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  • Jardiance Duo
    / Boehringer Ingelheim

    Active Ingredient *
    Empagliflozin 5 mg, 12.5 mg
    Metformin Hydrochloride 500, 850, 1000 mg

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    60 X 5 mg / 500 mg

    not in the basket chart

    Film Coated Tablets

    60 X 5 mg / 850 mg

    not in the basket chart 32905 10074

    Film Coated Tablets

    60 X 5 mg / 1000 mg

    not in the basket chart 32904 10073

    Film Coated Tablets

    60 X 12.5 mg / 500 mg

    not in the basket chart

    Film Coated Tablets

    60 X 12.5 mg / 850 mg

    not in the basket chart 32903 10072

    Film Coated Tablets

    60 X 12.5 mg / 1000 mg

    not in the basket chart 32902 10071

    Related information


    Recommended Dosage:
    1. In patients with volume depletion not previously treated with empagliflozin, correct this condition before initiating this formulation.
    2. Individualize the starting dose of this formulation based on the patient’s current regimen:
    – In patients on metformin hydrochloride, switch to this combined formulaion containing empagliflozin 5 mg
    with a similar total daily dose of metformin hydrochloride;
    – In patients already treated with empagliflozin and metformin hydrochloride, switch to this combined formulation containing the same total daily doses of each component.
    3. Take combined formulation twice daily with meals; with gradual dose escalation to reduce the gastrointestinal side effects due to metformin.
    4. Adjust dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of metformin hydrochloride 2000 mg and empagliflozin 25 mg.
    Recommended Dosage in Patients with Renal Impairment:
    1. Assess renal function prior to initiation of this combined formulaion and periodically, thereafter.
    2. This combined formulaion is contraindicated in patients with an eGFR less than 45 mL/min/1.73 m².
    Discontinuation for Iodinated Contrast Imaging Procedures:
    Discontinue this formulation at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 45 and 60 mL/min/1.73 m²; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Reevaluate eGFR 48 hours after the imaging procedure; restart this formulation if renal function is stable. 


    Indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control
    1. in patients inadequately controlled on their maximally tolerated dose of metformin alone.
    2. in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin.
    3. in patients already being treated with the combination of empagliflozin and metformin as separate tablets.


    This product is contraindicated in patients with:
    1. Moderate to severe renal impairment (eGFR less than 45 mL/min/1.73 m²), end stage renal disease, or dialysis.
    2. Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.
    3. History of serious hypersensitivity reaction to empagliflozin, metformin, or any of the excipients.

