Imidapril Hydrochloride Tablets

1 Pharmacology This product is an angiotensin converting enzyme (ACE) inhibitor. After oral administration, it is converted into the active metabolite imidaprilat in the body, which can inhibit the activity of ACE, prevent angiotensin I from being converted into angiotensin II, dilate peripheral blood vessels, reduce vascular resistance, and produce a hypotensive effect. 2 Toxicology (carcinogenicity, mutagenicity and reproductive toxicity) Rats and mice were orally administered this product (10 mg/kg and 30 mg/kg per day) for 18 months and 4 months respectively, and no carcinogenic effect was found. No mutagenic effect was found in the bacterial reverse mutation test, mouse micronucleus test, chromosome aberration and gene mutation test. No teratogenic and lethal effects were found in the reproductive toxicity study of rats and rabbits.

Imidapril hydrochloride.

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

1. Treatment of primary hypertension. 2. Treatment of secondary hypertension caused by renal parenchymal lesions.

Oral administration: 5-10 mg per time for adults, once a day; the starting daily dose for patients with severe hypertension or secondary hypertension due to renal parenchymal disease is 2.5 mg.

The adverse reactions of this product are mostly mild, mainly cough (4.5%), pharyngeal discomfort (0.5%), dizziness (0.2%), postural hypotension (0.2%), rash (0.1%), etc. Occasionally, there are angioedema of the face, tongue, and throat accompanied by dyspnea, severe thrombocytopenia, worsening of renal insufficiency, or elevated liver aminotransferase. There are reports that angiotensin converting enzyme inhibitors can cause various blood cell reductions.

1. Patients with a history of allergy to this product. 2. Patients with angioedema caused by other angiotensin converting enzyme inhibitors. 3. Patients treated with glucose sulfate cellulose adsorber. 4. Patients undergoing hemodialysis with sodium acrylonitrile methyl allyl sulfonate membrane (AN69?).

Precautions for children: As an antihypertensive drug, the safety and effectiveness of this product in children have not yet been determined. Precautions for pregnancy and lactation: 1. This product is contraindicated for women who are pregnant or may become pregnant. 2. This product should be used with caution by lactating women. Breastfeeding should be discontinued when the drug is necessary. Precautions for the elderly: When taking this product, the elderly should start with a low dose (such as 2.5 mg), and increase or decrease the dose as appropriate according to the patient's condition, and adjust the interval between doses.

1. The combination of this product with potassium-sparing diuretics (spironolactone, triamterene, etc.) or potassium supplements (potassium chloride, etc.) may increase serum potassium concentration. 2. The combination of this product with lithium preparations (lithium carbonate) may cause lithium poisoning. 3. For patients treated with diuretics (trichloromethiazide, hydrochlorothiazide, etc.), the first use of this product will enhance the antihypertensive effect. 4. The combination with non-steroidal anti-inflammatory drugs (indomethacin) will weaken the antihypertensive effect of this product. 5. Other drugs with antihypertensive effects (antihypertensive drugs, nitrate preparations, etc.) can also enhance the antihypertensive effect of this product.

Store in a cool, dry place.

10mg

36 months

Yuanda Pharmaceutical (Tianjin) Co., Ltd.

• Founded in:

  1993-10-15

• Address:

  No. 16, Weisan Road, Microelectronics Industrial Zone, Tianjin Economic and Technological Development Zone

• Tax NO.:

  91120116600576732H

• Registered Funds:

  110.533424 million yuan

• Email:

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