Schedule H

Intramuscular (IM), Intravenous (IV), Subcutaneous (SC), Inhalation, Endotracheal (ET), Intracardiac (rare)

• Injection: 1 mg/mL ampoule (1:1000 concentration)

• Injection: 0.1 mg/mL in 10 mL prefilled syringe (1:10,000 concentration)

• Auto-injector: 0.15 mg, 0.3 mg (availability variable in India)

• Inhalation solution: 2.25% racemic epinephrine (limited availability; specialist use only)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Anaphylaxis

Route: Intramuscular (mid-outer thigh preferred)

Parameter Details

Starting dose 0.3–0.5 mg IM (use 1:1000 concentration)

Titration Repeat every 5–15 minutes based on clinical response

Usual maintenance dose Not applicable (acute emergency use)

Maximum dose No formal maximum in life-threatening emergency; monitor closely

Clinical Notes:

• IM route preferred over SC due to faster absorption in shock states

• Auto-injectors (0.3 mg) suitable for prehospital/self-administration if available

• Do not delay administration to establish IV access

1. Cardiac Arrest (Advanced Life Support)

Route: Intravenous or Intraosseous

Parameter Details

Starting dose 1 mg IV/IO (use 1:10,000 concentration)

Titration Repeat every 3–5 minutes as per ACLS/Indian Resuscitation Council algorithm

Usual maintenance dose Not applicable

Maximum dose Continue as long as resuscitation ongoing

Clinical Notes:

• Flush IV line with 20 mL normal saline after each dose

• Endotracheal route (2–2.5 mg diluted in 10 mL NS) only if IV/IO access unavailable

• Document cumulative dose in CPR record

1. Severe Asthma / Status Asthmaticus (Adjunct Therapy)

Route: Subcutaneous or Intramuscular

Parameter Details

Starting dose 0.3–0.5 mg SC or IM

Titration May repeat every 20 minutes

Usual maintenance dose Not applicable

Maximum dose 3 doses (total 1.5 mg)

Clinical Notes:

• Reserve for patients unresponsive to inhaled beta-2 agonists

• Specialist supervision recommended

• Monitor heart rate and blood pressure closely

1. Septic Shock (Vasopressor — Refractory Hypotension)

Route: Intravenous infusion (ICU setting)

Parameter Details

Starting dose 2 mcg/min IV infusion

Titration Increase by 2 mcg/min every 10–15 minutes based on MAP response

Usual maintenance dose 2–10 mcg/min

Maximum dose Up to 35 mcg/min (as per haemodynamic requirement)

Clinical Notes:

• Central venous access preferred to avoid extravasation

• Use only after adequate volume resuscitation

• Often used as second-line after norepinephrine

Secondary Indications — Adults (Off-label, if any)

1. Upper Airway Obstruction with Stridor (Nebulised)

Parameter Details

Indication Acute upper airway oedema/stridor

Dose 0.5 mL of 2.25% racemic epinephrine diluted in 2.5 mL normal saline via nebuliser

Duration Single dose; may repeat once after 20 minutes if needed

Status OFF-LABEL; Specialist only (ENT/Emergency Medicine)

Evidence basis Indian ICU and ENT specialist practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Anaphylaxis

Weight/Age Starting Dose Titration Maximum Dose

<10 kg 0.01 mg/kg IM (1:1000) Repeat every 5–15 min as needed 0.15 mg per dose

10–25 kg 0.15 mg IM (auto-injector if available) Repeat every 5–15 min as needed 0.15 mg per dose

25 kg 0.3 mg IM Repeat every 5–15 min as needed 0.3 mg per dose

Safety Monitoring: Heart rate, blood pressure, respiratory status

1. Cardiac Arrest (Paediatric Advanced Life Support)

Parameter Details

Starting dose 0.01 mg/kg IV/IO (use 1:10,000 concentration; equivalent to 0.1 mL/kg)

Titration Repeat every 3–5 minutes as per PALS algorithm

Maximum single dose 1 mg

Safety Monitoring: Continuous ECG, end-tidal CO₂ if available

1. Severe Asthma (Refractory)

Parameter Details

Starting dose 0.01 mg/kg SC or IM (use 1:1000 concentration)

Titration May repeat every 20 minutes × 3 doses

Maximum single dose 0.3 mg

Safety Monitoring: Heart rate, rhythm monitoring; watch for tremor, tachycardia

Secondary Indications — Paediatric Doses (Off-label, if any)

1. Post-extubation Stridor / Laryngotracheobronchitis (Croup)

Parameter Details

Indication Upper airway oedema causing stridor

Dose 0.5 mL of 2.25% racemic epinephrine diluted in 2.5 mL normal saline via nebuliser; OR L-epinephrine 0.5 mL/kg of 1:1000 (max 5 mL) via nebuliser

Duration Single dose; may repeat after 20–30 minutes if needed

Status OFF-LABEL; Specialist only (Paediatric ICU/ENT)

Evidence basis IAP guidelines; Indian paediatric critical care practice

Age/Weight Restriction:

Not recommended below 1 month of age except under neonatologist supervision with appropriate weight-based dosing

No dose adjustment required

Note: Use with caution in patients with pre-existing renal hypoperfusion — epinephrine may worsen renal vasoconstriction in high doses

• Hypersensitivity to epinephrine or any formulation component (including sulfites in some preparations)

• Concurrent use with halogenated hydrocarbon anaesthetics (e.g., halothane) — high arrhythmia risk

• Use with ergot alkaloids — severe vasoconstriction

• Narrow-angle glaucoma (for ophthalmic preparations)

• During labour for tocolysis — risk of uterine vasoconstriction

Note: In true anaphylaxis, there are NO absolute contraindications — benefit outweighs risk

