Sandostatin (octreotide) solution for injection 0.05 mg/ml. 1ml. ampoules №5

Description

Sandostatin (octreotide) solution for injection 0.05 mg/ml. 1ml. ampoules №5

Composition

active substance: octreotide;

1 ml of solution contains octreotide (in the form of a free peptide) 0.05 mg or 0.1 mg;

excipients: lactic acid, mannitol (E 421), sodium bicarbonate, water for injections.

Medicinal form

Solution for injection.

Main physicochemical properties: transparent colorless solution.

Pharmacotherapeutic group

Hormone preparations for systemic use, with the exception of sex hormones and insulin. Hormones of the hypothalamus, pituitary gland and their analogues. Hypothalamic hormones. Somatostatin and analogues. Octreotide.
ATX code H01S B02.

Pharmacological properties

Sandostatin solution is a synthetic octapeptide, which is a derivative of the natural hormone somatostatin and has similar pharmacological effects, but a much longer duration of action. The drug suppresses the pathologically increased secretion of growth hormone (GH), as well as peptides and serotonin, which are produced in the gastroenteropancreatic endocrine system.

In animals, octreotide is a more potent inhibitor of growth hormone, glucagon, and insulin release than somatostatin, with greater selectivity for growth hormone and glucagon inhibition.

In healthy individuals, Sandostatin solution suppresses:

• arginine-induced growth hormone secretion, exercise-induced hypoglycemia, and insulin;
• the secretion of insulin, glucagon, gastrin and other peptides of the gastroenteropancreatic endocrine system, which is caused by food intake, as well as the secretion of insulin and glucagon, which is stimulated by arginine;
• thyroid-stimulating hormone (TSH) secretion caused by thyroliberin.

Indications

This drug inhibits the increased formation of growth hormone (somatostatin), as well as the release of serotonin and peptides produced by the endocrine cells of the stomach, intestines, and pancreas.
Sandostatin solution is indicated for the following conditions:

• acromegaly (in case of impossibility or ineffectiveness of the use of radiation therapy, surgical treatment or therapy with dopamine agonists);
• endocrine tumors: glucagonomas, insulomas, VIPomas, gastrinomas;
• tumors characterized by increased production of somatoliberin;
• for the prevention of complications during operations on the pancreas;
• refractory diarrhea (diarrheal syndrome) in AIDS;
• bleeding (including prevention of relapse) from varicose veins of the esophagus in cirrhosis (emergency treatment).

Contraindications

Sandostatin is contraindicated in case of hypersensitivity to it.

Application during pregnancy and lactation

Caution is required when using the pharmaceutical preparation Sandostatin in women during the indicated periods.

Method of administration and dosage

With acromegaly, the drug is initially administered subcutaneously at 0.05–0.1 mg every 8 or 12 hours. In the future, dose selection should be based on monthly determinations of GH and IGF-1 concentrations, analysis of clinical symptoms and tolerability of the drug (target hormone concentrations are: GH — less than 2.5 ng/ml, IGF-1 — within the normal range). For most patients, the optimal daily dose is 0.3 mg. The maximum daily dose is 1.5 mg, which should not be exceeded. In patients receiving a stable dose of Sandostatin solution, it is necessary to determine the concentrations of GH and IGF-1 every 6 months.

If within 3 months of treatment with Sandostatin solution, there is no sufficient decrease in the level of GH and improvement of the clinical picture of the disease, the therapy should be stopped.

For endocrine tumors of the gastrointestinal tract and pancreas, the drug is administered subcutaneously in an initial dose of 0.05 mg 1‒2 times a day. In the future, depending on the achieved clinical effect, as well as the effect on the level of hormones produced by the tumor (in the case of carcinoid tumors, on the excretion of 5-hydroxyindoleacetic acid in the urine), and tolerability, the dose of the drug can be gradually increased to 0.1–0, 2 mg 3 times a day. In exceptional cases, higher doses may be required.

Maintenance doses of the drug should be selected individually.

If within one week of treatment with Sandostatin solution in the maximum tolerated dose of carcinoid tumors, no improvement occurs, further therapy is not recommended.

For the prevention of complications after operations on the pancreas, the drug is administered subcutaneously at 0.1 mg 3 times a day for 7 consecutive days, starting from the day of the operation (at least 1 hour before laparotomy).

For bleeding from varicose veins of the esophagus, administer the drug at a dose of 25 mcg/h by continuous intravenous infusion for 5 days. Sandostatin solution can be diluted with 0.9% sodium chloride solution.

In patients with cirrhosis and bleeding from varicose veins of the stomach and esophagus, good tolerance to Sandostatin was noted when receiving a stable dose of the drug up to 50 mcg/h as a continuous intravenous infusion for 5 days.

Overdose

Due to an overdose of Sandostatin, hypotension, weakness, pancreatitis, drowsiness, diarrhea, arrhythmia, brain hypoxia, hepatitis steatosis, weight loss, lactic acidosis, liver enlargement, cardiac arrest can develop.
In case of an overdose of Sandostatin, the patient undergoes symptomatic treatment.

Side effects

When using the pharmaceutical drug Sandostatin, side effects such as flatulence, anorexia, acute pancreatitis, vomiting, abdominal pain, diarrhea, liver dysfunction, nausea, signs of acute intestinal obstruction, the formation of gallstones (in case of prolonged use), impaired tolerance to glucose, hair loss, hyper- or hypoglycemia.
At the injection site, there may be a burning sensation, itching, swelling, pain, redness.