Medication info

Dirtan Tablet 80 mg (Valsartan)

Prescription medicationTablet경구Expired
Ingredient · strength
Valsartan›80mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201503909 · Approved 2015.06.16

This product's status changed to Expired on 2025.06.16. 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 takes it
Adults · Children
Adult dose
1. Essential Hypertension - Adults: It is recommended to take 80 mg orally once a day as valsartan. - In cases where blood pressure is not well controlled, the dose may be increased to 160 mg per day or combined with a diuretic, and it may be increased to a maximum of 320 mg per day. - Elderly (75 years and older): Start with 40 mg orally once a day. - Patients with kidney impairment (creatinine clearance 10-20 mL/min) and blood fluid
Child dose
Safety and efficacy have not been established in children and adolescents under 18 years old.

Ingredients

Manufacturer
(주)셀트리온제약

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 medicine is used for essential hypertension as well as for the reduction of mortality risk after myocardial infarction and to treat heart failure. It is particularly effective for heart failure patients who are intolerant to ACE inhibitors. After a myocardial infarction, it helps reduce the risk of death in stable patients with left ventricular dysfunction and reduced systolic function. Therefore, it plays an important role in managing hypertension and improving cardiac function, effectively enhancing the cardiovascular health of patients.

How to take

Adult dose

1. Essential Hypertension - Adults: It is recommended to take 80 mg orally once a day as valsartan. - In cases where blood pressure is not well controlled, the dose may be increased to 160 mg per day or combined with a diuretic, and it may be increased to a maximum of 320 mg per day. - Elderly (75 years and older): Start with 40 mg orally once a day. - Patients with kidney impairment (creatinine clearance 10-20 mL/min) and blood fluid

Child dose

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

Precautions

This medication may cause severe harm to the fetus, especially when taken during the second and third trimesters of pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. Individuals with an allergy to this medication, women who are pregnant or may become pregnant, and breastfeeding women should not take this medication. Patients with severely impaired liver function or certain liver diseases, as well as those with severe kidney dysfunction, should refrain from using this medication. Patients with a history of angioedema or those experiencing angioedema symptoms while taking ACE inhibitors or angiotensin II receptor antagonists should avoid this medication. Elderly individuals, patients with high potassium levels, and those with mildly impaired liver function should use this medication with caution, and dosage adjustments may be necessary. This medication may cause a sudden drop in blood pressure upon initial use, which can lead to dizziness or fainting, especially in patients undergoing dialysis or taking diuretics; thus, it should be started at a lower dose gradually. During treatment with this medication, regular monitoring of blood pressure, kidney function, and electrolyte levels is essential to ensure no abnormalities occur. Taking this medication with potassium-sparing diuretics or potassium supplements may dangerously increase blood potassium levels, so caution is advised. Furthermore, taking it in conjunction with non-steroidal anti-inflammatory drugs (NSAIDs) may reduce its antihypertensive effects and impact kidney function, so caution is warranted. This medication may cause dizziness while driving or operating machinery, so attention is needed. Overdose may result in hypotension, reduced consciousness, shock, etc., thus requiring immediate appropriate treatment in a hospital. The safety and efficacy of this medication have not been fully established in children and adolescents, therefore its use is not recommended. Lastly, this medication should be kept out of reach of children, and it should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory distress with cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

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
  • orthostatic dizziness
  • orthostatic hypotension
  • vomiting
  • constipation
  • thirst
  • loss of appetite
  • malaise
  • rash
  • myalgia
  • dyspepsia
  • anemia
  • tinnitus
  • increased tension
  • decreased exercise capacity
  • confusion
  • chest pain
  • thrombocytopenia
  • leukopenia
  • none

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture ingress. Additionally, it should be kept in a cool place below 30 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 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.