OCTREOTIDE ACETATE- octreotide acetate injection, solution

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Sandoz Inc

INN (Isem Internazzjonali):

OCTREOTIDE ACETATE

Kompożizzjoni:

OCTREOTIDE 200 ug in 1 mL

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Octreotide acetate 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 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 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 clinical trials performed with octreotide a

Sommarju tal-prodott:

Octreotide acetate injection is available as: 200 mcg/mL octreotide (as acetate): NDC 0781-3165-75 box of one 5 mL multi-dose vial 1000 mcg/mL octreotide (as acetate): NDC 0781-3164-75 box of one 5 mL multi-dose vial For prolonged storage, octreotide acetate multi-dose vials should be stored at refrigerated temperatures 2°C to 8°C (36°F to 46°F) and store in outer carton in order to protect 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. Dispose unused product or waste properly. *Thomson Healthcare, Inc. 07-2013M U46095225 Manufactured in Canada by Sandoz Canada Inc. for Sandoz Inc. Princeton, NJ 08540

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

OCTREOTIDE ACETATE- OCTREOTIDE ACETATE INJECTION, SOLUTION
SANDOZ INC
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OCTREOTIDE ACETATE INJECTION
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 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 5 mL multi-dose
vials in 2 strengths, containing 200
and 1000 mcg/mL of octreotide (as acetate).
Each mL of the multi-dose vials also contains:
lactic acid, USP
3.4 mg
mannitol, USP
45 mg
phenol, USP
5.0 mg
sodium bicarbonate, USP
qs to pH 4.2 ± 0.3
water for injection, USP
qs to 1 mL
Lactic acid and sodium bicarbonate are added to provide a buffered
solution, pH to 4.2 ± 0.3.
The molecular weight of octreotide acetate 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 with acromegaly.
Single doses of octreot