SYNJARDY 12.5/850/MG FC TAB 60/FC TAB

Indications

Approved Uses

Type 2 diabetes mellitus in adults as an 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: Individualize based on current therapy; typically 1 tablet orally twice daily with meals; maximum total daily dose = empagliflozin 25 mg + metformin 2000 mg.

Initial Dose

In patients on metformin, switch to Synjardy containing empagliflozin 12.5 mg twice daily and a similar total daily dose of metformin. In patients on empagliflozin, switch to Synjardy containing metformin 850 mg twice daily and the same total daily dose of empagliflozin.

Maintenance Dose

1 tablet twice daily; dose may be adjusted based on glycemic response and tolerability

Maximum Dose

Empagliflozin 25mg/day; Metformin hydrochloride 2000mg/day

Children's Dosage

Individualize the dosage of SYNJARDY based on the patient’s current regimen for pediatric patients aged 10 years and older. Monitor effectiveness and tolerability, and adjust dosage as appropriate, not to exceed the maximum total daily dosage of empagliflozin 25 mg and metformin HCl 2,000 mg. Take SYNJARDY orally twice daily with meals; with gradual dose escalation to reduce gastrointestinal adverse reactions with metformin.

Dose Adjustment Notes

Assess renal function (eGFR) before start and periodically; do not initiate if eGFR <45 mL/min/1.73 m² and discontinue if eGFR persistently <30 mL/min/1.73 m²; titrate metformin to GI tolerance; temporarily withhold around iodinated contrast in at-risk patients and for major surgery/acute illness (risk of lactic acidosis/AKI).

How to Take

Oral: Take 1 tablet twice daily with meals; swallow whole with water (do not crush/chew).

Side Effects

Common Side Effects

Common: diarrhea, nausea/vomiting, abdominal discomfort; urinary tract infection; genital mycotic infection; increased urination; nasopharyngitis/upper respiratory tract infection.

Side Effect Frequency

Common (≥1%): genital mycotic infections, urinary tract infection, increased urination, gastrointestinal adverse effects (diarrhea, nausea/vomiting, abdominal discomfort), and (when used with insulin/sulfonylurea) hypoglycemia. Serious but uncommon/rare: lactic acidosis (metformin), diabetic ketoacidosis and volume depletion/AKI (SGLT2 inhibitor class), and Fournier’s gangrene (very rare).

Safety & Warnings

Contraindications

Contraindications: (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) history of serious hypersensitivity to empagliflozin or metformin.

Warnings & Precautions

Warnings/precautions: lactic acidosis risk (hold in hypoxia, dehydration, sepsis, reduced intake; assess renal function; manage around iodinated contrast in at-risk patients); ketoacidosis risk (educate and evaluate even with near-normal glucose); volume depletion/hypotension (caution elderly/diuretics); genital mycotic infections and serious UTIs; Fournier’s gangrene; vitamin B12 deficiency with long-term metformin; not for type 1 diabetes.

Age Restriction

Approved for adults and pediatric patients aged 10 years and older.

Drug Interactions

Drug Interactions

Key interactions: insulin/secretagogues (↑ hypoglycemia risk); diuretics (↑ volume depletion/hypotension); alcohol (↑ lactic acidosis risk with metformin); carbonic anhydrase inhibitors e.g., topiramate/acetazolamide (↑ metabolic acidosis/lactic acidosis risk); cationic drugs that reduce metformin clearance via renal tubular secretion (e.g., cimetidine, ranolazine, dolutegravir, trimethoprim) (↑ metformin exposure); iodinated contrast (requires temporary withholding of metformin in at-risk patients).

Interaction Severity

MAJOR/CLINICALLY SIGNIFICANT: Alcohol (↑ lactic acidosis risk with metformin); iodinated contrast in at-risk patients (AKI → metformin-associated lactic acidosis-temporarily hold metformin per guidance). MODERATE: Insulin/sulfonylureas (↑ hypoglycemia risk-may need dose reduction); diuretics/RAAS agents (↑ volume depletion/hypotension/renal function changes); carbonic anhydrase inhibitors (↑ metabolic acidosis/lactic acidosis risk); cationic drugs that reduce metformin clearance (e.g., cimetidine) (↑ metformin exposure).

