Sandostatin injection solution 0.1mg/ml Novartis reduces symptoms due to functional tumors of gastric endocrine system - intestines - pancreatic (5 tubes x 1ml)

Dosage form 5 -tube box
Specifications Octreotide

Ingredient

Composition informationContent
Octreotide0.1mg/ml

Uses

Indications

Sandostatin is indicated in the following cases:

Control symptoms and reduce growth hormone levels and IGF - 1 of plasma in extreme extreme patients who respond inadequate with surgical or radiation treatment.

Sandostatin is also indicated for treatment for extreme enlarged patients who are incompetent or not want to surgery, or in the waiting stage until radiation therapy is fully effective.

Reduce symptoms due to functional tumors of gastric endocrine system - pancreatic (GEP).

Carcinoids with the characteristics of carcinoid syndrome.

vipoma.

A alpha pancreatic cell tumor (Glucagonoma).

gastrinomas/Zollinger - Ellison syndrome is often combined with proton pump inhibitors, or H2.

Insulinoma, in controlling hypoglycemia before surgery and in maintenance treatment.

GRFoma.

Sandostatin is not an anti -tumor therapy and does not cure these diseases.

Prevention of complications after pancreatic surgery.

Emergency treatment to stop bleeding and avoid recurrent bleeding due to gastric varicose veins - esophagus due to cirrhosis . Sandostatin is used in combination with specific treatment such as endoscopic fibrosis.

Pharmacokology

Mechanism of action

Octreotide is a synthetic octapeptide that has a pharmacological effect similar to natural somatostin, but has a significant longer time. The drug inhibitors increased the pathology of growth hormones (GH) and peptides and serotonins of gastric endocrine systems (GEP: Gastroeropancreatic).

In healthy people, Sandostatin shows the inhibitory effects for

The release of growth hormone (GH) stimulated by arginine, hypoglycemia due to physical activity and by insulin.

The release of insulin, glucagon, gastrin, other peptides belong to the GEP endocrine system after meals and the release of insulin and glucagon stimulated by arginine.

The release of the thyroid stimulating hormone (TSH: thyroid stimulating hormone) stimulates by the hormone liberation of the armor (trh: thyrotropine - releasing hormone).

pharmacokinetic

absorption

After subcutaneous injection, Sandostatin is absorbed quickly and completely. Peak concentration in plasma is achieved within 30 minutes.

Distribution

The distribution of the drug is 0.27 l/kg and the entire clearance coefficient is 160 ml/min. The amount of drugs attached to plasma proteins up to 65%. The amount of Sandostatin attached to blood cells is negligible.

Elimination

Selling time after subcutaneous injection is 100 minutes. After intravenous injection, the drug is eliminated through 2 phases with the sale time of 10 minutes and 90 minutes. Most peptides are eliminated in feces, while about 32% are excreted in the urine in constant form.

Special patient group

impaired renal function does not affect the concentration of systemic drugs (AUC) of octreotide used in the skin.

The ability to eliminate drugs may be reduced for cirrhosis patients, but not reduced for patients with fatty liver.

Before taking Sandostatin injection solution 0.1mg/ml Novartis reduces symptoms due to functional tumors of gastric endocrine system - intestines - pancreatic (5 tubes x 1ml)

How to use

Skin injection

Patients with self -injections by subcutaneous injections must be accurate instructions from a doctor or nurse.

To reduce the discomfort in place, it is recommended that the injection solution should be returned to room temperature before injection. Should avoid repeat injection in the old injection site for a short time.

The syringe is only opened before use, the remaining part must be removed.

To prevent bacterial infections, it is recommended that the medicine should not be taken more than ten times from the multi -dose vial.

intravenous infusion

The drugs used on the gastrointestinal tract must be checked by the naked eye to see if it is discolored or cloudy before use.

Sandostatin (Octreotide acetate) stabilizes physical and chemicals for 24 hours after being mixed with aseptic physiological saline solution or 5% sterile dextrose (glucose) solution. However, because Sandostatin can affect glucose's lip balance, it is recommended to use physiological saline rather than the Dexrose solution. The solution has been mixed in physical and chemical sustainable for 24 hours with a temperature of less than 25 ° C. In terms of microorganisms, the infusion solution should be used immediately. If the infusion is not used immediately, the storage before use is the responsibility of the user and should be stored at a temperature of 2 - 8oC. Before using infusion, it must be brought back to room temperature.

The time period from the mixing of the solution is diluted, stored in the refrigerator and until the end of the drug is not exceeding 24 hours.

