Medication info
Xone Tablet 10/160 mg

Xone Tablet 10/160 mg

Prescription medicationTablet경구
Ingredient · strength
Valsartan›160mg / 1 tabletAmlodipine Adipate›13.57mg / 1 tablet
Manufacturer / importer
에이치케이이노엔(주)
Appearance
Bright yellow oval film-coated tablet
Packaging
30 tablets (10 tablets/PTP x 3), 30 tablets/bottle, 90 tablets/bottle
Approval status
Active

MFDS item code 201308287 · Approved 2013.07.18 · Insurance code 640006570

Summary

Main use
Improvement in the control of essential hypertension through the combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication is one tablet once a day, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). In patients with renal impairment: No dosage adjustment is needed for patients with mild to moderate renal impairment (creatinine clearance ≥ 10 mL/min). In patients with hepatic impairment: The daily dosage of valsartan for patients with mild to moderate hepatic impairment should not exceed 80 mg.
Child dose
The safety and efficacy of this medication have not been established in pediatric patients under 18 years, so its use is not recommended.

Ingredients

Manufacturer
에이치케이이노엔(주)

Efficacy & effects

Improvement in the control of essential hypertension through the combination of amlodipine and valsartan

  • Essential Hypertension
View approved original text

This medicine is used to effectively manage blood pressure in patients with essential hypertension who are inadequately controlled with monotherapy using amlodipine or valsartan.

How to take

Adult dose

The recommended dosage for this medication is one tablet once a day, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). In patients with renal impairment: No dosage adjustment is needed for patients with mild to moderate renal impairment (creatinine clearance ≥ 10 mL/min). In patients with hepatic impairment: The daily dosage of valsartan for patients with mild to moderate hepatic impairment should not exceed 80 mg.

Child dose

The safety and efficacy of this medication have not been established in pediatric patients under 18 years, so its use is not recommended.

Precautions

This medication may cause severe harm to the fetus and newborn if administered to pregnant women in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. Patients with an allergy to any of the ingredients in this medication or with severe renal and hepatic impairment should not use it. Patients with sodium or fluid depletion in the body may experience hypotension, so their condition should be carefully checked prior to administration, and close monitoring is required at the start of treatment. Patients with high potassium levels or those taking medications that may increase potassium levels should use this drug cautiously with frequent monitoring of potassium levels. Patients with renal artery stenosis or recent kidney transplants also require monitoring of kidney function when using this medication. If symptoms of angioedema occur, stop taking the medication immediately and do not re-administer it, and use it cautiously in patients with heart failure or myocardial infarction. In patients with acute myocardial infarction, caution is warranted at the initiation of treatment or dose escalation, as angina or myocardial infarction symptoms may worsen. Like other vasodilators, special caution is required when administering this drug to patients with aortic stenosis or obstructive hypertrophic cardiomyopathy. Combining this medication with RAAS-affecting drugs such as angiotensin-converting enzyme inhibitors or aliskiren is not recommended. While taking this medication, side effects such as headache, dizziness, palpitations, swelling, fatigue, rash, and dyspepsia may occur, so if any unusual symptoms arise, consult a physician. Dizziness or fatigue may occur when driving or operating machinery, so caution is advised. This medication may interact with certain other medications, so if you are taking other drugs, it is essential to inform your doctor or pharmacist. Women who are pregnant or planning to become pregnant should not use this medication, and breastfeeding women are also advised to avoid this medication. It is not recommended for children under 18 years, as safety and efficacy have not been established. Elderly patients can be given the same dosage as adults, but caution may be needed depending on their condition. In case of overdose, severe hypotension or heart function abnormalities may occur, so strict adherence to the prescribed dosage is essential, and if any unusual symptoms occur, notify healthcare personnel immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, abnormal respiratory symptoms accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, decreased urine output,

Mild side effects

  • Nasopharyngitis
  • influenza
  • anxiety
  • dizziness
  • drowsiness
  • postural dizziness
  • paresthesia
  • vertigo
  • tinnitus
  • tachycardia
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  • palpitations
  • orthostatic hypotension
  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • low back pain
  • arthritis
  • muscle cramps
  • weakness
  • polyuria
  • diuresis
  • erectile dysfunction
  • swelling
  • combined swelling
  • facial swelling
  • peripheral edema
  • fatigue

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is best to keep the storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Bright yellow oval film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3), 30 tablets/bottle, 90 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.