Medication info
Valsarex Tablet 5/80 mg (Amlodipine, Valsartan)

Valsarex Tablet 5/80 mg (Amlodipine, Valsartan)

Prescription medicationTablet경구
Ingredient · strength
Valsartan›80mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
(주)휴온스
Appearance
Dark yellow round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201308399 · Approved 2013.07.26 · Insurance code 670606590

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose is 1 tablet once daily, taken with water regardless of meals. It is advised to take it at the same time each day (e.g., morning). Dosing adjustments should be made according to blood pressure control based on 5/80 mg, 5/160 mg, and 10/160 mg strengths. Patients with renal impairment do not typically require dose adjustments, except for those with severe renal impairment. Patients with liver impairment
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established, therefore the use of this medication is not recommended.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used to effectively control blood pressure in patients with essential hypertension who have difficulty controlling their blood pressure with monotherapy of amlodipine or valsartan.

How to take

Adult dose

The recommended dose is 1 tablet once daily, taken with water regardless of meals. It is advised to take it at the same time each day (e.g., morning). Dosing adjustments should be made according to blood pressure control based on 5/80 mg, 5/160 mg, and 10/160 mg strengths. Patients with renal impairment do not typically require dose adjustments, except for those with severe renal impairment. Patients with liver impairment

Child dose

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

Precautions

This medication can cause severe harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Patients allergic to any of the ingredients in this medication or similar medications, pregnant women or women who may become pregnant, nursing mothers, and individuals with severe kidney or liver disease should not take this medication. In patients with low sodium or fluid volumes, hypotension may occur, so blood pressure should be carefully monitored before and during use. Patients with high potassium levels or those taking medications that may increase potassium levels should have their potassium levels monitored frequently. Patients with issues in renal arteries or those who have recently undergone kidney transplantation must meticulously monitor kidney function while taking this medication and should avoid use if necessary. If any symptoms of angioedema occur, the medication should be discontinued immediately and not resumed. Patients with heart failure or those who have had a myocardial infarction should be closely monitored for kidney function and symptoms while on this medication, as new angina symptoms may worsen upon initiation or dose increase in acute myocardial infarction patients. Like other vasodilators, this medication should be used cautiously in patients with specific heart valve diseases. Using this medication in combination with other medications of the same class is not recommended, particularly in patients with diabetes or severe kidney disease. Be cautious as dizziness or fatigue may occur when driving or operating machinery. In case of overdose, severe hypotension and arrhythmias may occur, so immediate medical attention is required. This medication is not recommended for children as its safety and efficacy have not been established, although elderly patients can take it at standard doses. While taking, regularly check blood pressure, kidney function, electrolyte levels, and consult medical personnel immediately if there are any abnormal symptoms.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, oral/eye mucosal pain, shortness of breath or breathing difficulty, asthma attack, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound systemic lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • paresthesia
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
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  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • weakness
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • facial swelling
  • peripheral edema
  • fatigue
  • flushing
  • asthenia
  • facial flushing
  • nasopharyngitis
  • influenza

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Dark yellow round film-coated tablet

Package unit

30 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.