Composition, form of production and packaging
Microspheres for the preparation of a suspension for the / m introduction in the form of a powder of white or almost white color.
1 f.
octreotide acetate 11.2 mg,
which corresponds to the content of octreotide 10 mg
[PRING] lactic and glycolic acid copolymer - 188.8 mg, mannitol - 41 mg.
Solvent: carmellose sodium (sodium carboxymethylcellulose) - 12.5 mg, mannitol - 15 mg, water d / and - up to 2.5 ml.
Glass bottles with a capacity of 5 ml, sealed with gray rubber stoppers with dark blue caps (1) complete with a solvent (2.5 ml syringes 1 pc.) And sterile needles (2 pcs.) - cardboard packs.
Microspheres for the preparation of a suspension for the / m introduction in the form of a powder of white or almost white color.
1 f.
octreotide acetate 22.4 mg,
which corresponds to the content of octreotide 20 mg
[PRING] lactic and glycolic acid copolymer - 377.6 mg, mannitol - 81.9 mg.
Solvent: carmellose sodium (sodium carboxymethylcellulose) - 12.5 mg, mannitol - 15 mg, water d / and - up to 2.5 ml.
Glass bottles with a capacity of 5 ml, sealed with gray rubber stoppers with orange covers (1) complete with a solvent (2.5 ml syringes 1 pc.) And sterile needles (2 pcs.) - cardboard packs.
Microspheres for the preparation of a suspension for the / m introduction in the form of a powder of white or almost white color.
1 f.
octreotide acetate 33.6 mg,
which corresponds to the content of octreotide 30 mg
[PRING] lactic and glycolic acid copolymer - 566.4 mg, mannitol - 122.9 mg.
Solvent: carmellose sodium (sodium carboxymethylcellulose) - 12.5 mg, mannitol - 15 mg, water d / and - up to 2.5 ml.
Glass bottles with a capacity of 5 ml, sealed with gray rubber stoppers with dark red lids (1) complete with a solvent (2.5 ml syringes 1 pc.) And sterile needles (2 pcs.) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Sandostatin В® LAR is a synthetic octapeptide, which is a derivative of the natural somatostatin hormone and has similar pharmacological effects, but a much longer duration of action. Octreotide depot inhibits the pathologically increased secretion of growth hormone (GH), as well as the release of GH caused by arginine, exercise and insulin hypoglycemia. The drug also inhibits the secretion of peptides of the gastro-entero-pancreatic system (for example, food-induced secretion of insulin, glucagon, gastrin) and serotonin. Also, the octreotide depot inhibits the secretion of insulin and glucagon stimulated with arginine; secretion of thyrotropin, caused by thyroidiberin.
Unlike somatostatin, octreotide suppresses GH secretion more than insulin secretion, and its administration is not accompanied by a ricochet effect in the form of hypersecretion of hormones (eg, GH in patients with acromegaly).
In patients with acromegaly, the use of depot octreotide ensures the maintenance of stable therapeutic concentrations of octreotide in the serum when the drug is administered once every 4 weeks. The introduction of depot octreotide provides, in most cases, a persistent reduction in serum GH and serum normalization of insulin-like growth factor-1 (IGF-1).
In most patients with acromegaly, octreotide depot form significantly reduces the severity of such symptoms as headache, increased sweating, paresthesia, a feeling of fatigue, pain in the bones and joints, carpal tunnel syndrome. In some clinical cases, treatment with octreotide depot form patients with pituitary adenomas, secreting GH, led to a decrease in tumor size.
When secreting endocrine tumors of the gastrointestinal tract and pancreas, the use of depot octreotide provides a constant control of the main symptoms of these diseases.
Octreotide depot form at a dose of 30 mg every 4 weeks slows tumor growth in patients with secreting and non-secretive common (metastatic) neuroendocrine tumors of lean, ileal,
ascending colon, transverse colon and vermiform appendage, or metastases of neuroendocrine tumors without a primary focus. The drug significantly increased the time to progression in this category of patients: the median time to progression was 14.3 months compared with 6 months in the placebo group. After 6 months of treatment, stabilization was observed in 66% of patients in the octreotide depot form group and 37% of patients in the placebo group. The drug was effective in increasing the time to progression, both for secreting and for non-secreting 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 plasma serotonin concentration and excretion of 5-hydroxyindoleacetic acid in the urine.
