Sandostatin - Instructions For Use, Price, Analogues, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Sandostatin

Sandostatin: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Sandostatin

ATX code: H01CB02

Active ingredient: octreotide (octreotide)

Producer: Novartis Pharma Stein AG (Switzerland)

Description and photo update: 2019-23-08

Prices in pharmacies: from 1749 rubles.

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Sandostatin is a drug with a somatostatin-like effect.

Release form and composition

The dosage form of Sandostatin is a solution for intravenous and subcutaneous administration: colorless, transparent (in 1 ml ampoules, in a cardboard box of 5 or 10 ampoules).

Composition of 1 ml solution:

• active substance: octreotide (in the form of a free peptide) - 50, 100 or 500 μg;
• additional components: sodium bicarbonate, lactic acid, mannitol, carbon dioxide, water for injection.

Pharmacological properties

Pharmacodynamics

The active substance of Sandostatin is octreotide, a synthetic octapeptide, an analogue of the natural hormone somatostatin, which has similar pharmacological effects, but a significantly longer duration of action.

Octreotide suppresses the secretion of growth hormone (GH), both pathologically increased and arising from insulin hypoglycemia, exercise, exposure to arginine. Sandostatin also suppresses the secretion of insulin, serotonin, gastrin and glucagon, increased pathologically or due to food intake. Suppresses the secretion of glucagon and insulin stimulated by arginine, as well as the secretion of thyrotropin caused by thyroliberin.

Unlike somatostatin, octreotide inhibits GH secretion to a greater extent than insulin secretion. The drug does not lead to subsequent hypersecretion of hormones (for example, growth hormone in patients with acromegaly). In acromegaly, Sandostatin reduces the level of GH and insulin-like growth factor (IGF-1) in the blood plasma. In 90% of patients, a decrease in the concentration of GH is noted by at least 50%, while the level of GH below 5 ng / ml can be achieved in about 50% of cases. In most patients with acromegaly, the drug reduces swelling of soft tissues, the severity of headache and hyperhidrosis, paresthesia and pain in the joints. For large pituitary adenomas, Sandostatin can slightly reduce the size of the tumor.

Octreotide can improve the course of the disease in case of insufficient effectiveness of the therapy (hepatic artery embolism, surgery, chemotherapy, including 5-fluorouracil and streptozotocin) of secreting endocrine tumors of the gastrointestinal tract and pancreas. So, in carcinoid tumors, Sandostatin reduces the severity of diarrhea and the sensation of flushing to the face, which is often accompanied by a decrease in the plasma concentration of serotonin and the excretion of 5-hydroxyindoleacetic acid in the urine. In VIPomas [tumors with overproduction of vasoactive intestinal peptide (VIP)], the drug in most cases reduces severe secretory diarrhea and, as a result, significantly improves the patient's quality of life. At the same time, concomitant electrolyte disturbances (for example, hypokalemia) decrease,which allows you to cancel parenteral and enteral administration of electrolytes and fluids. In some patients, Sandostatin slows down and even stops the progression of the tumor, reduces its size, as well as the size of liver metastases. Clinical improvement in the condition is usually accompanied by a decrease or normalization of the plasma concentration of VIP.

In glucagonomas, octreotide reduces erythema migrans. In diabetes mellitus, the drug does not significantly affect the severity of hyperglycemia, therefore, the need for hypoglycemic agents or insulin usually remains unchanged. An increase in body weight is possible due to a decrease in diarrhea. And although the decrease in the plasma glucagon concentration under the influence of Sandostatin is transient, the improvement in the clinical condition is stable throughout the entire period of taking the drug.

When gastrinomas / Zollinger - Ellison octreotide use as monotherapy or in combination with blockers of histamine H ₂ receptors or proton pump inhibitors may reduce the hypersecretion of hydrochloric acid in the stomach, a reduction in plasma concentration of gastrin and severity of hot flushes and diarrhea.

