Medication info

Idalbi Tablet 40 mg (Azilsartan Medoxomil Potassium)

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Potassium Azilsartan Medoxomil›42.68mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
White or nearly white round tablet
Packaging
PTP packaging: 14 tablets, 28 tablets, 30 tablets, 56 tablets, 90 tablets, 98 tablets per carton
Approval status
Approval withdrawn

MFDS item code 201702622 · 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This product's status changed to Approval withdrawn on 2024.03.21.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
Improvement of essential hypertension
Who uses it
Adults · Children
Adult dosage
The recommended initial dose of this medication is 40 mg once daily, taken regardless of meals. If blood pressure is not adequately controlled, it can be increased up to a maximum of 80 mg daily.
Children's dosage
The safety and efficacy of this medication for children and adolescents under 18 years of age have not been established.

Ingredients

Importer
(주)셀트리온제약

Efficacy & effects

Improvement of essential hypertension

  • Essential hypertension
View approved original text

Essential hypertension is a condition where blood pressure is persistently high. This medication is used to control blood pressure and prevent cardiovascular complications.

Dosage and Administration

Adult dosage

The recommended initial dose of this medication is 40 mg once daily, taken regardless of meals. If blood pressure is not adequately controlled, it can be increased up to a maximum of 80 mg daily.

Children's dosage

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

Precautions

This medication can cause serious harm to the fetus or newborn if used by women in the second and third trimesters of pregnancy. Therefore, it should be discontinued immediately upon confirmation of pregnancy. It should not be used by individuals allergic to this medication or any of its ingredients, pregnant women, and patients with certain kidney diseases or diabetes. In patients with compromised cardiac function or severe renal impairment, or those with narrowed renal arteries, this medication should be used cautiously, and blood pressure and kidney function should be monitored frequently. Taking this medication with other antihypertensives may increase the risk of side effects such as hypotension, hyperkalemia, and decreased renal function, so co-administration should be avoided. Patients with reduced blood volume or low salt levels may experience hypotension at the outset of treatment, so their status needs to be carefully assessed before administration, and appropriate measures should be taken if necessary. Taking this medication alongside potassium-sparing diuretics or potassium supplements may dangerously elevate serum potassium levels, necessitating periodic monitoring of potassium levels. This medication may cause side effects such as dizziness, hypotension, nausea, rash, and fatigue, particularly in the elderly or patients with impaired renal function, where the likelihood of side effects is increased. Caution is advised when driving or operating machinery, as dizziness or drowsiness may occur. Patients taking lithium or nonsteroidal anti-inflammatory drugs (NSAIDs) should consult their doctor, as side effects or efficacy changes may occur. Pregnant or nursing women are advised to avoid using this medication, especially during breastfeeding, as the drug may be transmitted through breast milk and its safety has not been established. In case of overdose, hypotension and dizziness may occur, and medical attention should be sought immediately for appropriate treatment. This medication should be kept out of reach of children and stored in its original packaging away from light and moisture.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • hypotension
  • fainting
  • syncope
  • dyspnea
  • acute kidney injury
  • acute renal failure
  • headache
  • subdural hematoma

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
  • weakness
  • constipation
  • vomiting
  • bad breath
  • dyslipidemia
  • hypercholesterolemia
  • gout
  • joint pain
  • muscle pain
  • musculoskeletal stiffness
  • increased aspartate aminotransferase
  • urinary tract infection
  • upper respiratory infection
  • menstrual irregularities
  • worsening hypertension
  • chest pain

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

Storage

This medication should be stored in a container that protects it from light and air, at a temperature between 1°C and 30°C. It is also important to avoid storing it in humid locations.

Appearance and packaging

Appearance

White or nearly white round tablet

Package unit

PTP packaging: 14 tablets, 28 tablets, 30 tablets, 56 tablets, 90 tablets, 98 tablets per 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

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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.