Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
OCTREOTIDE ACETATE (UNII: 75R0U2568I) (OCTREOTIDE - UNII:RWM8CCW8GP)
Fresenius Kabi USA, 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 p
Octreotide Acetate Injection is available in preservative free single-dose vials: For prolonged storage, octreotide acetate single 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 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. Single dose vials should be opened just prior to administration and the unused portion discarded. Dispose unused product or waste properly. The container closure is not made with natural rubber latex. PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license. Manufactured by: Fresenius Kabi Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451396B Revised: April 2022
Abbreviated New Drug Application
OCTREOTIDE - OCTREOTIDE ACETATE INJECTION, SOLUTION FRESENIUS KABI USA, LLC ---------- OCTREOTIDE ACETATE INJECTION RX ONLY PRESCRIBING INFORMATION 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 2 strengths, containing 100 mcg and 500 mcg octreotide (as acetate). Each mL of the single dose vial also contains: sodium chloride . . . . . . . . . . . . . . . . . 7 mg glacial acetic acid, USP . . . . . . . . . . . 2 mg sodium acetate trihydrate, USP . . . . . 2 mg water for injection, USP . . . . . . .qs to 1 mL 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 (watery diarrhea). Octreotide substantially reduces GH and/or insulin growth factor-1 (IGF-1; somatomedin C) levels in pa Lugege kogu dokumenti