XIGDUO XR 10/1000MG MR TAB 28/TAB

Indications

Approved Uses

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus: individualize starting dose based on current therapy; administer once daily in the morning with food. Maximum daily dose: dapagliflozin 10 mg/day and metformin HCl 2000 mg/day (as XR).

Initial Dose

For patients not already taking dapagliflozin or metformin HCl extended-release: dapagliflozin 5 mg/metformin HCl extended-release 500 mg once daily in the morning with food.

Maintenance Dose

Individualize dosage based on effectiveness and tolerability. Maximum recommended daily dosage is dapagliflozin 10 mg and metformin HCl extended-release 2000 mg. Take once daily in the morning with food.

Maximum Dose

Dapagliflozin 10 mg and metformin hydrochloride 2000 mg per day. [2, 9]

Children's Dosage

Approved for glycemic control in pediatric patients 10 years and older.

Dose Adjustment Notes

Assess renal function (eGFR) before initiation and periodically; do not initiate if eGFR <45 mL/min/1.73 m², and discontinue if eGFR persistently <30 mL/min/1.73 m². Titrate the metformin component gradually to improve GI tolerability. Temporarily discontinue around iodinated contrast in at-risk patients and for major surgery per metformin precautions.

How to Take

Swallow XIGDUO XR tablets whole once daily with the evening meal; do not crush, cut, or chew. The extended‑release tablet shell may be seen in the stool and this is normal.

Side Effects

Common Side Effects

Common: genital mycotic infections (female/male), urinary tract infection, nasopharyngitis, headache, diarrhea, nausea, vomiting, and increased urination (polyuria).

Side Effect Frequency

Very common/common: genital mycotic infections and urinary tract infections; increased urination and volume depletion-related symptoms can occur; GI effects (diarrhea, nausea, abdominal discomfort) are common due to metformin. Hypoglycemia is not common with this product alone but becomes common/very common when combined with insulin or sulfonylureas. Rare but serious: ketoacidosis (including euglycemic DKA), Fournier’s gangrene, and lactic acidosis.

Safety & Warnings

Contraindications

Contraindicated in: (1) Severe renal impairment (eGFR <30 mL/min/1.73 m²), end-stage renal disease, or dialysis; (2) Acute or chronic metabolic acidosis, including diabetic ketoacidosis; (3) History of a serious hypersensitivity reaction to dapagliflozin or metformin.

Warnings & Precautions

Warnings/precautions: lactic acidosis risk (monitor renal function; withhold in hypoxic/dehydrating states and for certain contrast/surgical situations); ketoacidosis risk (withhold perioperatively/prolonged fasting and evaluate symptoms even if glucose <250 mg/dL); volume depletion/hypotension and AKI risk (especially elderly, diuretics, renal impairment); genital mycotic infections and serious UTIs; Fournier’s gangrene; vitamin B12 deficiency with long-term metformin; hypoglycemia when combined with insulin/secretagogues.

Age Restriction

Approved for pediatric patients aged 10 years and older for glycemic control.

Drug Interactions

Interaction Severity

MAJOR/clinically significant: alcohol (↑ lactic acidosis risk with metformin); iodinated contrast media in at-risk patients (requires temporary metformin interruption to mitigate lactic acidosis risk); insulin/insulin secretagogues (↑ hypoglycemia risk-may need dose reduction). MODERATE: diuretics/other volume-depleting agents (↑ hypotension/AKI risk with SGLT2i), carbonic anhydrase inhibitors (↑ metabolic acidosis/lactic acidosis risk), cationic drugs affecting metformin renal tubular secretion (e.g., cimetidine, trimethoprim) (↑ metformin exposure).

Food Interaction

Take once daily in the morning with food; food improves metformin GI tolerability.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Advise not to breastfeed during treatment.

Children

Approved for glycemic control in pediatric patients 10 years and older.

Kidney Impairment

eGFR ≥45 mL/min/1.73 m²: no adjustment. eGFR 30-<45: do not initiate; if already on therapy, reassess benefit/risk and monitor renal function. eGFR <30 or ESRD/dialysis: contraindicated.

Storage & Patient Advice

Stopping the Medicine

Do not stop routinely without prescriber input; temporarily withhold for iodinated contrast in at-risk patients and around major surgery/prolonged fasting, and discontinue immediately if lactic acidosis or ketoacidosis is suspected.

Overdose

Metformin overdose may cause lactic acidosis (medical emergency); manage with immediate discontinuation, supportive care, and consider hemodialysis to remove metformin and correct acidosis. Dapagliflozin overdose is expected to cause increased glucosuria with volume depletion/hypotension; treat supportively (fluids, electrolytes, vitals, renal function).

Patient Counseling

Take XIGDUO XR once daily in the morning with food and swallow whole-do not crush, cut, or chew; the tablet shell may appear in stool. Maintain hydration and rise slowly to reduce dizziness/volume depletion. Monitor for genital yeast infection and UTI symp...

Monitoring Requirements

Monitor: renal function (eGFR) before start and periodically (at least annually; more often if at risk), glycemic control (HbA1c about every 3 months until stable then every 3-6 months), blood pressure/volume status, signs of genital mycotic infection and UTI, symptoms of ketoacidosis and lactic acidosis, and vitamin B12 periodically with long-term metformin use.

Product Information

Available Dosage Forms

Tablet, film-coated, extended-release (oral).

Composition per Dose

Each extended-release film-coated tablet: Dapagliflozin 10mg (as dapagliflozin propanediol monohydrate) + Metformin hydrochloride 1000mg

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 28-05-2026