In tumors characterized by hyperproduction of the vasoactive intestinal peptide (WIPOM) , 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 tumor progresses or stops, and even its size decreases, especially the metastatic foci in the liver. Clinical improvement is usually accompanied by a decrease (up to normal values) of the concentration of vasoactive intestinal peptide (VIP) in plasma.
With glucagonomes, the use of octreotide in most cases leads to a significant decrease in necrolytic migrating erythema, which is characteristic of this condition.Octreotide does not have any significant effect on the severity of diabetes mellitus, often observed in glucagonomes, and its use 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, the improvement of clinical symptoms persists for a long time.
In gastrinomas / Zollinger-Ellison syndrome, when octreotide is used alone or in combination with histamine H 2 receptor blockers and proton pump inhibitors, hydrochloric acid formation in the stomach can be reduced and clinical improvement can be improved, including a reduction in diarrhea. It is also possible to reduce the severity and other symptoms likely associated with the synthesis of peptides by the tumor, incl. tides. In some patients there is a decrease in the concentration of gastrin in the plasma.
In patients with insulinomas, octreotide reduces the level of immunoreactive insulin in the blood.
In patients with operable tumors, octreotide can provide restoration and maintenance of normoglycemia in the preoperative period. In patients with inoperable benign and malignant tumors, glycemic control can be improved without a simultaneous steady decrease in insulin levels in the blood.
In patients with rare tumors, hyper-growth hormone releasing factor (somatoliberinomas), 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, it is possible to reduce the size of the pituitary gland, which was increased before the treatment.
PHARMACOKINETICS
After the / m administration of depot octreotide, the concentration of octreotide in the serum reaches a short initial peak for 1 hour and thereafter progressively decreases for 24 hours until it reaches undetectable values. After the initial peak, observed on the first day, the concentration of octreotide in the next 7 days in most patients remains within the subtherapeutic values. After that, the octreotide concentrations increase again, reach the "plateau" by about the 14th day and remain relatively constant for the next 3-4 weeks. The peak concentration value on the first day is lower than the levels noted in the "plateau" phase. On the 1st day, no more than 0.5% of the total amount of active substance is released. After about 42 days, the concentrations of octreotide slowly decrease, which occurs simultaneously with the final stage of degradation of the polymer matrix of the dosage form.
After administration of acromegaly, octreotide depot form in single doses of 10 mg, 20 mg and 30 mg concentration of octreotide in the "plateau" phase were 358 ng / l, 926 ng / l and 1710 ng / l, respectively. C ss octreotide in serum, achieved after 3 injections of Sandostatin LAR at doses of 20 mg and 30 mg at 4-week intervals, were approximately 1.6-1.8 times higher and amounted to 1557 ng / L and 2384 ng / L, respectively.
In patients with carcinoid tumors who underwent multiple injections of depot octreotide at doses of 10 mg, 20 mg and 30 mg at 4-week intervals, the mean C ssoctreotide in serum increased linearly with increasing dose and amounted to 1231 (894) ng / l, 2620 (2270) ng / l and 3928 (3010) ng / l, respectively.
With the use of depot octreotide for 28 months (1 injection / month), no cumulation of octreotide was found beyond what one would expect due to partial overlapping of the pharmacokinetic curves.
The pharmacokinetic profile of octreotide after depot octreotide injection reflects its release profile from the polymer matrix and its biodegradation. After entering the systemic circulation, the distribution of octreotide occurs in accordance with its pharmacokinetic properties, which are described for the dosage form for SC administration. V d of octreotide in the equilibrium state is 0.27 l / kg. The total plasma clearance is 160 ml / min. Binding to plasma proteins is 65%. With the elemental blood of octreotide does not bind.
INDICATIONS
Treatment of acromegaly in the following cases:
- when adequate control of the manifestations of the disease is carried out due to the / s introduction of Sandostatin;
- in the absence of sufficient effect or with complete ineffectiveness of surgical treatment or radiotherapy, and after radiotherapy as a short-term treatment until its effect is fully developed.
Treatment of patients with symptoms of endocrine tumors of the gastrointestinal tract and pancreas, when the s / s of Sandostatin provides adequate control of manifestations of the disease:
- carcinoid tumors with manifestations of carcinoid syndrome;
- VIPoms;
- Glucagon;
- gastrinomas / Zollinger-Ellison syndrome;
- insulinomas - to control hypoglycemia in the preoperative period, as well as for maintenance therapy;
- somatoliberynomas (tumors characterized by hyperproduction of growth hormone releasing factor).
