Octreotide solution for intravenous and subcutaneous administration 50 mcg/ml ampoules 1 ml 5 pcs buy at a price of 1,309.0 rubles in an online pharmacy in Moscow

Pharmacological properties of the drug Octreotide

A synthetic octapeptide, which is a derivative of the natural hormone somatostatin and has pharmacological effects similar to it, but a much longer duration of action. Suppresses pathologically increased secretion of growth hormone, as well as peptides and serotonin produced in the gastroenteropancreatic zone. In acromegaly, octreotide reduces the concentration of growth hormone and/or somatomedin C in the blood plasma and the severity of symptoms such as headache, swelling, hyperhidrosis, joint pain and paresthesia. In endocrine tumors of the digestive tract and pancreas, octreotide changes some clinical manifestations of the disease. For tumors characterized by overproduction of vasoactive intestinal peptide (VIP), the use of octreotide in most patients leads to a decrease in the severity of secretory diarrhea. At the same time, there is a reduction in accompanying electrolyte imbalances. For glucagonomas, the use of the drug in most cases leads to a noticeable reduction in the necrotizing migratory rash that is characteristic of this condition. Octreotide does not have any significant effect on the severity of diabetes mellitus, often observed in glucagonomas, and usually does not lead to a reduction in the need for insulin or oral hypoglycemic drugs. The decrease in diarrhea observed during therapy is accompanied by an increase in the patient’s body weight. At the beginning of treatment, a rapid decrease in the concentration of glucagon in the blood plasma is often observed, but with long-term therapy this effect does not persist. At the same time, symptomatic improvement remains stable over a long period of time. For gastrinomas (Zollinger-Ellison syndrome), octreotide, used as monotherapy or in combination with H2-receptor blockers, can reduce acid production in the stomach, reduce the severity of diarrhea, hot flashes and other symptoms likely associated with the synthesis of peptides by the tumor. In some cases, there is a decrease in the concentration of gastrin in the blood plasma. In patients with insulinomas, octreotide reduces the level of immunoreactive insulin in the blood (this effect, however, may be short-lived - about 2 hours). In patients with a resectable tumor, octreotide can restore and maintain normoglycemia in the preoperative period. In patients with inoperable benign and malignant tumors, glycemic control may improve without a simultaneous prolonged decrease in blood insulin levels. In patients with a tumor that produces growth hormone RF (somatoliberinomas), octreotide reduces the severity of symptoms of acromegaly. In the future, pituitary hypertrophy may decrease. For refractory diarrhea in AIDS patients, the use of octreotide leads to complete or partial normalization of stool in approximately 1/3 of patients. The use of octreotide during and after pancreatic surgery reduces the incidence of typical postoperative complications (for example, pancreatic fistulas, abscesses, sepsis, postoperative acute pancreatitis). In the case of bleeding from varices of the esophagus and stomach in patients with cirrhosis of the liver, the use of octreotide in combination with specific treatment (for example, sclerotherapy) leads to more effective control of bleeding and prevention of early rebleeding, a reduction in the volume of transfusions and an improvement in 5-day survival, probably , by suppressing the production of vasoactive hormones such as vasoactive intestinal peptide and glucagon.

Buy Octreotide solution intravenously and subcutaneously 0.01% 1ml No. 10 in pharmacies

Octreotide Buy Octreotide in pharmacies Octreotide in the drug directory DOSAGE FORMS solution for intravenous and subcutaneous administration 50 µg/ml solution for injection 0.01%

MANUFACTURERS Deco Company (Russia) Pharm-Sintez (Russia)

GROUP Somatotropin antagonists

COMPOSITION The active substance is octreotide.

INTERNATIONAL NON-PROPENTED NAME Octreotide

SYNONYMS Genfastat, Octreotide FSintez, Octreotide-depot, Octreotide-long FS, Octride, Sandostatin, Sandostatin Lar, Seraxtal

