Medication info
Exvalset Tablets 5/160mg

Exvalset Tablets 5/160mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›160mg / 1 tablet
Manufacturer / importer
대원바이오텍주식회사
Appearance
Dark yellow oval film-coated tablets
Packaging
30 tablets/box [10 tablets/PTP X 3]
Approval status
Active

MFDS item code 201907958 · Approved 2019.11.18 · Insurance code 057600370

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is 1 tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). Consideration can be given to switching to this combination medication if blood pressure is not controlled with monotherapy using amlodipine or valsartan. Dose adjustments and caution are needed for patients with renal impairment, liver impairment, and the elderly.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age; therefore, this medication is not recommended.

Ingredients

Manufacturer
대원바이오텍주식회사

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used to control blood pressure in patients with essential hypertension whose blood pressure is not sufficiently controlled with monotherapy using amlodipine or valsartan.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). Consideration can be given to switching to this combination medication if blood pressure is not controlled with monotherapy using amlodipine or valsartan. Dose adjustments and caution are needed for patients with renal impairment, liver impairment, and the elderly.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years of age; therefore, this medication is not recommended.

Precautions

This medication can cause serious harm to the fetus and newborn when administered during the second and third trimester of pregnancy; therefore, it should be immediately discontinued upon confirmation of pregnancy. There are patients who should not take this medication. For example, individuals allergic to this medication or other similar medications, pregnant or potentially pregnant women, nursing mothers, and patients with severe renal or liver dysfunction should not take this medication. Additionally, for diabetic patients with moderate to severe renal dysfunction, concomitant use of this medication with certain other drugs may be risky and should be avoided. This medication can cause hypotension in patients with decreased sodium or fluid levels, making it important to verify and supplement this condition before administration. Patients with high potassium levels should also exercise caution, and frequent monitoring of blood potassium levels is required when taken with potassium supplements or potassium-rich medications. Patients with renal vascular issues or those who have had kidney transplants may also be affected in renal function upon administering this medication, requiring careful monitoring. Severe allergic reactions known as angioedema may occur, so if symptoms such as swelling of the face, lips, or tongue appear, the medication should be discontinued immediately. Patients with heart failure or following a myocardial infarction should closely monitor renal function while taking this medication, as hypotension or renal failure may occur in some cases. Caution is advised when driving or operating machinery as dizziness or fatigue may occur. This medication can interact with various other medications, so patients should inform healthcare providers of any other medications they are taking. In cases of overdose, severe hypotension or heart problems may occur, requiring immediate emergency intervention. The safety and effectiveness of this medication in patients under 18 years old have not been established, so it is not recommended for use in this population. For elderly patients, the usual adult dose can be administered, but careful monitoring is required. Regular liver function or renal function tests are recommended during treatment with this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes with fever, blisters, skin shedding, oral/ocular mucosal pain, severe dermal reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory issues accompanied by cough and fever, respiratory problems, jaundice (yellowing of the skin or eyes), severe lethargy, liver dysfunction (jaundice), sudden and serious issues.

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • paresthesia
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • orthostatic hypotension
  • hypotension
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  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • pruritus
  • joint swelling
  • low back pain
  • arthritis
  • muscle cramps
  • fatigue
  • polyuria
  • diuresis
  • erectile dysfunction
  • edema
  • edema of the abdomin
  • facial edema
  • peripheral edema
  • tiredness
  • flushing
  • asthenia
  • facial flushing
  • anxiety
  • nasal congestion.

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius. Proper storage will safely preserve the medication's effectiveness.

Appearance and packaging

Appearance

Dark yellow oval film-coated tablets

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.