Generic drug: empagliflozin and metformin extended-release
Brand name: Synjardy XR
What is Synjardy XR (empagliflozin and metformin extended-release), and how does it work?
It is not known if Synjardy XR is safe and effective in children younger than 18 years of age.
What are the side effects of Synjardy XR?
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.
Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information.
If metformin-associated lactic acidosis is suspected, immediately discontinue Synjardy XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.
Synjardy XR may cause serious side effects including:
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area,
- feeling unwell,
- little or no urination,
- stomach pain,
- unusual drowsiness,
- unusual muscle pain,
- trouble breathing,
- stomach pain,
- irregular heart rate,
- feeling cold,
- pain or burning when you urination,
- increased urination,
- blood in your urine, and
- pain in your pelvis or back
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Synjardy XR include:
- stomach pain,
- runny nose, and
- sore throat
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Synjardy XR. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Synjardy XR?
Prior To Initiation Of Synjardy XR
- Assess renal function before initiating Synjardy XR and as clinically indicated.
- In patients with volume depletion, correct this condition before initiating Synjardy XR.
Recommended Dosage And Administration
- Individualize the starting dose of Synjardy XR based on the patientâ€™s current regimen:
- In patients on metformin HCl, switch to Synjardy XR containing a similar total daily dose of metformin HCl and a total daily dose of empagliflozin 10 mg;
- In patients on empagliflozin, switch to Synjardy XR containing the same total daily dose of empagliflozin and a total daily dose of metformin HCl extended-release 1000 mg;
- In patients already treated with empagliflozin and metformin HCl, switch to Synjardy XR containing the same total daily doses of empagliflozin and a similar total daily dose of metformin HCl.
- Monitor effectiveness and tolerability, and adjust dosing as appropriate, not to exceed the maximum recommended daily dose of empagliflozin 25 mg and metformin HCl 2000 mg.
- The dose of metformin HCl should be gradually escalated to reduce the gastrointestinal side effects due to metformin.
- Take Synjardy XR orally once daily with a meal in the morning
- Swallow Synjardy XR tablets whole. Do not split, crush, dissolve, or chew.
- Synjardy XR 10 mg/1000 mg and 25 mg/1000 mg tablets should be taken as a single tablet once daily. Synjardy XR 5 mg/1000 mg and 12.5 mg/1000 mg tablets should be taken as two tablets together once daily.
Dosage Recommendations In Patients With Renal Impairment
- Initiation of Synjardy XR is not recommended in patients with an eGFR less than 45 mL/min/1.73 m², due to the metformin component.
- Synjardy XR is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m² or in patients on dialysis.
Discontinuation For Iodinated Contrast Imaging Procedures
Discontinue Synjardy XR at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR less than 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. Re-evaluate eGFR 48 hours after the imaging procedure; restart Synjardy XR if renal function is stable.
What drugs interact with Synjardy XR?
Table 4 : Clinically Relevant Interactions with Synjardy XR
|Carbonic Anhydrase Inhibitors|
|Clinical Impact||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.|
|Intervention||Concomitant use of these drugs with Synjardy XR may increase the risk of lactic acidosis. Consider more frequent monitoring of these patients.|
|Drugs that Reduce Metformin Clearance|
|Clinical Impact||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.|
|Intervention||Consider the benefits and risks of concomitant use.|
|Clinical Impact||Alcohol is known to potentiate the effect of metformin on lactate metabolism.|
|Intervention||Warn patients against excessive alcohol intake while receiving Synjardy XR.|
|Clinical Impact||Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.|
|Intervention||Before initiating Synjardy XR, assess volume status and renal function. In patients with volume depletion, correct this condition before initiating Synjardy XR. Monitor for signs and symptoms of volume depletion, and renal function after initiating therapy.|
|Insulin or Insulin Secretagogues|
|Clinical Impact||The risk of hypoglycemia is increased when empagliflozin is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin. Metformin may increase the risk of hypoglycemia when combined with insulin and/or an insulin secretagogue.|
|Intervention||Coadministration of Synjardy XR with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.|
|Drugs Affecting Glycemic Control|
|Clinical Impact||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.|
|Intervention||When such drugs are administered to a patient receiving Synjardy XR, the patient should be closely observed to maintain adequate glycemic control. When such drugs are withdrawn from a patient receiving Synjardy XR, the patient should be observed closely for hypoglycemia.|
|Positive Urine Glucose Test|
|Clinical Impact||SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests.|
|Intervention||Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.|
|Interference with 1,5-anhydroglucitol (1,5-AG) Assay|
|Clinical Impact||Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors.|
|Intervention||Monitoring glycemic control with 1,5-AG assay is not recommended. Use alternative methods to monitor glycemic control.|
Is Synjardy XR safe to use while pregnant or breastfeeding?
- Based on animal data showing adverse renal effects, Synjardy XR is not recommended during the second and third trimesters of pregnancy.
- Limited available data with Synjardy XR or empagliflozin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage.
- Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk.
- There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.
- There is no information regarding the presence of Synjardy XR or empagliflozin in human milk, the effects on the breastfed infant, or the effects on milk production. Limited published studies report that metformin is present in human milk.
Synjardy XR (empagliflozin and metformin extended-release) is a prescription medicine used to treat the symptoms of Type 2 Diabetes Mellitus. Serious side effects of Synjardy XR include lactic acidosis. Synjardy XR is not recommended in patients with type 1 diabetes mellitus.
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- Synjardy (empagliflozin and metformin)
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.