国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
OCTREOTIDE ACETATE (UNII: 75R0U2568I) (OCTREOTIDE - UNII:RWM8CCW8GP)
Teva Parenteral Medicines, Inc.
OCTREOTIDE ACETATE
OCTREOTIDE 50 ug in 1 mL
INTRAVENOUS
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
Octreotide Acetate Injection is available in 1 mL single-dose vials and 5 mL multiple-dose vials as follows: 0703-3301-04 50 mcg/mL 1 mL single-dose vial 25 per shelf tray 0703-3311-04 100 mcg/mL 1 mL single-dose vial 25 per shelf tray 0703-3321-04 500 mcg/mL 1 mL single-dose vial 25 per shelf tray 0703-3333-01 200 mcg/mL 5 mL multiple-dose vial packaged individually 0703-3343-01 1000 mcg/mL 5 mL multiple-dose vial packaged individually For prolonged storage, Octreotide Acetate Injection single-dose vials and multiple-dose vials should be stored at refrigerated temperatures 2°C to 8°C (36°F to 46°F) and protected from light. At room temperature (20°C to 30°C or 70°F to 86°F), Octreotide Acetate 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. After initial use, multiple-dose vials should be discarded within 14 days. Single-dose vials should be opened just prior to administration and the unused portion discarded. Dispose unused product or waste properly.
Abbreviated New Drug Application
OCTREOTIDE ACETATE- OCTREOTIDE ACETATE INJECTION, SOLUTION TEVA PARENTERAL MEDICINES, INC. ---------- OCTREOTIDE ACETATE INJECTION RX ONLY DESCRIPTION Octreotide Acetate Injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered acetate solution for administration by deep subcutaneous (intrafat) or intravenous (IV) 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. Octreotide Acetate Injection is available as sterile 1-mL single-dose vials in 3 strengths, containing 50 mcg, 100 mcg, or 500 mcg octreotide (as acetate), and sterile 5 mL multiple-dose vials in 2 strengths, containing 200 mcg/mL and 1000 mcg/mL of octreotide (as acetate). Each single-dose vial also contains: Glacial acetic acid, USP………….. 2 mg Sodium acetate trihydrate, USP…... 2 mg Mannitol, USP……………………. 45 mg Water for injection, USP…………. qs to 1 mL Each mL of the multiple-dose vials also contains: Glacial acetic acid, USP………….. 2 mg Sodium acetate trihydrate, USP…... 2 mg Phenol liquefied, USP……………... 5 mg Mannitol, USP……………………. 45 mg Water for injection, USP…………. qs to 1 mL Glacial acetic acid, USP and sodium acetate trihydrate, USP are added to provide a buffered solution, pH to 4.2 ± 0.5. The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C H N O S ) and its amino acid sequence is: 49 66 10 10 2 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 r 阅读完整的文件