Medication info

Valsartan Tablet 160 mg (Valsartan)

Prescription medicationApproval withdrawn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Approval withdrawn

MFDS item code 201105415 · 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This product's status changed to Approval withdrawn on 2023.07.18.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: The recommended dosage is 80 mg orally once daily. If blood pressure is not adequately controlled, it may be increased to 160 mg or combined with diuretics, and in case additional blood pressure reduction is needed, a maximum of 320 mg once daily can be considered. Elderly patients (75 years and older): Start with 40 mg orally once daily. For patients with renal impairment and those with fluid depletion, dosing adjustments may be necessary.

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 helps control blood pressure in patients with essential hypertension and can be safely used in heart failure patients who are intolerant to ACE inhibitors. It also shows a reduction in mortality risk in patients with left ventricular dysfunction after myocardial infarction. This drug improves blood pressure and symptoms of heart failure and contributes to the prevention of complications following myocardial infarction. Thus, it is used for essential hypertension, heart failure (including patients intolerant to ACE inhibitors), and reduction of mortality risk post-myocardial infarction.

Dosage and Administration

Adult dosage

Essential Hypertension: The recommended dosage is 80 mg orally once daily. If blood pressure is not adequately controlled, it may be increased to 160 mg or combined with diuretics, and in case additional blood pressure reduction is needed, a maximum of 320 mg once daily can be considered. Elderly patients (75 years and older): Start with 40 mg orally once daily. For patients with renal impairment and those with fluid depletion, dosing adjustments may be necessary.

Precautions

This drug can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters. Therefore, it should be discontinued immediately upon confirmation of pregnancy. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication. Patients with severe liver or kidney dysfunction, hereditary angioedema, primary hyperaldosteronism, and certain other conditions should not use this drug. Elderly patients, those with hyperkalemia, liver impairment, and patients with heart failure should be monitored carefully while taking this medication, especially since blood pressure can drop rapidly; starting with a low dose and increasing gradually is safer. As this drug has blood pressure-lowering effects, dizziness or fainting may occur when first taking it, so caution is advised, especially with driving or operating machinery. Potassium levels in the blood may elevate while taking this drug; therefore, careful management is required when using potassium-sparing diuretics or potassium supplements. Combination with other antihypertensives, diuretics, or non-steroidal anti-inflammatory drugs (NSAIDs) can lead to changes in effects due to drug interactions, so consultation with a healthcare professional is necessary. Patients with heart failure or post-myocardial infarction should take this medication while regularly monitoring kidney function and electrolyte status; combination with ACE inhibitors or aliskiren is not recommended. Safety in children and adolescents has not been established, and it is advisable not to use this drug. In cases of overdose, symptoms such as hypotension, altered consciousness, and shock may occur, requiring immediate medical attention. This medication should be kept out of the reach of children, and it is recommended not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling of skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), severe lethargy, sudden and severe headache, lightning headache, seizure, altered consciousness

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
  • weakness
  • insomnia
  • flushing
  • decreased libido
  • drowsiness
  • atrial fibrillation
  • vomiting
  • constipation
  • dry mouth
  • loss of appetite
  • malaise
  • rash
  • myalgia
  • indigestion
  • anemia
  • tinnitus
  • increased tension
  • reduced motor function
  • confusion
  • chest pain

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

Storage

This medication is sensitive to air and moisture; therefore, it should be stored in a tightly closed container. Additionally, it is crucial to keep it in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Orange oval film-coated tablets

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.