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Instruction for use: Octreotide-depo

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ATX Code H01CB02 Octreotide

Active substance: Octreotide

Pharmacological group

Somatostatin analogue synthetic [Hormones of the hypothalamus, pituitary gland, gonadotropins and their antagonists]

Somatostatin analogue synthetic [Antineoplastic hormonal agents and hormone antagonists]

Nosological classification (ICD-10)

C15 Malignant neoplasm of the esophagus

Esophageal carcinoma, Stenosing esophagus cancer, Esophageal carcinoma, Tumors of the esophagus

C16 Malignant neoplasm of stomach

Stomach cancer, Stenosing gastric cancer, Metastatic stomach cancer, Disseminated adenocarcinoma of the stomach, Tumors of the stomach

C18 Malignant neoplasm of colon

Common colorectal cancer, Common colon cancer, Disseminated colorectal cancer, Malignant neoplasm of colon, Malignant tumor of colon and rectum, Colorectal carcinoma, Colorectal cancer, Locally-advanced colon cancer, Metastatic Colorectal Cancer, Metastatic Colon Cancer, Colorectal cancer, Colon cancer

C22 Malignant neoplasm of the liver and intrahepatic bile ducts

Hepatic Lymphoma, Hepatoadenoma, Hepatoma, Primary liver tumor, Malignant liver tumor, Cholangiocellular liver cancer, Liver cancer, Liver cancer hepatocellular, Bile duct cancer, Liver tumors are primary malignant, Mesenchymal tumors of the liver, Lymphoma of the liver, Liver tumors

C25 Malignant neoplasm of pancreas

VIPoma, Glucagon, Locally spread pancreatic adenocarcinoma, Inoperable pancreatic cancer, Pancreas cancer, Carcinoid pancreatic tumor, Tumors of the pancreas, Pancreatic endocrine tumors, Pancreatic exocrine tumors

C25.4 Pancreatic islet cells

Insulinoma, Carcinoma of islet cells of the pancreas, Werner-Morrison syndrome, Nezidioblastosis, Pancreatic tumors island-cell, Ostrovkovletochnye tumors of the pancreas, Pancreatic cholera

C26 Malignant neoplasm of other and inaccurately indicated digestive organs

Bowel cancer, Gastrointestinal cancer, Carcinoid GI tract, Adenocarcinoma of the intestine, Cancer of other parts of the large intestine, Argentaffinoma, Carcinoid, Enterochromaffinoma, Cancer of the colon, Colon cancer

C61 Malignant neoplasm of prostate

Adenocarcinoma of the prostate, Hormone-dependent prostate cancer, Hormone-Resistant Prostate Cancer, Malignant tumor of prostate, Malignant neoplasm of prostate, Carcinoma of the prostate, Locally-distributed non-metastatic prostate cancer, Locally advanced prostate cancer, Locally spread prostate cancer, Metastatic prostatic carcinoma, Metastatic prostate cancer, Metastatic hormone-resistant prostate cancer, Non-metastatic prostate cancer, Incompatible prostate cancer, Prostate Cancer, Prostate cancer, Common prostate cancer, Testosterone-Depot Prostate Cancer

C75.1 Malignant neoplasm of pituitary gland

Pituitary Tumor, Aumada del Castillo Syndrome, Somatoliberinoma, Pituitary adenoma, Tumors of the pituitary and suprasellar region

C78.7 Secondary malignant neoplasm of the liver

Metastases in the liver, Metastatic liver disease, Metastatic liver tumors

C80 Malignant neoplasm without specification of localization

Malignant tumor, Malignant neoplasm, Malignant neoplasms of different localization, Malignant tumors, Eton-Lambert syndrome, Locally prevalent forms of malignant neoplasms, Metastatic ascites, Cerebellar degeneration in tumors, Hereditary cancers, Metastatic tumors, Cancer ascites, Solid tumors

D13.7 Benign neoplasm of islet cells of the pancreas

Insuloma, Nezidioblastosis, Pancreatic tumors island-cell, Ostrovkovletochnye tumors of the pancreas

