Schedule H

Oral

5 mg tablets

10 mg tablets

Fixed-dose combinations (FDCs): Dapagliflozin + Metformin (5/500 mg, 5/1000 mg, 10/500 mg, 10/1000 mg); Dapagliflozin + Saxagliptin (5/5 mg, 10/5 mg)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Type 2 Diabetes Mellitus (T2DM)

Parameter Recommendation

Starting dose 5 mg once daily in the morning

Titration Increase to 10 mg once daily after 4–8 weeks if glycaemic control inadequate and drug tolerated

Usual maintenance dose 5–10 mg once daily

Maximum dose 10 mg once daily

Key Clinical Notes:

• Adjunct to diet and exercise; monotherapy or add-on to other antidiabetics

• Glycaemic efficacy diminishes when eGFR <45 ml/min/1.73m²; avoid initiation for glycaemic control below this threshold

• May be continued for cardio-renal benefit even if eGFR falls during treatment

1. Heart Failure with Reduced Ejection Fraction (HFrEF) — NYHA Class II–IV

Parameter Recommendation

Starting dose 10 mg once daily

Titration Not applicable

Usual maintenance dose 10 mg once daily

Maximum dose 10 mg once daily

Key Clinical Notes:

• Effective irrespective of diabetes status

• Use alongside guideline-directed medical therapy (ACEi/ARNi, beta-blocker, MRA)

• Continue unless contraindication develops or patient becomes unstable

1. Chronic Kidney Disease (CKD) — Albuminuric, Stages 2–4

Parameter Recommendation

Starting dose 10 mg once daily

Titration Not applicable

Usual maintenance dose 10 mg once daily

Maximum dose 10 mg once daily

Key Clinical Notes:

• Initiate only if eGFR ≥25 ml/min/1.73m²

• May be continued if eGFR falls below 25 during treatment until dialysis or transplant

• Provides cardiovascular protection and delays CKD progression independent of diabetic status

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

Indication Dose Duration Notes

Type 1 Diabetes Mellitus 5 mg once daily (max 10 mg/day) Individualised OFF-LABEL; Specialist only. Evidence: Limited RCTs. Not recommended per ICMR 2022 due to elevated DKA risk. Use discouraged in Indian guidelines.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Type 2 Diabetes Mellitus in Paediatric Population:

Parameter Recommendation

Approval status NOT APPROVED in India for patients <18 years

Minimum age Not recommended under 18 years

Evidence Safety and efficacy not established in Indian population

Key Clinical Notes:

• Use only under paediatric endocrinologist supervision in exceptional cases where no alternatives exist

• Not endorsed by ICMR or IAP guidelines for routine paediatric use

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

Not applicable.

Dapagliflozin is not routinely used in paediatric nephrology or cardiology in India. No established off-label paediatric indications exist.

Hypersensitivity to dapagliflozin or any excipient

Type 1 diabetes mellitus (labelled contraindication due to DKA risk)

History of diabetic ketoacidosis

eGFR <25 ml/min/1.73m² for new initiation (glycaemic, HFrEF, or CKD indications)

Severe volume depletion or actively decompensated states

End-stage renal disease on dialysis

Volume depletion or hypotension risk (elderly, patients on loop diuretics, low BP at baseline)

History of recurrent genital mycotic infections or urinary tract infections

Moderate hepatic impairment

Concurrent use of insulin or sulfonylureas (increased hypoglycaemia risk — dose reduction of insulin/SU may be necessary)

Active lower limb ulcers or peripheral vascular disease (monitor closely)

Patients undergoing major surgery or fasting (hold drug 2–3 days prior to reduce DKA risk)

Acute febrile illness, vomiting, diarrhoea, or reduced oral intake — temporary discontinuation advised

Risk of euglycaemic DKA — high index of suspicion required even with normal blood glucose

Parameter Recommendation

Risk category Not recommended; limited human data

Trimester-specific concern Avoid in 2nd and 3rd trimester — potential for fetal renal developmental toxicity (animal data)

Preferred alternatives Insulin (all trimesters) as per ICMR and Indian obstetric guidelines

When it may be used Only under specialist input when insulin is not feasible and benefits clearly outweigh risks

Monitoring Fetal growth by ultrasound; amniotic fluid volume; maternal renal function

Parameter Recommendation

Compatibility Not compatible with breastfeeding

Milk excretion Expected (based on animal studies); human data unavailable

Preferred alternatives Insulin or metformin (both considered safe in lactation)

Infant monitoring If accidental exposure — monitor feeding, hydration status, urine output

Parameter Recommendation

Starting dose 5 mg once daily

Titration Slower; assess tolerance over 4–8 weeks before increasing

Special risks Orthostatic hypotension, falls, dehydration, acute kidney injury, urinary tract infections

Monitoring Renal function (eGFR) and volume status at baseline and regularly; blood pressure monitoring

