Octreotide Acetate (Sandostatin)

Trade Name : Sandostatin

Novartis Pharmaceuticals Corporation

INJECTION, SOLUTION

Strength 50 ug/mL

OCTREOTIDE ACETATE Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Octreotide Acetate (Sandostatin) which is also known as Sandostatin and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 50 ug/mL per ml. Read more

Octreotide Acetate (Sandostatin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Sandostatinn
  • ntttttttoctreotide acetatentttttt
  • Injectionnttttttt
  • Rx Only
  • Prescribing Information
  • 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 (IV) 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 (2u21927)-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, orntttttt500 mcg octreotide (as acetate), and sterile 5-mL multi-dose vials in 2 strengths, containingntttttt200 and 1000 mcg/mL of octreotide (as acetate).ntttttt
  • Each ampul also contains:
  • nttu00a0u00a0u00a0u00a0u00a0ntlactic acid, USP........................................................................................................ 3.4 mg
  • nttu00a0u00a0u00a0u00a0u00a0ntmannitol, USP........................................................................................................... 45 mg
  • nttu00a0u00a0u00a0u00a0u00a0ntsodium bicarbonate, USP ............................................. quantity sufficient to pH 4.2 u00b1 0.3
  • nttu00a0u00a0u00a0u00a0u00a0ntwater for injection, USP .......................................................... quantity sufficient to 1 mL
  • Each mL of the multi-dose vials also contains:
  • nttu00a0u00a0u00a0u00a0u00a0ntlactic acid, USP........................................................................................................ 3.4 mg
  • nttu00a0u00a0u00a0u00a0u00a0ntmannitol, USP........................................................................................................... 45 mg
  • nttu00a0u00a0u00a0u00a0u00a0ntphenol, USP ............................................................................................................. 5.0 mg
  • nttu00a0u00a0u00a0u00a0u00a0ntsodium bicarbonate, USP ............................................. quantity sufficient to pH 4.2 u00b1 0.3
  • nttu00a0u00a0u00a0u00a0u00a0ntwater for injection, USP .......................................................... quantity sufficient to 1 mL
  • Lactic acid and sodium bicarbonate are added to provide a buffered solution, pH to 4.2 u00b1 0.3.
  • The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, CHNOS) and its amino acid sequence is:
  • 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).
  • After subcutaneous injection, octreotide is absorbed rapidly and completely from the injection site. Peak concentrations of 5.2 ng/mL (100-mcg dose) were reached 0.4 hours after dosing. Using a specific radioimmunoassay, IV and subcutaneous doses were found to be bioequivalent. Peak concentrations and area under the curve (AUC) values were dose proportional after IV single doses up to 200 mcg and subcutaneous single doses up to 500 mcg and after subcutaneous multiple doses up to 500 mcg 3 times a day (1500 mcg/day).
  • In healthy volunteers, the distribution of octreotide from plasma was rapid (tu03b1u00bdu00a0=u00a00.2u00a0h), the volume of distribution (V) was estimated to be 13.6 L, and the total body clearance ranged from 7 L/hr to 10 L/hr. In blood, the distribution into the erythrocytes was found to be negligible and about 65% was bound in the plasma in a concentration-independent manner. Binding was mainly to lipoprotein and, to a lesser extent, to albumin.
  • The elimination of octreotide from plasma had an apparent half-life of 1.7 to 1.9 hours compared with 1-3 minutes with the natural hormone. The duration of action of Sandostatin is variable but extends up to 12 hours depending upon the type of tumor. About 32% of the dose is excreted unchanged into the urine. In an elderly population, dose adjustments may be necessary due to a significant increase in the half-life (46%) and a significant decrease in the clearance (26%) of the drug.
  • In patients with acromegaly, the pharmacokinetics differs somewhat from those in healthy volunteers. A mean peak concentration of 2.8 ng/mL (100-mcg dose) was reached in 0.7 hours after subcutaneous dosing. The volume of distribution (V) was estimated to be 21.6 u00b1 8.5 L, and the total body clearance was increased to 18 L/h. The mean percent of the drug bound was 41.2%. The disposition and elimination half-lives were similar to normals.
  • In patients with renal impairment, the elimination of octreotide from plasma was prolonged and total body clearance reduced. In mild renal impairment (CL 40-60 mL/min), octreotide t was 2.4 hours and total body clearance was 8.8 L/hr, in moderate impairment (CL 10-39 mL/min) t was 3.0 hours and total body clearance 7.3 L/hr, and in severely renally impaired patients not requiring dialysis (CL < 10 mL/min) t was 3.1 hours and total body clearance was 7.6 L/hr. In patients with severe renal failure requiring dialysis, total body clearance was reduced to about half that found in healthy subjects (from approximately 10u00a0L/hr to 4.5 L/hr).
  • Patients with liver cirrhosis showed prolonged elimination of drug, with octreotide t increasing to 3.7 hr and total body clearance decreasing to 5.9 L/hr, whereas patients with fatty liver disease showed t increased to 3.4 hr and total body clearance of 8.2 L/hr.
  • No data
  • 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. There have been postmarketing reports of cholelithiasis (gallstones) resulting in complications requiring cholecystectomy.
  • If complications of cholelithiasis are suspected, discontinue Sandostatin and treat appropriately.
  • No data
  • No data
  • A limited number of accidental overdoses of Sandostatin in adults have been reported. In adults, the doses ranged from 2,400-6,000 mcg/day administered by continuous infusion (100-250 mcg/hour) or subcutaneously (1,500 mcg 3 times a day). 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 IV 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.
  • There is no indication that Sandostatin has potential for drug abuse or dependence. Sandostatin levels in the central nervous system are negligible, even after doses up to 30,000 mcg.
  • 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. n
  • 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 3 times daily. Upward dose titration is frequently required. Dosage information for patients with specific tumors follows.
  • Sandostatin (octreotide acetate) Injection is available in 1 mL ampuls and 5-mL multi-dose vials as follows:
  • Package Label u2013 n- 50 mcg/mL
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0180-01
  • Sandostatinn
  • octreotide acetate
  • INJECTION
  • 50 mcg/mL (0.05 mg/mL)
  • For Subcutaneous Injection
  • 10 Ampules/1 mL size
  • Package Label u2013 n- 100 mcg/mL
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0181-01
  • Sandostatinn
  • octreotide acetate
  • INJECTION
  • 100 mcg/mL (0.1 mg/mL)
  • For Subcutaneous Injection
  • 10 Ampules/1 mL size
  • Package Label u2013 n- 500n- mn- cn- gn- /mL
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0182-01
  • Sandostatinn
  • octreotide acetate
  • INJECTION
  • 500 mcg/mL (0.5 mg/mL)
  • For Subcutaneous Injection
  • 10 Ampules/1 mL size
  • Package Label u2013 n- 200 mcg/mL
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0183-25
  • Sandostatinn
  • octreotide acetate
  • INJECTION
  • Total Volume 5 mL Multi-Dose Vial
  • Each mL contains 200 mcg (0.2 mg/mL)
  • For Subcutaneous Injection
  • Package Label u2013 n- 1000 mcg/mL
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0184-25
  • Sandostatinn
  • octreotide acetate
  • INJECTION
  • 1000 mcg/mL (1.0 mg/mL)
  • For Subcutaneous Injection
  • Total Volume 5 mL Multi-Dose Vial

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