Benazepril Hydrochlorothiazide Tablets

Pharmacological action therapy/pharmacodynamic classification: antihypertensive (angiotensin converting enzyme inhibitor and diuretic). This product combines the angiotensin converting enzyme (ACE) inhibitor benazepril with the diuretic hydrochlorothiazide, and their antihypertensive effects are synergistic. Benazepril inhibits the renin-angiotensin system and can block the reflex regulatory stimulatory effect of hydrochlorothiazide, making the two synergistic in antihypertensive treatment. The stimulation of the renin-angiotensin system induced by hydrochlorothiazide makes blood pressure more dependent on the level of angiotensin II, thereby enhancing the efficacy of benazepril. Clinical controlled trials have shown that the combined use of benazepril and hydrochlorothiazide has an additive effect on the stimulation of plasma renin activity and the inhibition of aldosterone.

Each tablet contains 10 mg of Benazepril HCl and 12.5 mg of Hydrochlorothiazide.

This product is a light pink film-coated irregular tablet, which appears white after removing the coating.

This product is suitable for patients who cannot achieve satisfactory therapeutic effects with single treatment; it can also be used as an alternative treatment for the combined use of two single drugs at corresponding doses. This fixed combination preparation is not suitable for the initial treatment of hypertension (see [Usage and Dosage] for details).

The recommended dose of this product for the treatment of hypertension is 10/12.5 mg, once a day. For patients whose blood pressure cannot be fully controlled using angiotensin-converting enzyme inhibitors (such as benazepril hydrochloride) alone, switching to this product once a day can achieve better blood pressure control results. For patients whose blood pressure cannot be fully controlled using hydrochlorothiazide or other thiazide diuretics, switching to this product can achieve a greater reduction in blood pressure. Patients receiving hydrochlorothiazide 25 mg (or 50 mg) once a day should stop the diuretic for at least 3 days before using this product. Adjust the dose as needed after using this product. This product can replace the combination treatment of benazepril hydrochloride and hydrochlorothiazide. Patients with creatinine clearance of 30 mL/min do not need to adjust the dose. For severe cases that require the use of diuretics

Expected frequency: very rare ([0.01%); rare (≥0.01%, [0.1%); uncommon (≥0.1%, [1%); common (≥1%, [10%); very common (≥10%). Adverse reactions reported with this product are similar to those reported with benazepril or hydrochlorothiazide; these adverse reactions are usually mild and transient. Common cardiovascular system: palpitations, postural hypotension. Rare: symptomatic hypotension, chest pain. Common gastrointestinal tract: nonspecific gastrointestinal dysfunction. Rare: diarrhea, constipation, nausea, vomiting, abdominal pain. Common skin: rash, redness, itching and photosensitivity. Common genitourinary system: frequent urination. Rare: hypokalemia, increased blood urea nitrogen and serum creatinine (recovery after discontinuation of drug). This change often occurs in patients with renal artery stenosis (see [Precautions]). Rare: hyponatremia. Metabolic effects Rare: increased blood uric acid level. Common respiratory tract: cough, respiratory symptoms. Central nervous system Common: headache, dizziness, fatigue. Uncommon: drowsiness, insomnia, nervousness, vertigo, anxiety, paresthesia. Sense organs Rare: tinnitus and taste disturbance. Allergic and immune reactions Rare: angioedema, facial and lip edema (see [Precautions]: Allergic and related reactions). Musculoskeletal system Rare: arthralgia, arthritis, myalgia, musculoskeletal pain.

This drug is contraindicated in patients with known allergy to benazepril, hydrochlorothiazide or any of the excipients in this product; known allergy to other ACE inhibitors or other sulfonamide derivatives; history of angioedema during previous ACE inhibitor treatment; anuria, severe renal failure (creatinine clearance 30 mL/min) and liver failure; patients with refractory hypokalemia, hyponatremia and symptomatic hyperuricemia, as well as pregnant women (see [Use in Pregnant and Lactating Women]).

Precautions for children: No studies have been conducted on the efficacy and safety of this product in children. Precautions for pregnancy and lactation: Pregnancy: This product is contraindicated during pregnancy (see [Contraindications]). The use of ACE inhibitors by pregnant women may cause fetal and neonatal defects and death. There have been dozens of reports in the global literature. Fetuses and neonates treated with ACE inhibitors in the 4th to 9th months of pregnancy may experience hypotension, neonatal skull dysplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has been reported, presumably as a result of fetal renal impairment, in which case oligohydramnios is associated with fetal limb contractures, craniofacial malformations, and pulmonary hypoplasia. Premature birth, intrauterine growth retardation, and patency of the ductus arteriosus have also been reported, although it is unclear whether these are related to the administration of ACE inhibitors. In addition, the use of ACE inhibitors in the first 3 months of pregnancy is associated with the use of ACE inhibitors in the elderly. Precautions for the elderly: Monitoring is required for elderly patients (creatinine clearance 30-60mL/min), see [Precautions] for details.

The combined use of potassium-sparing diuretics (such as spironolactone, triamterene, amiloride), potassium supplements, or potassium-containing salts is not recommended because the risk of hyperkalemia may increase when used together. If combined use is necessary, close monitoring of serum potassium concentrations is recommended. The use of ACE inhibitors (including benazepril) during lithium therapy can result in increased serum lithium levels and symptoms of lithium poisoning. Because thiazide diuretics can reduce the renal clearance of lithium, the risk of lithium poisoning may increase when thiazide diuretics are used in combination with ACE inhibitors (such as this product). This product should be used with caution in combination with lithium, and it is recommended to monitor serum lithium concentrations frequently. Diabetic patients who receive ACE inhibitors (including benazepril) and insulin or oral hypoglycemic drugs at the same time may experience hypoglycemia.

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Each tablet contains 10 mg of benazepril hydrochloride and 12.5 mg of hydrochlorothiazide

36 months

Guangzhou Nucien Pharmaceutical Co., Ltd.

• Founded in:

  1993-09-17

• Address:

  Building 1-2, No. 196, Kaiyuan Avenue, Luogang District, Guangzhou

• Tax NO.:

  91440101618440809W

• Registered Funds:

  65.25 million yuan

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