Medication info

Valsartan 80 mg Tablet

Prescription medicationApproval withdrawn
Ingredient · strength
Valsartan›Strength being verified
Manufacturer / importer
한림제약(주)
Appearance
Light red round film-coated tablet
Packaging
98 tablets (14 tablets/PTP packaging x 7), 30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201105416 · 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This product's status changed to Approval withdrawn on 2023.07.18.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
Adult dosage
Essential hypertension: Recommended oral dosage is 80 mg once daily. If blood pressure control is insufficient, the dosage may be increased to 160 mg per day, with a maximum of 320 mg. Elderly patients (75 years and older): Start with 40 mg once daily. Heart failure: Recommended oral dosage is 40 mg twice daily, with a possibility of increasing to 80 mg or 160 mg per dose. The maximum dose per day is 320 mg.

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 intolerant to ACE inhibitors, and left ventricular dysfunction after myocardial infarction.

Dosage and Administration

Adult dosage

Essential hypertension: Recommended oral dosage is 80 mg once daily. If blood pressure control is insufficient, the dosage may be increased to 160 mg per day, with a maximum of 320 mg. Elderly patients (75 years and older): Start with 40 mg once daily. Heart failure: Recommended oral dosage is 40 mg twice daily, with a possibility of increasing to 80 mg or 160 mg per dose. The maximum dose per day is 320 mg.

Precautions

This medication may cause serious harm to the fetus when taken during pregnancy, particularly in the second and third trimesters, so if pregnancy is confirmed, treatment must be discontinued immediately. It should not be used in patients with an allergy to this drug, severe liver or kidney disease, or a history of specific angioedema. Elderly patients, patients with hyperkalemia, those with impaired hepatic function, and those with heart or vascular issues should be monitored more carefully during administration, as hypotension or changes in renal function may occur. Dizziness or symptoms of hypotension may occur while taking this medication; therefore, caution is needed when driving or operating machinery. Patients who are likely to have elevated potassium levels or are taking potassium-sparing diuretics should have their serum potassium levels monitored closely. When used in combination with other antihypertensives or non-steroidal anti-inflammatory drugs, the drug's efficacy may be reduced or renal function may be affected, so consultation with healthcare professionals is advised. This medication is not recommended for breastfeeding women, and if it must be taken, cessation of breastfeeding is advised. The safety and efficacy in pediatric and adolescent patients have not yet been established, so use in this age group is discouraged. In case of overdose, severe hypotension or altered consciousness may occur, requiring immediate medical attention for appropriate treatment. Keep out of reach of children and do not transfer to other containers to maintain the drug's quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema (swelling of the face, lips, throat, tongue), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin abnormal reactions, shortness of breath or difficulty breathing, asthma attack, breathing abnormalities with cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy

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
  • arthralgia
  • edema
  • weakness
  • insomnia
  • flushing
  • decreased libido
  • drowsiness
  • vomiting
  • constipation
  • dry mouth
  • loss of appetite
  • malaise
  • rash
  • muscle pain
  • dyspepsia
  • anemia
  • tinnitus
  • increased tension
  • decreased motor function
  • confusion
  • chest pain
  • thrombocytopenia
  • agranulocytosis
  • leukopenia
  • erythrocytopenia

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

Storage

This medication may be sensitive to air and moisture; therefore, it should be stored in a sealed container. Additionally, it is important to store it in a cool place below 30 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

Light red round film-coated tablet

Package unit

98 tablets (14 tablets/PTP packaging x 7), 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.