Treatment of patients with secreting and non-secretive widespread (metastatic) neuroendocrine tumors of lean, iliac, blind, ascending colon, transverse colon, vermiform appendix or
metastases of neuroendocrine tumors without a primary focus.
DOSING MODE
Sandostatin В® LAR should be administered only deep in the / m, in the gluteal muscle. With repeated injections, the left and right sides should alternate.
Acromegaly
For patients in whom the administration of Sandostatin В® provides an adequate control of the manifestations of the disease, the recommended initial dose of Sandostatin В® LAR is 20 mg every 4 weeks for 3 months. Start treatment with the drug Sandostatin В® LAR can be the day after the last s / s of the introduction of Sandostatin. In the future, the dose is adjusted taking into account the serum concentrations of GR and IGF 1, as well as clinical symptoms. If after 3 months of treatment an adequate clinical and biochemical effect could not be achieved (in particular, if the GH concentration remains above 2.5 Ојg / L), the dose can be increased to 30 mg administered every 4 weeks.
If after 3 months of treatment failed to achieve an adequate clinical and biochemical effect (elevated levels of GH and IGF-1), the dose can be increased to 40 mg every 4 weeks.
If after 3 months of treatment with Sandostatin В® LAR at a dose of 20 mg there is a persistent decrease in serum GH concentration below 1 Ојg / l, normalization of IGF 1 concentration and disappearance of reversible symptoms of acromegaly, it is possible to reduce the dose of Sandostatin В® LAR up to 10 mg every 4 weeks.However, in these patients receiving a relatively small dose of SandostatinВ® LAR, serum concentrations of GH and IGF-1, as well as the symptoms of the disease, should be carefully monitored.
In patients receiving a stable dose of Sandostatin В® LAR, the determination of the concentrations of GH and IGF 1 should be performed every 6 months.
For patients in whom surgical treatment and radiation therapy are not effective or generally ineffective, as well as for patients requiring short-term treatment after the course of radiotherapy until the full effect develops, it is recommended to conduct a short trial course of treatment with s / s Sandostatin injections in order to assess its effectiveness and general tolerability, and only after that switch to the use of the drug Sandostatin В® LAR according to the above scheme.
Endocrine tumors of the gastrointestinal tract and pancreas
For patients in whom the administration of the drug Sandostatin В® provides adequate control of the manifestations of the disease , the recommended initial dose of the drug Sandostatin В® LAR is 20 mg every 4 weeks. The administration of Sandostatin В® should be continued for 2 weeks after the first injection of Sandostatin В®LAR.
For patients who have not received prior treatment with Sandostatin , it is recommended to start treatment with a s / s Sandostatin dose of 0.1 mg 3 times a day for a short period (approximately 2 weeks) in order to assess its effectiveness and overall tolerability. Only after this is prescribed Sandostatin В® LAR according to the above scheme.
In the case when therapy with Sandostatin В® LAR for 3 months provides adequate control of clinical manifestations and biological markers of the disease, it is possible to reduce the dose of Sandostatin В® LAR up to 10 mg every 4 weeks.
In those cases when after 3 months of treatment with LAD Sandostatin it was possible to achieve only partial control of symptoms, the dose of the drug can be increased to 30 mg every 4 weeks.
Against the background of treatment with Sandostatin В® LAR on certain days, the clinical manifestations characteristic of endocrine tumors of the gastrointestinal tract and pancreas may increase. This can occur mainly in the first 2 months of treatment, until the therapeutic concentrations of octreotide in plasma are reached. In these cases, an additional s / s of Sandostatin is recommended in the dose used before the treatment with Sandostatin В® LAR.
Secreting and non-secreting common (metastatic) neuroendocrine tumors of lean, iliac, blind, ascending colon, transverse colon and appendix, or metastases of neuroendocrine tumors without a primary focus
The recommended dose of Sandostatin В® LAR is 30 mg every 4 weeks. Therapy with Sandostatin В® LAR should continue until signs of tumor progression.
Impaired renal function does not affect AUC octreotide. When using the drug Sandostatin В® LAR in patients with impaired renal function, correction of its dose is not required.
Dysfunction of the liver. The results of the study, in which s / c and iv administration of Sandostatin were used, showed that a delay in excretion may occur in patients with cirrhosis, but this was not observed in patients with fatty hepatosis. Due to the wide therapeutic range of octreotide, there is no need to correct the dosage regimen of Sandostatin В® LAR in patients with cirrhosis of the liver.