E22.0 Acromegaly and pituitary gigantism

Pituitary gigantism, Acromegaly, Dysfunction of growth hormone secretion

E34.0 Carcinoid Syndrome

Carcinoid syndrome

K85 Acute pancreatitis

Acute pancreatitis, Pancreatitis, Pancreatitis hemorrhagic, Pancreatitis acute, Sepsis pancreatogenic, Acute necrotic pancreatitis, Pancreatitis edematous

K86.8.3 * Zollinger-Ellison Syndrome

Adenoma of the pancreas ulzerogennosti, gastrinoma, Zollinger-Ellison Syndrome, gastrinoma

Z100 * CLASS XXII Surgical practice

Abdominal surgery, adenomectomy, Amputation, Coronary angioplasty, Angioplasty of the carotid arteries, Antiseptic skin treatment for wounds, Antiseptic Hand, Appendectomy, atherectomy, Balloon coronary angioplasty, Vaginal hysterectomy, The coronary bypass, Interventions in the vagina and cervix, Interventions on the bladder, Intervention in the mouth, Restoration and reconstructive surgery, Hand hygiene of medical personnel, Gynecologic surgery, Gynecological intervention, Gynecological surgery, Hypovolemic shock during operations, Disinfection of purulent wounds, Disinfection of wounds edges, Diagnostic intervention, Diagnostic procedures, Cervical Diathermocoagulation, Long-surgery, Replacing the fistula catheters, Infection in orthopedic surgery, Artificial heart valve, cystectomy, Short-term outpatient surgery, Short-term operation, Short surgical procedures, Krikotireotomiya, Blood loss during surgery, Bleeding during surgery and in the postoperative period, Kuldotsentez, laser photocoagulation, laser coagulation, retinal laser coagulation, Laparoscopy, Laparoscopy in Gynecology, CSF fistula, Small gynecological operations, Small surgical procedures, Mastectomy and subsequent plastic, mediastinotomy, Microsurgical operations on the ear, Mukogingivalnye operation, suturing, Minor surgery, neurosurgical operation, Immobilization of the eyeball in ophthalmic surgery, testectomy, pancreatectomy, Perikardektomiya, The period of rehabilitation after surgery, The period of, convalescence after surgery, Percutaneous transluminal coronary angioplasty, Pleural thoracentesis, Pneumonia postoperative and posttraumatic, Preparation for surgical procedures, Preparation for surgery, Preparation of the surgeon's hands before surgery, Preparation of the colon for surgical procedures, Postoperative aspiration pneumonia in neurosurgical and thoracic surgery, Postoperative nausea, Postoperative bleeding, postoperative granuloma, postoperative shock, The early postoperative period, myocardial revascularization, Radiectomy, gastric Resection, bowel resection, uterine Resection, liver Resection, enterectomy, Resection of part of the stomach, Reocclusion of the operated vessel, Bonding tissues during surgical procedures, Removal of sutures, Condition after eye surgery, Condition after surgery, Condition after surgery in the nasal cavity, Condition after gastrectomy, Status after resection of the small intestine, Condition after tonsillectomy, Condition after removal of the duodenum, Condition after phlebectomy, Vascular surgery, Splenectomy, Sterilization of surgical instruments, Sterilization of surgical instruments, sternotomy, Dental surgery, Dental intervention in periodontal tissues, strumectomy, Tonsillectomy, Thoracic surgery, total gastrectomy, Transdermal intravascular coronary angioplasty, Transurethral resection, Turbinektomiya, Removal of a tooth, cataract surgery, Removal of cysts, tonsillectomy, Removal of fibroids, Removing the mobile primary teeth, Removing polyps, Removing broken tooth, Removal of the uterus body, Removal of sutures, Urethrotomy, Fistula likvoroprovodyaschih ways, Frontoetmoidogaymorotomiya, Surgical infection, Surgical treatment of chronic limb ulcersm, Surgery, The surgery in the anal area, The surgery on the colon, Surgical practice, The surgical procedure, Surgical interventions, Surgery on the gastrointestinal tract, Surgical procedures on the urinary tract, Surgical procedures on the urinary system, Surgical intervention of the genitourinary system, Surgical procedures on the heart, Surgical manipulation, surgery, Surgery on the veins, Surgical intervention, Vascular surgery, Surgical treatment of thrombosis, cholecystectomy, Partial gastric resection, transabdominal hysterectomy, Percutaneous transluminal coronary angioplasty, Percutaneous transluminal angioplasty, Coronary artery bypass, tooth Extirpation, Extirpation of milk teeth, pulpectomy, pulsative cardiopulmonary bypass, tooth Extraction, teeth Extraction, cataract extraction, Electrocoagulation, endourological intervention, episiotomy, Etmoidotomiya, Complications after tooth extraction

Composition

Liofilizate for the preparation of a suspension for intramuscular administration of prolonged action 1 fl.

active substance:

Octreotide 10 mg/ 20 mg/ 30 mg

Auxiliary substances: copolymer DL-lactic and glycolic acids - 270/560/850 mg; D-mannitol - 85/85/85 mg; Carboxymethylcellulose sodium salt - 30/30/30 mg; Polysorbate 80 - 2/2/2 mg

The solvent in the ampoule (mannitol, solution for injection 0.8%) 1 amp.

Mannitol 0.016 g

Water for injection up to 2 ml

Description of dosage form

Lyophilized powder or porous, compacted into a tablet mass of white or white with a weak yellowish hue of color.

Solvent: colorless transparent liquid.

Reconstituted suspension: a homogeneous suspension of white or white with a weak yellowish hue of color.

pharmachologic effect

The pharmacological action is somatostatin-like.

Pharmacodynamics

Octreotide depot is a long-acting octreotide dosage form for the / m administration, which ensures the maintenance of stable therapeutic concentrations of octreotide in the blood for 4 weeks. Octreotide is a pathogenetic therapy for tumors that actively express somatostatin receptors. Octreotide is a synthetic octapeptide, which is a derivative of the natural somatostatin hormone and possesses similar pharmacological effects, but a much longer duration of action.

The drug inhibits the pathologically increased secretion of growth hormone, as well as peptides and serotonin produced in the gastroenteropancreatic endocrine system.

In healthy individuals, octreotide, like somatostatin, suppresses the secretion of growth hormone caused by arginine, exercise and insulin hypoglycemia; Secretion of insulin, glucagon, gastrin and other peptides of the gastroenteropancreatic endocrine system caused by food intake, as well as the secretion of insulin and glucagon stimulated with arginine; Secretion of thyrotropin, caused by thyroidiberin. The suppressive effect on the secretion of growth hormone in octreotide, in contrast to somatostatin, is expressed to a much greater extent than on the secretion of insulin. The introduction of octreotide is not accompanied by the phenomenon of hypersecretion of hormones by the mechanism of negative feedback.

In patients with acromegaly, the administration of Octreotide Depot provides, in the overwhelming majority of cases, a persistent decrease in the concentration of growth hormone and the normalization of the concentration of IGF-1 / somatomedin C.

In most patients with acromegaly, Octreotide Depot significantly reduces the severity of such symptoms as headache, increased sweating, paresthesia, fatigue, pain in the bones and joints, peripheral neuropathy. It has been reported that treatment with Octreotide Depot by individual patients with pituitary adenomas that secrete growth hormone led to a decrease in tumor size.

When secreting endocrine tumors of the gastrointestinal tract and pancreas, the use of Octreotide Depot provides a constant control of the main symptoms of these diseases.

Octreotide depot at a dose of 30 mg every 4 weeks slows tumor growth in patients with secreting and non-secretive widespread (metastatic) neuroendocrine tumors of the lean, ileum, blind, ascending colon, transverse colon and appendix or metastases of neuroendocrine tumors without a primary focus. The drug was effective in increasing the time to progression of both secreting and non-secretive neuroendocrine tumors.

In carcinoid tumors, the use of octreotide can lead to a decrease in the severity of the symptoms of the disease, primarily such as hot flashes and diarrhea. In many cases, clinical improvement is accompanied by a decrease in serotonin concentration in plasma and excretion of 5-hydroxyindoleacetic acid in the urine.

