Schedule H

Subcutaneous (SC), Intravenous (IV), Intramuscular (IM — less common)

• Injection: 40 IU/mL (10 mL vial)

• Injection: 100 IU/mL (10 mL vial)

• Cartridge: 100 IU/mL (3 mL for pen devices)

• Pre-filled pen: 100 IU/mL (3 mL)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Type 1 Diabetes Mellitus

Parameter Recommendation

Starting dose (total daily insulin) 0.4–0.6 units/kg/day divided as basal + bolus

Titration Adjust by 1–2 units every 2–3 days based on SMBG; target premeal glucose 80–130 mg/dL

Usual maintenance dose 0.5–1.0 units/kg/day (total); Regular insulin as 50–60% of total daily dose divided before meals

Maximum dose Individualised; no fixed ceiling; guided by glycaemic targets

Clinical Notes:

• Administer SC 30 minutes before meals to align with pharmacokinetic profile

• Typically used in basal-bolus regimen with intermediate-acting (NPH) or long-acting insulin

• Onset: 30–60 minutes; Peak: 2–4 hours; Duration: 5–8 hours

1. Type 2 Diabetes Mellitus (Insulin-Requiring)

Parameter Recommendation

Starting dose 4–6 units SC before the largest meal OR 0.1–0.2 units/kg/day as prandial insulin

Titration Increase by 2–4 units every 3–4 days based on postprandial glucose

Usual maintenance dose Individualised; typically 0.3–0.5 units/kg/day as bolus component

Maximum dose No fixed ceiling; titrate to glycaemic targets

Clinical Notes:

• May be initiated when oral agents fail to achieve glycaemic control

• Can be used as add-on to basal insulin or as part of premixed regimen

• Administer 30 minutes before meals

1. Diabetic Ketoacidosis (DKA) — Intravenous Protocol

Parameter Recommendation

Starting dose 0.1 units/kg IV bolus (optional; omit if glucose <250 mg/dL) followed by 0.1 units/kg/hour continuous IV infusion

Titration Adjust infusion rate to achieve glucose reduction of 50–75 mg/dL/hour

Usual maintenance dose 0.05–0.1 units/kg/hour; reduce to 0.02–0.05 units/kg/hour when glucose <200 mg/dL (add 5% dextrose to IV fluids)

Maximum dose Guided by glucose response; if no response, double infusion rate

Clinical Notes:

• Initiate only after fluid resuscitation commenced

• Continue IV insulin until anion gap closes and patient can tolerate oral intake

• Transition to SC insulin with 1–2 hour overlap before discontinuing IV infusion

• Monitor hourly: blood glucose, electrolytes (especially potassium)

1. Hyperosmolar Hyperglycaemic State (HHS)

Parameter Recommendation

Starting dose 0.05–0.1 units/kg/hour IV infusion (after initial fluid resuscitation)

Titration Adjust to reduce glucose by 50–75 mg/dL/hour

Usual maintenance dose 0.02–0.05 units/kg/hour once glucose <300 mg/dL

Maximum dose Individualised based on response

Clinical Notes:

• Priority is aggressive fluid replacement before insulin initiation

• Avoid rapid glucose reduction to prevent cerebral oedema

• Transition to SC insulin once clinically stable and eating

1. Perioperative and ICU Glycaemic Control

Parameter Recommendation

Starting dose 0.5–2 units/hour IV infusion (or per institutional protocol)

Titration Adjust hourly based on blood glucose; target typically 140–180 mg/dL in ICU

Usual maintenance dose 1–4 units/hour; highly variable

Maximum dose No fixed ceiling; guided by glucose levels

Clinical Notes:

• Regular insulin is the only insulin approved for IV infusion

• Use dedicated IV line or Y-site compatible infusion

• Hourly blood glucose monitoring mandatory during IV insulin infusion

• Transition to SC insulin when patient stable and taking oral diet (overlap by 1–2 hours)

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

Indication Dose Duration Label Status Evidence Basis

Hyperkalaemia (emergency treatment) 10 units Regular insulin IV with 25 g dextrose (50 mL of 50% dextrose) Single dose; repeat as needed OFF-LABEL AIIMS/Indian hospital protocols; standard emergency medicine practice

Insulin-glucose infusion for cardiac protection (GIK therapy) Variable protocols; typically 10–20 units in 500 mL 25% dextrose Perioperative period OFF-LABEL; Specialist only Limited evidence; used in select Indian cardiac surgery centres

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Type 1 Diabetes Mellitus in Children

Prepubertal children 0.5–0.7 units/kg/day Divide prandial component (50–60% of TDD) into 3 premeal doses Administer 20–30 min before meals

Pubertal children 0.7–1.0 units/kg/day Divide prandial component into 3 premeal doses Higher requirements due to growth hormone and sex steroids