The results of the study, in which Sandostatin was administered to patients aged 65 years and older, showed that there was no need to change the dosage regimen inelderly patients . Likewise, this category of patients does not need to adjust the dose of Sandostatin В® LAR.
Rules for the preparation of a suspension for injection and drug administration
The following recommendations should be strictly observed. Introduce only a homogeneous suspension. Suspension Sandostatin В® LAR is prepared immediately prior to administration . Sandostatin В® LAR should be prepared and administered only by specially trained medical personnel.
Withdraw a bottle of Sandostatin LAR powder and a syringe with a solvent at room temperature. Remove the cap from the vial containing Sandostatin В® LAR.Tapping lightly on a vial, it is necessary to achieve, that the powder is evenly distributed on a bottom of a vial. The vial should be held vertically.
Remove the solvent from the tip of the syringe. To put on the enclosed syringe needle.
Disinfect the rubber stopper of the vial with an alcohol swab. Insert the needle into the vial with Sandostatin LAR, piercing the center of the rubber stopper. Without touching the contents of the bottle needle, gently introduce the solvent on the inner wall of the vial. No solvent is injected directly into a powder. Remove the syringe from the vial.
It is necessary that the bottle remains stationary as long until complete impregnation solvent contained in the vial of powder to form a slurry. After the solvent was completely infiltrated powder (approximately 2-5 minutes) without turning the bottle, check the presence of dry powder from the sides and bottom of the vial. Upon detection of the dry powder residue, leave the vial to complete the impregnation. At this time, we should prepare the patient for injection.
After confirming the absence of residual dry powder, the vial should be gently rotated for 30-60 seconds, until a homogeneous suspension. The vial should not be shaken, it can lead to flocculation and the unsuitability of the suspension.
Quickly insert the needle through the rubber stopper into the vial. Then, lowering the needle cut down and bent vial at 45 В°, to dial into the syringe slowly slurry completely. You can not turn the vial when filling the syringe - this may affect the amount of the bleed. Some small amount of the slurry may remain on the walls and bottom of the vial. This is normal, the flow rate for the remainder of the walls and bottom of the vial is taken into account.
Immediately change the needle on the syringe (the second needle out of the packaging).
The suspension should be administered immediately after preparation. Gently invert the syringe to achieve homogeneity of suspension. Remove air from the syringe.Alcohol swab to disinfect the injection site. , Then gently pull the syringe plunger back to insert the needle deep into the gluteal muscle to make sure that there is no damage to the vessel. Enter suspension / m slowly with constant pressure on the syringe plunger. By plugging the needle, replace it with another needle of the same diameter.
Sandostatin В® LAR to be administered deep into the gluteal muscle. You can not enter I / O. When injected into the blood vessel to be changed and the injection needle.
SIDE EFFECT
The main side effects were observed on the part of the digestive, nervous, hepatobiliary system, and metabolic disorders and the development of nutritional deficiencies.
In clinical studies were observed most often - diarrhea, abdominal pain, nausea, bloating, headache, formation of gallstones, hyperglycaemia and constipation; often -dizziness, pain of different localization, impaired bile colloidal stability (formation of cholesterol microcrystals), thyroid disorders (decreased TSH levels of total and free thyroxine), soft stool consistency, decreased glucose tolerance, vomiting, fatigue and hypoglycemia; in rare cases -events that resemble acute intestinal obstruction - progressive abdominal distension, severe epigastric pain, abdominal tension, muscle "protection".
Although fat excretion in the faeces can be increased, so far there is no evidence that prolonged
treatment with octreotide can lead to malnutrition due to suction disorders (malabsorption).
Reported very rare cases acute pancreatitis develops in the first few hours or days n / a application of octreotide (Sandostatin) and disappears after discontinuation of the drug. Furthermore, prolonged use of octreotide (Sandostatin) n / k there have been cases of pancreatitis associated with cholelithiasis.
ECG study data on the background of the drugin patients with carcinoid syndrome and acromegaly observed lengthening the interval QT, axis deviation, early repolarization, low voltage ECG type, displacement of the transition zone, the early P-wave and non-specific changes in ST segment and T wave Since these patients have heart disease causally effect relationship between the use of octreotide and the development of adverse event data is not installed.
Determining the frequency of adverse reactions in clinical trials: Very common (1/10?); often (? 1/100, <1/10); sometimes (1/1, 000, <1/100?); rarely (? 1/10 000, <1/1000); very rare (<1/10 000), including isolated reports.
