Medication info
Xoneal Tablet 5/80/10 mg

Xoneal Tablet 5/80/10 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›80mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
에이치케이이노엔(주)
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201902301 · Approved 2019.04.15 · Insurance code 640007370

Summary

Main use
(Hypertension, Dyslipidemia) Improvement and reduction of cardiovascular disease risk
Who takes it
Adults
Adult dose
This drug is taken as 1 tablet daily with water. It is recommended to take it at the same time each day (e.g., before breakfast) if possible. For the amlodipine/losartan combination, doses of 5/80 mg, 5/160 mg, or 10/160 mg are administered depending on blood pressure control status. Rosuvastatin can be taken at any time of the day, regardless of meals, as a single daily dose. The initial dose is 5 mg, and the maintenance dose is 10 mg.

Ingredients

Manufacturer
에이치케이이노엔(주)

Efficacy & effects

(Hypertension, Dyslipidemia) Improvement and reduction of cardiovascular disease risk

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hyperlipidemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease.
View approved original text

This drug is used for patients with essential hypertension whose blood pressure is not adequately controlled even when treated with a combination of amlodipine and losartan. The rosuvastatin component is used as an adjunct to dietary therapy in patients with hyperlipidemia (including familial hypercholesterolemia) and dyslipidemia. It is also beneficial for patients with homozygous familial hypercholesterolemia and primary dysbetalipoproteinemia, helping to slow the progression of atherosclerosis in patients with hyperlipidemia. In particular, it is used to lower the risk of cardiovascular diseases, stroke, myocardial infarction, and arterial revascularization surgeries in high-risk patients with elevated high-sensitivity C-reactive protein levels. In summary, this drug effectively improves cardiovascular risks associated with hypertension and various dyslipidemias.

How to take

Adult dose

This drug is taken as 1 tablet daily with water. It is recommended to take it at the same time each day (e.g., before breakfast) if possible. For the amlodipine/losartan combination, doses of 5/80 mg, 5/160 mg, or 10/160 mg are administered depending on blood pressure control status. Rosuvastatin can be taken at any time of the day, regardless of meals, as a single daily dose. The initial dose is 5 mg, and the maintenance dose is 10 mg.

Precautions

This drug can cause severe harm to the fetus and newborn when used during the second and third trimesters of pregnancy; therefore, it should be discontinued immediately if pregnancy is confirmed. Women who are pregnant or could become pregnant, as well as nursing mothers, should not use this drug. Patients with severe impairment of liver or kidney function should also refrain from taking this medication. Caution is needed for diabetic patients or those with moderate to severe renal impairment when used in conjunction with specific components. Patients with a history of muscle-related diseases or angioedema should also avoid taking this drug. Patients who are depleted of sodium or fluid should improve their condition prior to taking the drug and closely monitor blood pressure and symptoms during treatment. Blood potassium levels need to be frequently checked for patients with high potassium levels or those taking drugs that may increase potassium. Renal transplant patients or those with renal artery stenosis should carefully monitor kidney function during the use of this drug. Patients with heart failure or after myocardial infarction require careful monitoring, including assessments of renal function. This drug can be used in the elderly; however, particularly in those aged 75 and older, starting with a lower dose and gradually increasing is advisable. Caution is advised when driving or operating machinery as dizziness or fatigue may occur. Some of this drug's components may burden the liver and kidneys, thus regular tests of liver and kidney function are recommended. Additionally, if symptoms such as muscle pain or weakness occur, the patient should inform their doctor immediately, and blood tests may be required to check for muscle damage. As interactions with other medications may occur, it is essential to inform healthcare providers about any other drugs being taken. This drug contains certain dye components, so patients with allergies to these should exercise caution. Pregnant or nursing women should refrain from taking this drug, and women planning to become pregnant should use appropriate contraceptive methods. Safety and effectiveness have not been established for children, so it is not recommended. In cases of overdose, severe hypotension, shock, etc. can occur, necessitating immediate emergency treatment, while dosage adjustment and monitoring remain vital.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosae, difficulty or shortness of breath, asthma attacks, respiratory abnormalities with cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, urination issues.

Mild side effects

  • Peripheral edema
  • warmth
  • increased ALT
  • increased AST
  • increased serum creatinine
  • flank pain
  • throat pain
  • dizziness
  • sensory impairment
  • nasopharyngitis
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  • rash
  • rhinopharyngitis
  • influenza
  • anxiety
  • drowsiness
  • orthostatic dizziness
  • sensory abnormalities
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • sore throat and larynx
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • erythema
  • sweating
  • itching.

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

Storage

This drug should be kept in a tightly closed container to avoid exposure to air or moisture and should be stored at room temperature between 1 to 30 degrees Celsius. Proper storage can help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

30 tablets/bottle, 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.