Newly diagnosed (honeymoon phase) 0.3–0.5 units/kg/day Adjust based on SMBG May require very low doses initially

Titration:

• Adjust by 0.5–1 unit every 2–3 days based on premeal and postprandial glucose

• Target: Premeal 90–130 mg/dL; Postprandial <180 mg/dL

1. Diabetic Ketoacidosis (DKA) in Children

Parameter Recommendation

Starting dose 0.05–0.1 units/kg/hour IV infusion (NO IV bolus in children)

Titration Maintain glucose reduction of 50–75 mg/dL/hour; reduce rate if faster decline

Usual maintenance dose 0.05 units/kg/hour; reduce further when glucose <250–300 mg/dL

Maximum dose 0.1 units/kg/hour initially; rarely need higher

Clinical Notes:

• IV bolus NOT recommended in paediatric DKA due to risk of cerebral oedema

• Begin insulin infusion 1–2 hours after fluid resuscitation commenced

• Add 5% dextrose to IV fluids when glucose <250–300 mg/dL

• Monitor neurological status closely; signs of cerebral oedema include headache, altered sensorium, bradycardia

Safety Monitoring:

• Hourly blood glucose during IV insulin

• Electrolytes (especially potassium) every 2–4 hours

• Neurological assessment every hour

• Fluid balance charting

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

Indication Dose Duration Label Status Evidence Basis

Hyperkalaemia 0.1 units/kg IV with 0.5 g/kg dextrose Single dose; repeat as needed OFF-LABEL; Specialist only IAP protocols; Indian PICU practice

Neonatal hyperglycaemia (NICU) 0.01–0.05 units/kg/hour IV infusion Until glucose controlled OFF-LABEL; Specialist only AIIMS Neonatology protocols

Age Restriction: Not recommended in infants <1 year except under paediatric endocrinology or PICU/NICU specialist supervision.

Clinical Notes:

• Renal impairment reduces insulin clearance and gluconeogenesis

• Hypoglycaemia risk substantially increased in CKD stages 4–5

• Regular insulin preferred over long-acting analogues in severe CKD due to shorter duration

• Hypoglycaemia (active or recurrent unexplained episodes)

• Known hypersensitivity to regular insulin or any excipient in the formulation

• Renal or hepatic impairment (increased hypoglycaemia risk)

• Elderly and malnourished patients

• Irregular meal patterns or erratic food intake

• Gastroparesis (unpredictable absorption timing)

• Intercurrent illness, infection, or stress states (may increase insulin requirements)

• Adrenal or pituitary insufficiency (increased hypoglycaemia risk)

• Repeated injection at same site (lipohypertrophy risk)

• Hypokalaemia or risk of hypokalaemia (especially with IV use)

• Patients with impaired awareness of hypoglycaemia

Parameter Recommendation

Safety status Safe in pregnancy; preferred insulin for GDM and pre-existing diabetes

Preferred alternative Human insulin (regular and NPH) preferred over analogues; analogues (lispro, aspart, detemir) also acceptable

When to use Throughout pregnancy for diabetes management; essential for GDM not controlled by diet

Monitoring Frequent SMBG (4–7 times daily); HbA1c monthly; fetal growth monitoring; dose adjustment each trimester

Clinical Notes:

• Insulin requirements typically increase progressively, especially in 2nd and 3rd trimesters

• Risk of hypoglycaemia increased in 1st trimester

• Insulin requirements may drop rapidly postpartum

Parameter Recommendation

Compatibility Compatible with breastfeeding

Drug levels in milk Not applicable; insulin is a large peptide, not secreted in milk in significant amounts

Preferred alternative Human insulin is preferred; no concerns with any insulin type

Infant monitoring No specific monitoring required; observe for normal feeding and growth

Clinical Notes:

• Breastfeeding may increase maternal glucose utilisation; dose reduction may be needed

• Maintain adequate caloric intake to prevent hypoglycaemia

• Starting dose: 0.1–0.2 units/kg/day (lower end of dosing range)

• Titration: Conservative; increase by 1–2 units every 3–5 days

• Extra risks:

• Hypoglycaemia more common and more dangerous (risk of falls, cardiac events, cognitive impairment)

• Hypoglycaemia unawareness may be present

• Reduced renal function (even with normal creatinine)

• Polypharmacy increasing interaction risk

• Visual impairment affecting self-administration

• Recommendations:

• Less stringent glycaemic targets (HbA1c 7.5–8.5%) may be appropriate

• Simplified regimens preferred (avoid complex basal-bolus if possible)

