OCTREOTIDE ACETATE injection, solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Mylan Institutional LLC

INN (nemzetközi neve):

OCTREOTIDE ACETATE

Összetétel:

OCTREOTIDE 50 ug in 1 mL

Az alkalmazás módja:

SUBCUTANEOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

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

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

OCTREOTIDE ACETATE- OCTREOTIDE ACETATE INJECTION, SOLUTION
MYLAN INSTITUTIONAL LLC
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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 (