Food Interaction

Take with food

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Advise not to breastfeed

Children

Individualize the dosage of SYNJARDY based on the patient’s current regimen for pediatric patients aged 10 years and older. Monitor effectiveness and tolerability, and adjust dosage as appropriate, not to exceed the maximum total daily dosage of empagliflozin 25 mg and metformin HCl 2,000 mg. Take SYNJARDY orally twice daily with meals; with gradual dose escalation to reduce gastrointestinal adverse reactions with metformin.

Elderly

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

Kidney Impairment

Assess eGFR before and during therapy: eGFR ≥45 mL/min/1.73 m²-no adjustment; eGFR 30-<45-do not initiate and if already on therapy reassess benefit/risk and monitor closely; eGFR <30-contraindicated.

Liver Impairment

Avoid use in hepatic impairment (no dose adjustment recommended; generally not recommended due to increased lactic acidosis risk from metformin).

Storage & Patient Advice

Stopping the Medicine

Discontinue immediately if lactic acidosis or ketoacidosis is suspected; temporarily withhold around iodinated contrast (in at-risk patients) and for major surgery/acute illness or conditions predisposing to hypoxia, dehydration, or reduced renal function; routine stopping should be clinician-directed to avoid loss of glycemic control.

Overdose

Metformin overdose can cause lactic acidosis-urgent discontinuation, supportive care, and hemodialysis to remove metformin/lactate; empagliflozin overdose is usually managed with supportive care (monitor volume status, renal function, and hypotension).

Patient Counseling

Take twice daily with meals; maintain hydration; expect possible GI upset and report persistent symptoms; report genital itching/discharge or UTI symptoms promptly; avoid excessive alcohol; seek urgent care for symptoms of lactic acidosis (e.g., severe weakness, abdominal pain, rapid breathing) or ketoacidosis (nausea/vomiting, abdominal pain, dyspnea-even with normal glucose); inform providers before surgery or iodinated contrast procedures; monitor glucose as directed and follow sick-day rules (hold during severe dehydration/acute illness).

Monitoring Requirements

Monitor: renal function (eGFR/SCr) at baseline and periodically (at least annually; more often if at risk); glycemic control (SMBG as appropriate and HbA1c about every 3 months until stable then every 6 months); blood pressure/volume status; signs of genital mycotic infection/UTI; ketones if symptoms suggest ketoacidosis; vitamin B12 periodically with long-term metformin; consider electrolytes as clinically indicated.

Pharmacology

Mechanism of Action

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

Duration of Effect

Empagliflozin: ~24 hours; metformin: ~24 hours with twice-daily dosing (each dose effect ~10-16 hours).

Half-Life

Empagliflozin: terminal half-life ~12 hours. Metformin: plasma elimination half-life ~6 hours (with a longer apparent half-life in whole blood due to erythrocyte distribution).

Bioavailability

Empagliflozin oral bioavailability ≈ 78%; metformin absolute bioavailability ≈ 50-60% (fasting).

Metabolism

Empagliflozin: primarily metabolized by glucuronidation (UGT enzymes; minimal CYP involvement). Metformin: not metabolized; excreted unchanged.

Excretion

Empagliflozin: eliminated via both urine and feces (approximately half in urine and the remainder in feces, largely as unchanged drug). Metformin: eliminated renally as unchanged drug (majority of absorbed dose; negligible fecal elimination of absorbed drug).

Protein Binding

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

Product Information

Available Dosage Forms

Film-coated tablet (SYNJARDY), Extended-release film-coated tablet (SYNJARDY XR)

Composition per Dose

Each film-coated tablet: Empagliflozin 12.5mg + Metformin hydrochloride 850mg

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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