From the digestive system: very often - diarrhea, abdominal pain, nausea, constipation, flatulence, cholelithiasis; often - indigestion, vomiting, feeling of fullness / abdominal heaviness, steatorrhea, soft stool consistency, change in stool color, anorexia, cholecystitis, bile violation colloidal stability (formation of cholesterol microcrystals), hyperbilirubinemia, elevated liver transaminases.
From the nervous system: very often - headache; often - dizziness.
From endocrine system: very often - hyperglycemia; often - hypothyroidism / thyroid dysfunction (decreased TSH levels of total and free thyroxine), hypoglycemia, impaired glucose tolerance.
Dermatological reactions: often - itching, rash, hair loss.
From the respiratory system: often - shortness of breath.
Cardio-vascular system: often - bradycardia; sometimes - tachycardia.
Local reactions: often - pain at the injection site.
Other: sometimes - dehydration.
The therapy with octreotide in clinical practice were observed following adverse events irrespective of a causal connection with the use of the drug.
Allergic reactions: anaphylactic reactions, hypersensitivity.
Dermatologic reactions: urticaria.
From the digestive system: acute pancreatitis, acute hepatitis without cholestasis phenomena, cholestatic hepatitis, cholestasis, jaundice, cholestatic jaundice, increased activity of alkaline phosphatase, GGT.
Cardio-vascular system: arrhythmia.
CONTRAINDICATIONS
- Hypersensitivity to the components of the drug.
With caution should be used when the drug cholelithiasis, diabetes, pregnancy and lactation (breast feeding).
PREGNANCY AND LACTATION
The use of octreotide in pregnancy has not been studied. There is limited experience with the drug in pregnant patients with acromegaly in clinical practice (half of pregnancy outcome was not known).
Most pregnant patients received octreotide therapy I trimester of pregnancy (as Sandostatin 100-300 mg / day p / or preparation Sandostatin В® LAR 20-30 mg per month). Approximately 70% of patients with a known outcome independently made the decision to continue therapy with the drug during pregnancy. The majority of patients (cases with known outcome) pregnancies ended in the birth of healthy children, but also reported a number of spontaneous abortion in the I trimester and in cases of abortion.
In the application of octreotide during pregnancy there were no cases of congenital malformations in children.
Pregnant women the drug is prescribed only in cases of extreme necessity.
In experimental studies, octreotide had no direct or indirect adverse effect on the course of pregnancy, formation and maturation of fetal birth and postnatal development, except for the time delay of growth.
It is unknown whether octreotide in breast milk in humans is released. In experimental studies have indicated the selection of the drug in breast milk.
If you need to use the drug during lactation, breastfeeding should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER
Renal dysfunction did not affect the AUC of octreotide. In applying Sandostatin LAR in patients with impaired renal function the dose correction is not required.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Results of the study, which used n / a and / introduction sandostatin, showed that a reduction of elimination of the drug may occur in patients with liver cirrhosis, but in patients with FH not observed. Due to the wide therapeutic window of octreotide, no need to correct dosing regimen of Sandostatin LAR in patients with liver cirrhosis.
APPLICATION FOR CHILDREN
There is limited experience with the drug Sandostatin В® LAR in children and adolescents younger than 18 years .
APPLICATION IN ELDERLY PATIENTS
Results of the study, which Sandostatin injected s / c in patients aged 65 years and older, showed that there is no need to modify the dosing regimen of the drug inelderly patients . Similarly this category of patients is not required to correct the dose of Sandostatin LAR.
SPECIAL INSTRUCTIONS
When tumors of the pituitary, secreting GH, the patients must be carefully monitored, since may increase the size of the tumors with the development of serious complications such as narrowing of the visual field. In these cases, consideration should be given to the need for other treatments.
Since the reduction in GH levels and normalization of IGF-1 on the background of octreotide therapy can lead to the restoration of the ability to give birth in women with acromegaly, in the application of the patient's drug of childbearing age should use reliable methods of contraception.
When assigning Sandostatin LAR in the need to monitor thyroid function for a long period of time.
In the case of bradycardia during treatment with the drug Sandostatin В® LAR necessary to reduce the doses of beta-blockers, calcium channel blockers or drugs affecting fluid and electrolyte balance.