PHARMACOLOGICAL ACTION Pharmacological action is somatostatin-like. Inhibits the production of growth hormone, reduces the secretion of glucagon, insulin, serotonin, gastrin, vasoactive intestinal peptide, secretin, motilin and pancreatic polypeptide. Reduces blood flow in visceral organs. Eliminates symptoms associated with metastases of carcinoid tumors (hot flashes and diarrhea), increased secretion (adenomas) of vasoactive intestinal peptide (diarrhea), glucagon (diarrhea, weight loss, necrotizing migratory rash), insulin (hypoglycemia). Significantly reduces the concentration of growth hormone and/or somatomedin C in patients with acromegaly, the production of thyrotropin stimulated by thyrotropin-releasing hormone. Inhibits the contractility of the gallbladder, suppresses the flow of bile into the duodenum. After subcutaneous administration, it is quickly and completely absorbed. The maximum concentration is achieved within 25-30 minutes. The half-life after injection is 100 minutes. The duration of action is variable, on average about 12 hours, depending on the type of tumor. About 32% of the administered dose is excreted unchanged in the urine. In elderly patients, the clearance of octreotide is reduced and the half-life is prolonged. In severe renal failure requiring hemodialysis, clearance is reduced by half.

INDICATIONS FOR USE Acromegaly (if dopamine agonists are ineffective or surgical treatment or radiation therapy is impossible), endocrine tumors of the gastroenteropancreatic system (relief of symptoms of carcinoid tumors with signs of carcinoid syndrome, tumors characterized by overproduction of vasoactive intestinal peptide), glucagonomas, gastrinomas (Zollinger-Ellison syndrome ), insulinomas, somatoliberinomas, refractory diarrhea in patients with AIDS, operations on the pancreas (prevention of complications), bleeding (including prevention of relapses) with varicose veins of the esophagus in patients with cirrhosis of the liver.

CONTRAINDICATIONS Hypersensitivity, pregnancy and breastfeeding (stop during treatment).

SIDE EFFECTS Nausea, vomiting, anorexia, cramping abdominal pain, flatulence, diarrhea and steatorrhea, symptoms of acute intestinal obstruction, liver dysfunction, formation of gallstones (with long-term use), acute pancreatitis, hyper- or hypoglycemia, hair loss; locally - pain, itching or burning sensation, redness, swelling.

INTERACTIONS Reduces serum levels of cyclosporine and slows down the absorption of cimetidine and nutrients from the gastrointestinal tract. Dose adjustment of concomitantly used insulin, oral hypoglycemic drugs, beta-blockers, calcium channel blockers and diuretics is required.

METHOD OF APPLICATION AND DOSAGE Subcutaneously, intravenously (infusion). For acromegaly and tumors of the gastroenteropancreatic system, subcutaneously - 50-100 mcg 1-2 times a day (up to 100-200 mcg 3 times a day); For refractory diarrhea in AIDS, subcutaneously - 100 mcg 3 times a day (up to 250 mcg 3 times a day). In order to prevent complications after pancreatic surgery, the first dose of 100 mcg is administered subcutaneously 1 hour before laparotomy, then after surgery, 100 mcg is administered subcutaneously 3 times a day for seven consecutive days. To stop bleeding from varicose veins of the esophagus or stomach - 25 mcg/hour by continuous intravenous infusion for 5 days.

OVERDOSE Symptoms: bradycardia, flushing, diarrhea, nausea, feeling of emptiness and/or pain in the stomach. Treatment: symptomatic.

SPECIAL INSTRUCTIONS Significant fluctuations in blood glucose concentrations can be reduced by more frequent administration of smaller doses; It should be borne in mind that when treating gastroenteropancreatic endocrine tumors, a sudden relapse of symptoms cannot be excluded, and in patients with insulinomas, an increase in the severity and duration of hypoglycemia. Systematic monitoring of glucose concentration is necessary, especially in patients with bleeding from esophageal varices with cirrhosis of the liver, because the risk of developing type 1 diabetes mellitus (insulin-dependent) increases; the need for insulin changes if you already have diabetes.

STORAGE CONDITIONS List B. At a temperature of 2 to 8 degrees. C, in a place protected from light.

Indications for use of the drug Octreotide

Acromegaly (control of the main manifestations of the disease and a decrease in the level of growth hormone and somatomedin C in the blood plasma in cases where the effect of surgical treatment, radiation therapy and treatment with dopamine agonists is not sufficient); relief of symptoms of endocrine tumors of the digestive tract and pancreas: carcinoid tumors with the presence of carcinoid syndrome; VIPs; glucagonomas; gastrinomas/Zollinger-Ellison syndrome (usually in combination with H2-histamine receptor blockers); insulinomas (to control hypoglycemia in the preoperative period, as well as for maintenance therapy); somatoliberins; refractory diarrhea in patients with AIDS; prevention of complications after pancreatic surgery; stopping bleeding and preventing re-bleeding from esophageal varices in patients with cirrhosis of the liver (in combination with specific therapeutic measures, for example, endoscopic sclerotherapy).

