Medication info
Irbesartan/Hydrochlorothiazide 300/12.5 mg

Irbesartan/Hydrochlorothiazide 300/12.5 mg

Prescription medicationTablet경구
Ingredient · strength
Irbesartan›300mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200808749 · Notified 2008.08.18 · Insurance code 651202620

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
This medication is taken once daily regardless of meals. 1. For adult patients whose blood pressure is not adequately controlled with monotherapy: - Administer 1 tablet of Irbesartan 150 mg/Hydrochlorothiazide 12.5 mg once daily. - Administer 1 tablet of Irbesartan 300 mg/Hydrochlorothiazide 12.5 mg once daily. - Administer 1 tablet of Irbesartan 300 mg/Hydrochlorothiazide 25 mg once daily.
Child dose
Safety and efficacy have not been established for children and adolescents under 18 years of age.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
  • moderate hypertension
  • severe hypertension
View approved original text

This medication is used to control blood pressure in patients with essential hypertension. It is effective even when blood pressure control is difficult with monotherapy and is used as a first-line treatment in situations requiring combination therapy to reach the target blood pressure in patients with moderate to severe hypertension. In other words, this medication helps reliably manage blood pressure across various stages of hypertension.

How to take

Adult dose

This medication is taken once daily regardless of meals. 1. For adult patients whose blood pressure is not adequately controlled with monotherapy: - Administer 1 tablet of Irbesartan 150 mg/Hydrochlorothiazide 12.5 mg once daily. - Administer 1 tablet of Irbesartan 300 mg/Hydrochlorothiazide 12.5 mg once daily. - Administer 1 tablet of Irbesartan 300 mg/Hydrochlorothiazide 25 mg once daily.

Child dose

Safety and efficacy have not been established for children and adolescents under 18 years of age.

Precautions

This medication can cause serious harm to the fetus when used during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. It should not be used in women who are pregnant or may become pregnant, nursing mothers, or patients with certain kidney diseases or anuria. Additionally, patients who have had allergic reactions to this medication or its ingredients should avoid it. Caution is also needed for patients with severe renal dysfunction, certain liver diseases, or a history of angioedema. This medication may cause side effects such as dizziness, fatigue, nausea, vomiting, abnormal urination, and more rarely, hypotension, edema, liver function impairment, and angioedema. Particularly, there may be an increased risk of skin cancer, so caution should be exercised with sun exposure, and any new skin lesions should be reported to a doctor immediately. Dizziness and fatigue may occur when driving or operating machinery, so caution is advised. Patients at risk of hypotension, those with poor renal function, and patients with liver diseases should consult a doctor before taking this medication. This medication may cause electrolyte imbalances in the blood, so regular blood tests should be performed to monitor potassium, sodium, and other levels. There may be interactions with other medications, particularly lithium, potassium supplements, diuretics, antidiabetic drugs, and nonsteroidal anti-inflammatory drugs, so consultation with a specialist is necessary for those taking these medications. It is recommended to avoid taking this medication while breastfeeding, and it is not recommended for children and adolescents. Elderly patients may have increased sensitivity to the medication, so caution is warranted. Overdosage may result in hypotension, electrolyte abnormalities, and dehydration symptoms, requiring immediate medical assistance. This medication should be kept out of reach of children and stored in its original container; changing the container is not allowed.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema, chest tightness, difficulty breathing, pallor, severe rash with fever, blistering, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, jaundice (yellowing of the skin or eyes), generalized malaise, jaundice, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, coma

Mild side effects

  • Dizziness
  • fatigue
  • nausea/vomiting
  • abnormal urination
  • increased BUN
  • increased creatine kinase
  • increased creatinine
  • orthostatic dizziness
  • headache
  • fainting
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  • hypotension
  • tachycardia
  • flushing
  • cough
  • diarrhea
  • dyspepsia
  • altered taste
  • hepatitis
  • abnormal liver function
  • sexual dysfunction
  • changes in libido
  • peripheral edema
  • joint pain
  • muscle pain
  • tinnitus
  • decreased serum potassium and sodium
  • hyperkalemia
  • angioedema
  • rash
  • urticaria
  • thrombocytopenia

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius room temperature to help preserve its effectiveness.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

30 tablets/bottle, 300 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.