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Sandostatin

Drug Description
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SandostatinÒ
octreotide acetate
Injection

Rx Only

DRUG DESCRIPTION

SandostatinÒ (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.

SandostatinÒ (octreotide acetate) 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, C49H66N10O10S2) and its amino acid sequence is:

H-D-Phe-Cys-Phe-D-Trp-Lys-Thr-Cys-Thr-ol,
xCH3COOH                     where x = 1.4 to 2.5

Brand Name: Sandostatin
Generic Name: Octreotide Acetate

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