Octreotide 100mcg / ml injection 1ml №5 ampoules / Nativ /

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Oktreotid 100mkg / ml solution for injection 1 ml No. 5 ampoules / Nativ /

Composition

Solution for intravenous and subcutaneous administration 1 amp
active substance:  
octreotide 50 mcg
  100 mcg
excipients: sodium chloride - 9/9 mg; water for injection - up to 1/1 ml  

Description of the dosage form

Transparent colorless odorless liquid.

pharmachologic effect

- somatostatin-like.

Pharmacodynamics

Octreotide is a synthetic analogue of somatostatin, with similar pharmacological effects, but with a significantly longer duration of action. Octreotide inhibits the secretion of growth hormone (GH), both pathologically elevated, and caused by arginine, exercise and insulin hypoglycemia. The drug also inhibits the secretion of insulin, glucagon, gastrin, serotonin, as pathologically increased, and caused by food intake; also inhibits the secretion of insulin and glucagon, stimulated by arginine. Octreotide inhibits the secretion of thyrotropin, caused by thyroliberin.

In patients who are scheduled for surgery on the pancreas, the use of octreotide before, during and after surgery reduces the incidence of typical postoperative complications (for example, pancreatic fistulas, abscesses, sepsis, acute postoperative pancreatitis). When bleeding from varicose veins of the esophagus and stomach in patients with liver cirrhosis, the use of octreotide in combination with specific treatment (for example, sclerosing and hemostatic therapy) leads to more effective hemostasis and prevention of rebleeding.

Pharmacokinetics

After s / c administration, octreotide is rapidly and completely absorbed. Cmax plasma octreotide is reached within 30 minutes. Plasma protein binding is 65%. The binding of octreotide with blood cells is extremely small. Vd makes 0,27 l / kg. T1/2 after s / c administration of octreotide is 100 minutes. After iv injection, octreotide elimination is carried out in 2 phases, with T1/2 - 10 and 90 min, respectively. Most of the octreotide is excreted through the intestines, about 32% is excreted unchanged by the kidneys.
Total clearance is 160 ml / min. Elderly patients decrease clearance, and T1/2 increases.With severe chronic renal failure, clearance is reduced by 2 times.

Indications drug Octreotide

  • treatment of acute pancreatitis;
  • stopping bleeding in gastric ulcer and duodenal ulcer;
  • arrest of bleeding and prevention of rebleeding from esophageal varicose veins in patients with cirrhosis of the liver;
  • prevention and treatment of complications after abdominal surgery.

Contraindications

  • hypersensitivity to octreotide or other components of the drug;
  • children's age up to 18 years.

Carefully:

cholelithiasis (gallstone disease), diabetes mellitus, pregnancy, lactation.

Use during pregnancy and lactation

The use of octreotide during pregnancy has not been studied. Octreotide should be used during pregnancy only if the intended benefit to the mother outweighs the potential risk to the fetus.

It is not known whether the drug gets into breast milk, therefore, when using the drug during lactation, breastfeeding should be abandoned.

Side effects

On the part of the digestive tract, pancreas, liver and gallbladder: anorexia, nausea, vomiting, spastic pain in the abdomen, feeling of bloating, excessive gas formation, diarrhea, and steatorrhea are possible. Although the excretion of fat with feces may increase, there is no indication that prolonged treatment with Octreotide may lead to the development of malabsorption disorders (malabsorption). In rare cases, there may be symptoms resembling acute intestinal obstruction.

There are isolated cases of acute hepatitis without cholestasis, as well as hyperbilirubinemia in combination with an increase in the activity of alkaline phosphatase, GGT and to a lesser extent other transaminases.
Prolonged use of Octreotide can lead to the formation of stones in the gallbladder.
From the CCC: in some cases - arrhythmia, bradycardia.
On the part of carbohydrate metabolism: there may be impaired glucose tolerance after a meal (due to the suppression of insulin secretion), hypoglycemia; in rare cases, prolonged treatment may develop persistent hyperglycemia.
Local reactions: at the injection site pain, itching or burning, redness and swelling are possible (usually disappear within 15 minutes).
Other: allergic reactions, alopecia.

Interaction

Octreotide reduces the absorption of cyclosporine, slows down the absorption of cimetidine.
Correction of the dosing regimen of simultaneously used diuretics, beta-blockers, BPC, insulin, oral hypoglycemic drugs is necessary.
With simultaneous use of Octreotide and bromocriptine, the bioavailability of the latter increases.
Preparations metabolized by cytochrome P450 enzymes and having a narrow therapeutic dose range should be prescribed with caution.

Dosage and administration

P / C, in / in (drip).
For the treatment of acute pancreatitis, the drug is injected s / c at a dose of 100 mcg 3 times a day for 5 days. You can assign up to 1200 mg / day using the / in the route of administration.
To stop ulcerative bleeding, it is administered intravenously at a dose of 25–50 mcg / h in the form of intravenous infusion for 5 days.
To stop bleeding from the varicose veins of the esophagus injected into / in the dose of 25-50 mg / h in the form of continuous IV infusion for 5 days. Elderly patients do not need to reduce the dose of Octreotide.
For the prevention of complications after operations on the pancreas, the first dose of 100–200 mcg is given in sc 1–2 hours before laparotomy; then after the operation, SCs are administered 100–200 mcg 3 times / day for 5–7 consecutive days.

Overdose

Symptoms: short-term decrease in heart rate, feeling of flushing, spastic pain in the abdomen, diarrhea, nausea, feeling of emptiness in the stomach.
Treatment: symptomatic.

special instructions

In diabetic patients receiving insulin, Octreotide may reduce the need for insulin.

If gallstones are detected before treatment, the question of using Octreotide is solved individually, depending on the ratio of the potential therapeutic effect of the drug and possible risk factors associated with the presence of stones in the gallbladder.

Side effects from the gastrointestinal tract can be reduced if Octreotide injections are given between meals or before bedtime.

To reduce the phenomena of discomfort at the injection site, it is recommended to bring the solution of the drug before the introduction to room temperature and introduce a smaller volume of the drug. Multiple injections should be avoided at the same place at short intervals.
Influence on ability to steer the car and other mechanisms.Some side effects of octreotide may adversely affect the ability to drive a car and other mechanisms that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions of the drug Octreotide

In the dark place at a temperature of from 8 to 25 ° C.

Keep out of the reach of children.

The shelf life of the drug Octreotide
5 years.

Do not use after the expiration date printed on the package.



It is a drug. Consultation with a doctor is required.