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Sandostatin
Overview
What is Sandostatin?
Sandostatin (octreotide acetate) Injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered lactic acid solution for administration by deep subcutaneous (intrafat) or intravenous injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl)propyl]-, cyclic (2→7)-disulfide; [R-(R*, R*)] acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin.
Sandostatin Injection is available as: sterile 1-mL ampuls in 3 strengths, containing 50, 100, or 500 mcg octreotide (as acetate), and sterile 5-mL multi-dose vials in 2 strengths, containing 200 and 1000 mcg/mL of octreotide (as acetate).
Each ampul also contains:
lactic acid, USP
3.4 mg
mannitol, USP
45 mg
sodium bicarbonate, USP
qs to pH 4.2 ± 0.3
water for injection, USP
qs to 1 mL
Each mL of the multi-dose vials also contains:
lactic acid, USP
3.4 mg
mannitol, USP
45 mg
phenol, USP
5.0 mg
sodium bicarbonate, USP
qs to pH 4.2 ± 0.3
water for injection, USP
qs to 1 mL
Lactic acid and sodium bicarbonate are added to provide a buffered solution, pH to 4.2 ± 0.3.
The molecular weight of octreotide acetate is 1019.3 (free peptide, CHNOS) and its amino acid sequence is:
What does Sandostatin look like?
What are the available doses of Sandostatin?
Sorry No records found.
What should I talk to my health care provider before I take Sandostatin?
Sorry No records found
How should I use Sandostatin?
Sandostatin (octreotide acetate) is indicated to reduce blood levels of growth hormone and IGF-I (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. The goal is to achieve normalization of growth hormone and IGF-I (somatomedin C) levels (). In patients with acromegaly, Sandostatin reduces growth hormone to within normal ranges in 50% of patients and reduces IGF-I (somatomedin C) to within normal ranges in 50%-60% of patients. Since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with Sandostatin to reduce blood levels of growth hormone and IGF-I (somatomedin C) offers potential benefit before the effects of irradiation are manifested.
Improvement in clinical signs and symptoms or reduction in tumor size or rate of growth were not shown in clinical trials performed with Sandostatin; these trials were not optimally designed to detect such effects.
Sandostatin (octreotide acetate) may be administered subcutaneously or intravenously. Subcutaneous injection is the usual route of administration of Sandostatin for control of symptoms. Pain with subcutaneous administration may be reduced by using the smallest volume that will deliver the desired dose. Multiple subcutaneous injections at the same site within short periods of time should be avoided. Sites should be rotated in a systematic manner.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration Proper sterile technique should be used in the preparation of parenteral admixtures to minimize the possibility of microbial contamination.
Sandostatin is stable in sterile isotonic saline solutions or sterile solutions of dextrose 5% in water for 24 hours. It may be diluted in volumes of 50-200 mL and infused intravenously over 15-30 minutes or administered by IV push over 3 minutes. In emergency situations (e.g., carcinoid crisis) it may be given by rapid bolus.
The initial dosage is usually 50 mcg administered twice or three times daily. Upward dose titration is frequently required. Dosage information for patients with specific tumors follows.
What interacts with Sandostatin?
Sorry No Records found
What are the warnings of Sandostatin?
Sorry No Records found
What are the precautions of Sandostatin?
Sorry No Records found
What are the side effects of Sandostatin?
Sorry No records found
What should I look out for while using Sandostatin?
Sensitivity to this drug or any of its components.
Single doses of Sandostatin (octreotide acetate) have been shown to inhibit gallbladder contractility and decrease bile secretion in normal volunteers. In clinical trials (primarily patients with acromegaly or psoriasis), the incidence of biliary tract abnormalities was 63% (27% gallstones, 24% sludge without stones, 12% biliary duct dilatation). The incidence of stones or sludge in patients who received Sandostatin for 12 months or longer was 52%. Less than 2% of patients treated with Sandostatin for 1 month or less developed gallstones. The incidence of gallstones did not appear related to age, sex or dose. Like patients without gallbladder abnormalities, the majority of patients developing gallbladder abnormalities on ultrasound had gastrointestinal symptoms. The symptoms were not specific for gallbladder disease. A few patients developed acute cholecystitis, ascending cholangitis, biliary obstruction, cholestatic hepatitis, or pancreatitis during Sandostatin therapy or following its withdrawal. One patient developed ascending cholangitis during Sandostatin therapy and died.
What might happen if I take too much Sandostatin?
