Product Overview
[Drug Name]
Generic Name: Irbesartan Tablets
Trade Name: Kosu
Chinese Pinyin: EBeiShaTanPian
[Ingredients]
The main ingredient of this product is irbesartan.
[Properties]
This product is white to off-white tablets.
[Indications]
For the treatment of hypertension.
[Dosage and Administration]
Oral: The recommended starting dose is 0.15g once daily. Depending on the condition, it can be increased to 0.3g once daily. It can be used alone or in combination with other antihypertensive drugs. For severe hypertension or when blood pressure remains unsatisfactory after increasing the dose, a small dose of a diuretic (such as a thiazide) or other antihypertensive drug can be added.
[Adverse Reactions]
Common adverse reactions include headache, dizziness, palpitations, and occasional cough. These are generally mild and transient, and most patients can tolerate continued medication. Urticaria and angioedema are rare. Adverse reactions reported in the literature with an incidence greater than 1% include: dyspepsia, heartburn, diarrhea, musculoskeletal pain, fatigue, and upper respiratory tract infection, but these reactions were not significantly different from the blank control group. Adverse reactions reported 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 hypersensitivity to it.
[Precautions]
1. Correct hypovolemia and/or sodium depletion before initiating treatment. 2. Patients with renal insufficiency may require a dose reduction. In addition, monitor changes in blood urea nitrogen, serum creatinine, and potassium. 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 according to your doctor's instructions.
[Use in Special Populations]
Precautions for Children: No safety data are available for patients under 18 years of age.
Precautions for Pregnancy and Lactation: Contraindicated in pregnant and lactating women.
Precautions for Elderly: Not yet known.
[Drug Interactions]
1. When using this product with diuretics, be aware of hypovolemia or hypotension due to hyponatremia. When used with potassium-sparing diuretics (such as triamterene), avoid elevated serum potassium. 2. This product has no significant interaction with warfarin. 3. Concomitant use with digitalis drugs such as digoxin, blockers such as atenolol, and calcium channel blockers such as nifedipine does not affect the pharmacokinetics of these drugs.
[Storage] Store in sealed containers.
[Strength] 75mg x 12 tablets
[Packaging Size] Box
[Expiration Date] 36 months
[Approval Number] National Medicine Standard H20100164
[Manufacturer] Company Name: Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd.