In patients with insulinomas, Sandostatin helps to reduce the level of immunoreactive insulin in the blood (this effect can be short-lived, up to 2 hours). In the presence of operable tumors, the drug can restore and maintain normoglycemia in the preoperative period. With inoperable benign and malignant tumors, glycemic control can be improved without a simultaneous prolonged decrease in blood insulin concentration.

In patients with rare tumors that overproduce growth hormone releasing factor (somatoliberinomas), Sandostatin reduces the severity of acromegaly symptoms, since it suppresses the secretion of growth hormone releasing factor and growth hormone itself. In the future, a decrease in pituitary hypertrophy is also possible.

When bleeding from varicose veins of the esophagus and stomach in patients with cirrhosis of the liver, the addition of octreotide to specific treatment (for example, to sclerotherapy) can more effectively stop bleeding and prevent early rebleeding, reduces the volume of transfusions and improves 5-day survival. It is believed that the mechanism of action of Sandostatin is due to a decrease in organ blood flow due to the suppression of vasoactive hormones such as glucagon and VIP.

In patients who are indicated for surgical intervention on the pancreas, Sandostatin, used during and after surgery, reduces the incidence of typical postoperative complications (for example, postoperative acute pancreatitis, pancreatic fistulas, sepsis, abscesses).

With refractory diarrhea in patients with acquired immunodeficiency syndrome (AIDS), Sandostatin completely or partially normalizes stool in about 30% of cases when diarrhea cannot be controlled with adequate antidiarrheal and / or antimicrobial therapy.

Pharmacokinetics

After subcutaneous administration, octreotide is rapidly and completely absorbed. The maximum plasma concentration is reached within about 30 minutes.

It binds to plasma proteins by 65%. The connection with the formed elements of the blood is extremely insignificant. The volume of distribution is 0.27 l / kg. The total clearance is 160 ml / min.

After subcutaneous injection, the half-life (T _½) is 100 minutes. Withdrawal of the drug after intravenous administration is carried out in two phases, T _½ is 10 and 90 minutes, respectively. Most of the drug is excreted in the feces, about 32% - in the urine unchanged.

Indications for use

• acromegaly: with insufficient effectiveness of radiation / surgical therapy in order to control the main manifestations of the disease and lower levels of GH (growth hormone) and IGF-1 (insulin-like growth factor) in plasma; if the patient refuses to carry out the operation or if there are contraindications to it; short-term treatment in the intervals between courses of radiation therapy until its effect is fully developed;
• secreting endocrine tumors of the gastrointestinal tract (gastrointestinal tract) and pancreas (to control symptoms): VIPomas, glucagonomas, carcinoid tumors proceeding with carcinoid syndrome, insulinomas (for maintenance therapy and to control hypoglycemia in the preoperative period), somatoliberinomas (tumors which are characterized by overproduction of GH releasing factor), gastrinoma / Zollinger-Ellison syndrome (usually in combination with histamine H ₂ receptor antagonists and proton pump inhibitors). It should be borne in mind that Sandostatin is not an antineoplastic drug, and its use does not lead to the cure of this category of patients;
• refractory diarrhea in AIDS patients (to control symptoms);
• complications after operations on the pancreas (for prevention);
• bleeding from varicose veins of the stomach and esophagus with cirrhosis of the liver (in combination with specific therapeutic measures (for example, endoscopic sclerotherapy) to stop bleeding and prevent relapse).

Contraindications

An absolute contraindication to therapy is the presence of hypersensitivity to the components of the drug.

According to the instructions, Sandostatin should be used with caution in the following cases:

• cholelithiasis;
• diabetes;
• pregnancy;
• period of breastfeeding.

Instructions for the use of Sandostatin: method and dosage

Sandostatin is administered subcutaneously or intravenously.

