GLUCAGEN HYPOKIT(SC/IM) 1/MG POWDER IN VIAL @

Indications

Approved Uses

Treatment of severe hypoglycemia in patients with diabetes mellitus; diagnostic aid for radiologic examinations of the gastrointestinal tract (to inhibit GI motility/relax smooth muscle).

Off-Label Uses

Beta-blocker overdose, Calcium channel blocker overdose, Esophageal food bolus impaction, Refractory anaphylaxis.

Dosage & Administration

Dosing by Condition

Severe hypoglycemia: Adults and children ≥25 kg: 1 mg SC or IM once; children <25 kg: 0.5 mg SC or IM once. If no response after ~10-15 minutes, seek urgent medical care and consider repeat dosing per medical direction while ensuring definitive treatment (IV glucose) is arranged. Diagnostic GI relaxation (healthcare setting): dosing varies by procedure and route (commonly IV 0.2-0.5 mg for upper GI; IM 1-2 mg for lower GI), per institutional/procedure protocols.

Initial Dose

1 mg subcutaneously or intramuscularly as a single dose for severe hypoglycemia in adults

Maintenance Dose

Single-dose emergency use only; not used as maintenance therapy

Maximum Dose

Adults and children ≥25 kg: 1 mg per dose subcutaneously (or IM); may repeat 1 mg once after 10-15 minutes if no response while arranging urgent care (maximum 2 mg total). Children <25 kg: 0.5 mg per dose subcutaneously (or IM); may repeat 0.5 mg once after 10-15 minutes if no response (maximum 1 mg total).

Children's Dosage

Weight-based: 0.5 mg for children weighing less than 25 kg or younger than 6-8 years; 1 mg for children weighing more than 25 kg or older than 6-8 years.

Dose Adjustment Notes

Pediatrics: <25 kg (or typically <6-8 years depending on local labeling) use 0.5 mg; ≥25 kg use 1 mg. No routine dose adjustment is recommended for renal or hepatic impairment when used for emergency treatment of severe hypoglycemia.

How to Take

Reconstitute the 1 mg glucagon powder with the supplied diluent, gently swirl until clear, then inject immediately subcutaneously (SC) or intramuscularly (IM) (typical sites: outer thigh, upper arm, or buttock). Place an unconscious patient in the recovery position, call emergency services, and once awake and able to swallow give fast-acting carbohydrate followed by a longer-acting snack to prevent recurrence. IV use is generally restricted to healthcare professionals/clinical settings (e.g., diagnostic use) and is not the intended community route for the HypoKit.

How to Prepare

Inject the entire diluent (from the supplied prefilled syringe) into the vial containing glucagon powder, gently swirl/roll until fully dissolved and the solution is clear/colorless, then withdraw the dose back into the syringe and inject SC/IM immediately; discard any unused solution.

Side Effects

Common Side Effects

Nausea and vomiting (most common); may also cause headache and injection-site reactions.

Safety & Warnings

Contraindications

Pheochromocytoma; known hypersensitivity to glucagon or any excipient

Warnings & Precautions

Contraindicated in pheochromocytoma. Use with caution in insulinoma. Effectiveness depends on adequate hepatic glycogen-may be ineffective in starvation, adrenal insufficiency, or chronic hypoglycemia; after recovery give oral carbohydrates.

Age Restriction

No minimum age restriction; can be used in adults and children (including pediatrics) for severe hypoglycemia with weight-based pediatric dosing (typically 0.5 mg if <25 kg, 1 mg if ≥25 kg).

Drug Interactions

Food Interaction

No specific food interaction; once the patient is conscious and can swallow, give fast-acting carbohydrate followed by a longer-acting carbohydrate snack/meal to prevent recurrent hypoglycemia.

Special Populations

Children

Weight-based: 0.5 mg for children weighing less than 25 kg or younger than 6-8 years; 1 mg for children weighing more than 25 kg or older than 6-8 years.

Elderly

Standard adult dosing (1 mg); no specific dose adjustment required

Kidney Impairment

No adjustment needed.

Liver Impairment

No adjustment needed.

Storage & Patient Advice

Storage Conditions

Store below 25°C; after reconstitution use immediately and discard any unused portion.

Preparation Instructions

Inject the entire diluent (from the supplied prefilled syringe) into the vial containing glucagon powder, gently swirl/roll until fully dissolved and the solution is clear/colorless, then withdraw the dose back into the syringe and inject SC/IM immediately; discard any unused solution.

Missed Dose

Not applicable-used as a single, as-needed emergency dose (or as a procedure-directed dose in diagnostic settings).

Stopping the Medicine

Not applicable (single-use emergency medication); after response, give oral carbohydrates and seek medical evaluation.

Patient Counseling

Keep the kit accessible and train caregivers; reconstitute and inject SC/IM promptly during severe hypoglycemia, place the person on their side, and call emergency services. Once awake and able to swallow, give fast-acting sugar then a longer-acting carbohydrate snack/meal; check expiry and do not use if solution is discolored/particulate after mixing.

Monitoring Requirements

Monitor clinical response and blood glucose after administration and for recurrence; monitor airway/level of consciousness and for nausea/vomiting. In diagnostic/IV use or in patients with cardiac disease, consider heart rate/BP monitoring per institutional protocol.

Pharmacology

Mechanism of Action

Glucagon activates hepatic glucagon receptors → increases cAMP → stimulates glycogenolysis and gluconeogenesis to raise blood glucose; it also relaxes gastrointestinal smooth muscle, reducing GI motility.

Onset of Action

IM/SC: typically ~8-10 minutes; IV: within ~1 minute (healthcare setting).

Duration of Effect

Clinical glucose rise typically begins within ~10 minutes and the effect is short-lived; without carbohydrate replacement, hypoglycemia can recur within ~20-60 minutes (duration depends on hepatic glycogen stores and subsequent carbohydrate intake).

Half-Life

Approximately 45 minutes (apparent half-life after IM injection)

Bioavailability

Not well-defined/typically not reported as an absolute % for SC/IM glucagon; systemic absorption is rapid after SC/IM.

Metabolism

Metabolized by proteolytic degradation mainly in the liver, and also in kidneys and plasma.

Excretion

Cleared primarily by metabolic degradation (liver, kidney, plasma); metabolites are eliminated via the kidneys (urine).

Product Information

Available Dosage Forms

Powder and solvent for solution for injection (vial kit) (GlucaGen HypoKit).

Composition per Dose

Each vial: 1 mg glucagon (as hydrochloride) with 1 ml solvent (dilute hydrochloric acid solution)

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Both

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