• Ischaemic heart disease — increased myocardial oxygen demand

• Cardiac arrhythmias — may precipitate or worsen

• Uncontrolled hypertension — risk of hypertensive crisis

• Hyperthyroidism — exaggerated adrenergic response

• Diabetes mellitus — transient hyperglycaemia

• Elderly patients — increased cardiovascular sensitivity

• Patients on beta-blockers — paradoxical hypertension with reflex bradycardia possible

• Pheochromocytoma — may precipitate hypertensive crisis

Parameter Details

Safety category Use only if life-threatening indication (e.g., anaphylaxis, cardiac arrest)

Preferred alternatives For asthma: inhaled salbutamol preferred when feasible

When it may be used Anaphylaxis — benefit clearly outweighs risk; no contraindication in maternal emergency

What to monitor Maternal BP, heart rate; continuous fetal heart rate monitoring post-administration

Parameter Details

Compatibility Compatible with breastfeeding when used for emergency indications

Preferred alternatives Not applicable for emergency use

Expected levels in milk Low (rapid systemic metabolism limits milk transfer)

What to monitor in infant Generally not required for single/emergency doses

Parameter Recommendation

Starting dose Use lower end of dosing range (0.3 mg IM for anaphylaxis)

Titration More cautious; allow longer interval between doses if clinically stable

Extra risks Increased sensitivity to cardiovascular effects; higher risk of arrhythmias, hypertension, myocardial ischaemia

Special considerations Avoid IV bolus unless absolutely necessary; prefer IM route when possible

Interacting Drug Effect Recommendation

Non-selective beta-blockers (propranolol, carvedilol) Unopposed alpha-effect → severe hypertension with reflex bradycardia Avoid if possible; if epinephrine essential, monitor closely; glucagon may be alternative in anaphylaxis

MAO inhibitors Potentiation of pressor effect → hypertensive crisis Avoid concurrent use; if essential, use reduced doses with extreme caution

Tricyclic antidepressants Enhanced cardiovascular toxicity; arrhythmia risk Use with caution; monitor ECG

Halogenated anaesthetics (halothane, enflurane) Sensitisation of myocardium → ventricular arrhythmias Contraindicated during such anaesthesia

Ergot alkaloids (ergotamine, methylergonovine) Severe additive vasoconstriction → peripheral ischaemia Contraindicated

Interacting Drug Effect Recommendation

Alpha-blockers (prazosin, tamsulosin) Blunted pressor response May require higher epinephrine doses; monitor response

Thyroid hormones Synergistic tachycardia and arrhythmia Monitor heart rate and rhythm

Insulin / Oral hypoglycaemics Epinephrine may mask hypoglycaemic symptoms; causes transient hyperglycaemia Monitor blood glucose

Inhaled beta-2 agonists (salbutamol) Additive tachycardia, tremor Monitor; usually acceptable in emergency

Digoxin Increased arrhythmia risk Monitor ECG

Antihypertensives Blunted antihypertensive effect Monitor BP; adjust as needed

• Palpitations

• Tachycardia

• Anxiety and restlessness

• Tremor

• Headache

• Nausea and vomiting

• Sweating

• Transient hypertension

• Pallor

Adverse Effect Clinical Action

Ventricular arrhythmias (VT/VF) Discontinue if non-arrest situation; treat per ACLS

Hypertensive crisis Discontinue infusion; consider phentolamine or nitroprusside

Pulmonary oedema Supportive care; reduce/stop infusion

Cerebral haemorrhage (rare) Immediate neurology consultation; supportive care

Tissue necrosis from extravasation Immediate phentolamine infiltration (5–10 mg in 10 mL saline) into affected area

Myocardial ischaemia/infarction ECG monitoring; cardiology consultation

During therapy Continuous ECG and BP monitoring (IV infusions); watch for extravasation; SpO₂

Post-administration Heart rate, BP, clinical response for at least 30–60 minutes post-IM dose

Long-term Not applicable — short-acting emergency agent

• Adrenaline IP (Neon Laboratories, Samarth Life Sciences)

• Epimax (Troikaa Pharmaceuticals)

• Adrinerve

• EpiPen (auto-injector; limited/imported availability)

• Adrenallin Jr (auto-injector; variable access)

Inhalation solution 2.25% NOT ROUTINELY COMMERCIALLY AVAILABLE

Note: Epinephrine injection is included in NLEM India; government hospital supply available at lower cost

• IM is the preferred route for anaphylaxis — do not delay for IV access; use mid-outer thigh

• Always verify dilution before administration: 1:1000 (1 mg/mL) for IM/SC; 1:10,000 (0.1 mg/mL) for IV — medication errors are common

• In beta-blocker-treated patients with anaphylaxis: epinephrine may be less effective; consider glucagon 1–5 mg IV as adjunct

• Auto-injector availability remains inconsistent in India — counsel patients on proper technique and storage if prescribed

• For IV infusions, always use central line when feasible to prevent extravasation-induced tissue necrosis

• Document cumulative dose clearly in CPR and ICU records

epinephrine; adrenaline; anaphylaxis; cardiac arrest; ACLS; sympathomimetic; emergency medicine; resuscitation; vasopressor; NLEM India; Schedule H

RxIndia v1.0 — 06 May 2025

• CDSCO product inserts

• National Formulary of India (NFI) 2021

• NLEM India 2022

• Indian Resuscitation Council Guidelines

• ICMR Paediatric Protocols

• API Textbook of Medicine

• IAP Guidelines (Paediatric Emergency Care)

• AIIMS Emergency Medicine and Paediatrics Protocols

• WHO Essential Medicines List (supportive paediatric dosing)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics