XIGDUO XR 5/1000MG MR TAB 56/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; take 1 tablet once daily in the morning with food; titrate to glycemic response/tolerability. Maximum daily dose: dapagliflozin 10 mg and metformin HCl 2000 mg.

Initial Dose

One tablet (dapagliflozin 5mg/metformin 1000mg) once daily with morning meal, or based on patient's current metformin and dapagliflozin doses

Maintenance Dose

Dapagliflozin 5-10mg + Metformin 1000-2000mg once daily with morning meal

Maximum Dose

10 mg dapagliflozin and 2000 mg metformin hydrochloride extended-release per day.

Children's Dosage

Safety and effectiveness not established in pediatric patients.

Dose Adjustment Notes

Assess renal function before initiation and periodically; do not initiate if eGFR <45 mL/min/1.73 m² and discontinue if eGFR persistently falls below 45 mL/min/1.73 m². Correct volume depletion before starting; titrate the metformin component gradually to improve GI tolerability; avoid use in significant hepatic impairment due to metformin-associated lactic acidosis risk.

How to Take

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

Side Effects

Common Side Effects

Genital mycotic infections, urinary tract infection, increased urination, nasopharyngitis; metformin-related gastrointestinal effects (diarrhea, nausea, vomiting, abdominal discomfort).

Side Effect Frequency

Commonly reported (≥5% in trials): female genital mycotic infection, nasopharyngitis, urinary tract infection, diarrhea, headache; other known common effects include increased urination/volume depletion-related symptoms and GI intolerance (metformin).

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) Hypersensitivity to dapagliflozin, metformin, or any excipients.

Warnings & Precautions

Warnings/precautions: lactic acidosis risk (renal impairment, hepatic impairment, hypoxia, alcohol; hold for iodinated contrast and during acute illness/surgery as appropriate); ketoacidosis (including euglycemic DKA-stop if suspected; not for type 1 diabetes or for treating DKA); volume depletion/hypotension and acute kidney injury (assess volume status/renal function, caution with diuretics/elderly); serious urinary tract infections (urosepsis/pyelonephritis); Fournier’s gangrene; genital mycotic infections; hypoglycemia with insulin/secretagogues; and decreased vitamin B12 with long-term metformin (monitor periodically).

Age Restriction

Safety and effectiveness not established in pediatric patients.

Drug Interactions

Interaction Severity

MAJOR: Iodinated contrast media (temporarily discontinue metformin at/around the procedure in patients with risk factors for renal impairment and reassess renal function before restarting); Alcohol/excessive acute or chronic intake (increases lactic acidosis risk); Insulin or insulin secretagogues (hypoglycemia risk-may require dose reduction). MODERATE: Diuretics (volume depletion/hypotension/AKI risk), carbonic anhydrase inhibitors (metabolic acidosis risk), cationic drugs that reduce metformin clearance (e.g., cimetidine) and other nephrotoxic/renal function-reducing drugs.

Food Interaction

Take with food (preferably the morning meal).

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Risk Summary: Based on animal data and the mechanism of action of metformin and dapagliflozin, there may be risks to the fetus during pregnancy. Discontinue XIGDUO XR at least 1 month before a planned pregnancy.

Breastfeeding

Advise lactating women not to breastfeed while taking XIGDUO XR due to potential for serious adverse reactions in breastfed infant.

Children

Safety and effectiveness not established in pediatric patients.

Kidney Impairment

Assess eGFR before initiation and periodically. Contraindicated if eGFR <30 mL/min/1.73 m². Initiation is not recommended if eGFR 30-45 mL/min/1.73 m²; if eGFR falls persistently below 45 during therapy, reassess benefit/risk and consider discontinuation based on glycemic need and renal/metformin safety. No dose adjustment is needed when eGFR ≥45 mL/min/1.73 m² (while continuing routine renal monitoring).

Storage & Patient Advice

Stopping the Medicine

Do not stop without prescriber advice because glycemic control may worsen; temporarily withhold XIGDUO XR in situations that increase lactic acidosis/AKI risk (e.g., major surgery or acute serious illness with hypoxia/dehydration) and for iodinated contrast procedures per labeling, then restart when clinically stable and renal function is acceptable.

Overdose

Metformin overdose can cause lactic acidosis (medical emergency): stop drug, urgent hospital evaluation, supportive care, and consider hemodialysis to remove metformin and correct acidosis. Dapagliflozin overdose is expected to increase glucosuria with risk of volume depletion/hypotension; treat with supportive care and fluid/electrolyte management.

Patient Counseling

Take XIGDUO XR (dapagliflozin/metformin ER) once daily with food (preferably the morning meal); swallow whole-do not crush, cut, or chew. The tablet shell may appear in stool (normal). Maintain hydration and rise slowly to reduce dizziness/low blood pressure risk. Seek urgent care for lactic acidosis symptoms (unusual muscle pain, severe weakness, trouble breathing, abdominal pain with nausea/vomiting, feeling cold, dizziness) or ketoacidosis symptoms (nausea/vomiting, abdominal pain, rapid/deep breathing, confusion, unusual fatigue) even if glucose is not very high. Report urinary tract or genital yeast infection symptoms promptly. Avoid excessive alcohol. Tell clinicians before surgery or if you will receive iodinated contrast; metformin is typically held around contrast exposure and during acute illness/dehydration. Expect urine glucose to be positive while on dapagliflozin.

Monitoring Requirements

Renal function (eGFR) before initiation and periodically (at least annually; more often if at risk for renal decline); glycemic control (SMBG as appropriate and HbA1c about every 3 months until stable then every 6 months); blood pressure/volume status; signs of genital/urinary infections; symptoms of ketoacidosis; vitamin B12 with long-term metformin use (periodically, e.g., every 2-3 years or if anemia/neuropathy).

Pharmacology

Mechanism of Action

Dapagliflozin inhibits SGLT2 in the proximal renal tubule, reducing glucose reabsorption and increasing urinary glucose excretion; metformin decreases hepatic glucose production, decreases intestinal glucose absorption, and improves insulin sensitivity.

Product Information

Available Dosage Forms

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

Composition per Dose

Each extended-release film-coated tablet: Dapagliflozin 5mg (as dapagliflozin propanediol monohydrate) + Metformin hydrochloride 1000mg

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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