On January 31, 2023, Guangzhou Rier Pharmaceutical Technology Co., Ltd. received the Drug Registration Certificate issued by the State Drug Administration, and furosemide injection was approved for marketing

The basic information of the Drug Registration Certificate is as follows:

[Drug name]: Furosemide injection

[Acceptance No.]: CYHS2101269

[Certificate No.]: 2023S00127

[Approval No.]: GYZZ H20233104

[Dosage form]: injection

[Specification]: 2ml: 20mg

[Registration classification]: Class 3 chemical drugs

[Indications]:

1. Edematous diseases: including congestive heart failure, liver cirrhosis, kidney diseases (nephritis, kidney disease and acute and chronic renal failure caused by various reasons), especially when other diuretic drugs are not effective, the use of this kind of drugs may still be effective. Combined with other drugs to treat acute pulmonary edema and acute brain edema.

2. Hypertension: generally, it is not the first choice for the treatment of essential hypertension, but when thiazide drugs have poor efficacy, especially when accompanied by renal insufficiency or hypertension crisis, this kind of drugs is particularly applicable.

3. Prevention of acute renal failure: It is used to prevent renal blood perfusion insufficiency caused by various reasons, such as water loss, shock, poisoning, anesthesia accident, and circulatory insufficiency. It can be used in time while correcting the insufficiency of blood volume to reduce the chance of acute renal tubular necrosis.

4. Hyperkalemia and hypercalcemia

5. Dilutive hyponatremia: especially when the blood sodium concentration is lower than 120mmol/L.

6. Hypersecretion of antidiuretic hormone (SIADH)

7. Acute drug poisoning: such as barbiturate poisoning.

[Approval conclusion]: According to the Drug Administration Law of the People's Republic of China and relevant regulations, after examination, this product meets the relevant requirements of drug registration. The registration is approved and a drug registration certificate is issued.

The original preparation of furosemide injection is held by Sanofi Co., Ltd. (Sanofi Co., Ltd.) and has not been imported into China for the time being. The specification is 20mg and the volume is 2ml.

Furosemide injection (specification: 2ml: 20mg), a generic product of Guangzhou Ruier Pharmaceutical Technology Co., Ltd., was approved for marketing on January 31, 2023.

Furosemide is a powerful and quick-acting loop diuretic, characterized by strong, rapid and transient diuretic effect. Furosemide has an obvious dose-effect relationship. With the increase of dose, the diuretic effect is significantly enhanced. The concentration in urine is the key to determine the intensity of its action, and the drug dose range is large. It has vasodilation effect and has no adverse effect on glucose metabolism or renal function. The excretion of potassium is less than that of thiazide diuretics. It is a first-line choice in clinical practice when edema occurs in a variety of fluid retention diseases, such as heart failure, cirrhosis and ascites, and kidney disease.