In tumors characterized by hyperproduction of the vasoactive intestinal peptide (vipoma), the use of octreotide in most patients reduces the severe secretory diarrhea that is characteristic of this condition, which in turn leads to an improvement in the quality of life of the patient. At the same time, there is a decrease in associated electrolyte imbalance, for example, hypokalemia, which allows to cancel enteral and parenteral administration of fluid and electrolytes. According to computed tomography, in some patients, the progression of the tumor slows or stops and even a decrease in its size, especially the metastases to the liver. Clinical improvement is usually accompanied by a decrease (up to normal values) of the concentration of VIP in the plasma.

With glucagonomes, the use of octreotide in most cases leads to a marked decrease in the necrotic migrating rash that is characteristic of this condition. Octreotide does not have any significant effect on the severity of diabetes mellitus, often observed with glucagonomes, and usually does not lead to a decrease in the need for insulin or oral hypoglycemic drugs. In patients with diarrhea, octreotide causes it to decrease, which is accompanied by an increase in body weight. When octreotide is used, there is often a rapid decrease in plasma glucagon concentration, but this effect does not persist with long-term treatment. At the same time, symptomatic improvement remains stable for a long time.

In gastrinomas / Zollinger-Ellison syndrome, octreotide, used as a monotherapy or in combination with H2-histamine receptor blockers and proton pump inhibitors, can reduce the formation of hydrochloric acid in the stomach and lead to clinical improvement, incl. And in relation to diarrhea. It is also possible to reduce the severity and other symptoms, probably associated with the synthesis of peptides by a tumor, incl. Tides. In some cases, a decrease in the concentration of gastrin in the plasma.

In patients with insulinomas, octreotide reduces the concentration of immunoreactive insulin in the blood. In patients with operable tumors, octreotide can provide recovery and maintenance of normoglycemia in the preoperative period. In patients with inoperable benign and malignant tumors, the control of glycemia can be improved without a simultaneous prolonged decrease in the concentration of insulin in the blood.

In patients with rare tumors, hyper-releasing growth hormone releasing factor (somatoliberinoma), octreotide reduces the severity of the symptoms of acromegaly. This, apparently, is due to the suppression of the secretion of the releasing factor of growth hormone and the growth hormone itself. In the future, a decrease in the size of the pituitary gland, which before the treatment was increased.

In patients with hormone-resistant prostate cancer (GFRR), a pool of neuroendocrine cells expressing somatostatin receptors, affinity to octreotide (SS2- and SS5-types), increases, which determines the sensitivity of the tumor to octreotide. The use of Octreotide Depot in combination with dexamethasone against the background of androgen blockade (drug or surgical castration) in patients with PGRM restores sensitivity to hormonal therapy and leads to a decrease in PSA in more than 50% of patients.

In patients with PGRD with metastases in the bone, this therapy is accompanied by a pronounced and prolonged analgesic effect. In this case, all patients who responded to combination therapy with Octreotide Depot significantly improve quality of life and increase the median disease-free survival.

Indications

Therapy for acromegaly:

When an adequate control of the manifestations of the disease is due to the sc / o administration of octreotide;

In the absence of sufficient effect from surgical treatment and radiation therapy;

To prepare for surgical treatment;

For treatment between radiotherapy courses before the development of a persistent effect;

In inoperable patients.

Therapy of endocrine tumors of the gastrointestinal tract and pancreas:

Carcinoid tumors with the phenomena of carcinoid syndrome;

Insulinomas;

VIPoms;

Gastrinomas (Zollinger-Ellison syndrome);

Glucagonomes (for the control of hypoglycemia in the preoperative period, as well as for maintenance therapy);

Somatoliberynoma (tumors characterized by hyperproduction of growth hormone releasing factor).

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

Prevention of the development of acute postoperative pancreatitis: with extensive surgical operations on the abdominal cavity and thoracoabdominal interventions (including for stomach cancer, 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.

pregnancy and lactation

The experience of using Octreotide Depot during pregnancy and during breastfeeding is absent. Therefore, during pregnancy, the drug is prescribed only if the potential benefit to the mother exceeds the potential risk to the fetus. It is not recommended to breast-feed while using the drug during lactation.

