Finished product reference

Glucagon

Injection, Powder, for Solution · Parenteral · 1 mg

List code
597
0

Indications

INDICATIONS AND USAGE For the treatment of severe hypoglycemia: Glucagon is indicated as a treatment for severe hypoglycemia (low blood sugar) which may occur in patients with diabetes mellitus. 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, as use of glucagon in combination with anticholinergic drugs may result in increased side effects, the use of glucagon in combination with anticholinergic drugs is not recommended. INDICATIONS FOR USE Use glucagon to treat insulin coma or insulin reaction resulting from severe hypoglycemia (very low blood sugar).

Dosage and administration (summary)

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. 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.

Contraindications

CONTRAINDICATIONS Glucagon is contraindicated in patients with known hypersensitivity to it or in patients with known pheochromocytoma.

Warnings and precautions

WARNINGS Glucagon should be administered cautiously to patients with a history suggestive of insulinoma, pheochromocytoma, or both. In patients with insulinoma, intravenous administration of glucagon may produce an initial increase in blood glucose; however, because of glucagon’s hyperglycemic effect the insulinoma may release insulin and cause subsequent hypoglycemia. A patient developing symptoms of hypoglycemia after a dose of glucagon should be given glucose orally, intravenously, or by gavage, whichever is most appropriate.

Pregnancy

Pregnancy Reproduction studies have not been performed with recombinant glucagon. However, studies with animal sourced glucagon were performed in rats at doses up to 2 mg/kg glucagon administered two times a day (up to 40 times the human dose based on body surface area, mg/m 2 ), and have revealed no evidence of impaired fertility or harm to the fe…

Storage and supply

STORAGE Store the kit at controlled room temperature between 20° to 25°C (68° to 77°F) before mixing glucagon with the diluent. Glucagon that has been mixed with diluent should be used immediately. Discard any unused portion. Solutions should be clear and of a water-like consistency at time of use.

Source: Glucagon (Glucagon) — US FDA prescribing information, 2023-07-21, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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