Octreotide Acetate Injection Rx only

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Parenteral Medicines, Inc.

INN (International Name):

OCTREOTIDE ACETATE

Composition:

OCTREOTIDE 50 ug in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Octreotide Acetate Injection is available in 1 mL single-dose vials and 5 mL multiple-dose vials as follows: 0703-3301-04 50 mcg/mL 1 mL single-dose vial 25 per shelf tray 0703-3311-04 100 mcg/mL 1 mL single-dose vial 25 per shelf tray 0703-3321-04 500 mcg/mL 1 mL single-dose vial 25 per shelf tray 0703-3333-01 200 mcg/mL 5 mL multiple-dose vial packaged individually 0703-3343-01 1000 mcg/mL 5 mL multiple-dose vial packaged individually 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OCTREOTIDE ACETATE- OCTREOTIDE ACETATE INJECTION, SOLUTION
TEVA PARENTERAL MEDICINES, INC.
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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 (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 3 strengths,
containing 50 mcg, 100 mcg, or 500 mcg octreotide (as acetate), and
sterile 5 mL
multiple-dose vials in 2 strengths, containing 200 mcg/mL 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 g/mol (free
peptide,
C
H
N
O
S ) and its amino acid sequence is:
49
66
10
10 2
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 r