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Generic Name

Octreotide Acetate

Brand Names
Octreotide, Sandostatin, Bynfezia
FDA approval date: October 21, 1988
Classification: Somatostatin Analog
Form: Injection, Kit

What is Octreotide (Octreotide Acetate)?

Sandostatin Injection is a somatostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone and insulin growth factor-1 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.
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Related Clinical Trials

A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients Newly Diagnosed With Grade 1 and Grade 2 (Ki-67 <10%) Advanced GEP-NET With High Disease Burden (NETTER-3)

Summary: The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with high disease burden

Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome

Summary: Between 10% and 15% of patients with endogenous hypercortisolism (Cushing syndrome) have ectopic (non-pituitary) production of adrenocorticotropin hormone (ACTH) that causes cortisol excess. In approximately 50% of these patients, the tumoral source of ACTH cannot be found initially despite very detailed and extensive imaging, including studies such as computed tomography, magnetic resonance imagi...

Human Models of Selective Insulin Resistance: Diazoxide, Part I

Summary: The goal of this clinical trial is to compare a one-week course of diazoxide (2 mg/kg per dose x 14 doses) and placebo in people with obesity and insulin resistance (IR) with metabolic dysfunction-associated steatotic liver disease (MASLD). The main question it aims to answer are how mitigation of compensatory hyperinsulinemia with diazoxide affects hepatic de novo lipogenesis, a major contributor...

Brand Information

    Octreotide (OCTREOTIDE ACETATE)
    1DOSAGE FORMS AND STRENGTHS
    Octreotide Acetate Injection: 100 mcg per mL or 500 mcg per mL single-dose vial.
    2CONTRAINDICATIONS
    Sensitivity to this drug or any of its components.
    3Drug Metabolism Interactions
    Limited published data indicate that somatostatin analogs might decrease the metabolic clearance of compounds known to be metabolized by cytochrome P450 enzymes, which may be due to the suppression of GH. Since it cannot be excluded that octreotide may have this effect, other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index (e.g., quinidine, terfenadine) should therefore be used with caution.
    4Lutetium Lu 177 Dotatate Injection
    Octreotide competitively binds to somatostatin receptors and may interfere with the efficacy of lutetium Lu 177 dotatate. Discontinue Octreotide Acetate Injection at least 24 hours prior to each lutetium Lu 177 dotatate dose.
    5OVERDOSAGE
    A limited number of accidental overdoses of Octreotide Acetate Injection in adults have been reported. In adults, the doses ranged from 2,400 to 6,000 mcg/day administered by continuous infusion (100 to 250 mcg/hour) or subcutaneously (1,500 mcg 3 times a day). Adverse events in some patients included arrhythmia, complete atrioventricular block, hypotension, cardiac arrest, brain hypoxia, pancreatitis, hepatitis steatosis, hepatomegaly, lactic acidosis, flushing, diarrhea, lethargy, weakness, and weight loss.
    If overdose occurs, symptomatic management is indicated. Up-to-date information about the treatment of overdose can often be obtained from the National Poison Control Center at 1-800-222-1222.
    6DESCRIPTION
    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 or 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
    Octreotide Acetate Injection is available as: sterile 1 mL single dose vials in 2 strengths, containing 100 mcg and 500 mcg octreotide (as acetate). Each mL of the single dose vial also contains:
    • sodium chloride…………………..……... 7 mg
    • glacial acetic acid, USP ………………… 2 mg
    • sodium acetate trihydrate, USP ………… 2 mg
    • water for injection, USP ……………qs to 1 mL
    The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C
    Figure
    7PACKAGE LABEL - PRINCIPAL DISPLAY - Octreotide 1 mL Single Dose Vial Label
    NDC 63323-376-41       PRX370601
    Octreotide Acetate Injection
    100 mcg per mL
    For Subcutaneous or Intravenous Use
    Preservative free.
    Protect from light.
    Discard unused portion.
    1 mL Single Dose Vial Rx only
    PACKAGE LABEL - PRINCIPAL DISPLAY - Octreotide 1 mL Single Dose Vial Label
    8PACKAGE LABEL - PRINCIPAL DISPLAY - Octreotide 1 mL Single Dose Vial Tray Label
    NDC 63323-376-04       PRX370601
    Octreotide Acetate Injection
    100 mcg per mL
    For Subcutaneous or Intravenous Use
    Preservative free.
    10 x 1 mL
    Single Dose Vials Rx only
    PACKAGE LABEL - PRINCIPAL DISPLAY - Octreotide 1 mL Single Dose Vial Tray Label
    9PACKAGE LABEL - PRINCIPAL DISPLAY - Octreotide 1 mL Single Dose Vial Label
    NDC 63323-377-41       PRX370701
    Octreotide Acetate Injection
    500 mcg per mL
    For Subcutaneous or Intravenous Use
    Preservative free.
    Protect from light.
    Discard unused portion.
    1 mL Single Dose Vial Rx only
    PACKAGE LABEL - PRINCIPAL DISPLAY - Octreotide 1 mL Single Dose Vial Label
    10PACKAGE LABEL - PRINCIPAL DISPLAY - Octreotide 1 mL Single Dose Vial Tray Label
    NDC 63323-377-04       PRX370701
    Octreotide Acetate Injection
    500 mcg per mL
    For Subcutaneous or Intravenous Use
    Preservative free.
    10 x 1 mL
    Single Dose Vials Rx only
    PACKAGE LABEL - PRINCIPAL DISPLAY - Octreotide 1 mL Single Dose Vial Tray Label