JARDIANCE 25/MG FC TAB 30/FC TAB

Indications

Approved Uses

To improve glycemic control in adults and children aged 10 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise, 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 in adults with chronic kidney disease.

Dosage & Administration

Dosing by Condition

Type 2 diabetes: 10 mg PO once daily, may increase to 25 mg once daily for additional glycemic control; Heart failure: 10 mg PO once daily; Chronic kidney disease: 10 mg PO once daily; Cardiovascular risk reduction in T2D with established CVD: 10 mg PO once daily.

Initial Dose

10 mg once daily.

Maintenance Dose

10 mg to 25 mg once daily.

Maximum Dose

25 mg once daily.

Children's Dosage

Approved for children 10 years and older for type 2 diabetes. The safety profile is similar to adults, but the risk of hypoglycemia is higher.

Dose Adjustment Notes

Assess renal function (eGFR) before initiation and periodically; for glycemic control, do not initiate if eGFR <30 mL/min/1.73 m² and use is not recommended below this threshold; no dose adjustment is required for hepatic impairment; when used with insulin or insulin secretagogues, consider lowering their dose to reduce hypoglycemia risk.

How to Take

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

Side Effects

Common Side Effects

Urinary tract infection; genital mycotic infections (vulvovaginal candidiasis/vulvovaginitis, balanitis); increased urination (polyuria); thirst; nasopharyngitis/upper respiratory tract infection

Side Effect Frequency

Very common/common: genital mycotic infections (more frequent in females), urinary tract infection, increased urination, pruritus; hypoglycemia is common primarily when combined with insulin or insulin secretagogues; uncommon/rare but serious: ketoacidosis (including euglycemic), volume depletion/hypotension, acute kidney injury, Fournier’s gangrene.

Safety & Warnings

Contraindications

Contraindicated in: (1) serious hypersensitivity to empagliflozin or any excipient; (2) patients on dialysis.

Warnings & Precautions

Key warnings/precautions: ketoacidosis (withhold for major surgery/prolonged fasting and stop if suspected), volume depletion/hypotension (correct volume status; caution with diuretics/elderly), acute kidney injury/renal function monitoring, genital mycotic infections, serious UTIs (urosepsis/pyelonephritis), Fournier’s gangrene, and hypoglycemia risk when used with insulin/secretagogues.

Age Restriction

Approved for use in children 10 years of age and older (for type 2 diabetes); not indicated for type 1 diabetes.

Drug Interactions

Drug Interactions

Key clinically relevant interactions: insulin/insulin secretagogues (↑ hypoglycemia risk-consider dose reduction), diuretics (↑ volume depletion/hypotension), lithium (may ↓ lithium concentrations-monitor), and other agents that increase dehydration/AKI risk (e.g., NSAIDs) should be used cautiously.

Interaction Severity

MODERATE: Insulin and insulin secretagogues (e.g., sulfonylureas) - increased hypoglycemia risk requiring possible dose reduction; MODERATE: Diuretics (loop/thiazide) - additive volume depletion/hypotension risk.

Food Interaction

No restriction.

Special Populations

Pregnancy

Not recommended during 2nd and 3rd trimesters; insufficient data in 1st trimester; potential risk of congenital malformations and hypotension.

Breastfeeding

Present in human milk at low levels; use not recommended as benefits may not outweigh risks.

Children

Approved for children 10 years and older for type 2 diabetes. The safety profile is similar to adults, but the risk of hypoglycemia is higher.

Elderly

Standard adult dosing; greater caution warranted due to higher risk of volume depletion, hypotension, and renal impairment - assess renal function and blood pressure before initiating

Kidney Impairment

Do not initiate for glycemic control if eGFR <30 mL/min/1.73 m²; for HF/CKD indications, may be used down to eGFR ≥20 mL/min/1.73 m² per contemporary guidance; contraindicated in patients on dialysis.

Liver Impairment

No dosage adjustment required in hepatic impairment; use caution in severe hepatic impairment due to limited clinical experience.

Storage & Patient Advice

Stopping the Medicine

Can be stopped without tapering, but should be done in consultation with the prescriber because stopping may worsen glycemic control and/or HF/CKD outcomes depending on indication.

Overdose

Manage overdose with supportive care (monitor vitals, renal function, electrolytes; treat volume depletion/hypotension); consider GI decontamination if appropriate; removal by hemodialysis has not been studied and is unlikely to be effective.

Patient Counseling

Take once daily (often in the morning) with or without food; expect increased urination and maintain hydration; recognize and report genital yeast infection/UTI symptoms; seek urgent care for ketoacidosis symptoms (nausea/vomiting, abdominal pain, rapid breathing) even if glucose is not very high; report perineal pain/redness/swelling urgently (Fournier’s gangrene warning); discuss holding before major surgery/prolonged fasting/acute illness per clinician advice; if used with insulin/sulfonylurea, review hypoglycemia prevention; store below 30°C (per SFDA verified API data).

Monitoring Requirements

Renal function (eGFR/serum creatinine) before initiation and periodically; volume status and blood pressure (especially with diuretics/elderly); glycemic control (glucose/HbA1c) when used for diabetes; monitor for genital mycotic infections and UTIs; monitor for ketoacidosis symptoms (especially during acute illness, fasting, or perioperatively); consider lipids (LDL-C) as clinically indicated.

Pharmacology

Mechanism of Action

Selectively inhibits SGLT2 in the proximal renal tubule, reducing glucose reabsorption and increasing urinary glucose excretion, thereby lowering plasma glucose.

Onset of Action

Pharmacodynamic effect (urinary glucose excretion) begins after the first dose; peak plasma concentration occurs ~1.5 hours after dosing; clinically meaningful HbA1c reduction is typically assessed over weeks (about 4-12 weeks).

Duration of Effect

24 hours

Half-Life

Approximately 12.4 hours.

Bioavailability

Approximately 78%.

Metabolism

Primarily metabolized by glucuronidation via UGT enzymes (notably UGT1A3, UGT1A8, UGT1A9, UGT2B7) with minimal CYP involvement.

Protein Binding

Approximately 86% (about 86.2%).

Product Information

Available Dosage Forms

Film-coated tablet.

Composition per Dose

Each film-coated tablet: Empagliflozin 25 mg

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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