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Glucagon (Glucagon Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

For the treatment of hypoglycemia:

Glucagon is indicated as a treatment for severe hypoglycemia.

Because patients with type 1 diabetes may have less of an increase in blood glucose levels compared with a stable type 2 patient, supplementary carbohydrate should be given as soon as possible, especially to a pediatric patient.

For use as a diagnostic aid:

Glucagon is indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel, and colon when diminished intestinal motility would be advantageous.

Glucagon is as effective for this examination as are the anticholinergic drugs. However, the addition of the anticholinergic agent may result in increased side effects.

DOSAGE AND ADMINISTRATION

General Instructions for Use:

  • The diluent is provided for use only in the preparation of glucagon for parenteral injection and for no other use.
  • Glucagon should not be used at concentrations greater than 1 mg/mL (1 unit/mL).
  • Reconstituted glucagon should be used immediately. Discard any unused portion.
  • Reconstituted glucagon solutions should be used only if they are clear and of a water-like consistency.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Directions for Treatment of Severe Hypoglycemia:

Severe hypoglycemia should be treated initially with intravenous glucose, if possible.

  • If parenteral glucose can not be used, dissolve the lyophilized glucagon using the accompanying diluting solution and use immediately.
  • For adults and for pediatric patients weighing more than 44 lb (20 kg), give 1 mg (1 unit) by subcutaneous, intramuscular, or intravenous injection.
  • For pediatric patients weighing less than 44 lb (20 kg), give 0.5 mg (0.5 unit) or a dose equivalent to 20 to 30 μg/kg. 2-6
  • Discard any unused portion.
  • An unconscious patient will usually awaken within 15 minutes following the glucagon injection. If the response is delayed, there is no contraindication to the administration of an additional dose of glucagon; however, in view of the deleterious effects of cerebral hypoglycemia emergency aid should be sought so that parenteral glucose can be given.
  • After the patient responds, supplemental carbohydrate should be given to restore liver glycogen and to prevent secondary hypoglycemia.

Directions for Use as a Diagnostic Aid:

Dissolve the lyophilized glucagon using the accompanying diluting solution and use immediately. Discard any unused portion.

The doses in the following table may be administered for relaxation of the stomach, duodenum, and small bowel, depending on the onset and duration of effect required for the examination. Since the stomach is less sensitive to the effect of glucagon, 0.5 mg (0.5 units) IV or 2 mg (2 units) IM are recommended.

* Administration of 2 mg (2 units) doses produces a higher incidence of nausea and vomiting than do lower doses.

Dose Route of Administration Time of Onset of Action Approximate Duration of Effect
0.25-0.5 mg (0.25-0.5 units)
IV 1 minute 9-17 minutes
1-mg (1 unit) IM 8-10 minutes 12-27 minutes
2 mg* (2 units) IV 1 minute 22-25 minutes
2 mg* (2 units) IM 4-7 minutes 21-32 minutes

For examination of the colon, it is recommended that a 2 mg (2 units) dose be administered intramuscularly approximately 10 minutes prior to the procedure. Colon relaxation and reduction of patient discomfort may allow the radiologist to perform a more satisfactory examination.

HOW SUPPLIED

NDC:64725-8031-1 in a KIT of 1 KITS

Glucagon Emergency Kit for Low Blood Sugar (Glucagon for Injection [rDNA origin]) (MS8031):

1 mg (1 unit) — (VL7529), with 1 mL of diluting solution (Hyporet * HY7530) (1s) NDC 0002-8031-01 ®

___________________________

* Hyporet (disposable syringe, Lilly). ®

Stability and Storage:

— Vials of Glucagon, as well as the Diluting Solution for Glucagon, may be stored at controlled room temperature 20° to 25°C (68° to 77°F)[see USP]. Before Reconstitution

The USP defines controlled room temperature by the following: A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.

— Glucagon for Injection (rDNA origin) should be used immediately. After Reconstitution Discard any unused portion.

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