Medication info
X1-Al Tablet 5/160/10 mg

X1-Al Tablet 5/160/10 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›160mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
에이치케이이노엔(주)
Appearance
Pale orange, oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201902302 · Approved 2019.04.15 · Insurance code 640007380

Summary

Main use
(Hypertension, dyslipidemia) Improvement and reduction of cardiovascular disease risk
Who takes it
Adults
Adult dose
This medication is taken once daily, one tablet, with water. It is recommended to take it at the same time every day (e.g., before breakfast) if possible. Dosage should be individualized based on the effectiveness and tolerability of the amlodipine/valsartan combination and rosuvastatin for each patient. For Amlodipine/Valsartan Combination: • 5/80 mg: Administered to patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg monotherapy.

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
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary artery disease risk factors
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery disease
View approved original text

This medication is used for patients who need to take a combination of amlodipine and valsartan and also rosuvastatin. The amlodipine/valsartan combination is effective in controlling blood pressure in patients with essential hypertension who have difficulty managing their blood pressure with existing monotherapy. Rosuvastatin is used to improve hypercholesterolemia and dyslipidemia and serves as an adjunct therapy when diet alone is not sufficient. Additionally, rosuvastatin helps slow the progression of atherosclerosis and reduces the risk of stroke, myocardial infarction, and revascularization procedures in patients at high risk for cardiovascular disease. In summary, this medication is used to manage blood pressure and cholesterol levels, improving cardiovascular health.

How to take

Adult dose

This medication is taken once daily, one tablet, with water. It is recommended to take it at the same time every day (e.g., before breakfast) if possible. Dosage should be individualized based on the effectiveness and tolerability of the amlodipine/valsartan combination and rosuvastatin for each patient. For Amlodipine/Valsartan Combination: • 5/80 mg: Administered to patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg monotherapy.

Precautions

This medication may cause serious harm to the fetus when taken during the second and third trimester of pregnancy, so if pregnancy is confirmed, it should be discontinued immediately. Individuals who are allergic to this medication or similar ingredients, women who are pregnant or breastfeeding, or those with severe liver or kidney disease should not take this medication. Patients with low sodium or fluid levels may experience hypotension, so their condition should be carefully monitored before and during treatment, and blood pressure fluctuations should be closely observed. Patients with high potassium levels or those taking medications that can increase potassium should have their serum potassium levels frequently tested. Patients with impaired renal function or those who have had a kidney transplant should use this medication cautiously, and if symptoms of angioedema occur, they should discontinue use immediately. Patients with heart failure or those recovering from myocardial infarction should closely monitor their kidney function and symptoms while taking this medication. Elderly patients may respond more sensitively to this medication, so it is recommended to start with a lower dose and gradually adjust the dosage. Care should be taken when driving or operating machinery, as dizziness or fatigue may occur. Regular check-ups for liver function and muscle-related symptoms are important while taking this medication. If muscle pain, muscle weakness, or any unusual symptoms occur, consult a doctor immediately, and discontinue medication if necessary. Interactions with other medications may occur, so inform your doctor or pharmacist if you are taking other medications. Women who are pregnant or breastfeeding should not take this medication, and appropriate contraceptive measures should be taken if planning to become pregnant. Safety and effectiveness in children or teenagers under 18 years have not been established, so it is not recommended. Overdosage may result in severe hypotension, shock, heart problems, etc., so it is important to adhere to the prescribed dosage and visit a hospital immediately in case of overdose.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • chest tightness
  • difficulty breathing
  • cold sweat
  • pallor
  • severe rash with high fever
  • blisters
  • skin peeling
  • pain in oral/ocular mucosa
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  • Stevens-Johnson syndrome
  • angioedema
  • toxic epidermal necrolysis
  • jaundice
  • hepatitis
  • elevated liver function tests
  • severe edema
  • elevated blood pressure
  • acute renal failure
  • oliguria
  • thrombocytopenia
  • increased serum creatinine
  • spinal stenosis
  • aphasia

Mild side effects

  • Peripheral edema
  • heat sensation
  • increased ALT
  • increased AST
  • increased serum creatinine
  • flank pain
  • sore throat
  • dizziness
  • sensory impairment
  • rhinopharyngitis
Show 24 more
  • rash
  • nasopharyngitis
  • influenza
  • anxiety
  • drowsiness
  • orthostatic dizziness
  • paresthesia
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • oropharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • erythema
  • sweating
  • itching

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and humidity. Additionally, it is recommended to store the medication at room temperature between 1°C and 30°C, avoiding extremes of temperature.

Appearance and packaging

Appearance

Pale orange, 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.