OCTREOTIDE ACETATE injection

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

USV North America Inc.

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Acromegaly 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 were not s

Bidhaa muhtasari:

Octreotide Acetate Injection is available in 5 mL multi-dose vials as follows: Octreotide Acetate Injection 200 mcg/mL Box of one ...............................................................  NDC 76135-005-01 Octreotide Acetate Injection 1000 mcg/mL Box of one ...............................................................  NDC 76135-006-01 Storage For prolonged storage, octreotide acetate injection 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 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. After initial use, multiple dose vials should be discarded within 14 days. Dispose unused product or waste properly. Manufactured by: USV Private Limited H-13, 16, 16 A, 17, 18, 19, 20, 21 and E-22, OIDC, Mahatma Gandhi Udyog Nagar, Dabhel, Daman 396210, India Manufactured for: USV North America Inc., 641, Lexington Avenue, 14th Floor New York 100 22 Revised: 10/2016

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

OCTREOTIDE ACETATE - OCTREOTIDE ACETATE INJECTION
USV NORTH AMERICA INC.
----------
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Octreotide Acetate Injection, a cyclic octapeptide prepared as a clear
colorless sterile solution of
octreotide, acetate salt, in a buffered acetic acid solution for
administration by deep subcutaneous
(intrafat) or intravenous injection. Octreotide acetate, USP 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 acetate, USP.
Each mL of multi-dose vials also contains:
glacial acetic acid, USP .......................................... 2
mg
sodium acetate (trihydrate), USP ............................2 mg
sodium chloride, USP ............................................. 7
mg
phenol, USP
............................................................5 mg
water for injection, Int. Spec............................. qs to 1 mL
Glacial acetic acid USP, sodium acetate (trihydrate) USP, sodium
chloride USP are added to provide a
buffered solution, pH to 4.2 ± 0.3.
The molecular weight of octreotide acetate, USP 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 LHresponse to GnRH, decreases
splanchnic blood flow, and inhibits
release of serotonin, gastrin, vasoactive intestinal peptide,
secretin, motilin, andpancreatic polypeptide.
Byvirtue of these pharmacological actions, octreotide acetate has been
used totreat the symptoms
associated with