Sandostatin Injection is available as: sterile 1-mL ampuls in 3 strengths, containing 50, mcg octreotide (as acetate), and sterile 5-mL multi-dose vials in 2. Sep 3, Octreotide Acetate (Sandostatin ®) – Intravenous (IV) Dilution. Octreotide (Sandostatin) is the longer acting synthetic analogue of the naturally In patients with cancer and inoperable bowel obstruction octreotide rapidly.
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Contains less than 1 mmol 23 mg sodium per dose, i. Symptomatic control and reduction of growth hormone GH and IGF-1 plasma levels in patients with acromegaly who are inadequately controlled by surgery or radiotherapy.
Sandostatin is also indicated for acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective. Relief of symptoms associated with functional gastro-entero-pancreatic GEP endocrine tumours, e.
Emergency management to stop bleeding and to protect from re-bleeding owing to gastro-oesophageal varices in patients with cirrhosis. Sandostatin is to be used in association with specific treatment such as endoscopic sclerotherapy. In most patients, the optimal daily dose will be 0. A maximum dose of 1. If no relevant reduction in GH levels and no improvement in clinical symptoms have been achieved within 3 months of starting treatment with Sandostatin, therapy should be discontinued.
Depending on clinical response, effect on levels of tumour-produced hormones in cases of carcinoid tumours, on the urinary excretion of 5-hydroxyindole acetic acidand on tolerability, dosage can be gradually increased to 0. Under exceptional circumstances, higher doses may be required.
Octreotide 100 micrograms/1ml Solution for Injection
Maintenance doses have to be adjusted individually. In carcinoid tumours, if there is no beneficial response within 1 week of treatment with Sandostatin at the maximum tolerated dose, therapy should not be continued.
Sandostatin can be used in dilution with physiological saline. In cirrhotic patients with bleeding gastro-oesophageal varices, Sandostatin has been well tolerated at continuous i. The dosage sosis generally effective is micrograms three times a day by s. The dose can be adjusted according to the dosos of TSH and thyroid hormones. At least 5 days of treatment will be needed to judge the efficacy.
There is no evidence of reduced tolerability or altered dosage requirements in elderly patients treated with Sandostatin.
Sandostatin 50 microgram/1 ml, solution for injection/infusion
In patients with liver cirrhosis, the half-life of the drug may be increased, necessitating adjustment of the maintenance dosage. Impaired renal function did not affect the total exposure AUC to octreotide administered as s. Sandostatin may be administered directly dossi subcutaneous s.
For further instructions on handling and instructions for dilution of the medicinal product, refer to section 6. Known hypersensitivity to the active substance or to any of the excipients listed in section 6. As GH-secreting pituitary tumours may sometimes expand, causing serious complications e. If evidence of tumour expansion appears, alternative procedures may be advisable. The therapeutic benefits of a reduction in growth hormone GH levels and normalisation of insulin-like growth factor 1 IGF-1 concentration in female acromegalic patients could potentially restore fertility.
Female patients of childbearing potential should be advised to use adequate contraception if necessary during treatment with octreotide see section 4. Common cases of bradycardia have been reported. Dose adjustments of medicinal products such as beta blockers, calcium channel blockers, or agents to control fluid and electrolyte balance, may be necessary see section 4. Cholelithiasis is a very common event during Sandostatin treatment and may octreotice associated with cholecystitis and biliary duct dilatation see section 4.
Ultrasonic examination of the gallbladder before, and at about 6- to month intervals during Sandostatin therapy is therefore recommended. During the treatment of GEP endocrine tumours, there may be rare instances of sudden escape from symptomatic control by Sandostatin, with rapid recurrence of severe symptoms.
Octreoide the treatment is stopped, symptoms may worsen or recur. Because of its inhibitory action on growth hormone, glucagon, and insulin, Sandostatin may affect glucose regulation. Post-prandial glucose tolerance may be impaired and, in some instances, the state of persistent hyperglycaemia may be induced as a result of chronic administration. Hypoglycaemia has also been reported. In patients with insulinomas, octreotide, because of its greater relative potency in inhibiting the secretion of GH and glucagon than that of insulin, and because of the shorter duration of its inhibitory action on insulin, may increase the dosiis and prolong the duration of hypoglycaemia.
These patients should be closely monitored during initiation of Sandostatin therapy and at each change of dosage. Marked fluctuations in blood glucose concentration may possibly be reduced by smaller, more frequently administered doses. Dsois requirements of patients with type I diabetes mellitus therapy may be reduced by administration of Sandostatin. In non-diabetics and type II diabetics with partially intact insulin reserves, Ooctreotide administration octreotiide result in post-prandial increases in glycaemia.
It is therefore recommended to monitor glucose tolerance and antidiabetic treatment. Since, following bleeding episodes from oesophageal varices, there is an increased risk for the development of insulin-dependent diabetes or for changes in insulin requirement in patients with pre-existing diabetes, dosi appropriate monitoring of blood glucose levels is mandatory.
In dosiss week toxicity study in rats, predominantly in males, sarcomas were noted at the s. No hyperplastic or neoplastic lesions occurred at the s. There have been no reports of tumour formation at the injection sites in patients treated with Sandostatin for up to 15 years.
