Medication info
Diroltan 160mg (Valsartan)

Diroltan 160mg (Valsartan)

Prescription medicationTablet경구
Ingredient · strength
Valsartan›160mg / 1 tablet
Manufacturer / importer
이연제약(주)
Appearance
Oval film-coated tablet with an orange color that has a gray tint
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200811619 · Notified 2008.12.16 · Insurance code 658602540

Summary

Main use
Treatment of essential hypertension and heart failure (intolerance to ACE inhibitors), reduces the risk of mortality after myocardial infarction
Who takes it
Adults · Children
Adult dose
Essential Hypertension: The recommended initial dosage is 80 mg orally once daily as valsartan. If blood pressure is not adequately controlled, the dose may be increased to 160 mg once daily or a diuretic may be added, with a maximum increase up to 320 mg once daily. Elderly patients (75 years and older): Start with 40 mg once daily. Renal impairment patients: No dosage adjustment is needed for creatinine clearance 20 to 50 mL/min; 10 to 20 mL/min
Child dose
Safety and efficacy have not been established in children and adolescents under 18 years of age, so it should not be administered.

Ingredients

Manufacturer
이연제약(주)

Efficacy & effects

Treatment of essential hypertension and heart failure (intolerance to ACE inhibitors), reduces the risk of mortality after myocardial infarction

  • Essential hypertension
  • heart failure
  • left ventricular dysfunction
  • left ventricular systolic dysfunction
View approved original text

This medication is used to reduce essential hypertension, heart failure, and the risk of mortality after myocardial infarction. It is particularly effective in heart failure patients who are intolerant to ACE inhibitors and reduces the risk of mortality after myocardial infarction in patients with left ventricular dysfunction. Therefore, it is used as a medication that helps improve health by assisting in blood pressure control and enhancing heart function.

How to take

Adult dose

Essential Hypertension: The recommended initial dosage is 80 mg orally once daily as valsartan. If blood pressure is not adequately controlled, the dose may be increased to 160 mg once daily or a diuretic may be added, with a maximum increase up to 320 mg once daily. Elderly patients (75 years and older): Start with 40 mg once daily. Renal impairment patients: No dosage adjustment is needed for creatinine clearance 20 to 50 mL/min; 10 to 20 mL/min

Child dose

Safety and efficacy have not been established in children and adolescents under 18 years of age, so it should not be administered.

Precautions

This medication may cause severe harm to the fetus and newborn if taken during pregnancy, especially in the 2nd and 3rd trimesters, so it should be discontinued immediately if pregnancy is confirmed. It should not be used by people with certain conditions. For example, individuals allergic to this medication or its ingredients, pregnant or breastfeeding women, individuals with severe liver or kidney disease, and patients with a history of certain vascular edema should not use it. Elderly patients, those with hyperkalemia, patients with compromised liver function, and patients with heart valve diseases or related issues should use this medication cautiously, with careful monitoring of their condition before and after administration. While taking this medication, blood pressure may drop suddenly, so if symptoms such as dizziness or fainting occur, consult a healthcare professional immediately. Patients with poor kidney function, heart failure, or undergoing dialysis should regularly check their kidney function and electrolyte levels while taking this medication. This medication can increase potassium levels, so caution should be exercised when taken with potassium supplements or potassium-sparing diuretics. Additionally, there may be interactions when taken with other antihypertensive medications, diuretics, non-steroidal anti-inflammatory drugs (NSAIDs), so it is important to consult a healthcare professional. This medication is not recommended for use in children and adolescents as its safety and efficacy have not been established. In case of overdose, severe hypotension, decreased consciousness, shock, etc., may occur, so compliance with the recommended dosage is crucial, and if any unusual symptoms arise, emergency care should be sought immediately. Store this medication out of reach of children and do not transfer it to other containers for safety. Finally, while taking this medication, caution is required when driving or operating machinery, as symptoms like dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling ( edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urinary retention

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
  • joint pain
  • drowsiness
  • vomiting
  • constipation
  • dry mouth
  • loss of appetite
  • malaise
  • flushing
  • itching
  • serum sickness
  • vasculitis
  • fainting
  • nosebleed
  • hepatitis
  • arrhythmia
  • intestinal vascular edema
  • hypoglycemia
  • rhabdomyolysis
  • agranulocytosis
  • leukopenia
  • thrombocytopenia
  • blistering erythema

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 and moisture from entering. Additionally, it is important to store it in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Oval film-coated tablet with an orange color that has a gray tint

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.