A limited number of accidental overdoses of Sandostatin® in adults have been reported. In adults, the doses ranged from 2,400–6,000 micrograms/day administered by continuous infusion (100-250 micrograms/hour) or subcutaneously (1,500 micrograms t.i.d.). Adverse events in some patients included arrhythmia, hypotension, cardiac arrest, brain hypoxia, pancreatitis, hepatitis steatosis, hepatomegaly, lactic acidosis, flushing, diarrhea, lethargy, weakness, and weight loss.
Sandostatin Injection given in intravenous boluses of 1 mg (1000 mcg) to healthy volunteers did not result in serious ill effects, nor did doses of 30 mg (30,000 mcg) given intravenously over 20 minutes and of 120 mg (120,000 mcg) given intravenously over 8 hours to research patients.
If overdose occurs, symptomatic management is indicated. Up-to-date information about the treatment of overdose can often be obtained from the National Poison Control Center at 1-800-222-1222.
How should I store and handle Sandostatin?
For prolonged storage, Sandostatin ampuls and multi-dose vials should be stored at refrigerated temperatures 2ºC-8ºC (36ºF-46ºF) and store in outer carton in order to protect from light. At room temperature, (20ºC-30ºC or 70ºF-86ºF), Sandostatin is stable for 14 days if protected from light. The solution can be allowed to come to room temperature prior to administration. Do not warm artificially. After initial use, multiple-dose vials should be discarded within 14 days. Ampuls should be opened just prior to administration and the unused portion discarded. Dispose unused product or waste properly.Manufactured by:Novartis Pharma Stein AGStein, SwitzerlandDistributed by:Novartis Pharmaceuticals CorporationEast Hanover, NJ 07936© NovartisT2012-71March 2012For prolonged storage, Sandostatin ampuls and multi-dose vials should be stored at refrigerated temperatures 2ºC-8ºC (36ºF-46ºF) and store in outer carton in order to protect from light. At room temperature, (20ºC-30ºC or 70ºF-86ºF), Sandostatin is stable for 14 days if protected from light. The solution can be allowed to come to room temperature prior to administration. Do not warm artificially. After initial use, multiple-dose vials should be discarded within 14 days. Ampuls should be opened just prior to administration and the unused portion discarded. Dispose unused product or waste properly.Manufactured by:Novartis Pharma Stein AGStein, SwitzerlandDistributed by:Novartis Pharmaceuticals CorporationEast Hanover, NJ 07936© NovartisT2012-71March 2012For prolonged storage, Sandostatin ampuls and multi-dose vials should be stored at refrigerated temperatures 2ºC-8ºC (36ºF-46ºF) and store in outer carton in order to protect from light. At room temperature, (20ºC-30ºC or 70ºF-86ºF), Sandostatin is stable for 14 days if protected from light. The solution can be allowed to come to room temperature prior to administration. Do not warm artificially. After initial use, multiple-dose vials should be discarded within 14 days. Ampuls should be opened just prior to administration and the unused portion discarded. Dispose unused product or waste properly.Manufactured by:Novartis Pharma Stein AGStein, SwitzerlandDistributed by:Novartis Pharmaceuticals CorporationEast Hanover, NJ 07936© NovartisT2012-71March 2012For prolonged storage, Sandostatin ampuls and multi-dose vials should be stored at refrigerated temperatures 2ºC-8ºC (36ºF-46ºF) and store in outer carton in order to protect from light. At room temperature, (20ºC-30ºC or 70ºF-86ºF), Sandostatin is stable for 14 days if protected from light. The solution can be allowed to come to room temperature prior to administration. Do not warm artificially. After initial use, multiple-dose vials should be discarded within 14 days. Ampuls should be opened just prior to administration and the unused portion discarded. Dispose unused product or waste properly.Manufactured by:Novartis Pharma Stein AGStein, SwitzerlandDistributed by:Novartis Pharmaceuticals CorporationEast Hanover, NJ 07936© NovartisT2012-71March 2012For prolonged storage, Sandostatin ampuls and multi-dose vials should be stored at refrigerated temperatures 2ºC-8ºC (36ºF-46ºF) and store in outer carton in order to protect from light. At room temperature, (20ºC-30ºC or 70ºF-86ºF), Sandostatin is stable for 14 days if protected from light. The solution can be allowed to come to room temperature prior to administration. Do not warm artificially. After initial use, multiple-dose vials should be discarded within 14 days. Ampuls should be opened just prior to administration and the unused portion discarded. Dispose unused product or waste properly.Manufactured by:Novartis Pharma Stein AGStein, SwitzerlandDistributed by:Novartis Pharmaceuticals CorporationEast Hanover, NJ 07936© NovartisT2012-71March 2012For prolonged storage, Sandostatin ampuls and multi-dose vials should be stored at refrigerated temperatures 2ºC-8ºC (36ºF-46ºF) and store in outer carton in order to protect from light. At room temperature, (20ºC-30ºC or 70ºF-86ºF), Sandostatin is stable for 14 days if protected from light. The solution can be allowed to come