SYNJARDY 5/850/MG FC TAB 60/FC TAB

Indications

Approved Uses

Adults with type 2 diabetes mellitus: adjunct to diet and exercise to improve glycemic control when treatment with both empagliflozin and metformin is appropriate.

Dosage & Administration

Dosing by Condition

Type 2 diabetes (adults): individualize based on current therapy; typically 1 tablet orally twice daily with meals; do not exceed empagliflozin 25 mg/day and metformin 2000 mg/day (or the patient-specific metformin maximum).

Initial Dose

For patients not on empagliflozin, the recommended starting dose provides 5 mg of empagliflozin twice daily (10 mg total daily dose) and a similar dose of metformin to what the patient is already taking.

Maintenance Dose

One tablet twice daily; dose strength adjusted based on glycemic control and tolerability

Maximum Dose

Empagliflozin 25mg/day; Metformin hydrochloride 2000mg/day (some guidelines allow up to 3000mg/day for metformin alone, but combination product limits to 2000mg/day)

Children's Dosage

Approved for children aged 10 years and older. Dosing should be individualized.

Dose Adjustment Notes

Assess eGFR before start and periodically; do not initiate if eGFR <45 mL/min/1.73 m²; contraindicated if eGFR <30 mL/min/1.73 m²; titrate metformin to GI tolerance; temporarily withhold around iodinated contrast and major surgery/acute illness per metformin precautions.

How to Take

Swallow whole with water; take twice daily with meals; do not crush or chew.

Side Effects

Common Side Effects

Common: diarrhea, nausea/vomiting, abdominal discomfort (metformin GI effects); urinary tract infection; genital mycotic infections; increased urination/thirst; nasopharyngitis/URTI; hypoglycemia mainly when used with insulin or sulfonylurea.

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 empagliflozin, metformin, or excipients.

Warnings & Precautions

Warnings/precautions: lactic acidosis risk (stop immediately if suspected; manage urgently); ketoacidosis risk (evaluate symptoms even if glucose <250 mg/dL; hold during acute illness/surgery as appropriate); assess renal function before and during therapy; volume depletion/hypotension (caution elderly, diuretics, low BP); serious UTI and genital mycotic infections; Fournier’s gangrene; temporarily withhold around iodinated contrast in at-risk patients and restart after renal function is stable; long-term metformin may cause vitamin B12 deficiency (monitor periodically).

Age Restriction

Approved for pediatric patients aged 10 years and older

Drug Interactions

Drug Interactions

Key interactions: insulin/insulin secretagogues (↑ hypoglycemia risk-may need dose reduction); diuretics (↑ volume depletion/hypotension risk with SGLT2 inhibitor); alcohol (↑ lactic acidosis risk with metformin); carbonic anhydrase inhibitors e.g., topiramate/acetazolamide (↑ metabolic acidosis/lactic acidosis risk); drugs that reduce metformin clearance via renal tubular secretion (e.g., cimetidine, ranolazine, dolutegravir, trimethoprim) (↑ metformin exposure); iodinated contrast media (temporarily withhold metformin-containing products in at-risk patients and restart after renal function re-evaluation).

Interaction Severity

MAJOR: iodinated contrast (metformin-risk of lactic acidosis/AKI; withhold in at-risk patients and reassess renal function), excessive alcohol (lactic acidosis risk), insulin/sulfonylureas (hypoglycemia-may need dose reduction). MODERATE: diuretics/RAAS agents (volume depletion/hypotension/AKI risk), carbonic anhydrase inhibitors (lactic acidosis risk), cationic drugs that reduce metformin clearance (e.g., cimetidine, ranolazine, dolutegravir, trimethoprim).

Food Interaction

Take with food.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Advise nursing women that breastfeeding is not recommended

Children

Approved for children aged 10 years and older. Dosing should be individualized.

Elderly

Use with caution in patients ≥65 years; increased risk of volume depletion, renal impairment, and lactic acidosis. Monitor renal function more frequently. Dose selection should be conservative, starting at lower end of dosing range.

Kidney Impairment

Initiation not recommended if eGFR <45 mL/min/1.73 m². Contraindicated if eGFR <30 mL/min/1.73 m². Assess eGFR before initiation.

Storage & Patient Advice

Stopping the Medicine

Do not stop SYNJARDY without consulting the prescriber; stopping may worsen glycemic control and an alternative diabetes regimen may be needed.

Overdose

Overdose may cause metformin-associated lactic acidosis (e.g., malaise, myalgias, respiratory distress, abdominal pain, hypothermia, hypotension, bradyarrhythmias) and/or volume depletion from empagliflozin; stop the drug, provide urgent supportive care, and consider prompt hemodialysis to remove metformin and correct acidosis.

Patient Counseling

Take twice daily with meals; maintain hydration and monitor for dizziness/low BP; counsel on genital yeast/UTI symptoms; review sick-day rules and seek urgent care for ketoacidosis symptoms (nausea/vomiting, abdominal pain, rapid breathing, fruity breath) even with normal glucose; avoid excessive alcohol and recognize lactic acidosis symptoms; inform providers before surgery or iodinated contrast; monitor for hypoglycemia if used with insulin/sulfonylurea.

Monitoring Requirements

Monitor HbA1c about every 3 months until controlled then every 6 months; SMBG as clinically indicated; renal function (eGFR) before initiation and at least annually (more often if at risk); blood pressure/volume status; signs of genital/urinary infections; periodic vitamin B12 with long-term metformin; consider ketone assessment if symptoms of ketoacidosis occur.

Pharmacology

Mechanism of Action

Empagliflozin inhibits SGLT2 in the proximal renal tubule to reduce glucose reabsorption and increase urinary glucose excretion; metformin decreases hepatic glucose production, decreases intestinal glucose absorption, and improves insulin sensitivity.

Duration of Effect

Empagliflozin: ~24 hours. Metformin immediate-release: ~10-16 hours (glycemic effect persists with continued dosing; administered twice daily).

Half-Life

Empagliflozin: approximately 12.4 hours; Metformin: approximately 6.2 hours (plasma), 17.6 hours (blood)

Bioavailability

Empagliflozin: ~78% (absolute oral bioavailability); Metformin: ~50-60% under fasting conditions (decreases with higher doses/with food).

Metabolism

Empagliflozin: primarily metabolized by glucuronidation (UGT2B7, UGT1A3, UGT1A8, UGT1A9) with minimal CYP involvement; Metformin: not metabolized (excreted unchanged).

Excretion

Empagliflozin: excreted via urine and feces-approximately 54% in urine and 41% in feces (mostly as parent drug); Metformin: eliminated primarily by the kidneys as unchanged drug (majority of absorbed dose; ~90% recovered in urine within 24 hours in classic PK descriptions).

Protein Binding

Empagliflozin: ~86% protein bound; Metformin: negligible protein binding.

Product Information

Available Dosage Forms

Film-coated tablet (immediate-release).

Composition per Dose

Each film-coated tablet: Empagliflozin 5mg + Metformin hydrochloride 850mg

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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