JARDIANCE 10/MG FC TAB 30/FC TAB

Indications

Approved Uses

Type 2 diabetes mellitus: adjunct to diet and exercise to improve glycemic control in adults (and in pediatric patients aged ≥10 years where approved/labelled); to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease; to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure; to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.

Off-Label Uses

None listed in FDA labeling

Dosage & Administration

Dosing by Condition

Type 2 diabetes: Initial 10 mg once daily; may increase to 25 mg once daily for additional glycemic control. Heart failure (HFrEF): 10 mg once daily (no titration required). Chronic kidney disease: 10 mg once daily (no titration required)

Initial Dose

10 mg once daily in the morning

Maintenance Dose

10 mg once daily in the morning, taken with or without food. For additional glycemic control, the dose may be increased to 25 mg in patients tolerating JARDIANCE.

Maximum Dose

25 mg once daily

Children's Dosage

For type 2 diabetes in children 10 years and older: Initial dose is 10mg once daily, may be increased to 25mg once daily if needed.

Dose Adjustment Notes

Assess renal function before initiation and periodically; for glycemic control in T2DM, do not initiate if eGFR <30 mL/min/1.73 m² (and glycemic efficacy diminishes with low eGFR); for HF/CKD indications, may be used down to eGFR ≥20 mL/min/1.73 m² per contemporary labeling/guidelines; no dose adjustment for hepatic impairment; consider reducing insulin/secretagogue dose to reduce hypoglycemia risk; withhold empagliflozin at least 3 days before major surgery or prolonged fasting and restart when clinically stable and eating.

How to Take

Swallow tablet whole with water, with or without food, preferably in the morning

Side Effects

Common Side Effects

Genital mycotic infections (female and male), urinary tract infection, increased urination (polyuria), and volume depletion-related symptoms (e.g., hypotension/dizziness), with nasopharyngitis/URTI also commonly reported in trials.

Side Effect Frequency

Common (1-10%): Genital mycotic infections, urinary tract infection, increased urination, thirst. Hypoglycemia when used with insulin/sulfonylurea (frequency not >10%). Volume depletion uncommon.

Safety & Warnings

Contraindications

Contraindicated in patients with severe renal impairment, end-stage renal disease (ESRD), or on dialysis; history of serious hypersensitivity reaction to empagliflozin or excipients.

Warnings & Precautions

Key warnings/precautions: ketoacidosis (hold for major surgery/prolonged fasting and evaluate symptoms), volume depletion/hypotension (especially with diuretics/elderly/low BP), acute kidney injury/renal function monitoring, serious UTI (urosepsis/pyelonephritis), genital mycotic infections, Fournier’s gangrene (stop and treat urgently), and hypoglycemia risk when used with insulin/secretagogues.

Age Restriction

Approved for pediatric patients ≥10 years for type 2 diabetes; not indicated for <10 years.

Drug Interactions

Drug Interactions

Key interactions: insulin/insulin secretagogues (↑ hypoglycemia risk-consider dose reduction), diuretics (↑ volume depletion/hypotension), lithium (may ↓ lithium concentrations-monitor), and strong UGT inducers (e.g., rifampin) may ↓ empagliflozin exposure.

Interaction Severity

MODERATE: insulin/insulin secretagogues (increased hypoglycemia risk-may require dose reduction), diuretics (additive volume depletion/hypotension), lithium (may decrease lithium concentrations-monitor levels); Rifampin/UGT inducers can reduce exposure but is generally managed with clinical monitoring rather than routine avoidance.

Food Interaction

No restriction.

Special Populations

Pregnancy

Not recommended (Risk Summary: potential fetal renal injury)

Breastfeeding

Not recommended (present in human milk; potential adverse effects on breastfed infant)

Children

For type 2 diabetes in children 10 years and older: Initial dose is 10mg once daily, may be increased to 25mg once daily if needed.

Elderly

Standard adult dosing; greater attention to renal function, volume status, and blood pressure monitoring due to increased risk of volume depletion and renal impairment in elderly patients

Kidney Impairment

T2D glycemic control: do not initiate if eGFR <30 mL/min/1.73 m². HF/CKD indications: may initiate if eGFR ≥20 mL/min/1.73 m². Dialysis: contraindicated.

Liver Impairment

No dose adjustment required in hepatic impairment, including severe impairment; use with caution in severe hepatic impairment due to limited experience.

Storage & Patient Advice

Stopping the Medicine

Do not stop without consulting the prescriber; abrupt discontinuation can worsen glycemic control and/or HF/CKD outcomes.

Overdose

Likely effects: increased diuresis/volume depletion and hypotension; hypoglycemia is uncommon unless combined with insulin/secretagogues; management is supportive (fluids, vitals/electrolytes) and seek urgent medical care.

Patient Counseling

Take once daily (often in the morning) with or without food; expect increased urination and maintain hydration; practice genital hygiene and seek care for symptoms of genital yeast infection or UTI; recognize and urgently report ketoacidosis symptoms (nausea/vomiting, abdominal pain, rapid breathing, unusual fatigue) even with normal glucose; stand up slowly and report dizziness (volume depletion); inform clinicians before surgery/fasting and stop 3 days prior as directed; urine glucose tests will be positive while on therapy.

Monitoring Requirements

Renal function (eGFR/serum creatinine) before initiation and periodically; volume status and blood pressure (especially with diuretics/elderly); glycemic control (SMBG as appropriate and HbA1c); monitor for genital mycotic infections/UTIs; consider ketone assessment when symptoms or high-risk situations for ketoacidosis occur; electrolytes as clinically indicated.

Pharmacology

Mechanism of Action

Selective inhibition of SGLT2 in the proximal renal tubule, reducing glucose reabsorption and increasing urinary glucose excretion (insulin-independent glucose lowering) with associated natriuresis/osmotic diuresis.

Onset of Action

Within hours after the first dose (increased urinary glucose excretion).

Duration of Effect

Approximately 24 hours (supports once-daily dosing).

Half-Life

Approximately 12.4 hours.

Bioavailability

Approximately 75% (reported range ~70-80%).

Metabolism

Primarily glucuronidation via UGT1A3, UGT1A8, UGT1A9, and UGT2B7 with minimal CYP450 involvement.

Excretion

Renal (54.4%) and fecal (41.2%)

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 10 mg empagliflozin

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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