GLUCAGON- glucagon kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLUCAGON HYDROCHLORIDE (UNII: 1H87NVF4DB) (GLUCAGON - UNII:76LA80IG2G)

Available from:

Fresenius Kabi USA, LLC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Glucagon for Injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes. Glucagon for Injection is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. Glucagon for Injection is contraindicated in patients with: - Pheochromocytoma [see Warnings and Precautions (5.1)] - Insulinoma [see Warnings and Precautions (5.2)] because of the risk of hypoglycemia - Known hypersensitivity to glucagon or any of the excipients in Glucagon for Injection. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warnings and Precautions (5.3)] - Glucagonoma [see Warnings and Precautions (5.8)] because of risk of hypoglycemia when used as a diagnostic aid Risk Summary Available data from case reports and a small number of observational studies with glucagon use in pregnant women over decades of use have not

Product summary:

Glucagon for Injection is supplied as a sterile, lyophilized white powder available as follows: Before Reconstitution The package containing Glucagon for Injection vials may be stored up to 24 months at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature] prior to reconstitution. Do not freeze. Keep in the original package to protect from light. After Reconstitution Use reconstituted glucagon solution immediately. Discard any unused portion [see Dosage and Administration (2.3)] .

Authorization status:

New Drug Application

Summary of Product characteristics

GLUCAGON - GLUCAGON
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLUCAGON FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GLUCAGON FOR
INJECTION.
GLUCAGON FOR INJECTION, FOR SUBCUTANEOUS, INTRAMUSCULAR OR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 1960
RECENT MAJOR CHANGES
Indications and Usage (1)
09/2019
Dosage and Administration (2)
09/2019
Contraindications (4)
09/2019
Warnings and Precautions (5)
09/2019
INDICATIONS AND USAGE
Glucagon for Injection is an antihypoglycemic agent and a
gastrointestinal motility inhibitor indicated:
for the treatment of severe hypoglycemia in pediatric and adult
patients with diabetes (1.1)
as a diagnostic aid for use during radiologic examinations to
temporarily inhibit movement of the
gastrointestinal tract in adult patients (1.2)
DOSAGE AND ADMINISTRATION
Dosage in adults and pediatric patients using the glucagon emergency
kit for low blood sugar to treat
severe hypoglycemia (2.2)
Adults and Pediatric Patients Weighing More Than 25 kg or for
Pediatric Patients with Unknown Weight 6
Years and Older:
-
-
Pediatric Patients Weighing Less Than 25 kg or for Pediatric Patients
with Unknown Weight Less Than 6
Years of Age:
-
-
Important Administration Instructions for Using the Glucagon Emergency
Kit for Low Blood Sugar to Treat
Severe Hypoglycemia (2.1)
Glucagon for Injection is for subcutaneous, intramuscular, or
intravenous injection. Administer
intravenously ONLY under medical supervision.
See the Full Prescribing Information for administration instructions
Dosage in Adults for Using Glucagon for Injection Diagnostic Kit and
Glucagon for Injection Single-Dose Vial
as a Diagnostic Aid (2.4)
The recommended diagnostic dose for relaxation of the stomach,
duodenal bulb, duodenum, and small
bowel is 0.2 mg to 0.5 mg administered intravenously or 1 mg
administered intramuscularly; the
recommended dose to relax the colon is 0.5 mg to 0.75 mg administered
intravenously or