Recommended dosage regimen:

• acromegaly: initial single dose (subcutaneously) - 50-100 mcg, intervals between injections - 8 or 12 hours. Next, the dose is adjusted based on the concentration of GH and IGF-1 in the blood, determined monthly (target concentration: GH <2.5 ng / ml; IGF-1 should be within normal values), analysis of clinical symptoms and tolerance of therapy. In most cases, the optimal dose is 300 mcg per day. The maximum is 0.0015 mcg / kg per day. When using a stable dose of Sandostatin, the concentration of GH is determined every 6 months. In cases where, after 3 months of therapy, a sufficient decrease in the level of GH and an improvement in the clinical picture is not observed, Sandostatin is canceled;
• endocrine tumors of the gastrointestinal tract and pancreas: initial single dose (subcutaneously) - 50 μg, frequency of administration - 1-2 times a day. Further, the dose is adjusted based on the tolerance, the achieved clinical effect, the effect on the levels of hormones produced by the tumor. Perhaps a gradual increase in the dose to 100-200 mcg with a frequency of application 3 times a day. In some cases, the doctor may prescribe higher doses. Maintenance doses are prescribed individually. If the therapy of carcinoid tumors is ineffective at the maximum tolerated dose for 7 days, Sandostatin is canceled;
• refractory diarrhea in AIDS patients: the initial single dose (subcutaneously) is 100 μg, the frequency of administration is 3 times a day. If this single dose is ineffective for 7 days, it is increased individually (stool dynamics and the tolerance of Sandostatin are taken into account), in some cases - up to 250 μg. If the condition does not improve, treatment is interrupted;
• complications after operations on the pancreas (prophylaxis): single dose (subcutaneously) - 100 μg, frequency of administration - 3 times a day. The first dose is administered on the day of surgery (at least 1 hour before laparotomy), duration of use is 7 days daily;
• bleeding from varicose veins of the esophagus and stomach: daily dose (continuous intravenous infusion) - 25 μg / h, course duration - 5 days. Sandostatin can be diluted with isotonic sodium chloride solution. Against the background of liver cirrhosis, the therapy was well tolerated at a daily dose of up to 50 μg / h.

In children, experience with Sandostatin is limited.

Elderly patients, as well as in the presence of impaired renal function, dosage adjustment is not required.

For functional disorders of the liver, it is recommended to correct the maintenance dose (there is evidence of an increase in the half-life of octreotide in liver cirrhosis).

For self-administered subcutaneous administration of Sandostatin, you must first obtain detailed instructions from the nurse / doctor. The solution must be warmed to room temperature before administration (to reduce discomfort at the injection site). Do not inject the drug into the same place at short intervals. The ampoule must be opened immediately before the administration of the solution.

Before intravenous administration, Sandostatin should be carefully examined for discoloration / foreign particles. The drug maintains chemical and physical stability in physiological sterile solution or 5% glucose solution in water for 24 hours. Since Sandostatin can affect glucose metabolism, the use of saline is preferred. The prepared solution retains its physical and chemical stability for at least 24 hours at temperatures up to 25 ° C. To avoid microbial contamination, after dilution, Sandostatin must be administered immediately. If necessary, it can be stored at a temperature of 2–8 ° С. The total time from dilution to application is up to 24 hours. Before administration, the solution must be warmed to room temperature.

For intravenous administration, the contents of one ampoule containing 500 μg of the active substance must be diluted in 60 ml of saline. It is also possible to use lower concentrations of Sandostatin.

Side effects

The main side effects during the use of Sandostatin include gastrointestinal reactions and reactions at the injection site.

The most frequently observed development of the following disorders: abdominal pain, diarrhea, flatulence, irritation / pain at the injection site.

Transient gastrointestinal disorders were observed in 10% of cases. As a rule, they passed on their own and did not require discontinuation of therapy.

