Medication info

Idalbi Tablet 80mg (Azilsartan Medoxomil)

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Potassium Azilsartan Medoxomil›85.36mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Round tablets, white or almost white
Packaging
PTP package: 14 tablets, 28 tablets, 30 tablets, 56 tablets, 90 tablets, 98 tablets/carton
Approval status
Approval withdrawn

MFDS item code 201702621 · Approved 2017.05.26

This product's status changed to Approval withdrawn on 2024.03.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effectiveness in controlling essential hypertension
Who uses it
Adults · Children
Adult dosage
The recommended initial dose for this medication is 40mg once daily, regardless of meals. If blood pressure is not adequately controlled at this dose, it may be increased to a maximum of 80mg once daily. The blood pressure-lowering effect appears within 2 weeks after starting treatment, with maximum effect typically seen around 4 weeks.
Children's dosage
The safety and efficacy of this medication in children and adolescents under 18 years of age have not been established.

Ingredients

Importer
(주)셀트리온제약

Efficacy & effects

Effectiveness in controlling essential hypertension

  • Essential hypertension
View approved original text

Essential hypertension is a condition where blood pressure is persistently high, which can increase the risk of cardiovascular complications if not controlled. This medication helps lower blood pressure, reducing the strain on blood vessels and the heart, maintaining overall health. Therefore, it is used for essential hypertension.

Dosage and Administration

Adult dosage

The recommended initial dose for this medication is 40mg once daily, regardless of meals. If blood pressure is not adequately controlled at this dose, it may be increased to a maximum of 80mg once daily. The blood pressure-lowering effect appears within 2 weeks after starting treatment, with maximum effect typically seen around 4 weeks.

Children's dosage

The safety and efficacy of this medication in children and adolescents under 18 years of age have not been established.

Precautions

This medication can cause severe harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately if pregnancy is confirmed. People who are allergic to this drug or its ingredients, pregnant women, and patients with certain renal function impairments, such as those with diabetes, should not take it. Patients with heart failure, severe kidney disorders, or renal artery stenosis should use this medication cautiously and regularly check their blood pressure and kidney function. Care should be taken when co-administering this drug with other antihypertensive agents or certain diuretics, as there is an increased risk of hypotension, hyperkalemia, and renal function impairment. It can lower blood pressure suddenly, which may lead to dizziness or drowsiness, so caution is advised when driving or operating hazardous machinery. This drug can elevate serum potassium levels; therefore, potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes should be monitored regularly for blood potassium levels when used together. Patients with impaired renal or liver function should consult their physician before taking this drug and regularly monitor their renal and liver function during treatment. In case of overdose, hypotension and dizziness may occur, and if symptoms are severe, medical attention should be sought immediately, as this medication cannot be removed by hemodialysis. Store this medication away from light and moisture in its original container, and keep it out of reach of children.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • difficulty breathing
  • acute kidney injury
  • acute renal failure
  • hyperkalemia
  • hypotension
  • syncope
  • complete renal failure
  • subdural hematoma
Show 9 more
  • severe edema
  • decreased kidney function
  • increased blood pressure
  • severe allergic reactions
  • severe edema or urinary problems
  • severe skin adverse reactions
  • respiratory issues
  • liver abnormalities (jaundice)
  • severe neurological symptoms

Mild side effects

  • Dizziness
  • headache
  • nasopharyngitis
  • nausea
  • diarrhea
  • rash
  • itching
  • muscle cramps
  • fatigue
  • peripheral edema
Show 19 more
  • increased serum creatine phosphokinase
  • increased serum creatinine
  • increased serum uric acid/hyperuricemia
  • chest discomfort
  • angioedema
  • weakness
  • constipation
  • vomiting
  • bad breath
  • dyslipidemia
  • hypercholesterolemia
  • gout
  • hyperkalemia
  • joint pain
  • muscle pain
  • musculoskeletal stiffness
  • increased aspartate aminotransferase
  • urinary tract infection
  • upper respiratory tract infection

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

Storage

This medication should be stored in a container that is not exposed to light and air, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. Additionally, it should be stored away from humid places to maintain its effectiveness.

Appearance and packaging

Appearance

Round tablets, white or almost white

Package unit

PTP package: 14 tablets, 28 tablets, 30 tablets, 56 tablets, 90 tablets, 98 tablets/carton

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.