Medication info

Irbetan Duo Tablet 300/12.5mg

Prescription medicationExpired
Ingredient · strength
Irbesartan›300mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
(주)비씨월드제약
Appearance
Pink, biconvex, rectangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 200807711 · Notified 2008.07.11

This product's status changed to Expired on 2024.07.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Blood pressure control and hypertension treatment via a combination therapy
Who uses it
Adults · Children
Adult dosage
This medication is administered once daily, regardless of meals. 1. For patients whose blood pressure is not sufficiently controlled by monotherapy: - Administer Irbesartan 150 mg/Hydrochlorothiazide 12.5 mg, 1 tablet once daily. - Administer Irbesartan 300 mg/Hydrochlorothiazide 12.5 mg, 1 tablet once daily. - Administer Irbesartan 300 mg/Hydrochlorothiazide 25 mg, 1 tablet once daily.
Children's dosage
The safety and efficacy of this medication have not been established in pediatric and adolescent patients under 18 years of age.

Ingredients

Manufacturer
(주)비씨월드제약

Efficacy & effects

Blood pressure control and hypertension treatment via a combination therapy

  • Hypertension
View approved original text

This medication is used for patients whose blood pressure is not sufficiently controlled by monotherapy. It is particularly applicable as an initial treatment when combination therapy is needed from the start to achieve the target blood pressure in patients with moderate to severe hypertension. Therefore, it is used to effectively assist in the management of hypertension, allowing for stable control of blood pressure.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. 1. For patients whose blood pressure is not sufficiently controlled by monotherapy: - Administer Irbesartan 150 mg/Hydrochlorothiazide 12.5 mg, 1 tablet once daily. - Administer Irbesartan 300 mg/Hydrochlorothiazide 12.5 mg, 1 tablet once daily. - Administer Irbesartan 300 mg/Hydrochlorothiazide 25 mg, 1 tablet once daily.

Children's dosage

The safety and efficacy of this medication have not been established in pediatric and adolescent patients under 18 years of age.

Precautions

This medication should not be taken during pregnancy, especially in the second and third trimesters, as it can cause serious harm to the fetus. Women who are pregnant or breastfeeding, as well as those who are allergic to this medication or its components, should not take it. Patients with severely impaired kidney function or anuria should also avoid this medication. Special caution is advised for patients with low blood pressure, kidney problems, liver dysfunction, certain heart diseases, acute angle-closure glaucoma, and other similar conditions while taking this medication. The hydrochlorothiazide component may increase the risk of skin cancer, so patients should avoid sun exposure and regularly check their skin condition during therapy. Possible side effects include dizziness, fatigue, nausea, vomiting, abnormal urination, and changes in kidney function or electrolyte levels detected in blood tests. Caution is advised while driving or operating machinery due to potential dizziness or fatigue. While this medication lowers blood pressure, it carries a risk of hypotension, so body fluid and salt levels must be well managed. Interactions may occur with other antihypertensive medications, diuretics, lithium, potassium supplements, etc., so patients should inform their healthcare provider of any other medications they are taking. If pregnancy is confirmed, discontinue use immediately and consult a physician, and it is safest not to take this medication during breastfeeding. The safety and efficacy of this drug have not been established in children or adolescents, hence it is not recommended for them. Elderly patients may be more sensitive to this medication, so caution is needed during administration. In cases of overdose, symptoms such as hypotension, electrolyte imbalance, and dehydration may occur, thus immediate medical attention is required for appropriate treatment. This medication should be kept out of reach of children and stored sealed in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory difficulties accompanied by cough and fever, jaundice (yellowing of skin or eyes), severe lethargy, liver abnormalities (jaundice),

Mild side effects

  • Dizziness
  • fatigue
  • nausea/vomiting
  • abnormal urination
  • elevated BUN
  • elevated creatine kinase
  • elevated creatinine
  • headache
  • orthostatic dizziness
  • syncope
Show 22 more
  • hypotension
  • tachycardia
  • flushing
  • cough
  • diarrhea
  • dyspepsia
  • taste disturbances
  • hepatitis
  • abnormal liver function
  • sexual dysfunction
  • changes in libido
  • limb edema
  • arthralgia
  • myalgia
  • tinnitus
  • thrombocytopenia
  • depression
  • sleep disturbances
  • orthostatic hypotension
  • arrhythmia
  • aplastic anemia
  • bone marrow...

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the medication's effectiveness.

Appearance and packaging

Appearance

Pink, biconvex, rectangular film-coated tablet

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.

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.