Medication info
Idalbiclo Tablets 40/25 mg (Azilsartan Medoxomil Potassium, Chlorthalidone)

Idalbiclo Tablets 40/25 mg (Azilsartan Medoxomil Potassium, Chlorthalidone)

Prescription medicationTablet경구
Ingredient · strength
Potassium Azilsartan Medoxomil›42.68mg / 1 tabletChlorthalidone›25mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Bright red, bilaterally convex, round film-coated tablet
Packaging
28 tablets/PTP [(14 tablets * 2 ea)]
Approval status
Active

MFDS item code 202400976 · Approved 2024.04.25

Summary

Main use
Treatment of essential hypertension and stage 2 hypertension (blood pressure control)
Who takes it
Adults · Children
Adult dose
The recommended starting dose is 40/12.5 mg, taken with water regardless of meals. If blood pressure control is necessary, it can be increased to 40/25 mg after 2-4 weeks. Doses exceeding 40/25 mg are not beneficial. For patients whose blood pressure is not adequately controlled with monotherapy, it is recommended to adjust the dose with Azilsartan Medoxomil before starting this medicine, with a recommended starting dose of 40/12.5 mg once daily.
Child dose
The safety and efficacy of this medicine for children and adolescents under 18 years of age have not been established, and no dosing regimen is specified.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Treatment of essential hypertension and stage 2 hypertension (blood pressure control)

View approved original text

This medicine is used for patients with essential hypertension whose blood pressure is not adequately controlled by monotherapy with Azilsartan Medoxomil. It is also administered as initial therapy when combination therapy is required to achieve target blood pressure in patients with stage 2 hypertension. It helps improve blood pressure control.

How to take

Adult dose

The recommended starting dose is 40/12.5 mg, taken with water regardless of meals. If blood pressure control is necessary, it can be increased to 40/25 mg after 2-4 weeks. Doses exceeding 40/25 mg are not beneficial. For patients whose blood pressure is not adequately controlled with monotherapy, it is recommended to adjust the dose with Azilsartan Medoxomil before starting this medicine, with a recommended starting dose of 40/12.5 mg once daily.

Child dose

The safety and efficacy of this medicine for children and adolescents under 18 years of age have not been established, and no dosing regimen is specified.

Precautions

This medicine may cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Patients with poor liver function or progressing liver disease should be cautious as serious complications such as hepatic coma may occur while taking this medicine. Patients with severely impaired kidney function should use this medicine carefully as it may worsen kidney function, and regular kidney function tests should be conducted. Patients with allergies to the components of this medicine or hypersensitivity to certain diuretics, as well as pregnant or breastfeeding women, and those with anuria should not take this medicine. Patients with severely low blood pressure or electrolyte imbalances should stabilize their condition before taking this medicine and should regularly monitor blood pressure and blood electrolyte levels during treatment. Particularly, patients with very high or low potassium levels or hyperuricemia should be cautious as the risk of side effects is increased when taking this medicine. This medicine may exacerbate renal function decline or electrolyte imbalances when used in conjunction with other antihypertensives, so blood pressure and renal function should be closely monitored as directed by a physician during combined therapy. Symptoms such as dizziness, headache, nausea, and fatigue may occur during treatment, so caution is needed when driving or operating machinery. Acute glaucoma or other eye disorders may occur when taking this medicine, so if there are changes in vision or eye pain, immediate consultation with healthcare professionals is necessary. Overdosage may lead to hypotension and electrolyte imbalances, so it is crucial to adhere to the prescribed dosage and visit a medical institution immediately if any abnormal symptoms arise. This medicine should be stored in a safe place, away from light and moisture, and out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), difficulty breathing, liver abnormalities (jaundice), severe neurological symptoms (headache, syncope, confusion, visual disturbances, paralysis), hematuria, acute renal failure, subdural hemorrhage, intestinal vascular edema, severe angioedema

Mild side effects

  • Increased serum creatinine
  • headache
  • dizziness
  • increased serum uric acid
  • hypokalemia
  • hyponatremia
  • gout
  • orthostatic dizziness
  • diarrhea
  • nausea
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  • vomiting
  • rash
  • pruritus
  • muscle cramps
  • fatigue
  • increased blood urea
  • increased blood glucose
  • anemia
  • thrombocytopenia
  • leukopenia
  • agranulocytosis
  • eosinophilia
  • increased blood lipids
  • hypomagnesemia
  • hypercalcemia
  • diabetes
  • hypochloremic alkalosis
  • headache
  • orthostatic hypotension

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

Storage

This medicine should be stored in a container that is not exposed to light and air, at room temperature between 1 to 30 degrees Celsius. It is also advisable to keep it in a dry place, avoiding humid areas.

Appearance and packaging

Appearance

Bright red, bilaterally convex, round film-coated tablet

Package unit

28 tablets/PTP [(14 tablets * 2 ea)]

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.