Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
OCTREOTIDE ACETATE (UNII: 75R0U2568I) (OCTREOTIDE - UNII:RWM8CCW8GP)
Mylan Institutional LLC
OCTREOTIDE ACETATE
OCTREOTIDE 50 ug in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
Octreotide acetate injection is indicated to reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. The goal is to achieve normalization of GH and IGF-1 (somatomedin C) levels (see DOSAGE AND ADMINISTRATION). In patients with acromegaly, octreotide acetate injection reduces GH to within normal ranges in 50% of patients and reduces IGF-1 (somatomedin C) to within normal ranges in 50% to 60% of patients. Since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate injection to reduce blood levels of GH and IGF-1 (somatomedin C) offers potential benefit before the effects of irradiation are manifested. Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials pe
Octreotide Acetate Injection is available in a 1 mL single-dose syringe with a fixed 27 gauge ½ inch needle as follows: NDC 67457-239-01 octreotide acetate equivalent to octreotide 50 mcg/mL, carton of 10. NDC 67457-245-01 octreotide acetate equivalent to octreotide 100 mcg/mL, carton of 10. NDC 67457-246-01 octreotide acetate equivalent to octreotide 500 mcg/mL, carton of 10. Storage: For prolonged storage, octreotide acetate injection syringes should be stored at refrigerated temperatures 2° to 8°C (36° to 46°F) and store in outer carton in order to protect from light. At room temperature, (20° to 30°C or 70° to 86°F), octreotide acetate injection is stable for 14 days if protected from light. The solution can be allowed to come to room temperature prior to administration. Do not warm artificially. Dispose unused product or waste properly. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Italfarmaco S.p.A. V.le Fulvio Testi, 330 20126 Milano, Italy Revised: 11/2022 MI:OCTRIJ:R9 PK21477
Abbreviated New Drug Application
OCTREOTIDE ACETATE- OCTREOTIDE ACETATE INJECTION, SOLUTION MYLAN INSTITUTIONAL LLC ---------- The needle shield of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals. DESCRIPTION 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 (IV) injection. Octreotide acetate, known chemically as D-Phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N- [(1R,2R)-2-hydroxy-1-(hydroxymethyl)propyl]-L-cysteinamidecyclic(2--7)-disulfide acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Octreotide acetate injection is available as sterile 1 mL syringe in three strengths, each mL containing octreotide acetate equivalent to 50 mcg, 100 mcg, or 500 mcg of octreotide as the active and the following inactive ingredients: L-lactic acid 3 mg, sodium chloride 7 mg, sodium hydroxide to adjust pH, and water for injection, q.s. L-Lactic acid and sodium hydroxide are added to provide a buffered solution, pH range 3.9 to 4.5. The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C H N O S ) and its amino acid sequence is: CLINICAL PHARMACOLOGY Octreotide acetate injection exerts pharmacologic actions similar to the natural hormone, somatostatin. It is an even more potent inhibitor of growth hormone (GH), glucagon, and insulin than somatostatin. Like somatostatin, it also suppresses luteinizing hormone (LH) response to gonadotropin releasing hormone (GnRH), decreases splanchnic blood flow, and inhibits release of serotonin, gastrin, vasoactive intestinal peptide (VIP), secretin, motilin, and pancreatic polypeptide. By virtue of these pharmacological actions, octreotide has been used to treat the symptoms associated with metastatic carcinoid tumors (flushing and diarrhea), and VIP secreting adenomas ( Läs hela dokumentet