OCTREOTIDE ACETATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Wockhardt USA LLC.

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 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%-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 octre

Product summary:

Octreotide acetate injection, containing octreotide (as acetate) 50 mcg per mL, is supplied in 1 ml Single Dose Vials; NDC 64679-636-01 (package of 1 Single Dose Vial), NDC 64679-636-02 (package of 10 Single Dose Vials) Octreotide acetate injection, containing octreotide (as acetate) 100 mcg per mL, is supplied in 1 ml Single Dose Vials; NDC 64679-633-01 (package of 1 Single Dose Vial), NDC 64679-633-02 (package of 10 Single Dose Vials) Octreotide acetate injection, containing octreotide (as acetate) 500 mcg per mL, is supplied in 1 ml Single Dose Vials; NDC 64679-635-01 (package of 1 Single Dose Vial), NDC 64679-635-02 (package of 10 Single Dose Vials) Octreotide acetate injection, containing octreotide (as acetate) 200 mcg per mL, is supplied in 5 ml Multi Dose Vials; NDC 64679-634-01 (package of 1 Multi Dose Vial) Octreotide acetate injection, containing octreotide (as acetate) 1000 mcg per mL, is supplied in 5 ml Multi Dose Vials; NDC 64679-632-01 (package of 1 Multi Dose Vial) For prolonged storage, octreotide acetate single-dose and multi-dose vials should be stored at refrigerated temperatures 2°C-8°C (36°F-46°F) and store in outer carton in order to protect from light. At room temperature, (20°C-30°C or 70°F-86°F), octreotide acetate single dose and multi-dose vials are 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. Manufactured by: Wockhardt Limited Mumbai, India. Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA. Iss.101012

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OCTREOTIDE ACETATE- OCTREOTIDE ACETATE INJECTION
WOCKHARDT USA LLC.
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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 glacial acetic 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.
Each mL of single dose vial contains octreotide (as acetate), either
50 mcg (0.05 mg), 100 mcg (0.1 mg)
or 500 mcg (0.5 mg) with 7 mg sodium chloride USP in water for
injection USP.
The pH range is between 3.9 and 4.5 buffered with glacial acetic acid
USP, sodium acetate trihydrate
USP, and it is sealed under nitrogen NF.
Each mL of multi dose vial contains octreotide (as acetate), either
200 mcg or 1000 mcg with 7 mg
sodium chloride USP, 5 mg phenol USP in water for injection USP.
The pH range is between 3.9 and 4.5 buffered with glacial acetic acid
USP, sodium acetate trihydrate
USP, and it is sealed under nitrogen NF.
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 injection 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