams

Xoneal Tablet 5/160/2.5 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›160mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
에이치케이이노엔(주)
Appearance
Orange, egg-shaped film-coated tablet
Packaging
30 tablets per bottle
Approval status
Active

MFDS item code 202302825 · Approved 2023.09.25 · Insurance code 640007950

Summary

Main use
(Hypertension, Dyslipidemia) Effectiveness in controlling blood pressure and improving cholesterol levels
Who takes it
Adults
Adult dose
Take 1 tablet daily with water. It is recommended to take it at the same time each day (e.g., before breakfast). The dosage of amlodipine/valsartan combination therapy and rosuvastatin should be individualized for each patient. Amlodipine/valsartan combination therapy should be administered as follows: - 5/80 mg: For patients whose blood pressure is inadequately controlled on monotherapy with either 5 mg of amlodipine or 80 mg of valsartan.

Ingredients

Manufacturer
에이치케이이노엔(주)

Efficacy & effects

(Hypertension, Dyslipidemia) Effectiveness in controlling blood pressure and improving cholesterol levels

  • Essential hypertension
  • primary hypercholesterolemia
  • familial heterozygous hypercholesterolemia
  • mixed dyslipidemia
View approved original text

This medication is used in patients with essential hypertension who are inadequately controlled on amlodipine and valsartan combination therapy, and in patients with primary hypercholesterolemia or mixed dyslipidemia. Amlodipine and valsartan work to control blood pressure, while rosuvastatin lowers blood cholesterol levels, improving vascular health. This treatment is particularly beneficial for patients whose conditions cannot be controlled through diet and exercise alone, thus enhancing treatment outcomes. This medication effectively manages hypertension and dyslipidemia, improving cardiovascular health in patients.

How to take

Adult dose

Take 1 tablet daily with water. It is recommended to take it at the same time each day (e.g., before breakfast). The dosage of amlodipine/valsartan combination therapy and rosuvastatin should be individualized for each patient. Amlodipine/valsartan combination therapy should be administered as follows: - 5/80 mg: For patients whose blood pressure is inadequately controlled on monotherapy with either 5 mg of amlodipine or 80 mg of valsartan.

Precautions

This medication should not be taken during pregnancy, especially in the second and third trimesters, as it may cause serious harm to the fetus and newborn. If pregnancy is confirmed, use should be discontinued immediately. It should not be used in patients with hypersensitivity to certain components, in pregnant or breastfeeding women, or in patients with severe liver or kidney disease. Patients who are deficient in sodium or body fluids may experience hypotension, so their status should be carefully checked and monitored before administration. Patients with high potassium levels or those on other medications that may raise potassium levels should frequently monitor potassium levels and take caution. In patients with renal artery stenosis or those who have recently undergone kidney transplants, renal function changes should be closely observed when administering this drug. If signs of angioedema (airway obstruction or facial swelling) occur, use should be discontinued immediately and should not be re-administered. Patients with heart failure or those who have experienced a myocardial infarction need careful observation, including renal function assessments, as there is an increased risk of angina or worsening myocardial infarction in patients with acute myocardial infarction. Muscle-related side effects (myalgia, myopathy, rhabdomyolysis) can occur, so any symptoms of muscle pain or weakness should be reported to a healthcare provider immediately, and blood tests may be conducted if necessary. This medication may affect liver function, so it should be discontinued immediately if any signs of liver dysfunction occur. Patients with a history of liver disease are recommended to have liver function tests prior to taking this medication. Dizziness or fatigue may occur when driving or operating machinery, so caution is advised. This drug may interact with multiple medications, so patients should inform their doctor or pharmacist of any other medications they are taking. Pregnant or potentially pregnant women, as well as breastfeeding mothers, should not take this medication, and proper contraceptive methods should be used if planning to become pregnant. Its efficacy and safety in children under 18 years of age have not been established, so its use is not recommended in this population. No dosage adjustment is needed for the elderly, but older patients may be more sensitive to medications and should take caution in their usage. In cases of overdose, severe hypotension or cardiac issues may occur, necessitating an immediate visit to a medical facility for appropriate treatment.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes (mouth/eyes), shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary output changes

Mild side effects

  • Peripheral edema
  • warmth sensation
  • ALT increase
  • AST increase
  • blood creatinine increase
  • flank pain
  • throat pain
  • dizziness
  • sensory reduction
  • nasopharyngitis
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  • rash
  • rhinopharyngitis
  • influenza
  • anxiety
  • drowsiness
  • orthostatic dizziness
  • sensory abnormality
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • erythema
  • sweating
  • itching

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

Storage

Store this medication in a sealed container to protect it from air and moisture. It is advisable to keep the storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Orange, egg-shaped film-coated tablet

Package unit

30 tablets per 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.