Glucagon

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 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 a Diagnostic Aid ( 2.4 ) Doses required for relaxation of the stomach, duodenum, and small bowel, depend on the onset and duration of effect required for the examination. The dose for relaxation of the duodenum and small bowel is 0.25 mg to 0.5 mg given intravenously or 1 mg given intramuscularly. For the stomach 0.5 mg intravenous or 2 mg intramuscular doses are recommended. For the colon, it is recommended that a 2 mg dose be administered intramuscularly approximately 10 minutes prior to the procedure. See the Full Prescribing Information for administration instructions ( 2.3 ) 2.1 Important Administration Instructions for Using Glucagon for Injection to Treat Severe Hypoglycemia Glucagon for injection is for subcutaneous, intramuscular, or intravenous injection. Administer intravenously ONLY under medical supervision. Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about glucagon for injection and its Instructions for Use. Administer glucagon for injection as soon as possible when severe hypoglycemia is recognized. Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for glucagon for injection. Emphasize the following instructions to the patient or caregiver: Using the supplied prefilled syringe, carefully insert the needle through the rubber stopper of the vial containing glucagon for injection powder and inject all the liquid from the syringe into the vial. Swirl the vial gently until the powder is completely dissolved and no particles remain in the fluid. The reconstituted solution should be clear and of a water-like consistency at time of use. Inspect visually for particulate matter and discoloration. If the resulting solution is cloudy or contains particulate matter do not use. The reconstituted solution is 1 mg per mL glucagon. Use immediately after reconstitution. Immediately after reconstitution, use the same syringe to withdraw the correct dose of glucagon for injection. Inject the solution subcutaneously or intramuscularly in the upper arm, thigh, or buttocks. In addition, healthcare providers may administer intravenously. Call for emergency assistance immediately after administering the dose. If there has been no response after 15 minutes, an additional dose of glucagon for injection may be administered while waiting for emergency assistance. When the patient has responded to the treatment and is able to swallow, give oral carbohydrates to restore the liver glycogen and prevent recurrence of hypoglycemia. Discard any unused portion. 2.2 Dosage for Treatment of Severe Hypoglycemia 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. Alternatively, healthcare providers may administer the dose intravenously. If there has been no response after 15 minutes, an additional 1 mg dose (1 mL) of glucagon for injection 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 to 30 mcg/kg injected subcutaneously or intramuscularly into the upper arm, thigh, or buttocks. Alternatively, healthcare providers may administer the dose intravenously. If there has been no response after 15 minutes, an additional 0.5 mg dose (0.5 mL) of glucagon for injection may be administered while waiting for emergency assistance. 2.3 Important Administration Instructions for Using Glucagon for Injection as a Diagnostic Aid Reconstitute glucagon for injection with 1 mL of diluent. Swirl the vial gently until the powder is completely dissolved and no particles remain in the fluid. The reconstituted solution should be clear and of a water-like consistency at time of use. Inspect visually for particulate matter and discoloration. If the resulting solution is cloudy or contains particulate matter do not use. Withdraw the correct dose of glucagon for injection. The reconstituted solution is 1 mg per mL glucagon. Immediately after reconstitution, inject the solution intravenously or intramuscularly into upper arm, thigh, or buttocks. Discard unused portion. After the end of the diagnostic procedure, give oral carbohydrates to patients who have been fasting, if this is compatible with the diagnostic procedure. 2.4 Dosage in Adults for Use as a Diagnostic Aid Doses required for relaxation of the stomach, duodenum, and small bowel, depend on the onset and duration of effect required for the examination [see Pharmacodynamics ( 12.2 )] . The usual dose for relaxation of the stomach, duodenum and small bowel is 0.25 mg to 0.5 mg given intravenously or 1 mg given intramuscularly, but up to 2 mg intravenously or intramuscularly may be used if required (2 mg doses produce a higher rate of nausea and vomiting than lower doses) [see Adverse Reactions ( 6 )] . For the stomach because it is less sensitive to the effect of glucagon, 0.5 mg intravenous or 2 mg intramuscular doses are recommended. For the examination of the colon, it is recommended that a 2 mg dose be administered intramuscularly approximately 10 minutes prior to the procedure.

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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.