Possible adverse reactions (very often (≥1 / 10), often (≥1 / 100, ≤1 / 10), sometimes (≥1 / 1000, ≤1 / 100), rarely (≥1 / 10,000, ≤1 / 1000), very rarely (≤ 1/10 000, taking into account individual reports)):

• cardiovascular system: sometimes - tachycardia, bradycardia;
• digestive system: often - diarrhea, constipation, abdominal cramping, flatulence; sometimes - cholecystitis; rarely - bloating, steatorrhea, vomiting, nausea, formation of stones in the gallbladder; very rarely - anorexia, acute pancreatitis, acute hepatitis without cholestasis, loose stools, hyperbilirubinemia, increased levels of alkaline phosphatase, gamma-glutamyltransferase and hepatic transaminase activity;
• respiratory system: very rarely - shortness of breath;
• endocrine system: very rarely - hyperglycemia, hypoglycemia;
• local reactions: pain, burning / itching, swelling / redness at the site of subcutaneous injection (usually disappears within 15 minutes). Their severity decreases with the introduction of a solution of room temperature or a more concentrated solution of a smaller volume;
• allergic / dermatological reactions: sometimes temporary hair loss; rarely - rash, hypersensitivity; very rarely - anaphylaxis.

Despite the likelihood of increased excretion of fat in the feces, there is currently no evidence that prolonged use of Sandostatin can lead to the development of nutritional deficiencies due to malabsorption (malabsorption).

The incidence of adverse reactions in the digestive system can be reduced by increasing the intervals between meals and administration of the drug.

There is evidence of very rare cases of acute pancreatitis during the period of use of Sandostatin (in the first hours or days of subcutaneous use), which disappears after discontinuation of treatment. There is also information about the development of pancreatitis associated with cholelithiasis against the background of prolonged use of the drug.

In rare cases, the development of functional disorders of the thyroid gland (increase / decrease in activity), dyspeptic phenomena, arrhythmias was noted.

As a result of ECG studies, the following adverse reactions were recorded: low-voltage type of ECG, deviation of the electrical axis of the heart, lengthening of the QT interval, displacement of the transition zone, early repolarization, early P wave and nonspecific changes in the T wave and ST segment. Since many patients with carcinoid tumors and acromegaly have heart disease, a causal relationship between therapy and the occurrence of these disorders has not been established.

Overdose

When using Sandostatin subcutaneously in doses up to 2000 mcg three times a day for several months, no adverse reactions were observed.

One of the patients was mistakenly given an overdose by continuous infusion of 250 mcg / h for 48 hours instead of 25 mcg / h. No side effects have been reported.

The patient was given a maximum of 1000 μg bolus intravenously, which was accompanied by the development of the following symptoms: flushing of the face, decreased heart rate, diarrhea, abdominal cramping, nausea, feeling of emptiness in the stomach. All these phenomena disappeared within 24 hours after the administration of Sandostatin.

No life-threatening reactions in acute overdose have been noted.

Treatment is symptomatic.

special instructions

The condition of patients with pituitary tumors secreting GH during therapy should be closely monitored, since there is a possibility of an increase in the size of tumors with the development of such a serious complication as narrowing of the visual fields. In such cases, consider using other treatments.

With the development of bradycardia against the background of the use of Sandostatin, a decrease in the dose of calcium channel blockers, beta-blockers or drugs that affect the water-electrolyte balance is required.

In some cases, the use of Sandostatin can lead to a change in the absorption of fats in the intestine. During the treatment period, a decrease in the content of cyanocobalamin (vitamin B12) and the occurrence of deviations from the norm in the indicators of its absorption test (Schilling test) were noted.

With a history of vitamin B12 deficiency, it is recommended to monitor the content of cyanocobalamin in the body.

Recommendations for the management of gallbladder stones:

• an initial ultrasound examination of the gallbladder should be performed before Sandostatin is prescribed;
• repeated ultrasound examinations of the gallbladder during the period of use of the drug should be carried out at intervals of 6-12 months;
• in the presence of gallbladder stones, even before the start of the treatment course, before the appointment of Sandostatin, the benefit / risk ratio should be assessed. There is no information about any negative effect of the drug on the course or prognosis of an already existing gallstone disease.

