Schedule H

Intramuscular (IM), Intravenous (IV), Subcutaneous (SC)

• Powder for reconstitution for injection: 1 mg/vial (with diluent syringe)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Severe Hypoglycaemia

Used in unconscious patients or those unable to take oral glucose, when IV access is not immediately available.

Adult Dosing:

Parameter Recommendation

Starting dose 1 mg IM, SC, or IV as single dose

Titration Not applicable for emergency use

Usual maintenance dose Not applicable (single emergency dose)

Maximum dose 1 mg per episode; may repeat once after 15 minutes if no response

Clinical Notes:

• Response expected within 10–15 minutes of administration

• Must reconstitute powder immediately before use (unstable in solution)

• Once patient regains consciousness, administer oral carbohydrates immediately to prevent recurrence

• If no response within 15 minutes after second dose, initiate IV dextrose (25% or 50%)

• IM injection preferred if IV access unavailable; lateral thigh or deltoid suitable sites

1. Diagnostic Aid for Gastrointestinal Radiological Procedures

Used to relax smooth muscle and reduce motility during upper GI endoscopy, ERCP, barium studies, or CT/MRI enterography.

Adult Dosing:

Parameter Recommendation

Starting dose 0.2–0.5 mg IV (slow injection over 1 minute) OR 1 mg IM

Titration Not applicable

Usual maintenance dose Not applicable

Maximum dose 2 mg per procedure (higher doses increase nausea risk)

Clinical Notes:

• IV route provides faster onset (1 minute) compared to IM (8–10 minutes)

• Duration of smooth muscle relaxation: IV approximately 9–17 minutes; IM approximately 12–27 minutes

• Hospital/specialist setting use only

• Ensure patient is fasting before procedure

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Beta-blocker Overdose/Toxicity Starting dose: 3–5 mg IV bolus over 1–2 minutes; may repeat once. Followed by continuous IV infusion at 2–5 mg/hour titrated to clinical response Until haemodynamic stability achieved OFF-LABEL — Specialist only (Toxicology/Critical Care). Based on international case series and toxicology protocols. Use alongside other supportive measures including IV fluids, atropine, vasopressors. High-dose insulin euglycaemia therapy may be considered as adjunct.

Calcium Channel Blocker Overdose Starting dose: 3–5 mg IV bolus; Infusion: 2–5 mg/hour As clinically indicated OFF-LABEL — Specialist only. Limited evidence; consider as adjunct when standard therapy fails.

Oesophageal Food Bolus Impaction 1 mg IV single dose Single dose trial OFF-LABEL — Limited efficacy evidence; endoscopic removal remains preferred approach.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Severe Hypoglycaemia

Used when patient is unconscious or unable to take oral glucose and IV access is not available.

Weight-based Dosing:

Weight/Age Starting Dose Repeat Dose Maximum Dose

<25 kg or <6 years 0.5 mg (500 mcg) IM or SC May repeat 0.5 mg after 15 minutes if no response 1 mg total

≥25 kg or ≥6 years 1 mg IM or SC May repeat after 15 minutes if no response 1 mg per dose

Alternative Weight-based Calculation:

• 0.02–0.03 mg/kg IM or SC (maximum 1 mg)

Clinical Notes:

• Response expected within 10–15 minutes

• Administer oral carbohydrates immediately upon regaining consciousness

• Educate parents/caregivers on reconstitution, storage, and injection technique for home emergency kits

• If no response to glucagon, proceed with IV dextrose (2–5 mL/kg of 10% dextrose in neonates/infants; 2 mL/kg of 25% dextrose in older children)

Minimum Age: May be used in neonates and infants for severe hypoglycaemia under specialist supervision. No specific lower age limit for emergency use.

Safety Monitoring:

• Blood glucose every 15–30 minutes until stable

• Monitor for recurrent hypoglycaemia for at least 2 hours

• Observe for vomiting (aspiration risk in drowsy child)

Secondary Indications — Paediatrics (Off-label)

Indication Dose Notes

Beta-blocker Poisoning 0.05–0.15 mg/kg IV bolus (max 3–5 mg); Infusion: 0.05–0.1 mg/kg/hour OFF-LABEL — PICU/Toxicology specialist only. Based on paediatric toxicology case reports and extrapolated from adult data.

Congenital Hyperinsulinism (diagnostic/therapeutic) 0.02–0.03 mg/kg/hour IV infusion OFF-LABEL — Paediatric endocrinologist only. Used as bridge therapy pending definitive management.

No dose adjustment required.

• Known hypersensitivity to glucagon or any excipient (lactose in some formulations)

• Phaeochromocytoma (confirmed or suspected) — risk of catecholamine release precipitating hypertensive crisis

• Insulinoma — paradoxical insulin release may worsen hypoglycaemia

• Glucagonoma

• Prolonged fasting or starvation states — reduced hepatic glycogen stores; blunted glycaemic response expected

• Chronic alcoholism — depleted glycogen stores; glucagon may be ineffective

• Adrenal insufficiency — impaired counter-regulatory response

• Malnutrition or cachexia — reduced efficacy

• Cardiac disease (ischaemic heart disease, arrhythmias) — glucagon has positive inotropic and chronotropic effects

• Must reconstitute immediately before use; do not use if solution is cloudy or contains particles

• Ensure patient receives oral carbohydrates post-recovery to prevent rebound hypoglycaemia

Parameter Recommendation

Safety Category Generally considered safe; no evidence of fetal harm in animal or limited human studies

Preferred Alternative IV dextrose preferred when IV access available

When to Use Appropriate for severe hypoglycaemia when IV access not immediately available; may be life-saving

Monitoring Maternal blood glucose post-administration; fetal heart rate monitoring once mother stabilised

