SGLT2i + biguanide (fixed-dose) Pregnancy: §4.6: there are no data in pregnant women; use is not recommended during the second and third trimesters of pregnancy (rat studies with dapagliflozin showed toxicity to the developing kidney in the corresponding period). When the patient plans to become pregnant, and during pregnancy, it is recommended that diabetes is not treated with this medicinal product but that insulin is used to keep blood glucose as close to normal as possible. Should not be used while breast-feeding.

Dapagliflozin with metformin

Brand names: Xigduo

Used in: Chronic Kidney Disease Diabetes & DKA

A fixed-dose oral combination of dapagliflozin, an SGLT2 inhibitor, with metformin, a biguanide, used for type 2 diabetes when treatment with both agents is suitable.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: One tablet twice daily — a total daily dose equivalent to dapagliflozin 10 mg plus the total daily dose of metformin already being taken (or the nearest therapeutically appropriate dose)

Route: Oral

Frequency: Twice daily with meals (to reduce the gastrointestinal adverse reactions associated with metformin)

Max: Dapagliflozin maximum total daily dose 10 mg; metformin maximum daily dose 3 000 mg (GFR 60-89 mL/min) — see renal table

eMC §4.2 for 'Dapagliflozin/Metformin hydrochloride 5 mg/1000 mg film-coated tablet'; the recommended dose of one tablet twice daily applies to adults with normal renal function (GFR >= 90 mL/min). Each tablet contains a fixed dose of dapagliflozin and metformin — confirm the strength being prescribed delivers the intended total daily doses. FOR PATIENTS INSUFFICIENTLY CONTROLLED on metformin monotherapy, or metformin combined with other antidiabetic medicines: give a total daily dose equivalent to dapagliflozin 10 mg plus the total daily metformin dose already being taken, or the nearest therapeutically appropriate dose. SWITCHING from separate tablets of dapagliflozin (10 mg total daily dose) and metformin: give the same daily dose of each, or the nearest therapeutically appropriate metformin dose. When used in combination with insulin or an insulin secretagogue such as a sulphonylurea, a lower dose of insulin or sulphonylurea may be considered to reduce the risk of hypoglycaemia. The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Should not be initiated in patients with GFR < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min (§4.4). Must not be used in patients with hepatic impairment. Elderly (65 years and over): use with caution as age increases, with monitoring of renal function to help prevent metformin-associated lactic acidosis, and taking account of the risk of volume depletion with dapagliflozin. If no adequate combination strength is available, the individual mono-components should be used instead of the fixed-dose combination. PAEDIATRIC: safety and efficacy in children and adolescents aged 0 to under 18 years have not yet been established and no data are available; verify against a children's formulary.

Dose adjustments

Renal

§4.2 Table 1 — assess GFR before initiation and at least annually (every 3-6 months in those at increased risk of progression and in the elderly). GFR 60-89: metformin maximum daily dose 3 000 mg; dapagliflozin maximum total daily dose 10 mg (reduction may be considered with declining renal function). GFR 45-59: metformin maximum daily dose 2 000 mg with a starting dose of at most half the maximum; dapagliflozin should not be initiated, maximum total daily dose 10 mg. GFR 30-44: metformin maximum daily dose 1 000 mg with a starting dose of at most half the maximum; dapagliflozin is not recommended. GFR < 30: metformin is contraindicated and dapagliflozin is not recommended. §4.4 adds that the combination should not be initiated at GFR < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min; renal function should be assessed before initiation and regularly thereafter, and at least 2 to 4 times per year where GFR is below 60 mL/min and in elderly patients.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substances or to any of the excipients
Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
Diabetic pre-coma
Severe renal failure (GFR < 30 mL/min)
Acute conditions with the potential to alter renal function: dehydration, severe infection, shock
Acute or chronic disease which may cause tissue hypoxia: cardiac or respiratory failure, recent myocardial infarction, shock
Hepatic impairment; acute alcohol intoxication, alcoholism

Side effects

Vulvovaginitis, balanitis and related genital infections
Urinary tract infection; fungal infection; necrotising fasciitis of the perineum (Fournier's gangrene)
Hypoglycaemia when used with a sulphonylurea or insulin; volume depletion; thirst
Diabetic ketoacidosis; lactic acidosis (metformin)
Vitamin B12 decrease/deficiency; taste disturbance; dizziness
NOTE: the §4.8 frequency table was mangled in the fetched text and frequency categories could not be reliably mapped to individual reactions — frequencies have deliberately been omitted; verify against the SPC

Interactions

Insulin and insulin secretagogues (e.g. sulphonylureas) — a lower dose of insulin or sulphonylurea may be considered to reduce the risk of hypoglycaemia (§4.2)
Medicinal products that can acutely impair renal function (antihypertensives, diuretics, NSAIDs) — initiate with caution in metformin-treated patients because of the risk of lactic acidosis (§4.4)
Excessive alcohol intake — a risk factor for lactic acidosis (§4.4); acute alcohol intoxication and alcoholism are contraindications
NOTE: eMC §4.5 was not captured in the fetched bundle. The US dapagliflozin label additionally states that concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations (monitor more frequently on initiation and dose change), and that SGLT2 inhibitors cause positive urine glucose tests and unreliable 1,5-anhydroglucitol assays. Verify against the UK SPC before publication

Clinical monograph

How it works

Dapagliflozin increases urinary glucose excretion by inhibiting renal SGLT2-mediated reabsorption, while metformin lowers hepatic gluconeogenesis and improves insulin sensitivity.

Prescribing in practice

The most important safety point is risk of euglycaemic diabetic ketoacidosis from dapagliflozin and lactic acidosis from metformin; apply sick-day rules and withhold during acute illness, dehydration, or perioperatively.
Dapagliflozin predisposes to genital mycotic and urinary infections and rare Fournier's gangrene, and both components have renal-function thresholds that govern initiation and continuation.
Volume depletion and hypotension can occur, especially in the elderly or those on diuretics.

Monitoring

Monitor renal function, HbA1c, hydration and weight, and watch for ketoacidosis symptoms even with normal blood glucose.

Counselling the patient

Stop the medicine and seek urgent help if acutely unwell or dehydrated, or if you develop nausea, vomiting, abdominal pain, or breathlessness.
Report genital itching or soreness and maintain good genital hygiene.
Take with food to limit gastrointestinal upset.

Evidence & guidelines

NICE recommends SGLT2 inhibitors in type 2 diabetes, with dapagliflozin's broader cardiorenal benefits demonstrated in trials such as DAPA-HF and DAPA-CKD.

Reference: NICE NG28; MHRA; ADA-EASD; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Drugs

Canagliflozin with metformin · SGLT2i + biguanide (fixed-dose)

Pathways