Schedule H

Subcutaneous (SC)

• Injection: 100 units/mL in 10 mL vials

• Injection: 100 units/mL in 3 mL cartridges (for pen devices)

• Injection: 100 units/mL in 3 mL pre-filled pens

• Injection: 300 units/mL in 1.5 mL pre-filled pens (concentrated formulation)

• Injection: 300 units/mL in 3 mL pre-filled pens (concentrated formulation)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Type 1 Diabetes Mellitus — Basal Insulin Component

Parameter Recommendation

Starting dose 0.2–0.4 units/kg/day SC once daily

Titration Increase by 2–4 units every 3–4 days based on fasting blood glucose (target: 80–130 mg/dL)

Usual maintenance dose 0.3–0.6 units/kg/day (typically 40–50% of total daily insulin requirement)

Maximum dose Individualised; no fixed ceiling; guided by glycaemic targets and hypoglycaemia risk

Clinical Notes:

• Must be used as part of basal-bolus regimen with rapid/short-acting insulin for mealtime coverage

• Administer at the same time daily; bedtime or morning dosing acceptable

• Onset: 1–2 hours; No pronounced peak; Duration: ~24 hours

• Cannot be mixed with other insulins in the same syringe

1. Type 2 Diabetes Mellitus — Basal Insulin Therapy

Parameter Recommendation

Starting dose 10 units SC once daily OR 0.1–0.2 units/kg/day

Titration Increase by 2–4 units every 3–7 days based on fasting glucose (target: 80–130 mg/dL)

Usual maintenance dose 0.2–0.5 units/kg/day

Maximum dose Individualised; may reach 0.7–1.0 units/kg/day or higher in insulin-resistant patients

Clinical Notes:

• May be used in combination with oral antidiabetic agents (metformin, sulfonylureas, DPP-4 inhibitors, SGLT-2 inhibitors) or GLP-1 receptor agonists

• Can be combined with prandial insulin if glycaemic targets not achieved with basal insulin alone

• Reduce sulfonylurea dose when initiating glargine to minimise hypoglycaemia risk

• Administer at consistent time daily; timing may be adjusted based on lifestyle

Switching Between Glargine Formulations:

Switch Scenario Recommendation

NPH insulin once daily → Glargine 100 units/mL Same unit dose; adjust based on response

NPH insulin twice daily → Glargine 100 units/mL Reduce total daily dose by 20%; administer once daily

Glargine 100 units/mL → Glargine 300 units/mL Same unit dose initially; may require 10–18% higher dose to maintain glycaemic control

Glargine 300 units/mL → Glargine 100 units/mL Reduce dose by ~20%; monitor closely for hypoglycaemia

Important: Glargine 100 units/mL and 300 units/mL are NOT bioequivalent on a unit-per-unit basis.

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

Indication Dose Duration Label Status Evidence Basis

Transition from IV insulin in DKA/HHS (post-resolution) Start at 0.2–0.3 units/kg/day SC; overlap with IV insulin for 2–4 hours before discontinuing IV Continue as long-term basal therapy OFF-LABEL AIIMS Endocrinology protocols; Indian specialist practice

Steroid-induced hyperglycaemia (with prolonged steroid use) 0.1–0.2 units/kg/day SC; titrate based on fasting glucose Duration of steroid therapy OFF-LABEL; Specialist only Indian hospital protocols; clinical practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Type 1 Diabetes Mellitus in Children ≥2 Years

2–6 years 0.2–0.3 units/kg/day SC once daily Increase by 0.5–1 unit every 3–5 days based on fasting glucose 0.3–0.5 units/kg/day Higher hypoglycaemia risk; conservative titration

6–12 years 0.2–0.4 units/kg/day SC once daily Increase by 1–2 units every 3–4 days 0.4–0.6 units/kg/day Part of basal-bolus regimen

12–18 years 0.3–0.5 units/kg/day SC once daily Increase by 2–4 units every 3–4 days 0.5–0.8 units/kg/day Higher requirements during puberty

Clinical Notes:

• Glargine typically constitutes 30–50% of total daily insulin requirement; remainder as rapid-acting prandial insulin

• Administer at consistent time daily

• Target fasting glucose: 90–130 mg/dL (individualise based on age and hypoglycaemia awareness)

Safety Monitoring:

• SMBG at least 4 times daily (premeal and bedtime)

• Monitor for nocturnal hypoglycaemia (especially in younger children)

• Assess injection sites for lipohypertrophy at each visit

• HbA1c every 3 months

• Growth and weight monitoring

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

Indication Dose Duration Label Status Evidence Basis

Type 2 Diabetes Mellitus in adolescents 0.1–0.2 units/kg/day SC once daily; titrate as per adult protocol Long-term OFF-LABEL; Specialist only Limited paediatric data; extrapolated from adult studies; IAP protocols

Age Restriction: Not recommended in children below 2 years of age except under specialist paediatric endocrinology supervision with appropriate monitoring capability.

