Clinical Information
Gen. Code and Des.
16587 octreotide acetate INJECTION VIAL 200 MCG/ML
GCN and Des.
26541 octreotide acetate INJECTION VIAL 200 MCG/ML
Strength
0.2MG/ML
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
68290400 SOMATOSTATIN AGONISTS
Active Ingredients
4012 octreotide acetate 79517014
Inactive Ingredients
2272 mannitol 69658
3199 phenol 108952
756 sodium acetate 127093
SANDOSTATIN- octreotide acetate injection, solution
Novartis Pharmaceuticals Corporation
DESCRIPTION
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, C49 H66 N10 O10 S2 ) and its amino acid sequence is:
octreotide acetate amino acid sequence
(click image for full-size original)
CLINICAL 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 (see WARNINGS).
Sandostatin suppresses secretion of thyroid stimulating hormone (TSH).
