Sandostatin LAR

Drug Description

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Sandostatin LAR® Depot
(octreotide acetate) for Injectable Suspension.

DRUG 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-(hydroxy-methyl) 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, C₄₉H₆₆N₁₀O₁₀S₂) and its amino acid sequence is

Brand Name: Sandostatin LAR
Generic Name: Octreotide Acetate Injection

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