Octreotide Acetate Injection

It can inhibit the pathological excessive secretion of growth hormone, thyroid-stimulating hormone, gastrointestinal and pancreatic endocrine hormones; it can selectively reduce the blood flow and pressure of the portal vein and its collateral circulation, and reduce the pressure of varicose veins in the esophagus and gastric fundus; it can inhibit gallbladder emptying and have a therapeutic effect on pancreatic lesions; it can inhibit the secretion of gastric acid and gastrin, and improve the blood supply to the gastric mucosa; it can inhibit gastrointestinal motility.

Octreotide acetate. Chemical name: D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophanyl-L-lysyl-L-threonyl-L-cysteinyl-L-threonyl (2rarr; 7) cyclic disulfide acetate.

This product is a colorless or almost colorless clear liquid.

1. Emergency treatment of esophageal-gastric varicose bleeding caused by liver cirrhosis, used in combination with special treatments (such as endoscopic sclerotherapy). 2. Prevention of complications after pancreatic surgery. 3. Relieve symptoms and signs related to gastrointestinal endocrine tumors. There is sufficient evidence to show that this product is effective for the following tumors: carcinoid tumors with carcinoid syndrome; VIP tumors; glucagonomas. The efficacy of this product for the following tumors is about 50% (so far, the number of cases treated with this product is limited); gastrinoma/Zollinger-Ellison syndrome, insulinoma, growth hormone releasing factor tumor. 4. It can control symptoms and reduce the concentrations of growth hormone (GH) and growth hormone mediator C in patients with acromegaly who have failed surgery, radiotherapy or dopamine receptor agonists. It is also suitable for

1. Esophageal-gastric varicose bleeding: continuous intravenous infusion of 0.025 mg/hour. The maximum treatment period is 5 days, and it can be diluted with normal saline or glucose solution. 2. Prevention of complications after pancreatic surgery: 0.1 mg subcutaneous injection 3 times a day, continuous treatment for 7 days, the first injection should be performed at least 1 hour before surgery. 3. Gastroenteropancreatic endocrine tumors: The initial dose is 0.05 mg subcutaneous injection, once or twice a day, and then the dose can be gradually increased to 0.2 mg three times a day based on tolerance and efficacy. 4. Acromegaly: The initial dose is 0.05-0.1 mg subcutaneous injection once every 8 hours, and then the dose is adjusted based on monthly assessments of circulating GH concentrations, clinical responses and tolerance. Most patients should not exceed 1.5 mg/day. The dose can be reduced as appropriate after several months of treatment under the guidance of monitoring plasma GH levels. After 1 month of treatment with this product, if the GH concentration does not decrease and the clinical symptoms do not improve, the drug should be considered for discontinuation.

The main adverse reactions include pain or tingling at the injection site, which can generally be relieved after 15 minutes. Gastrointestinal adverse reactions include anorexia, nausea, vomiting, diarrhea, abdominal cramps and pain, and occasionally hyperglycemia, gallstones, impaired glucose tolerance and abnormal liver function.

Contraindicated in patients with hypersensitivity to octreotide or any of the excipients

Precautions for children: There is limited experience with the use of this product in children. Precautions for pregnancy and lactation: Studies on fertility and prenatal, perinatal and postnatal periods in female rats have shown that daily subcutaneous injection of 1 mg/kg of octreotide has no side effects on reproduction and offspring development. Temporary growth retardation in some young animals may be caused by the inhibition of growth hormone secretion caused by the pharmacological activity of the drug. There is limited experience with the use of octreotide in pregnant and lactating women. These patients should only be treated when absolutely necessary. Precautions for the elderly: There is no evidence that elderly patients have reduced tolerance to this product, so there is no need to reduce the dose when using this product.

This product can reduce the intestinal absorption of cyclosporine and delay the absorption of cimetidine.

Store in a refrigerator at 28°C, away from freezing and light.

1 ml: 0.1 mg (based on octreotide)

60 months.

SPH NO.1 Biochemical & Pharmaceutical Co., Ltd.

• Founded in:

  1994-07-30

• Address:

  No. 1317, Jianchuan Road, Minhang District, Shanghai

• Tax NO.:

  91310112133747458R

• Registered Funds:

  323.8 million yuan

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