OCTREOTIDE ACETATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

octreotide acetate (UNII: 75R0U2568I) (octreotide - UNII:RWM8CCW8GP)

Available from:

Sagent Pharmaceuticals

INN (International Name):

octreotide acetate

Composition:

octreotide 50 ug in 1 mL

Administration route:

SUBCUTANEOUS

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 p

Product summary:

Octreotide Acetate Injection is available as follows: Store refrigerated between 2° and 8°C (36° and 46°F). 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. Single-Dose Vials —should be opened just prior to administration and the unused portion discarded. Multi-Dose Vials —should be discarded within 14 days after initial use. Protect from light. Retain in carton until time of use. Dispose of unused product or waste properly. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2020 Sagent Pharmaceuticals, Inc. Revised: October 2020 SAGENT Pharmaceuticals®

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OCTREOTIDE ACETATE- OCTREOTIDE ACETATE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
----------
OCTREOTIDE ACETATE INJECTION
(FOR SUBCUTANEOUS OR INTRAVENOUS USE)
SAGENT
Rx only
DESCRIPTION
Octreotide acetate injection, a cyclic octapeptide prepared as a clear
sterile solution of
octreotide, acetate salt, in a buffered acetate solution with a pH
range 3.9 to 4.5 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 acetate, USP, and
sterile 5 mL
multi-dose vials in 2 strengths, containing 200 mcg and 1,000 mcg per
mL of octreotide
acetate, USP.
Each mL of the single-dose vial also contains:
Each mL of the multi-dose vial also contains:
The molecular weight of octreotide acetate is 1,019.3 g/mol (free
peptide,
C
H
N
O
S ) and its amino acid sequence is:
CLINICAL PHARMACOLOGY
®
sodium chloride, USP
....................................................................................7
mg
glacial acetic acid,
USP.................................................................................
2 mg
sodium acetate trihydrate, USP
.................................................................... 2
mg
water for injection, USP
.............................................quantity sufficient to 1
mL
sodium chloride,
USP...................................................................................
7 mg
glacial acetic acid,
USP.................................................................................
2 mg
sodium acetate trihydrate, USP
.................................................................... 2
mg
phenol,
US