to room temperature prior to administration. Do not warm artificially. After initial use, multiple-dose vials should be discarded within 14 days. Ampuls should be opened just prior to administration and the unused portion discarded. Dispose unused product or waste properly.Manufactured by:Novartis Pharma Stein AGStein, SwitzerlandDistributed by:Novartis Pharmaceuticals CorporationEast Hanover, NJ 07936© NovartisT2012-71March 2012For prolonged storage, Sandostatin ampuls and multi-dose vials should be stored at refrigerated temperatures 2ºC-8ºC (36ºF-46ºF) and store in outer carton in order to protect from light. At room temperature, (20ºC-30ºC or 70ºF-86ºF), Sandostatin is stable for 14 days if protected from light. The solution can be allowed to come to room temperature prior to administration. Do not warm artificially. After initial use, multiple-dose vials should be discarded within 14 days. Ampuls should be opened just prior to administration and the unused portion discarded. Dispose unused product or waste properly.Manufactured by:Novartis Pharma Stein AGStein, SwitzerlandDistributed by:Novartis Pharmaceuticals CorporationEast Hanover, NJ 07936© NovartisT2012-71March 2012For prolonged storage, Sandostatin ampuls and multi-dose vials should be stored at refrigerated temperatures 2ºC-8ºC (36ºF-46ºF) and store in outer carton in order to protect from light. At room temperature, (20ºC-30ºC or 70ºF-86ºF), Sandostatin is stable for 14 days if protected from light. The solution can be allowed to come to room temperature prior to administration. Do not warm artificially. After initial use, multiple-dose vials should be discarded within 14 days. Ampuls should be opened just prior to administration and the unused portion discarded. Dispose unused product or waste properly.Manufactured by:Novartis Pharma Stein AGStein, SwitzerlandDistributed by:Novartis Pharmaceuticals CorporationEast Hanover, NJ 07936© NovartisT2012-71March 2012For prolonged storage, Sandostatin ampuls and multi-dose vials should be stored at refrigerated temperatures 2ºC-8ºC (36ºF-46ºF) and store in outer carton in order to protect from light. At room temperature, (20ºC-30ºC or 70ºF-86ºF), Sandostatin is stable for 14 days if protected from light. The solution can be allowed to come to room temperature prior to administration. Do not warm artificially. After initial use, multiple-dose vials should be discarded within 14 days. Ampuls should be opened just prior to administration and the unused portion discarded. Dispose unused product or waste properly.Manufactured by:Novartis Pharma Stein AGStein, SwitzerlandDistributed by:Novartis Pharmaceuticals CorporationEast Hanover, NJ 07936© NovartisT2012-71March 2012Sandostatin (octreotide acetate) Injection is available in 1-mL ampuls and 5-mL multi-dose vials as follows:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Sandostatin (octreotide acetate) exerts pharmacologic actions similar to the natural hormone, somatostatin. It is an even more potent inhibitor of growth hormone, glucagon, and insulin than somatostatin. Like somatostatin, it also suppresses LH response to GnRH, decreases splanchnic blood flow, and inhibits release of serotonin, gastrin, vasoactive intestinal peptide, secretin, motilin, and pancreatic polypeptide.
By virtue of these pharmacological actions, Sandostatin has been used to treat the symptoms associated with metastatic carcinoid tumors (flushing and diarrhea), and Vasoactive Intestinal Peptide (VIP) secreting adenomas (watery diarrhea).
Sandostatin substantially reduces growth hormone and/or IGF-I (somatomedin C) levels in patients with acromegaly.
Single doses of Sandostatin have been shown to inhibit gallbladder contractility and to decrease bile secretion in normal volunteers. In controlled clinical trials the incidence of gallstone or biliary sludge formation was markedly increased ().
Sandostatin suppresses secretion of thyroid stimulating hormone (TSH).
Non-Clinical Toxicology
Sensitivity to this drug or any of its components.Single doses of Sandostatin (octreotide acetate) have been shown to inhibit gallbladder contractility and decrease bile secretion in normal volunteers. In clinical trials (primarily patients with acromegaly or psoriasis), the incidence of biliary tract abnormalities was 63% (27% gallstones, 24% sludge without stones, 12% biliary duct dilatation). The incidence of stones or sludge in patients who received Sandostatin for 12 months or longer was 52%. Less than 2% of patients treated with Sandostatin for 1 month or less developed gallstones. The incidence of gallstones did not appear related to age, sex or dose. Like patients without gallbladder abnormalities, the majority of patients developing gallbladder abnormalities on ultrasound had gastrointestinal symptoms. The symptoms were not specific for gallbladder disease. A few patients developed acute cholecystitis, ascending cholangitis, biliary obstruction, cholestatic hepatitis, or pancreatitis during Sandostatin therapy or following its withdrawal. One patient developed ascending cholangitis during Sandostatin therapy and died.
