OCTREOTIDE ACETATE injection, solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Hikma Pharmaceuticals USA Inc.

INN (International Adı):

OCTREOTIDE ACETATE

Kompozisyon:

OCTREOTIDE 50 ug in 1 mL

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

Octreotide Acetate Injection is available as follows:    NDC 0641-6174-10, 50 mcg/mL octreotide (as acetate), 1 mL Single Dose amber vial supplied in a carton of 10    NDC 0641-6175-10, 100 mcg/mL octreotide (as acetate), 1 mL Single Dose amber vial supplied in a carton of 10    NDC 0641-6176-10, 500 mcg/mL octreotide (as acetate), 1 mL Single Dose amber vial supplied in a carton of 10    NDC 0641-6177-01, 200 mcg/mL octreotide (as acetate), 5 mL Multiple Dose amber vials individually boxed    NDC 0641-6178-01, 1,000 mcg/mL octreotide (as acetate), 5 mL Multiple Dose amber vials individually boxed For prolonged storage, Octreotide Acetate Injection 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 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, the 5 mL multiple dose vials should be discarded within 14 days. Dispose unused product or waste properly. To report SUSPECTED ADVERSE REACTIONS , contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised July 2021 462-729-05

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

OCTREOTIDE ACETATE- OCTREOTIDE ACETATE INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
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 lactic acid solution for
administration by deep
subcutaneous (intrafat) or intravenous (IV) injection. Octreotide
acetate, known
chemically as
D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-_N_-
[(1_R_,2_R_)-2-hydroxy-1-(hydroxymethyl)propyl]-L-cysteinamide cyclic
(2→7)-disulfide
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 vials in 3
strengths, each mL
containing 50 mcg, 100 mcg, or 500 mcg of octreotide (as acetate) as
the active and
the following inactive ingredients: L-lactic acid 3 mg, sodium
chloride 7 mg, sodium
hydroxide, and water for injection, q.s.
Octreotide Acetate Injection is also available as sterile 5 mL
multiple dose vials in 2
strengths, each mL containing 200 mcg or 1,000 mcg of octreotide (as
acetate) as the
active and the following inactive ingredients: L-lactic acid 3 mg,
sodium chloride 7 mg,
sodium hydroxide, and water for injection, q.s. Phenol 5 mg has been
added as a
preservative.
L-Lactic acid and sodium hydroxide are added to provide a buffered
solution, pH range
3.9 to 4.5.
The molecular weight of octreotide acetate is 1019.3 g/mol (free
peptide,
C
H
N
O
S ) and its amino acid sequence is:
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 releasing hormone (GnRH),
decreases
splanchnic blood flow, and inhibits release of serotonin, gastrin,
vasoactive intestinal
peptide (VIP), secreti