Use of the drug Octreotide

For acromegaly, octreotide is first administered at 0.05–0.1 mg subcutaneously at intervals of 8 or 12 hours. Subsequently, the dose is selected individually. Typically, the optimal daily dose is 0.2–0.3 mg. The maximum dose of 1.5 mg per day should not be exceeded. If after 3 months of treatment there is no sufficient reduction in growth hormone levels and improvement in the clinical picture of the disease, therapy should be discontinued. For endocrine tumors of the digestive tract and pancreas, octreotide is administered subcutaneously at an initial dose of 0.05 mg 1–2 times a day. Subsequently, depending on the achieved clinical effect, the effect on the levels of hormones produced by the tumor (in the case of carcinoid tumors, the effect on the excretion of 5-hydroxyindoleacetic acid in the urine), and tolerability, the dose of octreotide can be gradually increased to 0.1–0.2 mg 3 once a day. In exceptional cases, higher doses may be required. Maintenance doses are selected individually. For refractory diarrhea in patients with AIDS, octreotide is administered subcutaneously at an initial dose of 0.1 mg 3 times a day. If after 1 week of treatment the symptoms of diarrhea do not disappear, the dose should be increased individually up to 0.25 mg 3 times a day. Dose adjustment is carried out taking into account the dynamics of bowel movements and tolerability of the drug. If no improvement occurs within 1 week of treatment with octreotide at a dose of 0.25 mg 3 times daily, therapy should be discontinued. To prevent complications after pancreatic surgery, 0.1 mg is administered subcutaneously 3 times a day for 7 consecutive days starting from the day of surgery (at least 1 hour before laparotomy). For bleeding from varicose veins of the esophagus, a dose of 25 mcg/hour is administered by continuous intravenous infusion for 5 days.

Side effects of the drug Octreotide

Possible pain, itching or burning sensation, redness and swelling at the injection site, anorexia, nausea, vomiting, cramping abdominal pain, bloating, flatulence, loose stools, diarrhea and steatorrhea, phenomena resembling acute intestinal obstruction (progressive bloating, severe pain in the epigastric region, muscle protection), formation of gallstones (with long-term use in 10–20% of patients), acute pancreatitis, hair loss, liver dysfunction, including acute hepatitis without cholestasis, hyperbilirubinemia, accompanied by increased alkaline levels phosphatases, γ-glutamyltransferases and, to a lesser extent, transaminases, decreased glucose tolerance, persistent hyperglycemia or hypoglycemia (with long-term use).

Octreotide-depot 20 mg No. 1 bottle + solvent

Content

Indications for the drug Octreotide-depot Contraindications Use during pregnancy and breastfeeding Side effects Interaction Method of administration and dose Rules for the preparation of the suspension and administration of the drug Precautions for use Special instructions Storage conditions for the drug Octreotide-depot Shelf life of the drug Octreotide-depot

Indications for the drug Octreotide-depot

Acromegaly therapy:

when adequate control of disease manifestations is achieved through subcutaneous administration of octreotide;
in the absence of sufficient effect from surgical treatment and radiation therapy;
for preparation for surgical treatment;
for treatment between courses of radiation therapy until a lasting effect develops;
in inoperable patients.

Therapy of endocrine tumors of the gastrointestinal tract and pancreas:

carcinoid tumors with symptoms of carcinoid syndrome;
insulinomas;
VIPs;
gastrinomas (Zollinger-Ellison syndrome);
glucagonomas (to control hypoglycemia in the preoperative period, as well as for maintenance therapy);
somatoliberinomas (tumors characterized by overproduction of growth hormone releasing factor).

Therapy of hormone-resistant prostate cancer: as part of combination therapy against the background of surgical or medical castration.

Prevention of the development of acute postoperative pancreatitis: during extensive surgical operations on the abdominal cavity and thoracoabdominal interventions (including for cancer of the stomach, esophagus, colon, pancreas, primary and secondary tumor lesions of the liver).

Contraindications

Hypersensitivity to octreotide or other components of the drug.

With caution: cholelithiasis; diabetes; pregnancy and lactation.

Use during pregnancy and breastfeeding

There is no experience with the use of Octreotide Depot during pregnancy and breastfeeding. Therefore, during pregnancy, the drug is prescribed only if the potential benefit to the mother outweighs the potential risk to the fetus. Breastfeeding is not recommended when using the drug during lactation.

