Medication info

Megavalartan Tablet 160 mg (Valsartan)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Valsartan›160mg / 1 tablet
Manufacturer / importer
(주)엘앤씨바이오
Appearance
Oval film-coated tablet with an orange color tinged with gray
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202002082 · Approved 2020.03.25

This product's status changed to Approval withdrawn on 2024.09.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of essential hypertension and heart failure, reduction of mortality risk after myocardial infarction.
Who takes it
Adults · Children
Adult dose
1. Essential Hypertension Adults: It is recommended to administer 80 mg orally once daily as valsartan. If blood pressure is not well controlled, the dosage can be increased to 160 mg once daily or up to a maximum of 320 mg. Elderly patients (age 75 and above): Start with 40 mg once daily. Patients with renal impairment or those with a deficiency of volume in the bloodstream should also start with 40 mg once daily, adjusted according to their condition. Liver impairment patients
Child dose
Children: Safety and efficacy have not been established in children and adolescents under 18 years of age.

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

Improvement of essential hypertension and heart failure, reduction of mortality risk after myocardial infarction.

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

This drug is used for essential hypertension, heart failure, and reduction of mortality risk after myocardial infarction. It is particularly effective in steadily controlling blood pressure in patients with essential hypertension and is helpful in cases where ACE inhibitors cannot be used in heart failure patients. Additionally, it helps reduce the mortality risk in stable patients post-myocardial infarction with left ventricular dysfunction. This drug is used to improve these conditions.

How to take

Adult dose

1. Essential Hypertension Adults: It is recommended to administer 80 mg orally once daily as valsartan. If blood pressure is not well controlled, the dosage can be increased to 160 mg once daily or up to a maximum of 320 mg. Elderly patients (age 75 and above): Start with 40 mg once daily. Patients with renal impairment or those with a deficiency of volume in the bloodstream should also start with 40 mg once daily, adjusted according to their condition. Liver impairment patients

Child dose

Children: Safety and efficacy have not been established in children and adolescents under 18 years of age.

Precautions

This drug can cause severe harm to the fetus, especially during the second and third trimesters of pregnancy, so it must be discontinued immediately if pregnancy is confirmed. Women who are pregnant, may become pregnant, or are nursing should not take this drug. It is also unsafe for patients with severe liver dysfunction, liver cirrhosis, or bile duct obstruction. Patients with hereditary angioedema or a history of angioedema should not take this drug. Patients with very poor kidney function, primary hyperaldosteronism, or diabetes patients with moderate to high decline in kidney function should not take this drug. Elderly patients, or those with elevated potassium or slightly reduced liver function, should be cautious while taking this drug and may require dosage adjustments. Patients with heart valve disease or hypertrophic cardiomyopathy, and patients with ischemic heart disease or cerebrovascular disease are also at risk of dangerously low blood pressure while taking this drug. When starting this medication, blood pressure may drop suddenly, so those on diuretics or who are dehydrated should start at a low dose and gradually increase it. Patients with renal artery stenosis may experience worsening kidney function while taking this medication, thus requiring special monitoring. Patients post-heart failure or myocardial infarction should regularly verify changes in kidney function, and concurrent use with beta-blockers or ACE inhibitors is not recommended. This drug may rarely cause side effects such as headache, dizziness, cough, diarrhea, and fatigue, and in rare instances, severe allergic reactions or angioedema, along with kidney function impairment. Blood tests may show decreased red blood cell counts or elevated liver function levels, so assessments are advisable when needed. This drug may interact with other antihypertensive medications or various drugs, so be sure to inform healthcare professionals of any medications currently being taken. Especially, taking potassium-sparing diuretics or potassium supplements together with this drug can dangerously elevate blood potassium levels. Women who are pregnant or nursing should not take this drug, and nursing should ideally be discontinued. Safety and efficacy have not been established for children under 18 years of age. Elderly individuals should be cautious for the risk of stroke due to blood pressure lowering and should start at a low dose while being monitored closely. In case of overdose, severe hypotension and decreased consciousness may occur, requiring immediate emergency treatment. This drug should be kept out of reach of children and not transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest discomfort, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, abnormal respiration accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis,

Mild side effects

  • Headache
  • dizziness
  • viral infections
  • upper respiratory tract infections
  • 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
  • lethargy
  • flushing
  • itching
  • serum sickness
  • vasculitis
  • hypoglycemia
  • rhabdomyolysis
  • agranulocytosis
  • leukopenia
  • thrombocytopenia
  • bullous dermatitis
  • dyspepsia
  • anemia
  • tinnitus
  • tension increase
  • decreased motor function
  • confusion

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

Storage

This drug should be stored in a sealed container to avoid exposure to air or moisture and kept in a cool place below 30 degrees Celsius. This will help to maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

Oval film-coated tablet with an orange color tinged with gray

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.

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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.