OCTREOTIDE ACETATE injection, solution

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Bryant Ranch Prepack

Пут администрације:

INTRAVENOUS

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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, was not shown in clinical tri

Резиме производа:

Octreotide Acetate Injection is available in 1 mL single-dose vials as follows: Storage 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.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

OCTREOTIDE ACETATE- OCTREOTIDE ACETATE INJECTION, SOLUTION
BRYANT RANCH PREPACK
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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 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, 100, or 500 mcg octreotide (as acetate), and sterile 5
mL multiple dose
vials in 2 strengths, containing 200 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 (free peptide, C
H
N
O
S )
and its amino acid sequence is:
49
66
10
10 2
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