Side effects

Local reactions: with intramuscular administration of the drug Octreotide-depot, pain is possible, less often - swelling and rashes at the injection site (usually mild and short-lived).
From the gastrointestinal tract: anorexia, nausea, vomiting, cramping abdominal pain, bloating, excessive gas formation, loose stools, diarrhea, steatorrhea. Although the excretion of fat in the feces may be increased, there is no evidence to date that long-term treatment with octreotide may lead to the development of certain nutritional deficiencies due to malabsorption. In rare cases, phenomena resembling acute intestinal obstruction may occur: progressive bloating, severe pain in the epigastric region, tension in the abdominal wall. Long-term use of Octreotide Depot can lead to the formation of gallstones.
On the part of the pancreas: rare cases of acute pancreatitis that developed in the first hours or days of use of octreotide have been reported. With long-term use, cases of pancreatitis associated with cholelithiasis have been reported.
From the liver: there are isolated reports of the development of liver dysfunction (acute hepatitis without cholestasis with normalization of transaminases after discontinuation of octreotide); slow development of hyperbilirubinemia, accompanied by an increase in alkaline phosphatase, GGT, and to a lesser extent other transaminases.
From the metabolic side: since the drug Octreotide-depot has an inhibitory effect on the formation of growth hormone, glucagon and insulin, it can affect glucose metabolism. Possible decrease in glucose tolerance after meals. With long-term use of subcutaneous octreotide, persistent hyperglycemia may develop in some cases. Hypoglycemic states have also been observed.
Other: in rare cases, temporary hair loss has been reported after administration of octreotide, bradycardia, tachycardia, shortness of breath, skin rash, and anaphylaxis. There are isolated reports of the development of hypersensitivity reactions.

Interaction

Octreotide reduces the absorption of cyclosporine from the intestine and slows down the absorption of cimetidine.

With simultaneous use of octreotide and bromocriptine, the bioavailability of the latter increases.

There is literature evidence that somatostatin analogues may reduce the metabolic clearance of substances metabolized by cytochrome P450 enzymes, which may be caused by growth hormone suppression. Since similar effects of octreotide cannot be excluded, drugs metabolized by cytochrome P450 enzymes and with a narrow therapeutic index (quinidine and terfenadine) should be prescribed with caution.

Directions for use and doses

Intramuscularly, deep into the gluteal muscle. For repeated injections, the left and right sides should be alternated. The suspension should be prepared immediately before injection. On the day of injection, the bottle with the drug and the ampoule with the solvent can be kept at room temperature.

When treating acromegaly in patients for whom subcutaneous administration of octreotide provides adequate control of the manifestations of the disease, the recommended initial dose of Octreotide-depot is 20 mg every 4 weeks for 3 months. Treatment with Octreotide-depot can be started the day after the last subcutaneous administration of octreotide. Subsequently, the dose is adjusted taking into account the serum concentrations of growth hormone and IGF-1, as well as clinical symptoms. If after 3 months of treatment it is not possible to achieve an adequate clinical and biochemical effect (in particular, if the concentration of growth hormone remains above 2.5 mcg/l), the dose can be increased to 30 mg administered every 4 weeks.

In cases where, after 3 months of treatment with Octreotide-depot at a dose of 20 mg, there is a persistent decrease in the serum concentration of growth hormone below 1 μg/l, normalization of IGF-1 concentration and the disappearance of reversible symptoms of acromegaly, you can reduce the dose of Octreotide-depot to 10 mg. However, in these patients receiving a relatively small dose of Octreotide Depot, serum concentrations of growth hormone and IGF-1, as well as symptoms of the disease, should continue to be carefully monitored.

In patients receiving a stable dose of Octreotide Depot, growth hormone and IGF-1 concentrations should be determined every 6 months.

For patients in whom surgery and radiation therapy are ineffective or ineffective, and for patients who require short-term treatment between courses of radiation therapy until it is fully effective, it is recommended that a trial course of treatment with subcutaneous injections of octreotide be undertaken to evaluate its effectiveness and general tolerability and only after that switch to using the drug Octreotide-depot according to the above scheme.

In the treatment of endocrine tumors of the gastrointestinal tract and pancreas in patients for whom subcutaneous administration of octreotide provides adequate control of the manifestations of the disease, the recommended initial dose of Octreotide Depot is 20 mg every 4 weeks. Subcutaneous administration of octreotide should be continued for another 2 weeks after the first administration of Octreotide-depot.