In 15-30% of patients receiving Sandostatin В®n / a for a long time, it may cause gallstones. The prevalence in the general population (age 40-60 years) is 5-20%. Previous long-term treatment with Sandostatin В® LAR acromegaly patients and tumors of the gastrointestinal tract and pancreas indicating that Sandostatin В® LAR, compared with n / k Sandostatin administration does not lead to an increase in the frequency of formation of gallstones. However, we recommend holding ultrasound of the gallbladder before starting treatment with Sandostatin В® LAR 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 shown conservative treatment (e.g., use of bile acids preparations) or surgical intervention.
In some patients, Octreotide may alter absorption of fats in the intestine.
Against the background of octreotide, a decrease content of cyanocobalamin (vitamin B 12 ) and abnormal indicators cyanocobalamin absorption test (Schilling test). In applying the drug Sandostatin В® LAR in patients with deficiency of vitamin B 12 in anamnesis it is recommended to control the content of cyanocobalamin in the body.
Patients with type 1 diabetes Sandostatin В®LAR may affect glucose metabolism and therefore reduces the need of insulin.
For patients with diabetes type 2 and patients without concomitant diseases n / a drug injection Sandostatin В® can lead to postprandial glycemia. In this connection, it is recommended to regularly monitor blood glucose levels and, if necessary, correct the hypoglycemic therapy.
Patients with insulinomas during treatment with octreotide can be marked increase in the severity and duration of hypoglycemia (this is due to more pronounced overwhelming effect on GH secretion and glucagon than insulin secretion, as well as the shorter duration of inhibition of insulin secretion). Displaying systematic monitoring of these patients.
Recommendations for the timely detection of gallstones and for the management of patients during treatment with Sandostatin В® LAR
1. Prior to the appointment of octreotide should conduct the initial ultrasound gallbladder.
2. During treatment with Sandostatin В® LAR should be repeated ultrasound of the gall bladder, preferably at intervals of 6 months.
3. If the gall bladder stones are detected before the start of the treatment, it is necessary to evaluate the potential benefits of therapy with Sandostatin В® LAR compared with the possible risk associated with the presence of gallstones. Currently, there is no any indication that Sandostatin В®LAR adversely affects the course or prognosis existing cholelithiasis.
4. Maintain patients with gall bladder stones are formed during treatment with Sandostatin В® LAR:
a) Asymptomatic gallstones. Use of a preparation Sandostatin В® LAR can terminate or continue (as assessed benefit / risk ratio). In any case, it does not require any other measures, in addition to the continuation of the inspections, making them more frequent if necessary.
b) Gallstones symptomatic. Use of a preparation Sandostatin В®LAR can stop or continue (in accordance with the assessment of benefit / risk ratio). In any case, the patient should be treated in the same way as in other cases of gallstone disease with clinical manifestations. Drug treatment may include the use of combinations of bile acids preparations (e.g., chenodeoxycholic acid in combination with ursodeoxycholic acid or ursodeoxycholic acid monotherapy) under ultrasound guidance - until complete disappearance of stones.
Use in Pediatrics
There is limited experience with the drug Sandostatin В® LAR in children and adolescents younger than 18 years .
Impact on the ability to drive vehicles and manage mechanisms
There is no data on the effect of the drug Sandostatin В® LAR on the ability to drive vehicles and operate machinery.
OVERDOSE
It reported some cases of drug overdose Sandostatin В® LAR in doses ranging from 100 mg to 163 mg per month. In these cases, the only adverse event was the development of hyperemia.
Sandostatin LAR When applied in a dose of 60 mg per month to 90 mg every 2 weeks in patients with malignant neoplasms of the drug was generally well tolerated; however, we note the following adverse events: frequent urination, fatigue, depression, anxiety and poor concentration.
DRUG INTERACTION
Octreotide reduces absorption from the intestinal absorption of cyclosporin and slows cimetidine.
With simultaneous application of octreotide and bromocriptine increases the bioavailability of the latter.
There are literature data that the somatostatin analogs can reduce the metabolic clearance of substances metabolized involving isozymes of cytochrome P450, which may be caused by suppression of GH. Since it is possible that octreotide can also have this effect, caution should be exercised when administering the drug metabolized isoenzyme CYP3A4 and having a narrow range of therapeutic concentrations (e.g., quinidine, terfenadine).
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored protected from light in the reach of children at a temperature of from 2 В° to 8 В° C (in a refrigerator). Shelf life - 3 years.
On the day of injection vial and the vial with the solvent can be kept at a temperature below 25 В° C.
