Octreotide 50mcg / ml injection for 1 ml №10 ampoules / Nativ /

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Octreotide 50 mcg / ml injection for injection 1 ml No. 10 ampoules / Nativ /

Solution for iv and p / to the introduction of 0.005% transparent, colorless, odorless.

1 ml
octreotide 50 mcg

Excipients:

sodium chloride - 9 mg, water d / and - up to 1 ml.

Clinico-pharmacological group:

Somatostatin analogue. Drug for intensive care in gastroenterology

Pharmaco-therapeutic group:

Somatostatin (synthetic analog)

Indications

- treatment of acute pancreatitis;
- stop bleeding with gastric ulcer and duodenal ulcer;
- arrest of bleeding and prevention of rebleeding from esophageal varicose veins in patients with liver cirrhosis;
- prevention and treatment of complications after operations on the abdominal organs.

Dosing regimen

For the treatment of acute pancreatitis, the drug is injected s / c at a dose of 100 mcg 3 times / 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 μg / h in the form of intravenous infusion for 5 days.
To stop bleeding from varicose veins of the esophagus injected into / in a 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 μg is injected s / c for 1-2 hours before laparotomy; then, after the operation, SCs are administered at 100–200 mcg 3 times / day for 5–7 consecutive days.

Side effect

On the part of the gastrointestinal tract and pancreas: anorexia, nausea, vomiting, cramping abdominal pain, bloating, excessive gas formation, loose stools, diarrhea, steatorrhea are possible. Although the excretion of fat with feces may increase, there is no indication that long-term 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, 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 gallstones.
Since the cardiovascular system: in some cases - arrhythmia, bradycardia.
On the part of carbohydrate metabolism: there may be a violation of glucose tolerance after a meal (due to the suppression of insulin secretion by the drug), hypoglycemia; in rare cases, prolonged treatment may develop persistent hyperglycemia.
Local reactions: at the injection site pain, itching or burning, redness, swelling (usually disappear within 15 minutes) are possible.
Other: allergic reactions, alopecia.

Contraindications

- children's age up to 18 years;
- hypersensitivity to octreotide or other components of the drug.
With care: cholelithiasis (cholelithiasis), 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.

Use in children
Contraindicated in children under 18 years of age.

Use in elderly patients
Elderly patients do not need to reduce the dose of Octreotide.

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 injections of octreotide are made 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 drive motor transport and control mechanisms
Some side effects of octreotide may adversely affect the ability to drive vehicles and other mechanisms that require increased concentration and psychomotor speed.

Overdose

Symptoms: short-term decrease in heart rate, feeling of blood "flush" to the face, abdominal cramping, diarrhea, nausea, feeling of emptiness in the stomach.
Treatment: symptomatic.

Drug interaction

Octreotide reduces the absorption of cyclosporine, slows down the absorption of cimetidine.
Correction of the dosing regimen of simultaneously used diuretics, beta-blockers, blockers of “slow” calcium channels, 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.

Terms and conditions of storage

The drug should be stored in a dark place at a temperature of 8 ° to 25 ° C, in places inaccessible to children.

Shelf life - 5 years. Do not use after expiration date.



It is a pharmaceutical drug. Use only as directed by your doctor.