In cases of intravenous Sandostatin, a 0.5 mg medicine tube is usually dissolved in 60 ml of physiological saline solution, diluted solution to be transmitted with a transmission pump. This therapy should be repeated regularly if necessary until the treatment period is prescribed. Sandostatin has also been transmitted at lower concentrations.

Special prudence when canceling the drug

Any drug or unused substance must be canceled according to local requirements.

Dosage

Object of common patients

extreme disease

Initial dose 0.05 - 0.1 mg injected under the skin every 8 hours or 12 hours. The adjustment of the dose should be based on the monthly assessment of the concentration of GH and IGF - 1 monthly (Objectives: GH

If the amount of GH does not decrease and clinical symptoms are not improved after three months of treatment with Sandostatin, it should be stopped.

The tumor belongs to the stomach - intestinal - pancreatic endocrine system

Initial dose 0.05 mg once or twice daily injected under the skin. Depending on the clinical response, the concentration of hormones produced by the tumor (in the case of carcinoid tumors, based on the secretion of the urinary tract of 5 - hydroyindole acetic acid), and based on the tolerance of the drug, the dose may increase to 0.1 - 0.2 mg; 3 times/day. In some exceptions, the dose may rise higher. The maintenance dose should be adjusted depending on the case.

In the case of Carcinoid tumor, if there is no beneficial response within a week of Sandostatin treatment with maximum tolerance, it is advisable to stop treatment.

Complications after pancreatic surgery

0.1 mg x 3 times/day of subcutaneous injection for 7 consecutive days, starting on surgery at least 1 hour before surgery.

Hemorrhage due to gastric varicose veins - esophagus

25 μg/hour continuous intravenous infusion for 5 days. Sandostatin can be diluted with physiological saline.

In patients with hemorrhage due to esophageal varicose veins, Sandostatin is well tolerated with continuous intravenous dosage up to 50 μg/hour for 5 days.

Special patient object

Hepatic failure

For patients with cirrhosis, the sale time of the drug can be prolonged, adjusting the maintenance dose is necessary.

kidney failure

Nephrotic function impaired does not affect the body concentration (AUC) of igtreotide used injected under the skin, so there is no need to adjust the dose of Sandostatin.

A group of children (under 18 years old)

Sandostatin treatment experience in children is very limited.

Group of elderly patients (from 65 years of age)

There is no evidence of the ability to be reduced or need to change the dose in the elderly treated with Sandostatin.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when using overdose? In adults, the dose is between 2,400 - 6,000 μg/day of continuous transmission (100 - 250 μg/hour) or subcutaneous injection (1,500 μg, 3 times/day). The adverse events are reported as arrhythmia, hypotension, cardiac arrest, reduced cerebral blood oxygen, pancreatitis, degenerative hepatitis, diarrhea, fatigue, sleeping, weight loss, liver and lactic acid infection.

In children, the dose is between 50 - 3,000 μg/day continuously (2.1 - 500 μg/hour) or subcutaneous injection (50 - 100 μg). The only side effect reported is mild hyperglycemia.

There are no unspecified unfavorable events reported in cancer patients using Sandostatin at a dose of 3,000 - 30,000 μg/day dividing subcutaneous dose.

Treatment

Overdose treatment is symptomatic treatment.

What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Sandostatin , you may experience unwanted effects (ADR).

Summary table of adverse drug reactions from clinical trials

The following adverse reactions (ADR) are listed in Table 1, which have been collected from clinical studies with Octreotide:

The adverse reactions of the drug (Table 1) are listed according to the Meddra Agency classification. In each organ system group, adverse reactions are arranged according to the frequency, the adverse reaction has the highest frequency of the first arrangement according to the convention: very common (≥ 1/10); Or meet (≥ 1/100,

Agree reactions from spontaneous reports and medical cases (unknown frequency)

The following adverse drug reactions are derived from after -sales experience with Sandostatin Lar through spontaneous cases and cases in literature .. In each organ system, the adverse reactions of the drug are presented in the order of severity of gradual decrease - see Table 2.

Instructions on how to handle ADR

Digestive complications usually occur during the first week of treatment and lose itself during treatment. To reduce the digestive complications, you should take the medicine away from meals, between meals and before going to bed. Besides, reducing the amount of fat in meals also works to reduce ADR.

Liver - bile complications often occur (40 - 60%) due to the gallbladder inhibitors, reducing bile secretion, changing fat absorption. Gallbladder and bile ducts are required before treatment and periodically every 6 months during treatment. If gallstones must stop the drug. If the pain is severe due to gallstones, surgery to get stones.