Sandostatin has been associated with alterations in nutrient absorption, so it may have an effect on absorption of orally administered drugs. Concomitant administration of Sandostatin with cyclosporine may decrease blood levels of cyclosporine and result in transplant rejection.
Patients receiving insulin, oral hypoglycemic agents, beta blockers, calcium channel blockers, or agents to control fluid and electrolyte balance, may require dose adjustments of these therapeutic agents.
Concomitant administration of octreotide and bromocriptine increases the availability of bromocriptine. Limited published data indicate that somatostatin analogs might decrease the metabolic clearance of compounds known to be metabolized by cytochrome P450 enzymes, which may be due to the suppression of growth hormones. Since it cannot be excluded that octreotide may have this effect, other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index (e.g., quinidine, terfenadine) should therefore be used with caution.
Sandostatin (octreotide acetate) alters the balance between the counter-regulatory hormones, insulin, glucagon and growth hormone, which may result in hypoglycemia or hyperglycemia. Sandostatin also suppresses secretion of thyroid stimulating hormone, which may result in hypothyroidism. Cardiac conduction abnormalities have also occurred during treatment with Sandostatin. However, the incidence of these adverse events during long-term therapy was determined vigorously only in acromegaly patients who, due to their underlying disease and/or the subsequent treatment they receive, are at an increased risk for the development of diabetes mellitus, hypothyroidism, and cardiovascular disease. Although the degree to which these abnormalities are related to Sandostatin therapy is not clear, new abnormalities of glycemic control, thyroid function and ECG developed during Sandostatin therapy as described below.
Risk of Pregnancy with Normalization of IGF-1 and GH
Although acromegaly may lead to infertility, there are reports of pregnancy in acromegalic women. In women with active acromegaly who have been unable to become pregnant, normalization of GH and IGF-1 may restore fertility. Female patients of childbearing potential should be advised to use adequate contraception during treatment with octreotide.
The hypoglycemia or hyperglycemia which occurs during Sandostatin therapy is usually mild, but may result in overt diabetes mellitus or necessitate dose changes in insulin or other hypoglycemic agents. Hypoglycemia and hyperglycemia occurred on Sandostatin in 3% and 16% of acromegalic patients, respectively. Severe hyperglycemia, subsequent pneumonia, and death following initiation of Sandostatin therapy was reported in one patient with no history of hyperglycemia.
In patients with concomitant Type I diabetes mellitus, Sandostatin Injection and Sandostatin LAR® Depot (octreotide acetate for injectable suspension) are likely to affect glucose regulation, and insulin requirements may be reduced. Symptomatic hypoglycemia, which may be severe, has been reported in these patients. In non-diabetics and Type II diabetics with partially intact insulin reserves, Sandostatin Injection or Sandostatin LAR Depot administration may result in decreases in plasma insulin levels and hyperglycemia. It is therefore recommended that glucose tolerance and antidiabetic treatment be periodically monitored during therapy with these drugs.
In acromegalic patients, 12% developed biochemical hypothyroidism only, 8% developed goiter, and 4% required initiation of thyroid replacement therapy while receiving Sandostatin. Baseline and periodic assessment of thyroid function (TSH, total and/or free T) is recommended during chronic therapy.
In acromegalics, bradycardia (<50 bpm) developed in 25%; conduction abnormalities occurred in 10% and arrhythmias occurred in 9% of patients during Sandostatin therapy. Other EKG changes observed included QT prolongation, axis shifts, early repolarization, low voltage, R/S transition, and early R wave progression. These ECG changes are not uncommon in acromegalic patients. Dose adjustments in drugs such as beta-blockers that have bradycardia effects may be necessary. In one acromegalic patient with severe congestive heart failure, initiation of Sandostatin therapy resulted in worsening of CHF with improvement when drug was discontinued. Confirmation of a drug effect was obtained with a positive rechallenge.
Several cases of pancreatitis have been reported in patients receiving Sandostatin therapy.
Sandostatin may alter absorption of dietary fats in some patients.
In patients with severe renal failure requiring dialysis, the half-life of Sandostatin may be increased, necessitating adjustment of the maintenance dosage.
Depressed vitamin B levels and abnormal Schilling’s tests have been observed in some patients receiving Sandostatin therapy, and monitoring of vitamin B levels is recommended during chronic Sandostatin therapy.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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