Product Overview
[Drug Name]
Generic Name: Irbesartan Capsules
Trade Name: Rundu/Yitaiqing
English Name: Irbesartan Capsules
Chinese Pinyin: Ebeishatan Jiaonang
[Ingredients]
Irbesartan. Chemical Name: 2-Butyl-3-4-2-(1H-tetrazol-5-yl)phenylbenzyl-1,3-diazaspiro-4,4-non-1-en-4-one. Molecular Formula: C₂₅H₂₅N₂O. Molecular Weight: 428.54
[Properties]
This product is a white or off-white powder or granules.
[Indications]
Hypertension
[Dosage and Administration]
Oral. The recommended starting dose is one capsule (0.15g) once daily. The dose may be increased to two capsules (0.3g) once daily depending on the condition. For severe hypertension and when blood pressure remains unsatisfactory after increasing the dose, a low-dose diuretic (such as a thiazide) or other antihypertensive medication may be added.
[Adverse Reactions]
Common adverse reactions include headache, dizziness, palpitations, and occasional cough. These are generally mild and transient, and most patients tolerate continued medication well. Urticaria and angioedema rarely occur. Literature reports of adverse reactions with an incidence greater than 1% for this product include: dyspepsia, heartburn, diarrhea, skeletal muscle pain, fatigue, and upper respiratory tract infection, but these reactions were not significantly different from the control group. Adverse reactions with an incidence greater than 1% but lower than the control group include: abdominal pain, anxiety, nervousness, chest pain, pharyngitis, nausea and vomiting, rash, and tachycardia. The incidence of hypotension and orthostatic hypotension is approximately 0.4%.
[Contraindications]
Use with caution in case of hypersensitivity to this product.
[Precautions]
1. Correct hypovolemia and/or sodium deficiency before initiating treatment. 2. Patients with renal impairment may require a dose reduction. Changes in blood urea nitrogen, serum creatinine, and serum potassium should be monitored. As a result of renin-angiotensin-aldosterone inhibition, some sensitive patients may experience changes in renal function. 3. Patients with mild to moderate hepatic impairment do not require dose adjustment when using this product. 4. Irbesartan cannot be excreted through hemodialysis.
[Special Population Use]
Precautions for Children: No safety data are available for use in patients under 18 years of age.
Precautions for Pregnancy and Lactation: Contraindicated in pregnant and lactating women.
Precautions for the Elderly: No dose adjustment is required for use in elderly patients.
[Drug Interactions]
This product has no significant interactions with hydrochlorothiazide, digoxin, warfarin, or nifedipine. However, when used with diuretics, caution should be exercised regarding hypovolemia or hyponatremia, which may cause hypotension. When used with potassium-sparing diuretics (such as triamterene), elevated serum potassium should be avoided. Coadministration with digitalis drugs such as digoxin, beta-blockers such as atenolol, and calcium antagonists such as nifedipine does not affect the pharmacokinetics of these drugs.
[Pharmacological Action]
This product is an angiotensin II (Ang I) receptor inhibitor, inhibiting the conversion of Ang I to Ang I. It specifically antagonizes the angiotensin-converting enzyme 1 receptor (AT1), with an antagonistic effect on ATI greater than 28,500 times that of AT1. By selectively blocking the binding of Ang II to the AT1 receptor, it inhibits vasoconstriction and aldosterone release, resulting in a hypotensive effect. This product does not inhibit angiotensin-converting enzyme (ACE), renin, or other hormone receptors, nor does it inhibit ion channels involved in blood pressure regulation and sodium homeostasis.
[Storage] Store in a sealed container (10-30°C). [Specification] 0.15g*7 tablets
[Packaging] Box
[Expiration Period] 24 months
[Approval Number] National Medicine Standard H20000540
[Manufacturer] Company Name: Zhuhai Rundu Pharmaceutical Co., Ltd.