Must monitor thyroid function, identify stool fat and quantify carotene in serum. If there is a bad development, a dose must be reduced. For patients with a history of hypothyroidism, consider the use of more thyroid hormones

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Sandostatin medicine contraindicated in the following cases:

  • Hypersensitivity to Octreotide or any component of excipients.

    • Precautions when using

    This drug is only used as prescribed by a doctor.

    General caution

    Due to the pituitary tumor, GH can sometimes grow, causing serious complications (such as market reduction), which should be monitored for all patients carefully. If there are signs of tumor growth, other treatments may be selected.

    The treatment benefits of reducing growth hormones (GH) and normalizing the concentration of growth as an insulin 1 (IGF - 1) in female patients with extreme extremes can restore fertility. Female patients with the ability to give birth should be advised to use adequate contraceptives if necessary during treatment with octreotide (see the use in pregnant and lactating women).

    Thyroid function should be monitored in prolonged treatment patients with octreotide.

    Cardiovascular -related events

    There have been reports on cases of slow heart rate (frequency: common). The dose of drugs may be needed such as beta blockers, calcium channel blockers or fluid and electrolyte control drugs.

    gallbladder and related events

    The formation of gallstones is recorded from 15-30% of patients using Sandostatin. This ratio in the general population is from 5-20%. Therefore, check the gallbladder ultrasound before and during Sandostatin treatment every 6 - 12 months is recommended.

    The tumor belongs to the stomach - intestinal - pancreatic endocrine system

    In the treatment of tumor belonging to the stomach - intestinal - pancreatic hormonal system, there are several rare cases that cannot control Sandostatin symptoms, with rapid recurrence of severe symptoms.

    Glucose metabolism

    Due to the inhibitory effect of growth on growth hormones, glucagon and insulin; Sandostatin may affect glucose regulation. Glucose tolerance after meals may be reduced and in some cases, there may be persistent hyperglycemia due to prolonged medication. Hypoglycemia has also been reported.

    esophageal varicose veins

    Because after the esophageal varicose veins, there is an increased risk of insulin -dependent diabetes or changes in the demand for insulin in people who have had diabetes in advance, closely monitoring glucose concentration in blood is required.

    Topical reaction

    There has not been a report on the formation of the injection tumor for patients treated with Sandostatin for up to 15 years. With all the figures that have been present, it shows that detections on rats are specialized in species and have no important implications for human use.

    Nutrition

    In some patients, Octreotide may change the absorption of fat in the diet.

    Observed the reduced level of vitamin B12 and the abnormal Schilling test in some patients treated with Octreotide. Vitamin B12 should be monitored during Sandostatin treatment in patients with a history of vitamin B12 deficiency.

    The ability to drive and operate machinery

    There is no data about affecting the ability to drive and operate machinery of Sandostatin.

    Pregnancy

    Warning ratings

  • au tga Pregnancy category: c.
  • us FDA Pregnancy Category: b.

    Pregnancy

    There are no adequate and well -controlled studies in pregnant women. Sandostatin should only be used for pregnant women when really necessary.

    Breastfeeding period

    It is unclear whether Octreotide will be excreted in breast milk. Animal studies show that there is an excretion of ooctreotide into breast milk. Patients should not breastfeed while being treated with Sandostatin.

    Drug interaction

    may need to adjust the dose of drugs such as beta blockers, calcium channel blockers or drugs to control fluid balance and electrolytes when Sandostatin is used simultaneously (see the warning section).

    may need to adjust insulin's dose and diabetic medications when Sandostatin is used simultaneously (see the warning section).

    Sandostatin has been recorded reducing ciclosporin absorption from the digestive tract and slowing down the absorption of gastrointestinal cimetidine.

    Use combination of octreotide and bromocriptine to increase the bioavailability of bromOriptine.

    The meager figures have been published showing that analogs somatostin can reduce the transformation of drugs metabolized by cytochrome P450 enzymes, which can be caused by growth inhibition of growth hormone. Because it is not possible to rule out the cause of igtreotide, it is necessary to be careful when using other drugs to metabolize mainly by Cy3A4 yeast and have a low treatment index (for example, quinidine, terfenadine).

    • Storage

    syringe

    Store the original syringe in the carton to avoid light.

    Long -term storage, Sandostatin syringe must be kept at a temperature of 2 - 8 ° C.

    Do not freeze.

    For daily use of drugs, it is possible to leave the drug at a temperature of less than 30 ° C for 2 weeks.

    multi -dose jars

    Store the multi -dose vials in the carton box to avoid light.

    Long -term storage, Sandostatin multi -dose vials must be kept at a temperature of 2 - 8oC.

    Do not freeze.

    For daily use of drugs can leave the drug at a temperature of less than 25 ° C for 2 weeks.

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