Medication info
Exvalza Tablet 5/80mg

Exvalza Tablet 5/80mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›80mg / 1 tablet
Manufacturer / importer
대원바이오텍주식회사
Appearance
Dark yellow round film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP X 3]
Approval status
Active

MFDS item code 201907960 · Approved 2019.11.18 · Insurance code 057600380

Summary

Main use
Improvement in blood pressure control in essential hypertension with combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication is 1 tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). For patients with mild to moderate renal impairment, dose adjustment is not necessary; however, it should not be administered to those with severe renal impairment or on dialysis. For patients with liver impairment, the daily dose of valsartan must not exceed 80 mg.
Child dose
The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, so its use is not recommended.

Ingredients

Manufacturer
대원바이오텍주식회사

Efficacy & effects

Improvement in blood pressure control in essential hypertension with combination of amlodipine and valsartan

  • Essential hypertension
View approved original text

This medication is used to effectively lower blood pressure in patients with essential hypertension whose blood pressure is not adequately controlled with monotherapy of either amlodipine or valsartan.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). For patients with mild to moderate renal impairment, dose adjustment is not necessary; however, it should not be administered to those with severe renal impairment or on dialysis. For patients with liver impairment, the daily dose of valsartan must not exceed 80 mg.

Child dose

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

Precautions

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it must be discontinued immediately upon confirmation of pregnancy. Patients with allergy to the active ingredients or similar medications, women who are pregnant or breastfeeding, and patients with severe renal or hepatic impairment should not use this medication. Patients with insufficient sodium or fluid in the body should stabilize their condition before taking this medication, and if symptoms of hypotension occur while using it, they should lie down immediately and seek treatment if necessary. Patients with high potassium levels should be careful when taking this medication alongside other drugs that can increase potassium levels, and regular blood tests should be conducted to monitor potassium levels. Patients with problems in renal blood vessels or those who have received a kidney transplant should use this medication cautiously due to the risk of worsening renal function. If symptoms of angioedema, such as swelling of the face, lips, or tongue occur during treatment, the medication should be discontinued immediately and medical advice sought. Patients with heart failure or after myocardial infarction should regularly monitor renal function changes while using this medication, and some cardiac patients should take caution when using it. The elderly can take the general dosage, but caution is advised as dizziness or fatigue may occur when driving or operating machinery. Taking this medication in combination with other antihypertensives may increase the risk of low blood pressure, hyperkalemia, and worsening renal function, so regular blood pressure and blood tests should be conducted during treatment. In case of overdose, severe hypotension or cardiac arrhythmias may occur, so it's important to adhere to the prescribed dosage and inform medical personnel immediately if any unusual symptoms arise. This medication is not recommended for children due to insufficient data on its safety and efficacy, and women who are pregnant or planning to become pregnant should avoid it.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, fainting, low blood pressure, Steven-Johnson syndrome, toxic epidermal necrolysis, vascular edema, liver dysfunction (hepatitis, jaundice), severe neurological symptoms (seizures, confusion), renal failure and kidney damage, angina, acute myocardial infarction, pulmonary edema

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • abnormal sensations
  • lightheadedness
  • tinnitus
  • tachycardia
  • palpitations
  • fainting
  • orthostatic hypotension
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  • low blood pressure
  • cough
  • pharyngitis and laryngitis
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • sweating
  • pruritus
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • fatigue
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • peripheral edema
  • facial swelling
  • tiredness
  • flushing
  • weakness
  • facial flushing
  • insomnia

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. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius. This storage method helps maintain the efficacy and safety of the drug for a long time.

Appearance and packaging

Appearance

Dark yellow round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP X 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.