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.

Each vial contains the active ingredient octreotide acetate equivalent to 100 μg of octreotide. Excipients include glacial acetic acid, sodium acetate, sodium chloride and water for injection. The chemical name of octreotide acetate is: D-phenylalanine-L-cysteine-L-phenylalanine-D-tryptophan-L-threonine-N-[2-hydroxy-1-(hydroxymethyl)propyl]-L-cysteine (2→7)-disulfide bond compound structure: Molecular formula: C49H66N10O10S2 Molecular weight: 1019.3

This product is a colorless, clear solution sealed in a 1 ml colorless FBCN glass ampoule with a green neck mark.

Digestive system medications. Esophageal gastric venous bleeding, peptic ulcer and emergency ulcer, acute pancreatitis, prevention of complications after pancreatic surgery, gastrointestinal pancreatic endocrine tumors, acromegaly.

1. Esophageal-gastric varicose bleeding: continuous intravenous infusion of 0.025 mg/hour. The maximum treatment period is 5 days. 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 at least 1 hour before surgery. 3. Gastroenteropancreatic endocrine tumors: The initial dose is 0.05 mg subcutaneous, 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 assessment of circulating GH concentration, clinical response and tolerance. The optimal dose for most patients is 0.2-0.3 mg/day, and the maximum dose 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. If the GH concentration does not decrease and the clinical symptoms do not improve after one month of treatment with this product, discontinuation of the drug should be considered.

1. Local reactions to injection, including pain, a tingling or burning sensation at the injection site, accompanied by redness and swelling. These phenomena rarely last more than 15 minutes. Allowing the solution to reach room temperature before injection can reduce local discomfort. 2. Gastrointestinal reactions, including loss of appetite, nausea, vomiting, spasmodic abdominal pain, flatulence, loose stools, diarrhea, and steatorrhea. In rare cases, gastrointestinal reactions may resemble acute intestinal obstruction with progressive severe upper abdominal pain, abdominal tenderness, muscle tension, and abdominal distension. 3. Long-term use may lead to the formation of gallstones. 4. Because this product can inhibit the release of GH, glucagon, and insulin, it may cause blood sugar regulation disorders. Because it can reduce patients' postprandial glucose tolerance, a small number of long-term users may cause persistent hyperglycemia, and hypoglycemia has been observed. 5. Others: A few reports of acute pancreatitis, which gradually disappears after discontinuation of the drug: In rare cases, octreotide acetate treatment has been reported to cause hair loss in patients. Long-term use of this product and the development of gallstones may also cause pancreatitis. Some patients develop liver dysfunction, including slowly onset hyperbilirubinemia with mild increases in alkaline phosphatase, gamma-glutamyl transferase and transaminase.

Patients who are allergic to octreotide or any of the excipients in this product are contraindicated.

Precautions for children: There is very limited experience with the drug in pediatric patients. 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 adverse effects on reproduction and offspring development. Temporary growth retardation in some young animals may be caused by 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: It is necessary to adjust the dose when using this product because the half-life of the drug is significantly prolonged and the drug clearance is significantly reduced.

It can reduce the intestinal absorption of cyclosporine and delay the absorption of cimetidine.

Store in a refrigerator at 2-8℃, avoid freezing and light.

1 ml: 100 micrograms

60 months.