SYNJARDY 5/1000/MG FC TAB 60/FC TAB

Indications

Approved Uses

Type 2 diabetes mellitus: As an adjunct to diet and exercise to improve glycemic control in adults when treatment with both empagliflozin and metformin is appropriate.

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus: Individualize based on current therapy; administer twice daily with meals; typical starting options are 5/500 mg or 5/1000 mg twice daily (or switch from metformin to the closest metformin dose while adding empagliflozin); maximum total daily dose 25 mg empagliflozin and 2000 mg metformin.

Initial Dose

For patients on metformin, switch to a tablet containing empagliflozin 5 mg twice daily (10 mg total daily) with a similar total daily dose of metformin.

Maintenance Dose

5mg/1000mg twice daily (most common maintenance dose)

Maximum Dose

25 mg empagliflozin and 2000 mg metformin HCl per day (for this 5 mg/1000 mg strength: maximum two tablets twice daily).

Children's Dosage

Approved for children aged 10 years and older. Dosing should be individualized, not to exceed a maximum total daily dose of 25 mg empagliflozin and 2,000 mg metformin.

Dose Adjustment Notes

Assess renal function before start and periodically; do not initiate if eGFR <45 mL/min/1.73 m²; contraindicated if eGFR <30 mL/min/1.73 m²; if eGFR falls persistently below 45, reassess risk/benefit and discontinue if <30; titrate metformin component gradually and do not exceed metformin 2000 mg/day and empagliflozin 25 mg/day.

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: genital mycotic infections, urinary tract infection, increased urination (polyuria/pollakiuria), nausea, diarrhea, abdominal pain, vomiting; nasopharyngitis/upper respiratory tract infection may occur.

Side Effect Frequency

Common (≥1%): genital mycotic infections, urinary tract infection, increased urination (polyuria/pollakiuria), and gastrointestinal adverse effects attributable to metformin (diarrhea, nausea, vomiting, abdominal pain). Serious but uncommon/rare: lactic acidosis (metformin), ketoacidosis, volume depletion/hypotension, acute kidney injury, and Fournier’s gangrene (empagliflozin class warnings).

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); history of serious hypersensitivity to empagliflozin or metformin.

Warnings & Precautions

Warnings/precautions: lactic acidosis risk (renal impairment, hypoxia, hepatic disease, alcohol; withhold for contrast in at-risk patients and around major surgery/acute illness); ketoacidosis risk-evaluate ketones if symptomatic; volume depletion/hypotension and AKI-assess volume status and renal function; serious UTI and genital mycotic infections; Fournier’s gangrene; vitamin B12 deficiency with long-term metformin; not for type 1 diabetes or treatment of DKA.

Age Restriction

Approved for adults and pediatric patients ≥10 years with type 2 diabetes (not for <10 years).

Drug Interactions

Drug Interactions

Key interactions: insulin/secretagogues (↑ hypoglycemia-may need dose reduction); diuretics (↑ volume depletion/hypotension/AKI risk); carbonic anhydrase inhibitors e.g., topiramate (↑ metabolic/lactic acidosis risk); cationic drugs competing for renal tubular secretion e.g., cimetidine (↑ metformin exposure); alcohol (↑ lactic acidosis risk); iodinated contrast media (requires temporary withholding of metformin-containing products in at-risk patients).

Interaction Severity

MAJOR/clinically significant: iodinated contrast media (temporarily stop metformin around contrast in at-risk patients), excessive alcohol (↑ lactic acidosis risk), insulin/secretagogues (↑ hypoglycemia risk-may need dose reduction). MODERATE: diuretics/volume-depleting agents (↑ hypotension/AKI risk with SGLT2i), carbonic anhydrase inhibitors (↑ metabolic/lactic acidosis risk), cationic drugs affecting renal tubular secretion (e.g., cimetidine) (↑ metformin exposure).

Food Interaction

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

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Not recommended

Children

Approved for children aged 10 years and older. Dosing should be individualized, not to exceed a maximum total daily dose of 25 mg empagliflozin and 2,000 mg metformin.

Elderly

Use with caution; renal function must be assessed before initiation and monitored regularly as elderly patients are more prone to renal impairment; dose selection should be conservative; monitor for lactic acidosis risk

Kidney Impairment

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

Liver Impairment

Avoid use in patients with hepatic impairment/clinical or laboratory evidence of hepatic disease (no dose adjustment recommended because use is generally not advised).

Storage & Patient Advice

Stopping the Medicine

Temporarily withhold for iodinated contrast imaging in at-risk patients and around major surgery/periods of reduced intake or hypoxia; otherwise do not discontinue without clinician advice because glycemic control may worsen.

Overdose

Metformin overdose may cause lactic acidosis (GI symptoms, malaise/myalgias, respiratory distress/hyperventilation, hypothermia, hypotension, bradyarrhythmias, altered mental status); management is immediate discontinuation, supportive care, and hemodialysis to remove metformin/lactate. Empagliflozin overdose may increase glucosuria and risk volume depletion-treat supportively.

Patient Counseling

Take twice daily with meals; maintain hydration and pause/seek advice during acute illness with reduced intake; report genital itching/discharge or UTI symptoms promptly; seek urgent care for symptoms of ketoacidosis (nausea/vomiting, abdominal pain, rapid breathing) even with normal glucose; avoid excessive alcohol; inform providers before surgery or iodinated contrast procedures (metformin may need temporary interruption); monitor for dizziness/low BP especially with diuretics; long-term: discuss periodic vitamin B12 monitoring.

Monitoring Requirements

Monitor: renal function (eGFR) before initiation and periodically; glycemic control (SMBG as appropriate and HbA1c); volume status/BP; signs of genital mycotic infection and UTI; ketones/clinical signs of ketoacidosis when symptomatic or during acute illness; vitamin B12 periodically with long-term metformin; consider electrolytes and renal parameters during intercurrent illness or diuretic use.

Pharmacology

Mechanism of Action

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

Duration of Effect

Empagliflozin: ~24 hours per dose. Metformin (immediate-release): ~10-16 hours; therefore the combination is typically dosed twice daily to maintain effect.

Half-Life

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

Bioavailability

Empagliflozin: ~78% (absolute oral bioavailability); Metformin (immediate-release): ~50-60% (fasting).

Metabolism

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

Excretion

Empagliflozin: excreted via both urine and feces (approximately ~54% urine and ~41% feces as total drug-related material); Metformin: eliminated renally, >90% excreted unchanged in urine.

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 1000mg

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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