SGLT2 Inhibitor (CKD — Renoprotective) Pregnancy: There are no data from the use of empagliflozin in pregnant women; as a precautionary measure it is preferable to avoid use during pregnancy. Animal studies show limited placental transfer in late gestation and no direct or indirect harmful effects on early embryonic development, but have shown adverse effects on postnatal development. Breast-feeding: no human data on excretion into milk; animal data show excretion in milk and a risk to newborns/infants cannot be excluded — empagliflozin should NOT be used during breast-feeding. Fertility: no human studies; animal studies do not indicate harmful effects.

Empagliflozin (CKD Indication)

Brand names: Jardiance

Empagliflozin used for the chronic kidney disease (CKD) indication is an SGLT2 inhibitor licensed to slow progression of diabetic and non-diabetic CKD and reduce associated cardiorenal events, on top of standard renin-angiotensin blockade.

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: Chronic kidney disease: 10 mg empagliflozin once daily

Route: Oral

Frequency: Once daily

Max: For chronic kidney disease the recommended dose is 10 mg once daily and no higher dose is given. §4.2 states a maximum daily dose of 25 mg, which applies to the type 2 diabetes mellitus indication only (and only in patients with eGFR at least 60 mL/min/1.73 m2)

Source: UK SPC (eMC) for Empagliflozin 10 mg film-coated tablets (previously known as Jardiance), §4.2 (https://www.medicines.org.uk/emc/product/5441/smpc). OTHER INDICATIONS IN §4.2: heart failure — 10 mg once daily; type 2 diabetes mellitus — recommended starting dose 10 mg once daily for monotherapy and for add-on combination therapy, and in patients tolerating 10 mg once daily who have an eGFR at least 60 mL/min/1.73 m2 and need tighter glycaemic control the dose can be increased to 25 mg once daily (maximum daily dose 25 mg). ALL INDICATIONS: when empagliflozin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia. MISSED DOSE: take it as soon as the patient remembers, but a double dose should not be taken on the same day. RENAL (see renalAdjustment): do not initiate at eGFR below 20 mL/min/1.73 m2; at eGFR below 60 mL/min/1.73 m2 the daily dose is 10 mg. HEPATIC: no dose adjustment required; exposure is increased in severe hepatic impairment where experience is limited and use is therefore not recommended. ELDERLY: no dose adjustment based on age, but an increased risk of volume depletion should be taken into account in patients 75 years and older. PAEDIATRIC (no per-kg dose is stated, so paedDose is null): for the paediatric population §4.2 gives a recommended starting dose of 10 mg once daily, increasable to 25 mg once daily in patients tolerating 10 mg and requiring additional glycaemic control; no data are available for children with eGFR below 60 mL/min/1.73 m2 or below 10 years of age, and the safety and efficacy of empagliflozin for HEART FAILURE or CHRONIC KIDNEY DISEASE IN CHILDREN UNDER 18 YEARS HAVE NOT BEEN ESTABLISHED (no data available) — so there is no paediatric dose for this page's indication. Verify any paediatric use against a children's formulary. METHOD: tablets can be taken with or without food, swallowed whole with water. KEY §4.4 WARNINGS: should not be used in patients with type 1 diabetes mellitus; ketoacidosis (including life-threatening and fatal cases, sometimes with only moderately raised blood glucose below 14 mmol/l, and also reported in patients without diabetes) — assess immediately for ketoacidosis if non-specific symptoms occur regardless of blood glucose, discontinue immediately if suspected or diagnosed, and interrupt treatment in patients hospitalised for major surgical procedures or acute serious medical illnesses with monitoring of blood (preferred over urine) ketones. NOTE ON SOURCES: eMC §4.5 (interactions) was NOT captured in this bundle, and §4.4 and §4.8 were truncated at the fetch limit — check the full SPC.

Dose adjustments

Renal

Due to limited experience, it is not recommended to INITIATE treatment with empagliflozin in patients with an eGFR below 20 mL/min/1.73 m2. In patients with an eGFR below 60 mL/min/1.73 m2 the daily dose of empagliflozin is 10 mg. In patients with type 2 diabetes mellitus the glucose-lowering efficacy is reduced at an eGFR below 45 mL/min/1.73 m2 and likely absent below 30 mL/min/1.73 m2, so if eGFR falls below 45 mL/min/1.73 m2 additional glucose-lowering treatment should be considered if needed.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients

Side effects

Common: vaginal moniliasis, vulvovaginitis, balanitis and other genital infection; urinary tract infection (including pyelonephritis and urosepsis); hypoglycaemia when used with a sulphonylurea or insulin; thirst; constipation; pruritus (generalised); rash; volume depletion
Uncommon: urticaria; angioedema
Rare: ketoacidosis
Very rare / not known: necrotising fasciitis of the perineum (Fournier's gangrene)
Indication-specific frequencies quoted in §4.8: volume depletion was the most frequent adverse reaction in the pooled EMPEROR heart failure studies (empagliflozin 10 mg 11.4% vs placebo 9.7%); in the EMPA-KIDNEY chronic kidney disease study the most frequent adverse events were gout (empagliflozin 7.0% vs placebo 8.0%) and acute kidney injury (empagliflozin 2.8% vs placebo 3.5%), both more frequently reported on placebo
The §4.8 table was truncated at the fetch limit (the renal and urinary disorders row was cut mid-entry) — the list above is not complete

Interactions

Sulphonylureas or insulin — a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (stated in §4.2, cross-referring to §4.5; the eMC §4.5 section itself was not captured in the source bundle and must be checked on the SPC)

Clinical monograph

How it works

It blocks the sodium-glucose co-transporter 2 in the proximal tubule, reducing glucose reabsorption and, via tubuloglomerular feedback, lowering intraglomerular pressure and albuminuria to confer nephroprotection.

Prescribing in practice

Anticipate and counsel on a small, reversible 'dip' in eGFR after initiation, which is expected and not a reason to stop; the long-term trajectory is preserved kidney function.
There is a lower eGFR threshold below which initiation is not recommended, so confirm renal function against the current SPC before starting.
Hold during acute illness, dehydration or perioperative fasting (sick-day rules) because of the risk of volume depletion and euglycaemic diabetic ketoacidosis.

Monitoring

Check renal function and volume status before starting and periodically thereafter, recognising the expected early eGFR reduction.

Counselling the patient

Pause the tablet if you become acutely unwell, dehydrated or are unable to eat or drink normally.
Maintain good genital hygiene as fungal infections can occur, and report any genital pain or swelling promptly.
Do not stop it just because a blood test shows a small fall in kidney readings soon after starting.

Evidence & guidelines

The EMPA-KIDNEY trial demonstrated reduced progression of kidney disease and cardiovascular death across diabetic and non-diabetic CKD, supporting NICE-endorsed use.

Reference: Herrington et al. NEJM 2023 (EMPA-KIDNEY); NICE NG203 (chronic kidney disease); MHRA Drug Safety Update 2016 (DKA); MHRA 2019 (Fournier's gangrene); 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

Dapagliflozin (CKD Indication) · SGLT2 Inhibitor (CKD — Renoprotective)

Pathways