Dapagliflozin Uses, Dosage, Side Effects & Benefits | DrugsAtlas
Authoritative Clinical Reference
Navigation
Therapeutic Class
Antidiabetic
Subclass
SGLT2 inhibitor (Sodium-glucose co-transporter 2 inhibitor
Speciality
Endocrinology
Schedule (India)
Schedule H
Routes
Oral
Formulations
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)
Adult indications
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
2. 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
3. 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 indications
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.
Renal Adjustments
| eGFR (ml/min/1.73m²) | Glycaemic Indication | HFrEF/CKD Indication |
|---|---|---|
| ≥60 | No adjustment | No adjustment |
| 45–59 | Start 5 mg; monitor efficacy closely | 10 mg once daily |
| 25–44 | Avoid initiation for glycaemic control | 10 mg once daily (may continue if already on therapy) |
| <25 | Not recommended | Not recommended for initiation; may continue if already stable on therapy |
| Haemodialysis | Avoid | Avoid |
| Peritoneal dialysis | Avoid | Avoid |
Hepatic adjustment
Contraindications
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
Cautions
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
Pregnancy
| 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 |
Lactation
| 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 |
Elderly
| 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 |
Major drug interactions
| 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 |
Moderate drug interactions
| 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 |
Common Adverse effects
- 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)
Serious Adverse effects
| 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 |
Monitoring requirements
| Timing | Parameters |
|---|---|
|
Baseline
|
eGFR, serum creatinine, blood pressure, volume status, HbA1c (if T2DM), urogenital infection history, LFTs (if hepatic concern) |
|
After initiation / dose change (2–4 weeks)
|
Blood pressure, hydration status, serum creatinine/eGFR, symptoms of hypotension or UTI |
|
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 |
Brands in India
| 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. |
Price range (INR)
| Formulation | Approximate Price |
|---|---|
| Dapagliflozin 10 mg (per tablet) | ₹12–30 (generics); ₹35–50 (branded) |
| Dapagliflozin 5 mg (per tablet) | ₹10–25 |
| FDC with metformin (per tablet) | ₹12–25 |
| FDC with saxagliptin (per tablet) | ₹20–35 |
NPPA status: 10 mg tablet included in NLEM 2022; price ceiling applicable.
Clinical pearls
- 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.
- 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.
- 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.
- Sick day rules: Advise temporary discontinuation during acute illness, dehydration, fasting, or major surgery (hold 2–3 days prior).
- Genital hygiene counselling: Reduces risk of candidiasis; especially important in females and uncircumcised males.
- Volume status first: Always assess hydration before initiation; consider reducing concurrent diuretics if hypotension risk is high.
Version
RxIndia v1.1 — 09 Jul 2025
Reference
- 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)
⚖️
Clinical Responsibility
This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
Content Feedback
Is this information helpful?
Help us improve our clinical database for the medical community.