Medication info

Tarec Film-Coated Tablet 80 mg (Valsartan)

Prescription medicationApproval withdrawn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Approval withdrawn

MFDS item code 200511378 · Notified 2005.10.24

This product's status changed to Approval withdrawn on 2023.06.26. 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
Essential Hypertension: The recommended oral dose of Valsartan is 80 mg once daily. If blood pressure is not well controlled, the dosage can be increased to 160 mg per day and may go up to a maximum of 320 mg per day. Elderly patients (75 years and older) start with 40 mg once daily. In patients with renal impairment, if creatinine clearance is between 10-20 mL/min, start with 40 mg once daily. If creatinine clearance is less than 10 mL/min
Children's dosage
The safety and efficacy for children and adolescents under 18 have not been established.

Ingredients

Importer
한국산도스(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 failure
  • left ventricular contractile dysfunction
View approved original text

This medication effectively lowers blood pressure in patients with essential hypertension and can also be used in heart failure patients who are intolerant to ACE inhibitors. Additionally, it helps reduce the mortality risk in stable patients with left ventricular dysfunction or contractile dysfunction after myocardial infarction. In other words, this medication is very useful for managing hypertension, treating certain heart failure patients, and reducing the risk of death after myocardial infarction.

Dosage and Administration

Adult dosage

Essential Hypertension: The recommended oral dose of Valsartan is 80 mg once daily. If blood pressure is not well controlled, the dosage can be increased to 160 mg per day and may go up to a maximum of 320 mg per day. Elderly patients (75 years and older) start with 40 mg once daily. In patients with renal impairment, if creatinine clearance is between 10-20 mL/min, start with 40 mg once daily. If creatinine clearance is less than 10 mL/min

Children's dosage

The safety and efficacy for children and adolescents under 18 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, so it must be discontinued immediately upon confirmation of pregnancy. Women who are pregnant or may become pregnant, patients with severe liver or kidney disease, and patients with certain hereditary angioedema should not take this medication. Elderly patients, patients with hyperkalemia, liver disease, and heart failure should take this medication with caution, as it may cause a sudden drop in blood pressure; starting with a low dose and observing their condition carefully is recommended. During treatment with this medication, side effects such as headache, dizziness, cough, diarrhea, and fatigue may occur; in severe cases, it may lead to hypotension, renal impairment, and hyperkalemia, necessitating periodic testing. Patients undergoing dialysis or on strict sodium restriction, as well as patients on diuretics, are at higher risk of hypotension and should exercise caution when taking this medication. This medication may interact with other antihypertensives, potassium-sparing diuretics, and certain non-steroidal anti-inflammatory drugs, so it is essential to consult a physician or pharmacist. Breastfeeding women should avoid taking this medication; if it is necessary, breastfeeding should be discontinued. The safety and efficacy for children and adolescents under 18 have not been established and it is advisable not to use it. In cases of overdose, there may be a rapid drop in blood pressure and loss of consciousness, requiring immediate medical attention. This medication should be kept out of reach of children and transferring it to other containers should be avoided as it can affect its quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blistering, skin peeling, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attack, cough with fever or respiratory difficulty, yellowing of skin or eyes (jaundice), extreme malaise, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, coma

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
  • drowsiness
  • vomiting
  • constipation
  • thirst
  • loss of appetite
  • malaise
  • flushing
  • itching
  • serum sickness
  • vasculitis
  • syncope
  • nasal bleeding
  • hepatitis
  • arrhythmia
  • hypoglycemia
  • confusion
  • chest pain
  • muscle pain
  • weakness
  • insomnia
  • decreased libido
  • decreased libido
  • thrombocytopenia
  • leukopenia
  • agranulocytosis

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

Storage

This medication is sensitive to air and moisture and should be stored in a sealed container. It is also important to keep it in a cool place below 30 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

Light reddish round film-coated tablet

Package unit

98 tablets (14 tablets/PTP packaging x 7)

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.