In patients who have not previously received subcutaneous octreotide, it is recommended to begin treatment with subcutaneous administration of octreotide at a dose of 0.1 mg 3 times a day for a relatively short period of time (approximately 2 weeks) in order to assess its effectiveness and overall tolerability. Only after this is the drug Octreotide-depot prescribed according to the above scheme.

In cases where therapy with Octreotide-depot for 3 months provides adequate control of clinical manifestations and biological markers of the disease, it is possible to reduce the dose of Octreotide-depot to 10 mg, prescribed every 4 weeks.

In cases where, after 3 months of treatment with Octreotide-depot, only partial improvement was achieved, the dose of the drug can be increased to 30 mg every 4 weeks. During treatment with Octreotide-depot, on some days there may be an increase in clinical manifestations characteristic of endocrine tumors of the gastrointestinal tract and pancreas. In these cases, additional subcutaneous administration of octreotide is recommended at the dose used before the start of treatment with Octreotide-depot. This may occur mainly in the first 2 months of treatment, until therapeutic plasma concentrations of octreotide are achieved.

Secreting and non-secreting common (metastatic) neuroendocrine tumors of the jejunum, ileum, cecum, ascending colon, transverse colon and appendix or metastases of neuroendocrine tumors without a primary identified focus - the recommended dose of Octreotide-depot is 30 mg every 4 weeks.

Therapy with Octreotide Depot should be continued until signs of tumor progression.

When treating HRPC, the recommended initial dose of Octreotide-depot is 20 mg every 4 weeks for 3 months. Subsequently, the dose is adjusted taking into account the dynamics of PSA concentration in the serum, as well as clinical symptoms. If after 3 months of treatment it was not possible to achieve an adequate clinical and biochemical effect (decrease in PSA), the dose can be increased to 30 mg administered every 4 weeks.

Treatment with Octreotide-depot is combined with the use of dexamethasone, which is prescribed orally according to the following regimen: 4 mg/day for 1 month, then 2 mg/day for 2 weeks, then 1 mg/day (maintenance dose).

Treatment with Octreotide-depot and dexamethasone in patients who have previously received drug antiandrogen therapy is combined with the use of a GnRH analogue. In this case, an injection of a GnRH analogue (depot form) is carried out once every 4 weeks.

For patients receiving Octreotide Depot, PSA concentrations should be determined every month.

In patients with impaired renal function, liver function and elderly patients, there is no need to adjust the dosage regimen of the drug Octreotide-depot.

To prevent acute postoperative pancreatitis, the drug Octreotide-depot in a dose of 10 or 20 mg is administered once, no earlier than 5 days and no later than 10 days before the intended surgical intervention.

Rules for preparing the suspension and administering the drug

the drug should only be administered intramuscularly;
prepare the suspension for intramuscular injection using the supplied solvent immediately before administration;
Only specially trained medical personnel should prepare and administer the drug;
before injection, the ampoule with the solvent and the bottle with the drug must be removed from the refrigerator and brought to room temperature (30–50 minutes are required);
Keep the bottle with Octreotide-depot strictly vertical. Lightly tapping the bottle to ensure that all the lyophilisate is at the bottom of the bottle;
open the package with the syringe, attach a 1.2 × 50 mm needle to the syringe to withdraw the solvent;
open the ampoule with the solvent and draw the entire contents of the ampoule with the solvent into the syringe, set the syringe to a dose of 2 ml;
remove the plastic cap from the bottle containing the lyophilisate. Disinfect the rubber stopper of the bottle with an alcohol swab. Insert the needle into the bottle with the lyophilisate through the center of the rubber stopper and carefully introduce the solvent along the inner wall of the bottle, without touching the contents of the bottle with the needle. Remove the syringe from the bottle;
the bottle should remain motionless until the lyophilisate is completely saturated with the solvent and a suspension is formed (approximately 3–5 minutes). After which, without turning the bottle over, you should check for the presence of dry lyophilisate on the walls and bottom of the bottle. If dry residues of the lyophilisate are detected, leave the bottle until completely saturated;
After the health care worker ensures that there are no residues of dry lyophilisate, the contents of the bottle should be carefully mixed in a circular motion for 30–60 s until a homogeneous suspension is formed. Do not turn over or shake the bottle; this may cause flakes to fall out and the suspension to become unusable;
quickly insert the needle through the rubber stopper into the bottle. Then lower the cut of the needle down and, tilting the bottle at an angle of 45°, slowly draw the entire suspension into the syringe. Do not invert the bottle when taking it. A small amount of the drug may remain on the walls and bottom of the bottle. Consumption for the residue on the walls and bottom of the bottle is taken into account;
immediately after drawing the suspension, replace the needle with a pink pavilion with a needle with a green pavilion (0.8×40 mm), carefully turn the syringe over and remove air from the syringe;
administer the Octreotide-depot suspension immediately after preparation;
the suspension of the drug Octreotide-depot should not be mixed with any other drug in the same syringe;
Use an alcohol swab to disinfect the injection site. Insert the needle deep into the gluteal muscle, then pull the syringe plunger back slightly to ensure that there is no damage to the vessel. Inject the suspension intramuscularly slowly, with constant pressure on the syringe plunger;
if it gets into a blood vessel, the injection site and needle should be changed;
if the needle becomes clogged, replace it with another needle of the same diameter;
with repeated injections, the left and right sides should be alternated.

