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Sandostatin LAR Depot (Octreotide Acetate Long Acting) - Description

 


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DESCRIPTION

Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Octreotide is 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*)].

Sandostatin LAR® Depot (octreotide acetate for injectable suspension) is available in a vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a monthly intragluteal injection. The octreotide is uniformly distributed within the microspheres which are made of a biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer. Sterile mannitol is added to the microspheres to improve suspendability.

Sandostatin LAR® Depot is available as: sterile 5-mL vials in 3 strengths delivering 10 mg, 20 mg or 30 mg octreotide free peptide. Each vial of Sandostatin LAR® Depot delivers:

Name of Ingredient 10 mg 20 mg 30 mg
octreotide acetate 11.2 mg* 22.4 mg* 33.6 mg*
D,L-lactic and glycolic acids copolymer 188.8 mg 377.6 mg 566.4 mg
mannitol 41.0 mg 81.9 mg 122.9 mg
*Equivalent to 10/20/30 mg octreotide base.

Each syringe of diluent contains:

carboxymethylcellulose sodium 12.5 mg

mannitol 15.0 mg

water for injection 2.5 mL

The molecular weight of octreotide is 1019.3 (free peptide, C49 H66 N10 O10 S2) and its amino acid sequence is:

Page last updated: 2006-07-03

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