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Sandostatin®
Sandostatin ®
octreotide acetate
Injection |
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Rx Only
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, C49H66N10O10S2) and its amino acid sequence is:
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