Medication info

Itex Valsartan Tablet 80 mg

Prescription medicationExpired
Ingredient · strength
Valsartan›Strength being verified
Manufacturer / importer
(주)테라젠이텍스
Appearance
Orange round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201307904 · Approved 2013.06.28

This product's status changed to Expired on 2023.06.28. 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 (including ACE inhibitor intolerance), reduction of mortality risk after myocardial infarction
Who uses it
Adults · Children
Adult dosage
Essential Hypertension: Taken orally with water during or between meals, preferably once daily at the same time (e.g., in the morning) at a recommended dose of 80 mg. If blood pressure is not well controlled, the dose may be increased to 160 mg daily or combined with diuretics, and may be escalated up to a maximum of 320 mg. Elderly patients (age 75 or older) begin with a dose of 40 mg daily. Heart Failure: The initial dose is 1 day.
Children's dosage
The safety and efficacy in children and adolescents under 18 years of age have not been established.

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Treatment of essential hypertension and heart failure (including ACE inhibitor intolerance), 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 treat essential hypertension. It is also effective in heart failure patients (NYHA Class II to IV) who are intolerant to ACE inhibitors. It is utilized to reduce the risk of death from left ventricular dysfunction following myocardial infarction. Thus, it is a medication that helps manage hypertension as well as prevent complications associated with heart failure and myocardial infarction. It is used to improve cardiovascular health in patients with these efficacies.

Dosage and Administration

Adult dosage

Essential Hypertension: Taken orally with water during or between meals, preferably once daily at the same time (e.g., in the morning) at a recommended dose of 80 mg. If blood pressure is not well controlled, the dose may be increased to 160 mg daily or combined with diuretics, and may be escalated up to a maximum of 320 mg. Elderly patients (age 75 or older) begin with a dose of 40 mg daily. Heart Failure: The initial dose is 1 day.

Children's dosage

The safety and efficacy in children and adolescents under 18 years of age have not been established.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, and should be immediately discontinued if pregnancy is confirmed. People with allergies to this drug or its components, pregnant or possibly pregnant women, nursing mothers, patients with severe liver disease, patients with a history of hereditary angioedema, patients with severe renal impairment, and patients with certain endocrine disorders should not take this medication. Elderly patients, those with elevated potassium levels, those with slightly impaired liver function, patients with heart diseases, and patients with dehydration should exercise particular caution when using this drug, starting at a lower dose and monitoring their condition closely. Side effects may include headaches, dizziness, fatigue, cough, and dyspepsia; serious and rare side effects such as severe angioedema, renal function deterioration, hepatitis, hypoglycemia, and muscle disorders may occur, necessitating immediate consultation with a doctor. If blood pressure drops rapidly, leading to dizziness or fainting, treatment should be ceased immediately and appropriate care sought, especially for those on diuretics or with dehydration. Regular blood tests are necessary when taken with other antihypertensives, diuretics, or potassium supplements, as potassium levels may become excessively elevated. It is advisable for pregnant or nursing women to avoid this medication; if nursing, it is preferable to discontinue either the drug or breastfeeding. Safety regarding use in children or adolescents under the age of 18 has not been established, hence, its use is not recommended. In cases of overdose, serious hypotension or decreased consciousness may occur, requiring immediate medical attention. This medication should be stored out of reach of children and should not be transferred to other containers to ensure safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blistering, peeling skin, pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory problems accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis

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
  • thirst
  • loss of appetite
  • malaise
  • rash
  • myalgia
  • dyspepsia
  • anemia
  • tinnitus
  • tension
  • reduced exercise capacity
  • confusion
  • chest pain

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

Storage

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

Appearance and packaging

Appearance

Orange round film-coated tablet

Package unit

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.