Side effects

Local reactions: with the / m introduction of Octreotide Depot, pain is possible, less often - swelling and eruptions at the injection site (usually mild, short-lived).

From the gastrointestinal tract: anorexia, nausea, vomiting, abdominal cramping, bloating, excessive gas formation, loose stools, diarrhea, steatorrhea. Although the release of fat with feces may increase, to date, there is no evidence that prolonged treatment with octreotide can lead to a deficit in some nutritional components due to impaired absorption (malabsorption). In rare cases, there may be phenomena reminiscent of acute intestinal obstruction: progressive bloating, severe pain in the epigastric region, stress of the abdominal wall. Long-term use of Octreotide Depot can lead to the formation of gallstones.

From the side of the pancreas: reported rare cases of acute pancreatitis that developed in the first hours or days of octreotide. With prolonged use, there have been cases of pancreatitis associated with cholelithiasis

On the part of the liver: there are separate reports on the development of violations of liver function (acute hepatitis without cholestasis with normalization of transaminases after octreotide abolition); The slow development of hyperbilirubinemia, accompanied by an increase in the parameters of alkaline phosphatase, GGT, and to a lesser extent other transaminases.

On the part of metabolism: since the drug Octreotide Depot has an overwhelming effect on the formation of growth hormone, glucagon and insulin, it can affect the exchange of glucose. Perhaps a decrease in glucose tolerance after eating. With prolonged use of octreotide, in some cases persistent hyperglycemia may develop. There were also conditions of hypoglycemia.

Other: in rare cases, reported temporary hair loss after octreotide administration, the occurrence of bradycardia, tachycardia, respiratory distress, skin rash, anaphylaxis. There are separate reports on the development of hypersensitivity reactions.

Interaction

Octreotide reduces intestinal absorption of cyclosporine and slows the absorption of cimetidine.

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

There are published data that somatostatin analogues can reduce the metabolic clearance of substances metabolized by cytochrome P450 enzymes, which may be caused by suppression of growth hormone. Since it is impossible to exclude similar effects of octreotide, drugs metabolized by enzymes of the cytochrome P450 system and with a narrow therapeutic range (quinidine and terfenadine) should be prescribed with caution.

Dosing and Administration

In / m, deep in the gluteus muscle. With repeated injections, the left and right sides should alternate. Suspension should be prepared immediately before injection. On the day of injection, the vial with the preparation and the ampoule with the solvent can be kept at room temperature.

In the treatment of acromegaly in patients for whom the octreotide administration 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. You can start treatment with Octreotide Depot on the next day after the last SC administration of octreotide. In the future, the dose is corrected taking into account the concentration in the serum of growth hormone and IGF-1, as well as clinical symptoms. If after 3 months of treatment failed to achieve an adequate clinical and biochemical effect (in particular, if the concentration of growth hormone remains above 2.5 μg / l), the dose can be increased to 30 mg administered every 4 weeks.

In cases where after a 3-month treatment with Octreotide Depot at a dose of 20 mg there is a persistent decrease in serum concentration of growth hormone below 1 μg / l, normalization of IGF-1 concentration and disappearance of reversible symptoms of acromegaly, it is possible to reduce the dose of Octreotide Depot up 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 the symptoms of the disease, should be carefully monitored.

Patients receiving a stable dose of Octreotide Depot, the determination of growth hormone concentrations and IGF-1 should be performed every 6 months.

Patients in whom surgical treatment and radiotherapy are not effective or generally ineffective, as well as patients who need short-term treatment between the radiotherapy courses and the time of its full effect, it is recommended that a trial of treatment with octreotide supplements be made to evaluate it Efficiency and general tolerability, and only after this switch to the use of Octreotide Depot according to the above scheme.

In the treatment of endocrine tumors of the gastrointestinal tract and pancreas in patients to whom SC 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. SC administration of octreotide should continue for another 2 weeks after the first administration of Octreotide Depot.