• Consider caregiver training for insulin administration

Interacting Drug/Class Mechanism/Effect Recommendation

Beta-blockers (especially non-selective: propranolol) Mask hypoglycaemia symptoms (tremor, tachycardia); may prolong hypoglycaemia Use cardioselective beta-blockers if needed; educate patient on neuroglycopenic symptoms

Systemic corticosteroids Increase insulin resistance; raise blood glucose May require significant insulin dose increase (sometimes 2–3 fold); monitor closely

Fluoroquinolones (especially gatifloxacin) Unpredictable glycaemic effects (hypo- or hyperglycaemia) Avoid gatifloxacin; monitor closely with other fluoroquinolones

Thiazolidinediones (pioglitazone) Additive hypoglycaemic effect; fluid retention Monitor for hypoglycaemia and oedema; dose adjustment may be needed

Interacting Drug/Class Mechanism/Effect Recommendation

ACE inhibitors / ARBs May enhance insulin sensitivity Monitor for hypoglycaemia, especially when initiating

Thiazide diuretics May cause hyperglycaemia May require insulin dose increase

Alcohol Potentiates hypoglycaemia; impairs counter-regulatory response Counsel patients; avoid excess; ensure food intake with alcohol

Salicylates (high-dose aspirin) May enhance hypoglycaemic effect Monitor glucose if high-dose aspirin used

Octreotide Variable effect on insulin requirements Monitor closely; may reduce or increase requirements

MAO inhibitors May enhance hypoglycaemic effect Monitor glucose closely

Pentamidine May cause hypoglycaemia initially, then hyperglycaemia Close glucose monitoring during treatment

• Hypoglycaemia (most common and dose-limiting)

• Injection site reactions (pain, erythema, pruritus)

• Lipohypertrophy at injection sites

• Weight gain

• Peripheral oedema (insulin oedema; usually transient)

• Transient visual disturbances (refractive changes with initiation)

• Severe hypoglycaemia (neuroglycopenia, seizures, loss of consciousness, coma) — requires immediate intervention with glucose/glucagon

• Hypokalaemia (especially with IV insulin; can precipitate arrhythmias)

• Anaphylaxis and severe allergic reactions (rare)

• Lipoatrophy at injection sites (rare with human insulin)

• Insulin antibody formation (rare; may affect glycaemic control)

After initiation/dose change SMBG 4–7 times daily (premeal, 2-hour postprandial, bedtime); more frequent with IV insulin (hourly)

Long-term HbA1c every 3 months; annual renal function, lipid profile, retinal examination; injection site inspection at each visit

IV insulin (DKA/HHS/ICU) Hourly blood glucose; electrolytes (especially potassium) every 2–4 hours; fluid balance

Human Regular Insulin (Soluble):

• Actrapid® (Novo Nordisk)

• Huminsulin®-R (Eli Lilly)

• Wosulin®-R (Wockhardt)

• Insuman® Rapid (Sanofi)

• Insugen®-R (Biocon)

• Recosulin®-R (Biocon)

• Human Insulin Injection IP (multiple generic manufacturers)

Note: Verify insulin type and concentration (40 IU/mL vs 100 IU/mL) before dispensing; use matching syringes.

NLEM Status: Soluble insulin injection is included in NLEM 2022; NPPA price-controlled.

Government Supply: Available through government hospitals, NHM, and Jan Aushadhi stores at subsidised rates.

• Regular insulin must be administered 30 minutes before meals; failure to do so results in postprandial hyperglycaemia followed by late hypoglycaemia

• Only Regular (soluble) insulin can be given intravenously; never use insulin analogues or cloudy insulin preparations IV

• For DKA management, continue IV insulin until anion gap closes, not just until glucose normalises; overlap SC insulin by 1–2 hours before stopping IV infusion

• Always verify insulin type and concentration; mixing up 40 IU/mL and 100 IU/mL formulations with incorrect syringes is a common and dangerous error

• Rotate injection sites systematically to prevent lipohypertrophy; injecting into lipohypertrophic areas causes erratic absorption

• When treating hyperkalaemia with insulin-dextrose, always co-administer dextrose to prevent hypoglycaemia; monitor glucose every 30–60 minutes for 4–6 hours

diabetes; insulin; short-acting; DKA; HHS; IV insulin; hyperkalaemia; pregnancy-safe; NLEM India; paediatricRxIndia

v1.0 — 29 May 2025

• CDSCO product database

• Indian Pharmacopoeia / National Formulary of India

• NLEM 2022

• API Textbook of Medicine

• ICMR Guidelines for Management of Type 2 Diabetes

• AIIMS Protocols for DKA and HHS Management

• IAP Guidelines for Paediatric Diabetes and DKA

• ISPAD Clinical Practice Consensus Guidelines (supportive reference for paediatric DKA)

• WHO Model List of Essential Medicines (supportive)