Clinical Notes:

• Renal impairment reduces insulin clearance and gluconeogenesis, increasing hypoglycaemia risk

• Insulin requirements may decrease as CKD progresses

• Frequent SMBG essential in CKD stages 4–5

• Hypoglycaemia (active episode)

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

• Intravenous or intramuscular administration (not approved for these routes)

• Renal impairment (increased hypoglycaemia risk due to reduced insulin clearance)

• Hepatic impairment (impaired gluconeogenesis increases hypoglycaemia risk)

• Elderly patients (risk of unrecognised hypoglycaemia)

• Hypoglycaemia unawareness

• Erratic meal patterns or variable physical activity

• Switching between insulin formulations (dose may not be equivalent)

• Concurrent illness, infection, or stress (may alter insulin requirements)

• Lipohypertrophy from repeated injection at same site

• Visual or cognitive impairment (risk of dosing errors)

• Concomitant use with thiazolidinediones (fluid retention risk)

Parameter Recommendation

Safety status Limited data; generally considered acceptable when benefit outweighs risk

Preferred alternative Human insulin (NPH for basal coverage) is historically preferred in Indian obstetric practice

When to use May be continued if already on glargine pre-conception; initiation during pregnancy under specialist care

Monitoring Frequent SMBG (6–8 times daily); HbA1c monthly; fetal growth monitoring; adjust dose each trimester

Clinical Notes:

• Insulin requirements typically increase during 2nd and 3rd trimesters

• Risk of hypoglycaemia increased in 1st trimester

• Insulin requirements drop rapidly post-delivery

• Endocrinology and obstetric co-management recommended

Parameter Recommendation

Compatibility Compatible with breastfeeding

Drug levels in milk Negligible; insulin is a large peptide molecule degraded in infant GI tract

Preferred alternative Any insulin (human or analogue) acceptable during lactation

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

Clinical Notes:

• Breastfeeding increases maternal glucose utilisation; insulin dose may need reduction

• Ensure adequate maternal caloric intake to prevent hypoglycaemia

• Starting dose: Reduce by 20–25% from standard adult dose (e.g., start at 0.1–0.15 units/kg/day or lower fixed dose)

• Titration: Slower; increase every 5–7 days rather than 3–4 days

• Extra risks:

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

• Hypoglycaemia unawareness may be present

• Reduced renal function (even with normal serum creatinine)

• Polypharmacy increasing interaction risk

• Visual and cognitive impairment affecting self-administration

• Recommendations:

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

• Simplified regimens preferred

• Consider caregiver involvement in insulin administration

• Regular assessment of injection technique and sites

Interacting Drug/Class Mechanism/Effect Recommendation

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

Thiazolidinediones (pioglitazone) Additive hypoglycaemic effect; risk of fluid retention and heart failure Monitor for oedema and heart failure; may need insulin dose reduction

MAO inhibitors Enhanced hypoglycaemic effect Monitor glucose closely; reduce insulin dose if needed

Systemic corticosteroids Significant increase in insulin resistance May require substantial insulin dose increase (sometimes 2–3 fold); adjust on steroid initiation/cessation

Interacting Drug/Class Mechanism/Effect Recommendation

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

Thiazide diuretics May cause hyperglycaemia May require insulin dose increase

Fluoroquinolones Unpredictable glycaemic effects Monitor blood glucose closely

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

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

Octreotide / Somatostatin analogues Variable effect on insulin requirements Monitor closely; may increase or decrease requirements

Rifampicin May reduce glycaemic control (enzyme induction affecting other diabetes medications) Monitor and adjust therapy accordingly

Oral contraceptives May increase insulin resistance May require dose adjustment

• Hypoglycaemia (most common; especially nocturnal)

• Injection site reactions (pain, erythema, pruritus)

• Lipohypertrophy at injection sites

• Weight gain

• Peripheral oedema (usually mild and transient)

• Transient visual disturbances (refractive changes during glycaemic improvement)

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

• Anaphylaxis and severe systemic allergic reactions (rare)

• Severe local allergic reactions

• Lipoatrophy at injection sites (rare with analogues)

• Hypokalaemia (with high doses or during correction of hyperglycaemia)

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

After initiation/dose change Daily fasting SMBG; additional postprandial glucose if on prandial insulin; adjust dose every 3–7 days

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

Glargine 100 units/mL:

• Lantus® (Sanofi)

• Basalog® (Biocon)

• Glaritus® (Lupin)

• Basalin® (Wockhardt)

• Semglee® (Biocon/Mylan)

• Lupisulin G® (Lupin)

Glargine 300 units/mL:

• Toujeo® (Sanofi)

Note: Biosimilar glargine products are available; verify bioequivalence when switching between brands.

NLEM Status: Insulin glargine 100 units/mL (vial) is included in NLEM 2022; NPPA price-controlled.

Government Supply: Available through some government hospitals and CGHS at subsidised rates.

• Glargine has a relatively peakless profile over ~24 hours; it addresses basal insulin needs but NOT postprandial glucose excursions — prandial insulin or oral agents needed for mealtime coverage in Type 1 DM and many Type 2 DM patients

• Glargine 300 units/mL has a flatter, more prolonged profile with less nocturnal hypoglycaemia compared to 100 units/mL, but requires ~10–18% higher doses to achieve equivalent glycaemic control — these formulations are NOT interchangeable unit-for-unit

• Do NOT mix glargine with any other insulin in the same syringe — the acidic pH will cause precipitation and alter pharmacokinetics

• Systematic rotation of injection sites is essential to prevent lipohypertrophy, which causes erratic insulin absorption and unpredictable glycaemic control

• When initiating basal insulin in Type 2 DM patients on sulfonylureas, consider reducing sulfonylurea dose by 50% to minimise hypoglycaemia risk

• In pregnancy, NPH insulin remains the historically preferred basal insulin in Indian practice, though glargine may be continued under specialist supervision if patient was stable on it pre-conception

insulin; diabetes; basal insulin; long-acting; glargine; T1DM; T2DM; NLEM India; SC insulin; hypoglycaemia-risk

RxIndia v1.0 — 29 May 2025

• CDSCO product database and approved inserts

• Indian Pharmacopoeia / National Formulary of India

• NLEM 2022

• API Textbook of Medicine (Diabetes Mellitus chapter)

• ICMR Guidelines for Management of Type 2 Diabetes (2018)

• AIIMS Endocrinology Protocols

• IAP Guidelines for Paediatric and Adolescent Diabetes

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (supportive reference)