Product Overview
[Drug Name]
Generic Name: Irbesartan Tablets
Trade Name: Jijia/Hengrui
English Name: Irbesartan Tablets
Chinese Pinyin: EBeiShaTanPian
[Ingredients]
The main ingredient of this product is irbesartan. Its chemical name is 2-butyl-3-[[o-1H-5-tetrazolylphenyl)benzyl]-1,3-diazaspiro[4,4]non-1-en-4-one. Its molecular formula is C₂₅H₂₅N₂O, and its molecular weight is 428.5.
[Properties]
This product is a film-coated tablet that appears white or off-white after removal of the coating.
[Indications]
Hypertension.
[Dosage and Administration]
Oral: The recommended starting dose is 0.15g once daily. This can be increased to 0.3g once daily depending on the condition. It can be used alone or in combination with other antihypertensive medications. 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]
This product is contraindicated in patients with allergies.
[Precautions]
1. Correct hypovolemia and/or sodium deficiency before initiating treatment. 2. Patients with renal insufficiency 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. No dose adjustment is required for patients with hepatic insufficiency or the elderly. 4. Irbesartan is not excreted through hemodialysis. Please read the package insert carefully and use as directed by your doctor.
[Special Population Use]
Precautions for Children: Safety and efficacy in children have not been established.
Precautions for Pregnancy and Lactation: Contraindicated in pregnant and lactating women.
Precautions for the Elderly: Although a starting dose of 75 mg may be considered for patients over 75 years of age, dose adjustment is generally not required for elderly patients.
[Drug Interactions] 1. When using this drug with diuretics, be aware of hypovolemia or hyponatremia, which may cause hypotension. When used with potassium-sparing diuretics (such as triamterene), avoid elevated serum potassium. 2. There are no significant interactions between this drug and warfarin. 3. Concomitant use 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.
[Storage] Store in sealed containers.
[Specification] 0.15g x 7 tablets
[Packaging] Box
[Expiration Date] 24 months
[Approval Number] National Medicine Standard H20000513
[Manufacturer] Company Name: Jiangsu Hengrui Medicine Co., Ltd.