In patients who have not received octreotide before, it is recommended to start treatment with SC administration of octreotide at a dose of 0.1 mg 3 times / day for a relatively short period of time (approximately 2 weeks) in order to evaluate its effectiveness and overall tolerance . Only after this, the drug Octreotide Depot is prescribed according to the above scheme.

In the case when 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, administered every 4 weeks.

In those cases when, 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. Against the background of treatment with the drug Octreotide Depot on certain days, it is possible to increase the clinical manifestations characteristic of endocrine tumors of the gastrointestinal tract and pancreas. In these cases, an additional SC administration of octreotide is recommended in the dose used before the start of treatment with Octreotide Depot. This can occur mainly in the first 2 months of treatment, until the therapeutic concentrations of octreotide in plasma are reached.

Secreting and non-secretive common (metastatic) neuroendocrine tumors of lean, iliac, blind, ascending colon, transverse colon and appendix or metastasis of neuroendocrine tumors without a primary 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.

In the treatment of PGRFA, the recommended initial dose of Octreotide Depot is 20 mg every 4 weeks for 3 months. In the future, the dose is corrected taking into account the dynamics of serum PSA concentration, as well as clinical symptoms. If after 3 months of treatment failed to achieve an adequate clinical and biochemical effect (reduction of PSA), the dose can be increased to 30 mg, administered every 4 weeks.

Treatment with Octreotide Depot is combined with dexamethasone, which is prescribed internally as follows: 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 had previously undergone drug and anti-androgen therapy are combined with the use of the GnRH analogue. In this case, an injection of the GnRH analogue (depot form) is carried out once every 4 weeks.

Patients receiving the Octreotide Depot preparation should be assessed every month.

In patients with impaired renal function, liver and elderly patients, there is no need to correct the dosage regimen of Octreotide Depot.

For the prevention of acute postoperative pancreatitis Octreotide Depot preparation in a dose of 10 or 20 mg is administered once, not earlier than 5 days and no later than 10 days before the proposed surgical intervention.

Rules for preparation of suspension and drug administration

- Enter the drug only in / m;

- Suspension for intravenous injection should be prepared with the help of the applied solvent immediately before administration;

- Only trained medical personnel should prepare and administer the drug;

- before injecting the ampoule with the solvent and the vial with the drug must be obtained from the refrigerator and brought to room temperature (30-50 min is required);

- Flask with Octreotide Depot should be kept strictly vertically. Easily tapping on the vial, to ensure that all the lyophilizate was at the bottom of the vial;

- open the package with a syringe, attach a 1.2 × 50 mm needle to the syringe for solvent extraction;

- open the ampoule with the solvent and draw into the syringe all the contents of the ampoule with the solvent, install the syringe to a dose of 2 ml;

- remove the plastic cap from the vial containing the lyophilizate. Disinfect the rubber stopper of the bottle with an alcohol swab. Insert the needle into the vial with lyophilizate through the center of the rubber stopper and gently insert the solvent into the inner wall of the vial without touching the needle with the contents of the vial. Remove the syringe from the vial;

- the vial should remain stationary until the solvent is fully saturated with the lyophilizate and a suspension is formed (about 3-5 minutes). After that, without turning the bottle, you should check the presence of dry lyophilizate on the walls and the bottom of the vial. If a dry residue of the lyophilizate is found, leave the vial until it is completely soaked;

- after the health worker has ascertained that there are no residues of dry lyophilizate, the contents of the vial should be gently stirred in a circular motion for 30-60 seconds until a uniform suspension is formed. Do not overturn or shake the bottle; this may result in the loss of flakes and the unfitness of the suspension;

- quickly insert the needle through the rubber stopper into the vial. Then cut the needle cut down and, tilting the bottle at an angle of 45 , slowly fill the syringe completely. Do not flip the bottle when typing. A small amount of the drug can remain on the walls and bottom of the vial. The expenditure on the remainder on the walls and the bottom of the vial is taken into account;

- immediately after dialing the suspension, replace the needle with the pink pavilion on the needle with the green pavilion (0.8 × 40 mm), gently turn the syringe and remove the air from the syringe;

- Suspension of Octreotide Depot should be administered immediately after preparation;

- Suspension of the drug Octreotide Depot should not be mixed with any other drugs in one syringe;

- Use an alcohol swab to disinfect the injection site. Insert the needle deep into the gluteus muscle, then slightly pull the syringe plunger backward to make sure that there is no damage to the vessel. Introduce the suspension in / m slowly, with constant pressure on the plunger of the syringe;

- If you get into a blood vessel, you should change the injection site and the needle;

- when the needle is clogged, replace it with another needle of the same diameter;

- with repeated injections, the left and right sides should alternate.

