[倍悦] 厄贝沙坦氢氯噻嗪片 0.15g:12.5mg*28片/盒

Basic Information

• Product Name：Irbesartan and Hydrochlorothiazide Tablets
• Trade Name：Beiyue
• Approval Number：国药准字 H20058709 (H20058709 in Chinese Pharmacopoeia)
• Manufacturer：Zhejiang Huahai Pharmaceutical Co., Ltd.
• Specification：0.15g:12.5mg×28 tablets/box
• Type：Compound preparation

Indications

Pharmacological Action

Usage and Dosage

• Orally, 2 tablets (irbesartan/hydrochlorothiazide: 150mg/12.5mg) once a day, taken on an empty stomach or during a meal2.
• The recommended dose should not exceed irbesartan 300mg/hydrochlorothiazide 25mg once a day2.
• If necessary, it can be used in combination with other antihypertensive drugs2.

Adverse Reactions

• Nervous System：Common: Dizziness; Uncommon: Orthostatic dizziness
• Cardiac：Occasional: Hypertension, edema, syncope, tachycardia
• Vascular：Occasional: Flushing
• Gastrointestinal Tract：Common: Nausea/vomiting; Occasional: Diarrhea, dry mouth
• Skeletal Muscle, Connective Tissue and Bone：Uncommon: Distal limb edema, muscle/bone pain
• Skin and Subcutaneous Tissue：Occasional: Rash
• Kidney and Urinary Tract：Common: Dysuria
• Reproductive System and Breast：Occasional: Change in libido, sexual dysfunction
• General Disorders and Administration Site Conditions：Common: Fatigue; Occasional: Weakness
• Laboratory Tests：Common: Increase in BUN (blood urea nitrogen), creatinine and creatine kinase; Occasional: Decrease in serum potassium and sodium levels

Contraindications

• Known allergy to the active ingredients of this product or any excipient ingredients, or allergy to other sulfonamide derivatives (hydrochlorothiazide is a sulfonamide derivative).
• Severe renal impairment (creatinine clearance rate <30ml/min).
• Refractory hypokalemia, hypercalcemia.
• Severe liver function impairment, biliary cirrhosis and cholestasis.

Precautions1

• Hypotension-Volume Depletion：In hypertensive patients without other risk factors for hypotension, this combination is rarely associated with symptomatic hypotension. Symptomatic hypotension may occur in patients with fluid and sodium depletion due to the use of potent diuretics, strict dietary salt restriction, diarrhea and vomiting. These conditions should be corrected before treatment with this combination.
• Renal Artery Stenosis-Renovascular Hypertension：In patients with bilateral renal artery stenosis or stenosis of the artery of a single functioning kidney, the use of angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists may carry a risk of severe hypotension and renal insufficiency.
• Renal Impairment and Kidney Transplantation：In patients with renal impairment, serum potassium, creatinine and uric acid should be monitored regularly.
• Liver Function Impairment：In patients with liver function impairment or progressive liver disease, small changes in fluid and electrolyte balance may precipitate hepatic coma, so thiazide diuretics should be used with caution in such patients.
• Aortic and Mitral Stenosis, Hypertrophic Obstructive Cardiomyopathy：Like the use of other vasodilators, this product should be used with caution in patients with aortic and mitral stenosis and hypertrophic obstructive cardiomyopathy.
• Primary Aldosteronism：Patients with primary aldosteronism usually do not respond to antihypertensive drugs that inhibit the renin-angiotensin system, so this product is not recommended for these patients.
• Metabolic and Endocrine Effects：Thiazide diuretic therapy may reduce glucose tolerance. Diabetic patients may need to adjust the dosage of insulin and oral hypoglycemic drugs. Hyperuricemia may occur in some patients receiving thiazide diuretic therapy, and even trigger gout.
• Electrolyte Disorders：Like any patient receiving diuretic therapy, serum electrolytes should be measured regularly. Thiazide diuretics including hydrochlorothiazide can cause fluid or electrolyte disorders (hypokalemia, hyponatremia and hypochloremic alkalosis).

Drug Interactions1

• Other Antihypertensive Drugs：When this product is used in combination with other antihypertensive drugs, the antihypertensive effect may be enhanced.
• Lithium Agents：There is a risk of increased lithium toxicity when lithium agents are used in combination with this product.
• Potassium Affecting Drugs：The potassium-lowering effect of hydrochlorothiazide can be attenuated by the potassium-retaining effect of irbesartan.
• Other Drugs Affected by Potassium Disorders：When this combination is used in combination with other drugs affected by potassium disorders (such as digitalis glycosides, antiarrhythmic drugs), regular monitoring of serum potassium is recommended.