OCTREOTIDE ACETATE injection, solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

OCTREOTIDE ACETATE (UNII: 75R0U2568I) (OCTREOTIDE - UNII:RWM8CCW8GP)

थमां उपलब्ध:

USV North America Inc.

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Acromegaly Octreotide acetate injection is indicated to reduce blood levels of growth hormone and IGF-I (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 growth hormone and IGF-I (somatomedin C) levels (see DOSAGE AND ADMINISTRATION). In patients with acromegaly, octreotide acetate injection reduces growth hormone to within normal ranges in 50% of patients and reduces IGF-I (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 growth hormone and IGF-I (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

उत्पाद समीक्षा:

Octreotide Acetate Injection is a clear colorless sterile solution and is available in amber vials containing 1 mL of solution. NDC 76135-009-01 ; 50 mcg/mL octreotide (as acetate), carton of 10 single-dose 1 mL vials. NDC 76135-010-01 ; 100 mcg/mL octreotide (as acetate), carton of 10 single-dose 1 mL vials. NDC 76135-011-01 ; 500 mcg/mL octreotide (as acetate), carton of 10 single-dose 1 mL vials. Storage For prolonged storage, octreotide acetate injection vials should be stored at refrigerated temperatures 2° to 8°C (36° to 46°F) and protected 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 by: USV Private Limited H-13, 16, 16 A, 17, 18, 19, 20, 21 and E-22, OIDC, Mahatma Gandhi Udyog Nagar, Dabhel, Daman 396210, India   Manufactured for: USV North America Inc. 641, Lexington Avenue, 14th Floor, New York 100 22 Issued: December 2017

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

OCTREOTIDE ACETATE - OCTREOTIDE ACETATE INJECTION, SOLUTION
USV NORTH AMERICA INC.
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RX ONLY
DESCRIPTION
Octreotide Acetate Injection, a cyclic octapeptide prepared as a
clear, colorless sterile solution of
octreotide, acetate salt, in a buffered acetic acid solution for
administration by deep subcutaneous
(intrafat) or intravenous injection. Octreotide acetate, USP known
chemically as D-phenylalanyl-L-
cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-_N_-[(1_R_,2_R_)-2-hydroxy-1-(hydroxyl
methyl)propyl]-L-cysteinamide cyclic (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 single-dose
vials in 3 strengths, each mL
containing 50 mcg, 100 mcg, or 500 mcg of octreotide acetate, USP as
the active and the following
inactive ingredients: glacial acetic acid USP 2 mg, sodium chloride 7
mg, sodium acetate (trihydrate)
USP 2 mg, and water for injection, q.s.
Glacial acetic acid USP and sodium acetate (trihydrate) USP are added
to provide a buffered solution,
pH range 3.9 to 4.5.
The molecular weight of octreotide acetate, USP is 1019.3 (free
peptide, C
H N O S ) and its
amino acid sequence is:
CLINICAL PHARMACOLOGY
Octreotide acetate exerts pharmacologic actions similar to the natural
hormone, somatostatin. It is an
even more potent inhibitor of growth hormone, glucagon, and insulin
than somatostatin. Like
somatostatin, it also suppresses LH response to GnRH, decreases
splanchnic blood flow, and inhibits
release of serotonin, gastrin, vasoactive intestinal peptide,
secretin, motilin, and pancreatic polypeptide.
By virtue of these pharmacological actions, octreotide acetate has
been used to treat the symptoms
associated with metastatic carcinoid tumors (flushing and diarrhea),
and Vasoactive Intestinal Peptide
(VIP) secreting adenomas (watery diarrhea). Octreotide acetate
substantially reduces growth hormone
and/or IGF-I (somatomedin C) levels in patients