Precautions for use

When tumors of the pituitary gland secreting growth hormone, careful monitoring of the patients is necessary. It is possible to increase the size of tumors with the development of such a serious complication, as narrowing the fields of vision. In these cases, consideration should be given to the need for other treatments.

In 15-30% of patients receiving octreotide s / c for a long time, there may be the appearance of stones in the gallbladder. The prevalence in the general population (age 40-60 years) is 5-20%. The experience of long-term treatment with octreotide prolonged action of patients with acromegaly and tumors of the gastrointestinal tract and pancreas suggests that octreotide prolonged action, in comparison with short-acting octreotide, does not lead to an increased incidence of gallbladder stones. Nevertheless, it is recommended to have an ultrasound of the gallbladder before starting treatment with Octreotide Depot and approximately every 6 months during treatment. Stones in the gallbladder, if nevertheless they are found, as a rule, are asymptomatic. In the presence of clinical symptoms, conservative treatment (eg, administration of bile acid preparations) or surgical intervention is indicated.

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

In patients with insulinomas, treatment with octreotide may show an increase in the severity and duration of hypoglycemia (this is associated with a more pronounced effect on the secretion of growth hormone and glucagon than on insulin secretion, and also with a shorter duration of inhibitory effect on insulin secretion). A systematic observation of these patients is shown.

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

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

If gallbladder stones are found even before the start of treatment, it is necessary to evaluate the potential benefits of therapy with Octreotide Depot compared to the possible risk associated with the presence of gallstones.

At present, there is no evidence that Octreotide Depot drug adversely affects the course or prognosis of an already existing cholelithiasis.

Management of patients whose gallstones are formed during treatment with Octreotide Depot

Asymptomatic stones of the gallbladder. The use of Octreotide Depot can be stopped or continued - in accordance with the benefit / risk ratio estimate. In any case, no other measures are required, except to continue inspections, making them, if necessary, more frequent.

Stones of the gallbladder with clinical symptoms. The use of Octreotide Depot can be stopped or continued - in accordance with the benefit / risk ratio estimate. 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 / day in combination with UDCA at the same dose) under ultrasound control until the stones disappear completely.

Overdose

At present, cases of an overdose of Octreotide Depot were not reported.

special instructions

Special precautions for the destruction of unused medicinal product. A vial with a preparation, a syringe and needles destroy separately.

Effect on the ability to drive and other mechanisms. At present, there is no evidence of the effect of Octreotide Depot on the ability to drive and work with mechanisms requiring increased attention and speed of mental and motor reactions.

Form of issue

Lyophilizate for the preparation of suspension for intramuscular administration of prolonged action. By 0,01, 0,02 or 0,03 g of octreotide in dark glass bottles with the capacity of 10 ml. 2 ml of solvent (mannitol solution for injection 0.8%) in neutral glass ampoules with a tension ring or break point for opening. 1 fl. With the drug, 1 amp. With a solvent (2 ml), 1 syringe with a single application of 5 ml capacity, 2 sterile needles, ampoule opener or ampoule scarifier, 2 alcohol tampons are packaged in a contoured cell pack of PVC film. The kit is designed for one injection. When you pack the solvent to prepare the suspension in ampoules with a tension ring or break point for dissection, the ampoule scaler or the opener for opening the ampoules is not inserted. 1 contour mesh package is placed in a cardboard box or a pack of cardboard box.

Terms of leave from pharmacies

On prescription.

Storage conditions

In a dry, dark place at a temperature of 2 to 8 C.

Keep out of the reach of children.

Shelf life

Lyophilizate - 3 years; Solvent - 5 years.

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

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