Glucagon 1 mg/mL
Glucagon · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Fresenius Kabi USA, LLC
Glucagon is a injection, powder, lyophilized, for solution containing glucagon at 1 mg/mL, taken intramuscular. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- Glucagon
- Generic Name
- Glucagon
- NDC Code (Product)
63323-596- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 1 mg/mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- NDA201849
- Marketing Start
- 05/08/2015
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Eli Lilly & Company
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Novo Nordisk Inc
Defective delivery system: detached needles on the syringe in the kit.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 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 ) 1.1 Severe Hypoglycemia Glucagon for Injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus. 1.2 Diagnostic Aid 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.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Dosage in adult and pediatric patients to treat severe hypoglycemia ( 2.2 ) • Adults and Pediatric Patients Weighing 20 kg or More: ▪ The recommended dosage is 1 mg (1 mL) injected subcutaneously or intramuscularly into the upper arm, thigh, or buttocks, or intravenously. ▪ If there has been no response after 15 minutes, an additional 1 mg dose (1 mL) may be administered while waiting for emergency assistance. • Pediatric Patients Weighing Less Than 20 kg: ▪ The recommended dosage is 0.5 mg (0.5 mL) or dose equivalent to 20 mcg/kg to 30 mcg/kg injected subcutaneously or intramuscularly into the upper arm, thigh, or buttocks, or intravenously. ▪ If there has been no response after 15 minutes, an additional 0.5 mg dose (0.5 mL) may be administered while waiting for emergency assistance. Important Administration Instructions for Using Glucagon for Injection 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 as …
Contraindications
4 CONTRAINDICATIONS Glucagon for Injection is contraindicated in patients with: • Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warning and Precautions (5.1) ] • Insulinoma because of the risk of hypoglycemia [see Warning and Precautions (5.2) ] • 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 Warning and Precautions (5.3) ] • Glucagonoma when used as a diagnostic aid because of the risk of hypoglycemia [see Warnings and Precautions (5.8) ] • Pheochromocytoma ( 4 ) • Insulinoma ( 4 ) • Known hypersensitivity to glucagon or to any of the excipients ( 4 ) • Glucagonoma when used as a diagnostic aid ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 1: Clinically Significant Drug Interactions with Glucagon for Injection Beta-Blockers Clinical Impact: Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given Glucagon for Injection. Intervention: The increase in blood pressure and heart rate may require therapy in patients with coronary artery disease. Indomethacin Clinical Impact: In patients taking indomethacin, Glucagon for Injection may lose its ability to raise blood glucose or may even produce hypoglycemia. Intervention: Monitor blood glucose levels during glucagon treatment of patients taking indomethacin. Anticholinergic Drugs Clinical Impact: The concomitant use of anticholinergic drugs and Glucagon for Injection increase the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. Intervention: Concomitant use of anticholinergic drugs with Glucagon for Injection for use as a diagnostic aid is not recommended. Warfarin Clinical Impact: Glucagon for Injection may increase the anticoagulant effect of warfarin. Intervention: Monitor patients for unusual bruising or bleeding, as adjustments in warfarin do…
Adverse Reactions
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: • Hypersensitivity and Allergic Reactions [see Warnings and Precautions (5.3) ] • Necrolytic Migratory Erythema [see Warnings and Precautions (5.5) ] • Hyperglycemia in Patients with Diabetes Mellitus when Used as a Diagnostic Aid [see Warnings and Precautions (5.6) ] • Blood Pressure and Heart Rate Increase in Patients with Cardiac Disease when used as a Diagnostic Aid [see Warnings and Precautions (5.7) ] The following adverse reactions have been identified during post-approval use of glucagon. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Injection site reactions including erythema and swelling • Nausea • Vomiting • Headache • Dizziness • Asthenia • Pallor • Diarrhea • Somnolence • Generalized allergic reactions including anaphylactic shock with breathing difficulties and hypotension • Hypertension and tachycardia • Decreased blood pressure. Hypotension has been reported up to 2 hours after administration in p…
Frequently Asked Questions
What is Glucagon used for?
Glucagon contains Glucagon. It is a injection, powder, lyophilized, for solution taken intramuscular. Consult your doctor for specific uses.
Is Glucagon a controlled substance?
Glucagon is not classified as a controlled substance by the DEA.
What is the generic name for Glucagon?
The generic name for Glucagon is Glucagon. There are 5 other brand versions of Glucagon.
What is the NDC code for Glucagon 1 mg/mL?
The NDC (National Drug Code) for Glucagon 1 mg/mL is 63323-596, listed by Fresenius Kabi USA, LLC.