    Special Precautions

    This formulation is not indicated for patients with type 1 diabetes.
    Lactic acidosis: Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
    Hypotension: Empagliflozin causes intravascular volume contraction. Symptomatic hypotension may occur after initiating empagliflozin particularly in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Before initiating this formulation, assess for volume contraction and correct volume status if indicated. Monitor for signs and symptoms of hypotension after initiating therapy and increase monitoring in clinical situations where volume contraction is expected.
    Ketoacidosis: Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose co-transporter-2 (SGLT2) inhibitors, including empagliflozin. Fatal cases of ketoacidosis have been reported in patients taking empagliflozin. This formulation is not indicated for the treatment of patients with type 1 diabetes mellitus.
    Acute Kidney Injury and 
    Impairment in Renal Function: Empagliflozin causes intravascular volume contraction and can cause renal impairment. There have been postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients receiving SGLT2 inhibitors, including empagliflozin; some reports involved patients younger than 65 years of age.
    Urosepsis and Pyelonephritis: There have been postmarketing reports of serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization in patients receiving SGLT2 inhibitors, including empagliflozin.
    Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Empagliflozin: Insulin and insulin secretagogues are known to cause hypoglycemia. The risk of hypoglycemia is increased when empagliflozin is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin. Therefore, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia when used in combination with this formulation.
    Metformin: Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, but could occur when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or during concomitant use with other glucose-lowering agents (such as SUs and insulin) or ethanol. Elderly, debilitated, or malnourished patients, and those with adrenal or pituitary insufficiency or
    alcohol intoxication are particularly susceptible to hypoglycemic effects. Hypoglycemia may be difficult to recognize in the elderly, and in people who are taking β-adrenergic blocking drugs. Monitor for a need to lower the dose of this formulation to minimize the risk of hypoglycemia in these patients.
    Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Reports of necrotizing fasciitis of the perineum (Fournier’s gangrene), a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in postmarketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors, including empagliflozin. Cases have been reported in both females and males. Serious outcomes have included hospitalization, multiple surgeries, and death.
    Patients treated with JARDIANCE DUO presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise, should be assessed for necrotizing fasciitis. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement.
    Discontinue JARDIANCE DUO, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.
    Genital Mycotic Infections: Empagliflozin increases the risk for genital mycotic infections. Patients with a history of chronic or recurrent genital mycotic infections were more likely to develop genital mycotic infections. Monitor and treat as appropriate.
    Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions, (e.g., angioedema) in patients treated with empagliflozin, one of the components of this formula. If a hypersensitivity reaction occurs, discontinue this product; treat promptly per standard of care, and monitor until signs and symptoms resolve. This product is contraindicated in patients with a previous serious hypersensitivity reaction to empagliflozin or any of the excipients in this formula.
    Vitamin B12 Levels: In controlled, 29-week clinical trials of metformin, a decrease to subnormal levels of previously normal serum vitamin B12 levels, without clinical manifestations, was observed in approximately 7% of metformin-treated patients.
    Increased Low-Density Lipoprotein Cholesterol (LDL-C): Increases in LDL-C can occur with empagliflozin. Monitor and treat as appropriate.
    Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with
    this formulation.
    Lower limb amputations: An increase in cases of lower limb amputation (primarily of the toe) has been observed in ongoing long-term
    clinical studies with another SGLT2 inhibitor. It is unknown whether this constitutes a class effect. Like for all diabetic patients it is important to counsel patients on routine preventative footcare.

    Side Effects

    Lactic Acidosis,  Hypotension, Ketoacidosis, Acute Kidney Injury and Impairment in Renal Function, Urosepsis and Pyelonephritis ,Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues, Necrotizing Fasciitis of the Perineum, Genital Mycotic Infections, Hypersensitivity Reactions, Vitamin B12 Deficiency,Increased Low-Density Lipoprotein Cholesterol.
    See prescribing information for full details.

    Drug interactions

    Drug Interactions with Empagliflozin: 
    Diuretics: Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
    Insulin or Insulin Secretagogues: Coadministration of empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.
    Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.
    Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
    Drug Interactions with Metformin Hydrochloride:
    Drugs that Reduce Metformin Clearance: 
    Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal
    elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis. Consider the benefits and risks of concomitant use.
    Carbonic Anhydrase Inhibitors: Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide)
    frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with this product may increase the risk of lactic acidosis. Consider more frequent monitoring of these patients.
    Drugs Affecting Glycemic Control: Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include
    the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving this product, the patient should be closely observed to maintain adequate glycemic control. When such drugs are withdrawn from a patient receiving this product, the patient should be observed closely for hypoglycemia.
    Alcohol: Alcohol is known to potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake while receiving this product.

    Pregnancy and Lactation

    Pregnancy: Based on animal data showing adverse renal effects, this formulation is not recommended during the second and third trimesters of pregnancy.
    Lactation: There is no information regarding the presence of this formulation or empagliflozin in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed infant, including the potential for empagliflozin to affect postnatal renal development, advise women that use of this product is not recommended while breastfeeding.
    See prescribing information for full details.


    Employ the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment) as dictated by the patient’s clinical status. Removal of empagliflozin by hemodialysis has not been studied. However, metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful partly for removal of accumulated metformin from patients in whom this formulation overdosage is suspected.
    Metformin hydrochloride: Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams.
    Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases.

    Important notes

    Storage: Store below 25°C.

    Boehringer Ingelheim Pharma KG, Germany