Precautions for use

For pituitary tumors that secrete growth hormone, careful monitoring of patients is necessary, because it is possible that the size of the tumors may increase with the development of such a serious complication as a narrowing of the visual fields. In these cases, the need for other treatment methods should be considered.

Gallstones may develop in 15–30% of patients receiving subcutaneous octreotide for a long time. Prevalence in the general population (ages 40–60 years) is 5–20%. Experience of long-term treatment with long-acting octreotide in patients with acromegaly and tumors of the gastrointestinal tract and pancreas indicates that long-acting octreotide, in comparison with short-acting octreotide, does not lead to an increase in the incidence of gallstones. However, it is recommended to perform an ultrasound scan of the gallbladder before starting treatment with Octreotide Depot and approximately every 6 months during treatment. Gallstones, if they are found, are usually asymptomatic. If clinical symptoms are present, conservative treatment (for example, the use of bile acid preparations) or surgery is indicated.

In patients with type 1 diabetes mellitus, Octreotide Depot can affect glucose metabolism and, therefore, reduce the need for administered insulin. For patients with type 2 diabetes mellitus and patients without concomitant carbohydrate metabolism disorders, subcutaneous injections of octreotide may lead to postprandial glycemia. In this regard, it is recommended to regularly monitor the concentration of glucose in the blood and, if necessary, adjust hypoglycemic therapy.

Before prescribing octreotide, patients should undergo a baseline ultrasound of the gallbladder.

During treatment with Octreotide Depot, repeat ultrasound of the gallbladder should be performed, preferably at intervals of 6–12 months.

If gallstones are detected before starting treatment, it is necessary to evaluate the potential benefits of therapy with Octreotide Depot versus the possible risks associated with the presence of gallstones.

Currently, there is no evidence that Octreotide Depot adversely affects the course or prognosis of existing gallstone disease.

Management of patients in whom gallstones form during treatment with Octreotide-depot

Asymptomatic gallstones. The use of the drug Octreotide-depot can be stopped or continued - in accordance with the assessment of the benefit/risk ratio. In any case, no other measures are required other than continuing inspections, making them more frequent if necessary.

Gallstones with clinical symptoms. The use of the drug Octreotide-depot can be stopped or continued - in accordance with the assessment of the benefit/risk ratio. In any case, the patient should be treated in the same way as in other cases of cholelithiasis with clinical manifestations. Drug treatment includes the use of combinations of bile acid preparations (for example, chenodeoxycholic acid at a dose of 7.5 mg cm/day in combination with UDCA at the same dose) under ultrasound control until the stones completely disappear.

special instructions

Special precautions when destroying unused medicinal products. The bottle with the drug, syringe and needles are destroyed separately.

Influence on the ability to drive a car and other mechanisms. Currently, there is no data on the effect of the drug Octreotide-depot on the ability to drive a car and operate machinery, which requires increased attention and speed of mental and motor reactions.

Storage conditions for the drug Octreotide-depot

In a dry place, protected from light, at a temperature of 2 to 8 °C.

Keep out of the reach of children.

Shelf life of the drug Octreotide-depot

Lyophilisate - 3 years; solvent - 5 years.

