Medication info

Balsar 40 mg Tablet (Valsartan)

Prescription medicationApproval withdrawn
Ingredient · strength
Valsartan›Strength being verified
Manufacturer / importer
한림제약(주)
Appearance
Yellow round oval film-coated tablet
Packaging
28 tablets (14 tablets/PTP packaging x 2), 30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201105414 · Notified 2011.08.18

This product's status changed to Approval withdrawn on 2023.07.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of essential hypertension and heart failure (intolerance to ACE inhibitors), reduction of mortality risk after myocardial infarction
Who uses it
Adults · Children
Adult dosage
1. Essential Hypertension Regardless of gender or race, 80 mg orally once daily is recommended as Valsartan. For patients whose blood pressure is not well controlled, the dosage can be increased to 160 mg per day or combined with a diuretic. If necessary, a maximum daily dose of 320 mg can be increased. Elderly patients (aged 75 and above) should start with 40 mg orally once daily. Patients with renal impairment who have a creatinine clearance of 10-20 mL/min should start at 40 mg once daily.
Children's dosage
Safety and efficacy in children and adolescents under 18 years have not been established.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Treatment of essential hypertension and heart failure (intolerance to ACE inhibitors), reduction of mortality risk after myocardial infarction

  • Essential hypertension
  • heart failure
  • left ventricular dysfunction
  • left ventricular systolic dysfunction
View approved original text

This medication is used to reduce the risk of death in patients with essential hypertension, heart failure (particularly in patients who cannot use ACE inhibitors), and left ventricular dysfunction following myocardial infarction.

Dosage and Administration

Adult dosage

1. Essential Hypertension Regardless of gender or race, 80 mg orally once daily is recommended as Valsartan. For patients whose blood pressure is not well controlled, the dosage can be increased to 160 mg per day or combined with a diuretic. If necessary, a maximum daily dose of 320 mg can be increased. Elderly patients (aged 75 and above) should start with 40 mg orally once daily. Patients with renal impairment who have a creatinine clearance of 10-20 mL/min should start at 40 mg once daily.

Children's dosage

Safety and efficacy in children and adolescents under 18 years have not been established.

Precautions

This drug can cause serious harm to the fetus or newborn if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. Women who are pregnant or may become pregnant, nursing mothers, patients with severe liver disease, severe kidney disease, and patients with a history of certain angioedema should not take this medication. Caution is especially advised for elderly patients, those with impaired kidney function, hyperkalemia, and heart failure patients, starting at a low dose and observing their condition. This drug lowers blood pressure, so caution is needed as dizziness or fainting may occur due to a rapid decrease in blood pressure when first taken. Patients on hemodialysis or those under strict sodium restriction should start with a low dose and increase it gradually while closely monitoring their condition. This drug can increase potassium levels when taken with other blood pressure medications, diuretics, or potassium-sparing drugs, so it is particularly important to manage patients with impaired kidney function carefully. Caution is also required when driving or operating machinery due to possible dizziness or drowsiness. Regular monitoring of kidney function, blood pressure, serum potassium, and other conditions should be performed while using this medication to check for any abnormalities. In case of overdose, hypotension, decreased consciousness, or shock may occur, so immediate emergency treatment is necessary, and hemodialysis is not effective. Safety and efficacy in children and adolescents have not been established, so use is not recommended. This medication should be kept out of reach of children, and transferring it to another container is not advisable for maintaining quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attack, cough with fever and respiratory abnormalities, skin or eye yellowing (jaundice), extreme sluggishness, sudden and very severe headaches, lightning headaches, seizures, confusion, visual disturbances, paralysis, urination problems

Mild side effects

  • Headache
  • dizziness
  • viral infection
  • upper respiratory tract infection
  • cough
  • diarrhea
  • fatigue
  • rhinitis
  • sinusitis
  • back pain
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  • abdominal pain
  • nausea
  • pharyngitis
  • joint pain
  • weakness
  • insomnia
  • flushing
  • decreased libido
  • drowsiness
  • vomiting
  • constipation
  • thirst
  • loss of appetite
  • malaise
  • rash
  • muscle pain
  • indigestion
  • anemia
  • tinnitus
  • tension headache
  • reduced motor function
  • confusion
  • chest pain
  • serum sickness
  • vasculitis
  • epistaxis
  • hepatitis
  • arrhythmia
  • hypoglycemia
  • rhabdomyolysis

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 also important to store it in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Yellow round oval film-coated tablet

Package unit

28 tablets (14 tablets/PTP packaging x 2), 30 tablets/bottle, 300 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.