Medication info

Idalbi Clopidogrel Tablet 40/25 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Potassium Azilsartan Medoxomil›42.68mg / 1 tabletChlorthalidone›25mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Bright red, double convex, round film-coated tablet
Packaging
28 tablets (14 tablets/PTP X 2), 56 tablets (14 tablets/PTP X 4)
Approval status
Approval withdrawn

MFDS item code 201803208 · Approved 2018.08.06 · Insurance code 693903540

This product's status changed to Approval withdrawn on 2024.05.13. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood pressure control in essential hypertension and stage 2 hypertension
Who takes it
Adults · Children
Adult dose
The recommended initial dose of this medication is 40/12.5 mg, taken with water regardless of meals. The antihypertensive effects typically become apparent within 1-2 weeks, and if blood pressure control is needed after 2-4 weeks, the dose can be increased to 40/25 mg. Doses exceeding 40/25 mg are not beneficial. For patients not adequately controlled by monotherapy, it is recommended to adjust the dose with azilsartan medoxomil before using this medication.
Child dose
The safety and efficacy of this medication have not been established in children and adolescents under the age of 18.

Ingredients

Importer
(주)셀트리온제약

Efficacy & effects

Improvement of blood pressure control in essential hypertension and stage 2 hypertension

  • Essential hypertension
  • stage 2 hypertension
View approved original text

This medication is used for patients with essential hypertension whose blood pressure is not adequately controlled by azilsartan medoxomil monotherapy, and for patients with stage 2 hypertension who require combination therapy to reach their target blood pressure. In other words, this medication helps to effectively control blood pressure in various types of hypertension treatment.

How to take

Adult dose

The recommended initial dose of this medication is 40/12.5 mg, taken with water regardless of meals. The antihypertensive effects typically become apparent within 1-2 weeks, and if blood pressure control is needed after 2-4 weeks, the dose can be increased to 40/25 mg. Doses exceeding 40/25 mg are not beneficial. For patients not adequately controlled by monotherapy, it is recommended to adjust the dose with azilsartan medoxomil before using this medication.

Child dose

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

Precautions

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimester of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Patients with impaired liver function or advanced liver disease may experience fluid and electrolyte imbalances while taking this medication, leading to serious issues such as hepatic coma. Caution is advised for patients with severe kidney disease, as this medication’s diuretic component may induce hyperazotemia. Patients with allergies to this medication or its components, pregnant or breastfeeding women, anuria patients, and those with severe liver or kidney dysfunction should not take this medication. Patients with low blood volume or salt deficiency may experience hypotension; hence, conditions should be corrected before administration, and if hypotension occurs, they should lie down and receive intravenous fluids if necessary. Patients with decreased kidney function must be regularly monitored for worsening kidney function during treatment, and discontinuation may be necessary if the condition worsens. The safety of this medication has not been established in patients with severely impaired liver function, so its use is not recommended. This medication may cause electrolyte imbalances, particularly hyponatremia and hypokalemia, so electrolyte levels should be regularly monitored through blood tests. Caution is necessary for patients with a history of hyperuricemia or gout, as symptoms may worsen during use. Concurrent use with other renin-angiotensin-aldosterone system (RAAS) acting medications may increase the risk of hypotension, hyperkalemia, and kidney dysfunction, so combination should be avoided. Elderly patients and those with cardiovascular disease or certain heart valve diseases also require special attention when taking this medication. Dizziness or drowsiness may occur during treatment, so caution is advised when driving or operating hazardous machinery. There may be interactions when used with lithium, non-steroidal anti-inflammatory drugs (NSAIDs), potassium-sparing diuretics, etc., so consulting with a doctor or pharmacist is essential. Use of this medication during pregnancy or breastfeeding is not recommended, especially during lactation, since the ingredients may be transmitted through breast milk and pose risks to the newborn. In case of overdose, symptoms such as hypotension, dizziness, and electrolyte imbalances may occur, necessitating immediate medical attention. 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
  • severe swelling (edema)
  • difficulty breathing
  • yellowing of the skin (jaundice)
  • sudden and severe headache
  • confusion
  • paralysis
  • markedly reduced urine output
  • increased blood pressure
  • significant angioedema
Show 1 more
  • subdural hematoma

Mild side effects

  • Increased serum creatinine
  • headache
  • dizziness
  • increased serum uric acid
  • hypokalemia
  • increased serum potassium
  • hyponatremia
  • decreased serum sodium
  • gout
  • orthostatic dizziness
Show 19 more
  • sensory disturbances
  • hypotension
  • diarrhea
  • nausea
  • vomiting
  • rash
  • itching
  • muscle cramps
  • fatigue
  • increased blood urea
  • increased blood sugar
  • anemia
  • thrombocytopenia
  • leukopenia
  • agranulocytosis
  • eosinophilia
  • increased serum lipids
  • hypomagnesemia
  • hyper

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

Storage

This medication should be stored in a tightly closed container protected from light, at room temperatures between 1 degree Celsius and 30 degrees Celsius. Additionally, it should be kept in a manner that prevents exposure to moisture.

Appearance and packaging

Appearance

Bright red, double convex, round film-coated tablet

Package unit

28 tablets (14 tablets/PTP X 2), 56 tablets (14 tablets/PTP X 4)

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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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.