Interacting Drug Effect Management

Loop diuretics (furosemide, torsemide) Additive volume depletion; increased risk of hypotension and AKI Assess volume status; consider reducing diuretic dose at initiation

Insulin Increased hypoglycaemia risk Reduce insulin dose by 10–20% at initiation; close glucose monitoring

Sulfonylureas (glimepiride, gliclazide) Increased hypoglycaemia risk Consider reducing SU dose; educate patient on hypoglycaemia symptoms

Other SGLT2 inhibitors No additive benefit; increased adverse effects Avoid duplication

Lithium Altered renal clearance of lithium Monitor serum lithium levels closely

Interacting Drug Effect Management

NSAIDs (ibuprofen, diclofenac) Increased risk of AKI Monitor renal function; avoid prolonged concurrent use

ACE inhibitors / ARBs Cumulative hypotensive effect; risk of AKI at initiation Monitor BP and creatinine after starting; ensure adequate hydration

Rifampicin Induces UGT1A9; may reduce dapagliflozin exposure Monitor HbA1c; may need alternative antidiabetic in TB patients

Thiazide diuretics Additive diuresis and electrolyte disturbance Monitor electrolytes and hydration status

Digoxin May slightly increase digoxin levels Clinical significance low; routine monitoring sufficient

• Genital fungal infections (vulvovaginal candidiasis, balanitis) — more frequent in females

• Urinary tract infection

• Increased urinary frequency / polyuria

• Thirst

• Mild weight loss (1–3 kg typically)

• Nasopharyngitis

• Back pain

• Hypoglycaemia (when combined with insulin or sulfonylureas)

• Dizziness or postural hypotension (especially in volume-depleted patients)

Adverse Effect Notes

Diabetic ketoacidosis (DKA) May occur with near-normal or mildly elevated glucose (euglycaemic DKA); requires immediate discontinuation and hospitalisation

Fournier's gangrene Necrotising fasciitis of the perineum; rare but life-threatening; urgent surgical referral

Acute kidney injury Higher risk in elderly, volume-depleted, or those on nephrotoxic agents; discontinue if AKI develops

Severe hypoglycaemia When used with insulin or sulfonylureas

Lower limb amputation Reported in class; monitor foot health in diabetics

Bone fractures Rare; consider in patients with osteoporosis risk

Severe UTI / Urosepsis Discontinue and treat promptly

Every 3–6 months HbA1c (for glycaemic indication), renal function

Long-term / Annual eGFR, urine albumin-creatinine ratio (for CKD), periodic foot examination, genital hygiene review

Sick day / Acute illness Urine or blood ketones if patient unwell; temporary discontinuation if vomiting, fasting, or dehydrated

Brand Name Manufacturer Notes

Forxiga AstraZeneca Innovator brand

Dapaglyn Sun Pharma

Oxra Intas

Dapaworth Lupin

Dapasure Mankind

Dapact Zydus

Kombiglyze XR AstraZeneca FDC with saxagliptin

Xigduo AstraZeneca FDC with metformin

Various generics Multiple Dapazide, Dapacose, etc.

NPPA status: 10 mg tablet included in NLEM 2022; price ceiling applicable.

1. First-line add-on in high-risk T2DM: Prefer dapagliflozin in patients with established ASCVD, HFrEF, or CKD with albuminuria — irrespective of HbA1c at baseline.

1. Glycaemic benefit diminishes at low eGFR: Do not initiate for glucose lowering if eGFR <45 ml/min/1.73m², but cardio-renal benefits persist at lower eGFR.

1. Euglycaemic DKA awareness: Counsel patients on symptoms (nausea, abdominal pain, fatigue, dyspnoea) even with normal glucose. High index of suspicion in fasting, perioperative, or low-carb diet settings.

1. Sick day rules: Advise temporary discontinuation during acute illness, dehydration, fasting, or major surgery (hold 2–3 days prior).

1. Genital hygiene counselling: Reduces risk of candidiasis; especially important in females and uncircumcised males.

1. Volume status first: Always assess hydration before initiation; consider reducing concurrent diuretics if hypotension risk is high.

T2DM; HFrEF; SGLT2 inhibitor; CKD; renal-protective; cardio-renal; NLEM India; endocrinology; cardiology; nephrology; euglycaemic DKA; off-label caution; eGFR-based dosing

RxIndia v1.1 — 09 Jul 2025

• CDSCO approved prescribing information

• Indian National List of Essential Medicines (NLEM 2022)

• API Textbook of Medicine (11th Edition)

• ICMR Guidelines for Management of Type 2 Diabetes (2022)

• AIIMS Formulary

• Cardiological Society of India — Heart Failure Guidelines (aligned sections)

• DAPA-HF, DAPA-CKD, DECLARE-TIMI 58 trials (evidence support for approved indications as aligned with Indian regulatory approvals)

• KDIGO 2022 (cited only where aligned with Indian nephrology protocols)