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

Special instructions for the use of the drug Octreotide

In case of a pituitary tumor that secretes growth hormone, strict medical supervision of patients receiving octreoid is necessary, since it is possible that the size of the tumors may increase with the development of such a serious complication as a narrowing of the visual fields. When treating endocrine tumors of the digestive tract and pancreas with octreotide, in rare cases a sudden relapse of the disease may occur. In patients with insulinoma during treatment with octreoid, an increase in the severity and duration of hypoglycemia may be observed. In diabetic patients receiving insulin, Octreoid may reduce the need for insulin. There is no experience with the use of Octreoid during pregnancy and lactation; during this period the drug is prescribed only for absolute indications.

Octreotide

For pituitary tumors that secrete GH, careful monitoring of patients receiving octreotide is necessary, since an increase in the size of tumors is possible with the development of such a serious complication as narrowing of visual fields. In these cases, the need for other treatment methods should be considered. Since a decrease in the level of growth hormone and normalization of the level of insulin-like factor-1 during therapy with octreotide can lead to the restoration of fertility in women with acromegaly, patients of childbearing age should use reliable methods of contraception when using the drug.

When prescribing octreotide for a long period of time, it is necessary to monitor thyroid function.

If bradycardia develops during the use of octreotide, if necessary, it is possible to reduce the dose of beta-blockers, calcium channel blockers or drugs that affect water and electrolyte balance.

In some patients, octreotide may alter the absorption of fats in the intestine.

During the use of octreotide, there was a decrease in the content of cobalamin (vitamin B12) and deviations from the norm in the cobalamin absorption test (Schilling test).

When using octreotide in patients with a history of vitamin B12 deficiency, it is recommended to monitor the level of cobalamin in the body.

Before prescribing octreotide, patients should undergo an initial ultrasound examination of the gallbladder.

During treatment with Octreotide, repeated ultrasound examinations of the gallbladder should be performed, preferably at intervals of 6-12 months.

If gallstones are detected before treatment begins, the potential benefits of octreotide therapy must be weighed against the possible risks associated with their presence. There is no data on any negative effect of octreotide on the course or prognosis of existing gallstone disease.

Asymptomatic gallstones. The use of octreotide can be discontinued or continued according to the benefit/risk assessment. In any case, there is no need to do anything other than continue monitoring, making it more frequent if necessary.

Gallstones with clinical symptoms. The use of octreotide can be discontinued or continued according to the benefit/risk assessment. In any case, the patient should be treated in the same way as in other cases of cholelithiasis with clinical manifestations. Drug treatment includes the use of combinations of bile acid preparations (for example, chenodeoxycholic acid at a dose of 7.5 mg/kg per day in combination with ursodeoxycholic acid at the same dose) under ultrasound control until the stones completely disappear.

When treating endocrine tumors of the gastrointestinal tract and pancreas with octreotide, in rare cases a sudden relapse of symptoms of the disease may occur.

In patients with insulinomas, during treatment with octreotide, an increase in the severity and duration of hypoglycemia may be observed (this is due to a more pronounced suppressive effect on the secretion of GH and glucagon than on insulin secretion, as well as a shorter duration of the inhibitory effect on insulin secretion). Careful regular monitoring of these patients should be ensured both at the beginning of treatment with Octreotide and whenever the dose of the drug is changed. Significant fluctuations in blood glucose concentrations can be reduced by administering octreotide more frequently and in smaller doses. In patients with type 1 diabetes mellitus, octreotide may reduce the need for insulin. In patients without diabetes and with type 2 diabetes with partially preserved insulin secretion, administration of octreotide may lead to postprandial hyperglycemia. When using octreotide in patients with diabetes mellitus, monitoring of blood glucose concentrations and antidiabetic therapy is recommended.

Since after bleeding from varicose veins of the esophagus and stomach, the risk of developing type 1 diabetes mellitus is increased, and in patients with diabetes mellitus, changes in insulin requirements are also possible, in these cases systematic monitoring of blood glucose concentrations is necessary.

It is necessary to adjust the dosage regimen of simultaneously used diuretics, beta-blockers, slow calcium channel blockers, insulin, oral hypoglycemic agents, and glucagon.

Impact on the ability to drive vehicles and operate machinery

Some side effects of octreotide may negatively affect the ability to drive vehicles and other mechanisms that require increased concentration and speed of psychomotor reactions. In this regard, it is recommended that when these symptoms appear, caution is exercised when driving vehicles or machinery that require increased concentration.