Irbesartan Plus 300/12.5 mg Tablet

Adult dose

This medication is administered once daily regardless of meals. 1. Patients whose blood pressure is not adequately controlled by monotherapy - For patients adequately controlled with Irbesartan 150 mg or Hydrochlorothiazide alone, administer 1 tablet of Irbesartan 150 mg/Hydrochlorothiazide 12.5 mg once daily. - For patients whose blood pressure is not adequately controlled with Irbesartan 300 mg or Irbesartan 150 mg/Hydrochlorothiazide 12.5 mg, administer 1 tablet of Irbesartan 300 mg/Hydrochlorothiazide 12.5 mg once daily. - For patients whose blood pressure is not adequately controlled with Irbesartan 300 mg/Hydrochlorothiazide 12.5 mg, administer 1 tablet of Irbesartan 300 mg/Hydrochlorothiazide 25 mg once daily. Dosages exceeding Irbesartan 300 mg/Hydrochlorothiazide 25 mg are not recommended. If necessary, this medication can be co-administered with other antihypertensive agents. 2. For initial treatment of moderate or severe hypertension (stage 2), individualization is necessary considering baseline blood pressure, target blood pressure, and the expected extent of increased treatment goal attainment compared to single agents. Usually, start with 1 tablet of Irbesartan 150 mg/Hydrochlorothiazide 12.5 mg once daily and may increase to a maximum of Irbesartan 300 mg/Hydrochlorothiazide 25 mg after 1 to 2 weeks if blood pressure control is needed. It is not recommended to initiate this medication in patients with intravascular volume depletion. ○ Renal impairment patients Due to the Hydrochlorothiazide component, this medication is not recommended for patients with severe renal impairment (creatinine clearance < 30 mL/min). Loop diuretics are preferred for this patient group. Patients with creatinine clearance > 30 mL/min do not require dosage adjustment. ○ Patients with volume depletion In cases of sodium and/or fluid loss, equilibrium must be restored before administering this medication. ○ Liver impairment patients This medication is not for use in patients with severe liver impairment. Thiazide medications should be used cautiously in liver impairment patients. Patients with mild to moderate liver impairment do not require dosage adjustments. ○ Elderly Elderly patients do not require dosage adjustment for this medication. ○ Pediatrics The safety and efficacy of this medication have not been established in children and adolescents under 18 years of age.

This medication can cause serious harm to the fetus and newborn during pregnancy, so it must be discontinued immediately if pregnancy is confirmed. Pregnant women and nursing mothers should not take this medication. Patients with severely impaired kidney function, anuria, specific electrolyte abnormalities, or liver dysfunction should also refrain from using this drug. This medication should be administered cautiously to patients with hypotension, kidney function abnormalities, liver dysfunction, or heart issues, as the risk of skin cancer may increase, and regular monitoring of skin conditions is necessary. During treatment, side effects such as dizziness, fatigue, nausea, vomiting, and urination abnormalities may occur, and if symptoms are severe, consultation with a physician is necessary. Dizziness or fatigue may occur while driving or operating machinery, so caution is needed. Blood pressure may drop too low or electrolyte imbalances may occur; hence, especially in cases of diarrhea, vomiting, or excessive use of diuretics, it is crucial to ensure adequate sodium and fluid intake as directed by a physician. Diabetic patients may be affected in blood sugar control, so it is important to manage blood glucose and medication dosage well both before and during treatment. This medication may interact with other drugs, especially with lithium, drugs affecting potassium, heart medications, and anti-inflammatory agents, so consultation with a physician or pharmacist is essential when used in conjunction with them. In cases of overdose, symptoms may include hypotension, electrolyte imbalances, and dehydration; immediate medical attention is required. It is not recommended for children or adolescents as safety and efficacy have not been established, and caution is warranted with the elderly as they may be more sensitive to this medication. Keep the medication out of reach of children, and store it securely in its original container.

Serious side effects

Urticaria, severe swelling (edema), liver abnormalities (jaundice), angioedema, severe allergic reactions, severe dermatological reactions, toxic epidermal necrolysis (Lyell's syndrome), necrotizing vasculitis, severe neurological symptoms (sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis), severe edema or urination abnormalities, anaphylactic shock, intestinal vascular edema, respiratory distress due to pneumonia and pulmonary edema, acute

Mild side effects

Dizziness, fatigue, nausea/vomiting, abnormal urination, headache, fainting, hypotension, tachycardia, flushing, cough, diarrhea, dyspepsia, taste disturbances, hepatitis, abnormal liver function, sexual dysfunction, changes in libido, limb swelling, arthralgia, myalgia, tinnitus, rash, hyperkalemia, decreased serum potassium and sodium, increased BUN and creatine kinase, serum electrolyte imbalances (including hypokalemia and hyponatremia), hyperuricemia, diabetes

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. The storage temperature should maintain room temperature between 1 to 30 degrees Celsius. This ensures the medication remains effective and safe for an extended period.

Appearance

Pink rectangular film-coated tablets

Package unit

30 tablets/bottle