Octreotide | Octreotide solution for iv. and p / leather 100 Ојg / ml 1 ml ampoule 5 pcs.

Release form

Intravenous and subcutaneous solution

Packing

5 pcs.

Pharmacological action

Octreotide, a synthetic octapeptide derived from the natural hormone somatostatin, has similar pharmacological effects, but with a significantly longer duration of action.

Octreotide suppresses both pathologically increased secretion of growth hormone (GH), as well as that caused by arginine, exercise, and insulin hypoglycemia.

The drug inhibits the secretion of serotonin, gastrin, insulin and glucagon and other peptides produced in the gastro-entero-pancreotic endocrine system.

In patients undergoing pancreatic surgery, the use of octreotide during and after surgery reduces the incidence of typical postoperative complications (acute postoperative pancreatitis, pancreatic fistula, abscesses, sepsis).

In case of bleeding from varicose veins n * -98 / of the esophagus and stomach in patients with cirrhosis of the liver, the use of octreotide as part of complex therapy leads to an effective stop of bleeding, prevention of early rebleeding and improved survival.

The mechanism of action of octreotide is associated with a decrease in organ blood flow through the suppression of vasoactive hormones (vasoactive intestinal peptide, glucagon).

Indications

prophylaxis and treatment of complications after operations on the pancreas and gastroduodenal zone

as part of complex therapy for stopping bleeding and preventing rebleeding from varicose veins of the esophagus in patients with cirrhosis of the liver

treatment of acute pancreatic ulcer disease and srd 12 duodenal ulcer.

Contraindications

Hypersensitivity to the components of the drug.

Precautions

Diabetes mellitus,

gallstone disease.

Composition

1 ml of the solution contains:

Active ingredient: octreotide acetate (in terms of octreotide) 0.100 mg.

Excipients:

Sodium chloride 9.0 mg

Water for injection up to 1.0 ml

Dosage and administration of

In the treatment of acute pancreatitis, Octreotide is administered sc at a dose of 100 mcg 3 times / day for 5-7 days. It is possible to prescribe up to 1200 Ојg / day, the selection of the dose is based on the determination of the concentration of amylase, lipase, inflammatory blood cytokines.

For the prevention of complications after pancreatic surgery, the first dose of Octreotide 100 Ојg is administered s.c. 1 hour before laparotomy, then after the operation, s.c. is administered 100 Ојg 3-4 times / day for 7 consecutive days. To stop bleeding from varicose veins of the esophagus, the drug is administered iv in a dose of 25 Ојg / h in the form of continuous infusions for 5 days.

To stop bleeding with gastric ulcer and duodenal ulcer, it is recommended to administer Octreotide in the form of iv infusion at a dose of 25 mcg / h for 5 days. In elderly patients, there is no need to reduce the dose of Octreotide.

In patients with impaired renal function, correction of the dosage regimen of octreotide is not required.

In patients with impaired liver function, a maintenance dose adjustment is recommended because there is evidence of an increase in T1 / 2 octreotide in patients with cirrhosis. Experience with octreotide in children is very limited.

Side effects

Local reactions: pain, itching or burning sensation, redness and swelling are possible at the injection site (usually go away within 15 minutes).

From the gastrointestinal tract, pancreas, liver and gall bladder: possible - anorexia, nausea, vomiting, spastic abdominal pain, bloating, excessive gas formation, loose stools, diarrhea and steatorrhea.

Although the excretion of fat with feces may increase, there is no indication that long-term treatment with octreotide can lead to the development of malabsorption (malabsorption). In rare cases, phenomena resembling acute intestinal obstruction can occur: progressive bloating, severe pain in the epigastric region, tension of the abdominal wall.

Prolonged use of octreotide can lead to gallstones.

Certain cases of acute hepatitis without cholestasis are known (normalization of transaminases after cancellation of octreotide), as well as hyperbilirubinemia in combination with an increase in the activity of alkaline phosphatase, gamma-glutamyl transferase and other transaminases.

There are some reports of rare cases of acute pancreatitis, which developed in the first hours or days of the use of octreotide. From the cardiovascular system: in some cases - tachycardia, bradycardia.

From the side of metabolism: impaired glucose tolerance after eating is possible (octreotide has an inhibitory effect on the formation of GH, glucagon and insulin), hypoglycemia in rare cases, with prolonged treatment, persistent hyperglycemia may develop.

Other: rarely - allergic reactions, allopecia in some cases - anaphylactic reactions.

Overdose

Known that the administration of octreotide at a dose of up to 2000 mcg as a sc injection 3 times over several months was well tolerated. The maximum single dose for iv bolus administration to an adult patient was 1000 mcg.

At the same time, symptoms such as a decrease in heart rate, flushing of the face, abdominal pain of a spastic nature, diarrhea, nausea, a feeling of emptiness in the stomach were noted. All these symptoms resolved within 24 hours of administration of the drug.

One patient was mistakenly injected with an excess dose of 250 mcg / h octreotide (instead of 25 mcg / h) by prolonged infusion, which was not accompanied by side effects.

In acute overdose, no life-threatening reactions were observed.

Treatment: symptomatic therapy.

Active ingredient

Octreotide



pharmacy terms and conditions

prescription

Dosage form

solution for injection and infusions