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Pentagastrin (AnazaoHealth Corporation)

Available Formats

Dosage Form Package Information Links
SOLUTION 5 mL in 1 VIAL (51808-207-01) Label Information

Complete Pentagastrin Information

  • DESCRIPTION

    Pentagastrin, a diagnostic aid, is supplied as a sterile solution (1.1 ml/5 ml vial) containing:

    • 250 micrograms Pentagastrin per ml
    • 0.8 mg Methylparaben and 0.2 mg Propylparaben per mL
    • 0.9 mg sodium chloride per mL
    • pH 8

  • CLINICAL PHARMACOLOGY

    The exact mechanism by which Pentagastrin stimulates gastric acid, pepsin, and intrinsic factor secretion is unknown; however, since Pentagastrin is an analogue of natural gastrin, it is believed that it excites the oxyntic cells of the stomach to secrete to their maximum capacity. Pentagastrin stimulates pancreatic secretion, especially when administered in large intramuscular doses. Pentagastrin also increases gastrointestinal motility by a direct effect on the intestinal smooth muscle. However, it delays gastric emptying time probably by stimulation of terminal antral contractions, which enhance retropulsion.

    OTHER ACTIONS/EFFECTS Pentagastrin increases blood flow in the gastric mucosa, inhibits absorption of water and electrolytes from the ileum, and promotes sodium and chloride diuresis. It causes contraction of the smooth muscle of the lower esophageal sphincter when administered intravenously. Pentagastrin produces an increase in the motor activity of the colon and rectum

    ONSET OF ACTION 10 minutes

    TIME TO PEAK EFFECT 20 to 30 minutes

    DURATION OF ACTION 60 to 80 minutes


  • INDICATIONS AND USAGE

    1. Anacidity (diagnosis)—Pentagastrin is indicated as a diagnostic aid for evaluation of gastric acid secretory function. It is effective in testing for anacidity (achlorhydria) in patients with suspected pernicious anemia, atrophic gastritis, or gastric carcinoma. It is also effective in determining the reduction in acid output after operations for peptic ulcer, such as vagotomy or gastric resection.
    2. Hypersecretory conditions, gastric (diagnosis)—Pentagastrin is indicated as a diagnostic aid in testing for gastric hypersecretion in patients with suspected duodenal ulcer or postoperative stomal ulcer, and for the diagnosis of Zollinger-Ellison tumor

  • DOSAGE AND ADMINISTRATION

    The intravenous infusion dose has ranged from 0.1 to 12 mcg (0.0001 to 0.012 mg) per kg of body weight per hour administered in a 0.9% sodium chloride injection. It can also be used as a subcutaneous injection for gastric function study with a dose of 6 mcg (0.006 mg) per kg of body weight.


  • INTERACTIONS

    The following may affect pentagastrin’s  action:

    • Antacids, anticholinergics, histamine H2-receptor antagosnists, or omeprazole
    • Acute, obstructing, penetrating or bleeding peptic ulcers

    Storage and Handling

    Keep refrigerated between 2â—¦ and 8â—¦C. Protect from light


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Figure 1

    9292f201-figure-01

  • INGREDIENTS AND APPEARANCE
    PENTAGASTRIN 
    pentagastrin solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51808-207
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PENTAGASTRIN (UNII: EF0NX91490) (PENTAGASTRIN - UNII:EF0NX91490) PENTAGASTRIN 250 ug  in 1.6 mL
    Inactive Ingredients
    Ingredient Name Strength
    METHYLPARABEN (UNII: A2I8C7HI9T) 1.8 mg  in 1.6 mL
    PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.2 mg  in 1.6 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51808-207-01 5 mL in 1 VIAL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 06/19/2012
    Labeler - AnazaoHealth Corporation (011038762)
    Establishment
    Name Address ID/FEI Business Operations
    AnazaoHealth Corporation 011038762 MANUFACTURE