Recommendations for the formation of gallbladder stones during the treatment:

• asymptomatic course: the decision to continue or interrupt therapy is made after assessing the benefit / risk ratio. The continuation of monitoring the condition is shown, if necessary - more frequent;
• the presence of clinical symptoms: the decision to continue or interrupt therapy is made after assessing the benefit / risk ratio. In any case, the patient must be treated with standard methods under ultrasound guidance using combinations of bile acid preparations (until the stones disappear completely).

In rare cases, in the treatment of endocrine tumors of the gastrointestinal tract and pancreas, a sudden relapse of symptoms of the disease is possible. With insulinomas, the severity and duration of hypoglycemia may increase. It is required to ensure careful regular monitoring of this category of patients at the beginning of therapy and at each change in the dosage regimen. Significant fluctuations in blood glucose concentration can be tried to be reduced by more frequent administration of Sandostatin in lower doses.

In cases of a likely change in insulin demand (for example, after bleeding from varicose veins of the esophagus and stomach), systematic monitoring of the concentration of glucose in the blood should be carried out.

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

Influence on the ability to drive vehicles and complex mechanisms

There is no data on the effect of the components of Sandostatin on cognitive and psychomotor functions.

Application during pregnancy and lactation

The experience of using the drug during pregnancy and lactation is limited, therefore, women during these periods can be prescribed Sandostatin only after a careful balance of the expected benefit for the patient and possible risks to the fetus / child.

Pediatric use

Experience with octreotide in pediatrics is very limited.

With impaired renal function

No adjustment of the Sandostatin dosage regimen is required for patients with impaired renal function.

For violations of liver function

It is known that with cirrhosis of the liver, the half-life of octreotide increases, therefore patients with impaired hepatic function are recommended to adjust the maintenance dose of Sandostatin.

Use in the elderly

Until now, no data have been obtained indicating a decrease in the tolerance of Sandostatin in old age, which would require a reduction in the dose of the drug.

Drug interactions

With the combined use of Sandostatin with certain drugs / substances, the following effects may develop:

• cyclosporine: a decrease in its absorption;
• bromocriptine: increasing its bioavailability;
• cimetidine: slowing down its absorption;
• drugs metabolized by the isoenzyme CYP3A4 and having a narrow range of therapeutic concentrations (terfenadine, quinidine): a decrease in their metabolic clearance (the combination requires caution).

Analogs

Analogs of Sandostatin are: SERAKSTAL, Octretex, Octreotid FSintez, Octrestatin, Octreotid Kabi, Octra, Genfastat, Octreotid-Long FS, Okeron, Ukreotid, Octreotid Sun, Oktride, Octrin, Octreotid, Octreotid-Actavis, Octreotid.

Terms and conditions of storage

Store in a dark place, out of reach of children, without freezing, at a temperature of 2-8 ° C, in its original packaging.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Sandostatin

On specialized medical forums and sites, there are practically no reviews about Sandostatin from patients to whom the drug was prescribed for medicinal purposes.

It is indicated that octreotide significantly improves the appearance in acromegaly and is effective in pancreatitis. The positive effect of Sandostatin is often noted in various types of tumor processes, for example, with pituitary adenoma. However, the drug has a short-term effect and does not radically affect the course of the disease. In addition, therapy is quite expensive.

It is noted that Sandostatin has a noticeable effect on the liver, which is why it is often necessary to stop treatment, even if it is successful.

The price of Sandostatin in pharmacies

Sandostatin prices may vary depending on the region of sale and the pharmacy chain. The approximate cost of a package of 5 ampoules, depending on the dosage of the drug: 50 mcg - 1101-1926 rubles, 100 mcg - 1725-2160 rubles.

Sandostatin: prices in online pharmacies

Drug name Price Pharmacy

Sandostatin 0.1 mg / ml solution for intravenous and subcutaneous administration 1 ml 5 pcs. 1749 RUB Buy

Sandostatin solution for intravenous and subcutaneous intravenous administration. 0.1mg / ml 1ml 5 pcs. RUB 2168 Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!