Product Overview
[Drug Name]
Generic Name: Irbesartan Tablets
Trade Name: Sushi
English Name: Irbesartan Tablets
Chinese Pinyin: Ebeishatan Pian
[Ingredients]
The main ingredient of this product is irbesartan. Its chemical name is 2-butyl-3-[4-[2-(1H-tetrazol-5-yl)phenyl]benzyl]-1,3-diazaspiro-[4,4]non-1-en-4-one.
[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. Depending on the condition, it can be increased to 0.3g once daily. This 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 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 are rare. Literature reports of adverse reactions with an incidence greater than 1% for this drug include: dyspepsia, heartburn, diarrhea, musculoskeletal muscle pain, fatigue, and upper respiratory tract infection, but these reactions were not significantly different from the control group. Other 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 drug is contraindicated in patients with allergies.
[Precautions]
1. Correct hypovolemia and/or sodium depletion before initiating treatment. 2. Patients with renal insufficiency may require a reduced dose of this drug. 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 impairment or the elderly. 4. Irbesartan cannot be excreted through hemodialysis.
[Use in Special Populations]
Precautions for Children:
The safety and efficacy of Ambroxol in children have not been established.
Precautions for Pregnancy and Lactation:
1. As a precautionary measure, this drug should not be used during the first trimester of pregnancy.
2. This drug is contraindicated in pregnant women between the fourth and ninth months of pregnancy.
3. This drug is contraindicated during lactation.
Precautions for the Elderly:
Although a starting dose of 75 mg may be considered for patients over 75 years of age, no dose adjustment is generally 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 increasing serum potassium. 2. There are no significant interactions between this drug and warfarin. 3. Co-administration 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 II) receptor inhibitor, inhibiting the conversion of Ang I to Ang II. It specifically antagonizes the angiotensin-converting enzyme 1 receptor (AT1), with an antagonistic effect on AT1 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 sealed containers.
[Specification] 0.15g x 7 tablets
[Packaging Size] Box
[Expiry Date] 24 months.
[Approval Number] National Medicine Standard H20000511
[Manufacturer] Company Name: Shenzhen Haibin Pharmaceutical Co., Ltd.