Parameter Recommendation

Breastfeeding Compatibility Compatible with breastfeeding

Drug Levels in Milk Expected to be minimal to nil; glucagon is a peptide hormone degraded in GI tract

Preferred Alternatives Not applicable for emergency indication

Infant Monitoring No specific monitoring required; routine observation

Parameter Recommendation

Starting dose Standard adult dose (1 mg IM/SC for hypoglycaemia)

Titration Not applicable

Special Considerations Response may be slower or blunted in malnourished or hepatically compromised elderly patients

Additional Risks Cardiovascular effects (tachycardia, transient hypertension); increased risk in patients with underlying cardiac disease; monitor BP and heart rate

Alternative Consideration If hepatic glycogen depletion suspected, proceed directly to IV dextrose

Interacting Drug Mechanism/Effect Management

Indomethacin May blunt hyperglycaemic response to glucagon Monitor blood glucose response; higher glucagon dose or alternative therapy may be needed

Warfarin and other oral anticoagulants Glucagon may enhance anticoagulant effect; mechanism unclear (possibly via hepatic effects) Monitor INR closely if multiple glucagon doses administered; adjust anticoagulant dose if needed

Insulin (high-dose infusion) Antagonistic effects; may reduce glucagon efficacy In insulin overdose, glucagon is adjunct; ensure adequate glucose replacement

Interacting Drug Effect Management

Beta-blockers Glucagon causes catecholamine release; may lead to transient hypertension and tachycardia in patients on beta-blockers; paradoxically, glucagon is also used to treat beta-blocker toxicity Monitor cardiovascular parameters; therapeutic interaction in overdose setting

Anticholinergic drugs Additive GI effects (decreased motility); increased risk of nausea when glucagon used for diagnostic GI imaging Use lower diagnostic doses; have antiemetics available

Diazoxide May exaggerate hyperglycaemic effect Monitor blood glucose

Sulfonylureas and other hypoglycaemic agents Post-glucagon rebound hypoglycaemia possible, especially if oral agents continue to act Monitor blood glucose for several hours; ensure adequate carbohydrate intake

• Nausea (dose-related; more common with IV and doses >1 mg)

• Vomiting

• Injection site reactions (pain, erythema, induration)

• Transient tachycardia

• Transient hypertension

• Headache

Adverse Effect Clinical Significance

Anaphylaxis/severe hypersensitivity Rare; presents as urticaria, angioedema, hypotension, bronchospasm; discontinue immediately and treat as medical emergency

Severe hypertension Risk in phaeochromocytoma (contraindicated); monitor BP

Hypokalaemia Transient; more likely with high IV doses or continuous infusion; monitor potassium in ICU settings

Rebound hypoglycaemia Occurs if oral carbohydrates not given after recovery; may be severe; ensure adequate post-recovery feeding

Necrolytic migratory erythema Reported with prolonged high-dose infusions (rare); discontinue if skin lesions develop

Baseline (if feasible in emergency):

• Capillary or venous blood glucose

• Level of consciousness

• Blood pressure, heart rate

After Administration:

• Regain of consciousness expected within 10–15 minutes

• Blood glucose every 15–30 minutes for at least 2 hours post-administration

• Monitor for recurrent hypoglycaemia symptoms

• Ensure oral carbohydrate intake upon recovery

For Repeated Doses or Continuous Infusion (ICU setting):

• Serum potassium

• Continuous cardiac monitoring (rhythm, rate)

• Blood glucose hourly

• Blood pressure monitoring

For Diagnostic Use:

• GI motility return assessment

• Monitor for nausea/vomiting post-procedure

• GlucaGen® (Novo Nordisk) — 1 mg powder for injection with diluent

• Glucagon Emergency Kit (Novo Nordisk)

Note: Limited availability; primarily stocked in tertiary care hospitals, diabetes centres, and emergency departments. Not widely available at primary care level.

• Not included in NLEM

• Not under NPPA price control

• May be available in government tertiary care emergency departments

• Some NHM-supported facilities may stock for emergency use

• Check expiry dates regularly as shelf-life awareness is critical

• First-line consideration: Glucagon is invaluable when IV access is difficult or delayed in severe hypoglycaemia; however, IV dextrose remains more reliable and faster-acting when IV access is available

• Glycogen dependency: Glucagon works by mobilising hepatic glycogen; it will be ineffective in patients with depleted glycogen stores (chronic alcoholism, prolonged fasting, severe malnutrition, advanced liver disease) — proceed directly to IV dextrose in such patients

• Post-recovery feeding: Always ensure oral carbohydrates are given once patient regains consciousness to prevent rebound hypoglycaemia; failure to do so is a common mistake

• Storage and reconstitution: Educate patients with diabetes (especially those on insulin) and caregivers about proper storage (2–8°C), reconstitution technique, and administration; reconstituted solution must be used immediately

• Emergency kit check: Regularly verify expiry dates of glucagon in emergency kits; expired glucagon should not be used

• Beta-blocker toxicity: High-dose glucagon is a key antidote in beta-blocker overdose; ensure adequate supply in ICU/emergency settings

glucagon; severe hypoglycaemia; emergency medicine; beta-blocker overdose; hyperglycaemic agent; antidote; paediatric emergency; insulin overdose; renal-safe; pregnancy-safe

RxIndia v1.0 — 10 Jan 2025

• CDSCO approved prescribing information

• Indian Pharmacopoeia (IP)

• National Formulary of India (NFI)

• API Textbook of Medicine

• ICMR Guidelines for Management of Diabetes Emergencies

• AIIMS Emergency Drug Protocols

• Indian Society of Paediatric and Adolescent Endocrinology (ISPAE) protocols

• IAP Drug Formulary

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• International toxicology literature (for off-label beta-blocker overdose indication)