All the information available at present indicates that the findings in rats are species specific and have no significance for the use of the drug in humans see section 5. Depressed vitamin B12 levels and abnormal Schilling’s tests have been observed in some patients receiving octreotide therapy. Monitoring of vitamin B12 levels is recommended during therapy with Sandostatin in patients who have a history of vitamin B12 deprivation. Sandostatin contains less than 1 mmol 23 mg sodium per dose, i.
Dose adjustment of medicinal products such as beta blockers, calcium channel blockers, or agents to control fluid and electrolyte balance may be necessary when Sandostatin dosus administered ocreotide see section 4. Dose adjustments of insulin and antidiabetic medicinal products may be required when Sandostatin is administered concomitantly see section 4. Sandostatin has been found to reduce the intestinal absorption of ciclosporin and to delay that of cimetidine.
Concomitant administration of octreotide and bromocriptine increases the bioavailability of bromocriptine. Limited published data indicate that somatostatin analogues might decrease the metabolic clearance of compounds known to be metabolised by cytochrome P enzymes, which may be due to the suppression of growth hormone. Since it cannot be excluded that octreotide may have this effect, other drugs mainly metabolised by CYP3A4 and which have a low therapeutic index should therefore be used with caution e.
There is a limited amount of data less than pregnancy outcomes from the use of octreotide in pregnant women, dsis in approximately one third of the cases the pregnancy octreotixe are unknown. No causal relationship to octreotide is suspected for these cases. Animal studies dosks not indicate direct or indirect harmful effects with respect to reproductive toxicity see section 5. As a precautionary measure, it is preferable to avoid the use of Sandostatin during pregnancy see section 4.
It is unknown whether octreotide is excreted in human breast milk. Animal studies have shown excretion of octreotide in breast milk. Patients should not breast-feed during Sandostatin treatment. It is not known whether octreotide has an effect on human fertility. Late descent of the testes was found for male offsprings of dam treated during pregnancy and lactation. Sandostatin has no or negligible influence on the ability to drive and use machines.
The most frequent adverse reactions reported during octreotide therapy include gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, and metabolism and nutritional disorders.
The most commonly reported adverse reactions in clinical trials with octreotide administration were diarrhoea, abdominal pain, nausea, flatulence, headache, cholelithiasis, hyperglycaemia and constipation.
Other commonly reported adverse reactions were dizziness, localised pain, biliary sludge, thyroid dysfunction e. The following adverse drug reactions, listed in Table 1, have been accumulated from clinical studies with octreotide:. Adverse drug reactions Table 1 are ranked under heading of frequency, the most frequent first, using the following convention: Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Dilution Octreotide -Sandostatin ® – GlobalRPH
Hypothyroidism, thyroid disorder e. Spontaneously reported adverse reactions presented in Table 2, are reported voluntarily and it is not always possible to reliably establish frequency or a causal relationship to drug exposure. Acute pancreatitis, acute hepatitis without cholestasis, cholestatic hepatitis, cholestasis, jaundice, cholestatic jaundice. Somatostatin analogues have been shown to inhibit gallbladder contractility and decrease bile secretion, which may lead to gallbladder abnormalities or sludge.
If gallstones do occur, they usually asymptomatic; symptomatic stones should be treated either by dissolution therapy with bile acids or by surgery.
In rare instances, gastrointestinal side effects may resemble acute intestinal obstruction, with progressive abdominal distension, severe epigastric pain, abdominal tenderness and guarding. The frequency of gastrointestinal adverse events is known to decrease over time with continued treatment.
Occurrence of gastrointestinal side-effects may be reduced by avoiding meals around the time of Sandostatin s.
Hypersensitivity and allergic reactions have been reported during post-marketing experience. When these occur, they mostly affect the skin, rarely the mouth and airways. Isolated cases of anaphylactic shock have been reported. Pain or a sensation of stinging, tingling or burning at the site of s. Local discomfort may be reduced by allowing the solution to reach room temperature before injection, or by injecting a smaller volume using a more concentrated solution.
Although measured faecal fat excretion may increase, there is no evidence to date that long- term treatment with octreotide has led to nutritional deficiency due to malabsorption. In very rare instances, acute pancreatitis has been reported within the first hours or days of Sandostatin s.
In addition, cholelithiasis induced pancreatitis has been reported for patients on long-term Sandostatin s. Bradycardia is a common adverse reaction with somatostatin analogues. The relationship of these events to octreotide acetate is not octrdotide because many of these patients have underlying cardiac diseases see section 4.
Dosing Sandostatin® LAR®
Thrombocytopenia has been reported during post-marketing experience, particularly during treatment with Sandostatin i. This is reversible after discontinuation of treatment. Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: A limited octreofide of accidental overdoses of Sandostatin in adults and children have been reported.
The adverse events reported were arrhythmia, hypotension, cardiac arrest, brain hypoxia, pancreatitis, hepatic steatosis, diarrhoea, weakness, lethargy, weight loss, hepatomegaly, and lactic acidosis.
The only adverse event reported was mild hyperglycaemia. Octreotide is a synthetic octapeptide derivative of naturally occurring somatostatin with similar pharmacological effects, but with a considerably prolonged duration of action.