Medication info
Valsarct 160 mg (Valsartan)

Valsarct 160 mg (Valsartan)

Prescription medicationTablet경구
Ingredient · strength
Valsartan›160mg / 1 tablet
Manufacturer / importer
제이더블유중외제약(주)
Appearance
Orange oval film-coated tablets with a grayish tint
Packaging
30 tablets (6 tablets/PTPX5)
Approval status
Active

MFDS item code 200809207 · Notified 2008.09.03 · Insurance code 644912460

Summary

Main use
Treatment of essential hypertension and heart failure (intolerance to ACE inhibitors), and reduction of the risk of death following myocardial infarction.
Who takes it
Adults · Children
Adult dose
1. Essential hypertension - Recommended oral dosage: 80 mg once daily - May increase to 160 mg once daily if blood pressure is not well-controlled - If needed, may increase up to a maximum of 320 mg once daily - Elderly patients (75 years or older): Start with 40 mg once daily - For renal impairment patients: start with 40 mg or do not adjust dosage - Patients with fluid depletion: start with 40 mg once daily. 2. Heart failure Adults: Recommended starting dose is 40 mg orally twice daily, which can be increased to 80 mg or 160 mg once per dose. Dose reduction of diuretics should be considered when this drug is co-administered. The maximum daily dose is 320 mg, divided in two doses. Triple therapy with ACE inhibitors and beta-blockers is not recommended. 3. Reduction of mortality risk after myocardial infarction Adults: Administration can begin within 12 hours of myocardial infarction onset. The recommended starting dose is 20 mg orally, twice a day, gradually increasing to 40 mg, 80 mg, and 160 mg, considering patient tolerance. If symptoms of hypotension or kidney failure appear, dose reduction should be considered. This medication can also be used in patients receiving other treatments after myocardial infarction (e.g., thrombolytics, acetylsalicylic acid, beta-blockers, and statins). However, combination with ACE inhibitors is not recommended. 4. Renal impairment: No dose adjustment is required for patients with creatinine clearance above 10 mL/min; however, there is no experience with patients with creatinine clearance below 10 mL/min or on dialysis, so this medication should not be administered to them. 5. Liver impairment: For mild and moderate liver disease, it is advisable not to exceed a daily dose of 80 mg. If exceeding 80 mg daily, the benefits of increasing the dose must outweigh the risks. This medication should not be administered to patients with severe liver impairment, cirrhosis, or cholestasis.
Child dose
Safety and efficacy have not been established in pediatric and adolescent patients under 18 years of age.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

Treatment of essential hypertension and heart failure (intolerance to ACE inhibitors), and reduction of the risk of death following 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, heart failure (especially in cases of intolerance to ACE inhibitors), and to reduce the risk of death following myocardial infarction. It is particularly effective in stable myocardial infarction patients with left ventricular dysfunction. This helps improve the patient's health status by aiding major cardiovascular diseases.

How to take

Adult dose

1. Essential hypertension - Recommended oral dosage: 80 mg once daily - May increase to 160 mg once daily if blood pressure is not well-controlled - If needed, may increase up to a maximum of 320 mg once daily - Elderly patients (75 years or older): Start with 40 mg once daily - For renal impairment patients: start with 40 mg or do not adjust dosage - Patients with fluid depletion: start with 40 mg once daily. 2. Heart failure Adults: Recommended starting dose is 40 mg orally twice daily, which can be increased to 80 mg or 160 mg once per dose. Dose reduction of diuretics should be considered when this drug is co-administered. The maximum daily dose is 320 mg, divided in two doses. Triple therapy with ACE inhibitors and beta-blockers is not recommended. 3. Reduction of mortality risk after myocardial infarction Adults: Administration can begin within 12 hours of myocardial infarction onset. The recommended starting dose is 20 mg orally, twice a day, gradually increasing to 40 mg, 80 mg, and 160 mg, considering patient tolerance. If symptoms of hypotension or kidney failure appear, dose reduction should be considered. This medication can also be used in patients receiving other treatments after myocardial infarction (e.g., thrombolytics, acetylsalicylic acid, beta-blockers, and statins). However, combination with ACE inhibitors is not recommended. 4. Renal impairment: No dose adjustment is required for patients with creatinine clearance above 10 mL/min; however, there is no experience with patients with creatinine clearance below 10 mL/min or on dialysis, so this medication should not be administered to them. 5. Liver impairment: For mild and moderate liver disease, it is advisable not to exceed a daily dose of 80 mg. If exceeding 80 mg daily, the benefits of increasing the dose must outweigh the risks. This medication should not be administered to patients with severe liver impairment, cirrhosis, or cholestasis.

Child dose

Safety and efficacy have not been established in pediatric and adolescent patients under 18 years of age.

Precautions

This drug can cause serious harm to the fetus and newborn if taken during pregnancy, especially in the second and third trimesters; therefore, if pregnancy is confirmed, it should be discontinued immediately. Patients with allergic reactions to this drug, severe liver or kidney malfunction, and pregnant or breastfeeding women should not take this medication. Elderly patients, patients with hyperkalemia, liver disease, heart disease, etc., should take this medication cautiously, starting at a low dose, and monitoring their condition closely as there is a risk of sudden drops in blood pressure initially. While this medication lowers blood pressure, side effects such as headache, dizziness, fatigue, cough, and diarrhea may occur, and severe adverse reactions such as kidney function decline or hyperkalemia may arise in severe cases. Particularly, patients after heart failure or myocardial infarction may require an evaluation of kidney function changes, regular checks are necessary as blood pressure may drop too low or kidney function may worsen. This drug may interact with other antihypertensive medications, diuretics, or potassium supplements, so consultation with a doctor or pharmacist is essential. Breastfeeding women are advised to avoid this medication, and if it must be taken, breastfeeding should be discontinued. Safety in children and adolescents has not been established, thus it is preferable not to use it. In cases of overdose, severe hypotension or reduced consciousness may occur, requiring immediate medical attention. Keep the medication out of the reach of children and avoid transferring it to other containers. If any abnormal symptoms occur while taking this medication, it is important to consult medical staff immediately for appropriate measures.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory issues with cough and fever, jaundice (yellowing of the skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes.

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
  • hypoglycemia
  • dialysis-related hypotension
  • rhabdomyolysis
  • agranulocytosis
  • leukopenia
  • thrombocytopenia
  • bullous dermatitis
  • dyspepsia
  • anemia
  • tinnitus
  • tension headache.

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

Storage

Store this medication in a tightly sealed container to prevent air and moisture ingress, and keep it in a cool place below 30 degrees Celsius. This will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Orange oval film-coated tablets with a grayish tint

Package unit

30 tablets (6 tablets/PTPX5)

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.