SYNJARDY 12.5/1000/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 mellitus (adults): individualize based on current therapy; administer twice daily with meals. Usual maximum daily dose: empagliflozin 25 mg/day and metformin 2000 mg/day (i.e., 12.5/1000 mg twice daily).

Initial Dose

One tablet (12.5mg/1000mg) twice daily with meals, based on current antidiabetic regimen

Maintenance Dose

One tablet (12.5mg/1000mg) twice daily with meals

Maximum Dose

Empagliflozin 25mg/day; Metformin 2000mg/day (as combination product: two tablets of 12.5mg/1000mg per day)

Children's Dosage

Safety and effectiveness not established in pediatric patients younger than 10 years

Dose Adjustment Notes

Assess renal function before initiation and periodically; do not initiate if eGFR <45 mL/min/1.73 m² and discontinue if eGFR persistently <45; contraindicated if eGFR <30. Titrate metformin to improve GI tolerability. Temporarily withhold around iodinated contrast in at-risk patients and for major surgery/acute illness with hypoxia/dehydration; restart when renal function and clinical status are stable.

How to Take

Swallow tablets whole with water. Take with meals to reduce gastrointestinal side effects. Do not crush or split tablets.

Side Effects

Common Side Effects

Common: diarrhea, nausea/vomiting and other GI upset (metformin-related); urinary tract infection; genital mycotic infections; increased urination (polyuria) and thirst; nasopharyngitis.

Side Effect Frequency

Very common (≥10%): genital mycotic infections; gastrointestinal adverse effects attributable to metformin (e.g., diarrhea, nausea). Common (1-10%): urinary tract infection, increased urination (polyuria), thirst, nasopharyngitis; hypoglycemia when used with insulin or sulfonylurea

Safety & Warnings

Contraindications

Contraindicated in: severe renal impairment (eGFR <30 mL/min/1.73 m²), end-stage renal disease or dialysis; acute or chronic metabolic acidosis (including diabetic ketoacidosis); hypersensitivity to empagliflozin or metformin (or excipients).

Warnings & Precautions

Warnings/precautions: lactic acidosis risk (renal impairment, hypoxia, dehydration, alcohol, hepatic disease; hold for contrast/surgery as appropriate); ketoacidosis (may occur with normal glucose); volume depletion/hypotension; AKI; serious UTI/urosepsis and genital mycotic infections; Fournier’s gangrene; monitor renal function and consider B12 monitoring with long-term metformin; not for type 1 diabetes or treatment of DKA.

Age Restriction

Approved for adults and pediatric patients aged 10 years and older; safety and effectiveness not established in pediatric patients younger than 10 years

Driving Warning

No effect on ability to drive or use machines

Drug Interactions

Drug Interactions

Key interactions: iodinated contrast media (temporary discontinuation of metformin component in appropriate patients); carbonic anhydrase inhibitors (↑ metabolic acidosis/lactic acidosis risk); alcohol (↑ lactic acidosis risk); insulin/secretagogues (↑ hypoglycemia-consider dose reduction); diuretics/RAAS agents (↑ volume depletion/renal adverse effects); cationic drugs affecting metformin clearance (e.g., cimetidine, ranolazine, dolutegravir, trimethoprim) (↑ metformin exposure).

Interaction Severity

MAJOR: iodinated contrast (metformin-lactic acidosis risk in AKI); alcohol excess (metformin-lactic acidosis risk). MODERATE: insulin/secretagogues (hypoglycemia risk-may need dose reduction); diuretics/RAAS blockers and other agents causing volume depletion or hypotension (SGLT2-dehydration/AKI risk); carbonic anhydrase inhibitors (e.g., topiramate/acetazolamide-metabolic acidosis/lactic acidosis risk); cationic drugs that raise metformin levels (e.g., cimetidine/trimethoprim).

Food Interaction

Take with meals (food reduces metformin-related gastrointestinal adverse effects).

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Not recommended during pregnancy; discontinue prior to or at time of conception

Breastfeeding

Not recommended during breastfeeding

Children

Safety and effectiveness not established in pediatric patients younger than 10 years

Elderly

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

Kidney Impairment

Assess eGFR before and during therapy: contraindicated if eGFR <30; initiation not recommended if eGFR <45; if eGFR falls persistently below 45, reassess benefit/risk and consider discontinuation (do not exceed metformin component limits and stop if <30).

Liver Impairment

Avoid use in hepatic impairment (especially severe hepatic disease); no specific dose adjustment is recommended because metformin-associated lactic acidosis risk is increased.

Storage & Patient Advice

Stopping the Medicine

Do not stop without prescriber advice; temporarily discontinue for iodinated contrast in at-risk patients and for major surgery/periods of restricted intake, and restart when clinically stable with renal function reassessed (often ≥48 hours post-procedure).

Overdose

Overdose: primary concern is metformin-associated lactic acidosis; treat with immediate medical evaluation, supportive care, and consider hemodialysis to remove metformin and correct acidosis; empagliflozin overdose may cause glucosuria and volume depletion-supportive management.

Patient Counseling

Take twice daily with meals; maintain hydration and pause/seek advice during acute illness with poor intake (sick-day rules). Report genital itching/discharge or UTI symptoms promptly. Seek urgent care for symptoms of ketoacidosis (nausea/vomiting, abdominal pain, rapid breathing) even if glucose is not very high, and for severe perineal pain/swelling (Fournier’s). Avoid excessive alcohol. Inform providers before surgery or iodinated-contrast imaging. Recognize lactic acidosis symptoms (unusual fatigue, myalgias, dyspnea, abdominal discomfort) and seek emergency care.

Monitoring Requirements

Renal function (eGFR/SCr) before initiation and periodically; HbA1c and/or SMBG as clinically indicated; volume status/BP; signs of genital mycotic infection and UTI; ketones/clinical assessment if symptoms suggest ketoacidosis; vitamin B12 periodically with long-term metformin; consider foot/skin monitoring in high-risk patients.

Pharmacology

Mechanism of Action

Empagliflozin inhibits SGLT2 in the proximal renal tubule, reducing glucose reabsorption and increasing urinary glucose excretion; metformin decreases hepatic gluconeogenesis, decreases intestinal glucose absorption, and improves peripheral insulin sensitivity.

Duration of Effect

Approximately 24 hours per dose with continued daily dosing (empagliflozin ~24 hours; metformin effect persists with regular twice-daily administration).

Half-Life

Empagliflozin: terminal t1/2 ≈ 12 hours (about 12.4 h). Metformin: plasma t1/2 ≈ 6.2 hours; whole-blood/erythrocyte t1/2 ≈ 17.6 hours.

Bioavailability

Empagliflozin: ~78% absolute oral bioavailability; metformin: ~50-60%.

Metabolism

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

Excretion

Empagliflozin: eliminated via both urine and feces (substantial fraction excreted unchanged); metformin: excreted unchanged in urine (predominantly renal clearance).

Protein Binding

Empagliflozin: ~86% plasma protein binding. Metformin: negligible protein binding (essentially none).

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: 12.5mg empagliflozin and 1000mg metformin hydrochloride

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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