Lisinopril Capsules

1 Pharmacology This product is a competitive angiotensin converting enzyme inhibitor. It prevents angiotensin I from being converted to angiotensin II, reduces aldosterone secretion, increases plasma renin activity, and inhibits the degradation of bradykinin, reducing vascular resistance. Clinical trials have shown that the antihypertensive effect of this product alone in African hypertensive patients (usually low renin) is lower than that of other patients. This product does not cause reflex tachycardia while lowering blood pressure. This product dilates arteries and veins, reduces peripheral vascular resistance or afterload, reduces pulmonary capillary wedge pressure or preload, and also reduces pulmonary vascular resistance, thereby improving cardiac output in patients with heart failure and prolonging exercise tolerance and time. Large-scale clinical trials have confirmed that early use of this product in patients with acute myocardial infarction can reduce mortality. 2 Toxicology This product can pass through the blood-brain barrier of mice. This product has no adverse effects on the reproductive capacity of female and male mice when administered at 300 mg/kg per day. Pregnant rats, mice, and rabbits were given this product at 55 times, 33 times, and 0.15 times the maximum recommended human dose (calculated by body surface area), and no teratogenic effects were found. Pregnant mice were given isotope-labeled lisinopril, and radioactivity was found in the placenta, but not in the fetus. Lactating mice were given 14C-labeled lisinopril, and radioactivity was found in the milk. No carcinogenicity was found in this product. Rats were given this product orally at 90 mg/kg/day for 105 weeks or 135 mg/kg/day for 92 weeks, and no carcinogenicity was found in this product.

Chemical name of this product: 1-[N2-[（S）-1-carboxy-3-phenylpropyl]-L-lysinyl]-L-proline dihydrate, molecular formula: C21H31N3O4?2H2O, molecular weight: 441.52.

This product is a capsule, and the contents are white or off-white powder.

Hypertension (can be used alone or in combination with other antihypertensive drugs such as diuretics)

1 The initial dose for lowering blood pressure is usually 10 mg/time, the maintenance dose is 10 mg/time, and the maximum dose is 80 mg/time. Patients who are taking diuretics should stop taking diuretics 3 days before starting treatment with this product. For those who cannot stop taking diuretics, the initial dose is reduced to 5 mg, and then adjusted according to blood pressure. Diuretics can be used again if necessary. For patients with renal failure and creatinine clearance of 10-30 mL/min, the initial dose is 2.5 mg-5 mg/day; for patients with creatinine clearance less than 10 mL/min, the initial dose is 2.5 mg/day, and the maximum dose is 40 mg/day. 2 The initial dose for patients with chronic heart failure and hypertension is 2.5 mg/day, and the commonly used effective dose is 5 mg-20 mg, once a day. For patients with symptomatic hypotension, with or without hyponatremia, with reduced blood volume or receiving strong diuretics, they should be corrected as much as possible before using this product, and the effect of each medication on blood pressure should be carefully monitored. 3. For acute myocardial infarction, the first dose is 5 mg orally, followed by 5 mg and 10 mg after 24 hours and 48 hours respectively, followed by 10 mg per day, which should be continued for 6 weeks. Patients with low systolic blood pressure (systolic blood pressure ￡120 mmHg) or patients within 3 days after infarction should be given a lower dose of 2.5 mg. If hypotension occurs (systolic blood pressure below 100 mmHg), the maintenance dose can be temporarily reduced to 2.5 mg; if hypotension persists (systolic blood pressure below 90 mmHg for 31 hours), the drug should be discontinued. This drug can be used as a secondary prevention drug for myocardial infarction.

Most patients tolerate this product well, with mild and short-term headaches, dizziness, fatigue, drowsiness, nausea, and cough being the most common. The most common reasons for discontinuation are headaches and coughs. Rare adverse reactions include: postural hypotension, syncope, erythema and fatigue, allergic/angioneurotic edema (occasionally occurring on the face, limbs, lips, tongue, glottis, and/or larynx). The following side effects are occasionally seen: Cardiovascular system: ischemic heart disease or cerebrovascular disease (when the patient's blood pressure drops excessively, it leads to myocardial infarction or cerebrovascular accident, palpitations, tachycardia); Digestive system: abdominal pain, dry mouth, hepatocellular or cholestatic hepatitis, cirrhosis; Nervous system: emotional changes, confusion. Skin: urticaria, rash, sweating, photosensitivity or other skin symptoms; Urogenital system: uremia, decreased urine volume/anuria, renal insufficiency, acute renal failure, impotence; Others: fever, vasculitis, myalgia, joint neuralgia/arthritis; Laboratory tests: increased blood urea and serum creatinine, slightly decreased hemoglobin and hematocrit, positive antinuclear antibodies, accelerated erythrocyte sedimentation rate, increased eosinophils and leukocytosis, and hyperkalemia.

Those who are allergic to any component of this product. Those who have experienced angioedema after using angiotensin-converting enzyme inhibitors. Those with solitary kidney, transplanted kidney, bilateral renal artery stenosis and renal impairment.

Precautions for children: The dosage for children has not been determined and the research is insufficient. In newborns and infants, there is a risk of oliguria and neurological abnormalities, which may be related to the renal and cerebral ischemia caused by the product lowering blood pressure. Precautions for pregnancy and lactation: Pregnant women taking angiotensin-converting enzyme inhibitors can cause fetal and neonatal death. Once pregnancy is discovered, this product should be discontinued immediately. The use of angiotensin-converting enzyme inhibitors during pregnancy for 6-9 months can cause hypotension, skeletal dysplasia in newborns, anuria, reversible and non-reversible renal failure, and even death. It is not known whether this product is secreted in human breast milk. Precautions for the elderly: Age has no effect on the efficacy and safety of this drug. However, for the elderly with renal function decline, the dose of this drug should be reduced, and then adjusted according to the blood pressure.

Patients with heart failure who use cardiac glycosides and diuretics already have water and sodium deficiency. When starting to use this product, a small dose should be used; combined use with potassium-sparing diuretics such as spironolactone, triamterene, and amiloride may cause hyperkalemia, especially in patients with renal insufficiency. Nonsteroidal anti-inflammatory analgesics, especially indomethacin, can inhibit renal prostaglandin synthesis and cause water and sodium retention, weakening the antihypertensive effect of this product. When used in combination with other antihypertensive drugs, it has a synergistic antihypertensive effect, among which it has a greater additive effect with drugs that cause renin release or affect sympathetic activity. Combination with lithium salts can reduce the excretion of lithium salts, and the concentration of lithium salts must be monitored.

Keep in a light-proof and airtight container.

10 mg

18 months

Jiangsu Tasly DIYI Pharmaceutical Co., Ltd.

• Founded in:

  1999-03-24

• Address:

  No. 168, Chaoyang West Road, Qingpu Industrial Park, Huai'an City

• Tax NO.:

  91320800139432975C

• Registered Funds:

  66.86 million yuan

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