Jardiamet

Jardiamet is a combination of Jardiamet hydrochloride indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Jardiamet hydrochloride is appropriate.

​Empagliflozin (Jardiamet) is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. However, the effectiveness of Jardiamet on reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease has not been established.

Limitations of Use

Jardiamet is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Jardiamet are oral diabetes medicines that help control blood sugar levels. Empagliflozin (Jardiamet) works by helping the kidneys get rid of glucose from your bloodstream. Metformin (Jardiamet) lowers glucose production in the liver and also causes your intestines to absorb less glucose.

Jardiamet is a combination medicine used together with diet and exercise to treat type 2 diabetes. Empagliflozin (Jardiamet) is not for treating type 1 diabetes.

Jardiamet may also be used for purposes not listed in this medication guide.

Recommended Dosage

• In patients with volume depletion not previously treated with Empagliflozin (Jardiamet), correct this condition before initiating Jardiamet.
• Individualize the starting dose of Jardiamet based on the patient’s current regimen:

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  In patients on Metformin (Jardiamet) hydrochloride, switch to Jardiamet containing a similar total daily dose of Metformin (Jardiamet) hydrochloride and a total daily dose of Empagliflozin (Jardiamet) 10 mg;

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  In patients on Empagliflozin (Jardiamet), switch to Jardiamet containing the same total daily dose of Empagliflozin (Jardiamet) and a total daily dose of Metformin (Jardiamet) hydrochloride extended-release 1000 mg;

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  In patients already treated with Jardiamet hydrochloride, switch to Jardiamet containing the same total daily doses of Empagliflozin (Jardiamet) and a similar total daily dose of Metformin (Jardiamet) hydrochloride.

• Adjust dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of Metformin (Jardiamet) hydrochloride 2000 mg and Empagliflozin (Jardiamet) 25 mg.
• The dose of Metformin (Jardiamet) hydrochloride should be gradually escalated to reduce the gastrointestinal side effects due to Metformin (Jardiamet) hydrochloride.
• Take Jardiamet orally once daily with a meal in the morning
• Swallow Jardiamet tablets whole. Do not split, crush, dissolve, or chew before swallowing. There have been reports of incompletely dissolved tablets being eliminated in the feces for other tablets containing Metformin (Jardiamet) hydrochloride extended-release. If a patient reports seeing tablets in feces, the healthcare provider should assess adequacy of glycemic control.
• Jardiamet 10 mg/1000 mg and 25 mg/1000 mg tablets should be taken as a single tablet once daily. Jardiamet 5 mg/1000 mg and 12.5 mg/1000 mg tablets should be taken as two tablets together once daily.

2.2 Recommended Dosage in Patients with Renal Impairment

• Assess renal function prior to initiation of Jardiamet and periodically, thereafter.
• Jardiamet is contraindicated in patients with an eGFR less than 45 mL/min/1.73 m2.

Discontinuation for Iodinated Contrast Imaging Procedures

Discontinue Jardiamet 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. Re-evaluate eGFR 48 hours after the imaging procedure; restart Jardiamet if renal function is stable.

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Jardiamet is contraindicated in patients with:

• Renal impairment (e.g., serum creatinine levels greater than or equal to 1.5 mg/dL for males or 1.4 mg/dL for females, or eGFR is less than 45 mL/min/1.73 m2), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia; end stage renal disease (ESRD) or patients on dialysis.
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.
• History of serious hypersensitivity reaction to Empagliflozin (Jardiamet) or Metformin (Jardiamet) hydrochloride.

Use: Labeled Indications

Diabetes mellitus, type 2, treatment: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Jardiamet is appropriate. Note: Empagliflozin (Jardiamet) is also indicated for risk reduction of cardiovascular mortality in adults with type 2 diabetes mellitus and established cardiovascular disease.

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Drug Interactions With Empagliflozin (Jardiamet)

Diuretics

Coadministration of Empagliflozin (Jardiamet) 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 (Jardiamet) 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 (Jardiamet) Hydrochloride

Drugs That Reduce Metformin (Jardiamet) Clearance

Drugs that are eliminated by renal tubular secretion (e.g., cationic drugs such as cimetidine) have the potential for interaction with Metformin (Jardiamet) by competing for common renal tubular transport systems, and may increase the accumulation of Metformin (Jardiamet) and the risk for lactic acidosis. Consider more frequent monitoring of these patients.

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 Jardiamet 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 Jardiamet, the patient should be closely observed to maintain adequate glycemic control. When such drugs are withdrawn from a patient receiving Jardiamet, the patient should be observed closely for hypoglycemia.

Alcohol

Alcohol is known to potentiate the effect of Metformin (Jardiamet) on lactate metabolism. Warn patients against excessive alcohol intake while receiving Jardiamet.

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Applies to Empagliflozin (Jardiamet) / Metformin (Jardiamet): oral tablet

As well as its needed effects, Empagliflozin (Jardiamet) / Metformin (Jardiamet) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Empagliflozin (Jardiamet) / Metformin (Jardiamet), check with your doctor immediately:

More common:

• Abdominal or stomach discomfort
• bladder pain
• bloody or cloudy urine
• blurred vision
• chills
• coma
• confusion
• cool, pale skin
• decreased appetite
• depression
• difficult, burning, or painful urination
• dizziness
• fast heartbeat
• fast, shallow breathing
• frequent urge to urinate
• general feeling of discomfort
• headache
• increased hunger
• lower back or side pain
• muscle pain or cramping
• nausea
• nightmares
• seizures
• shakiness
• shortness of breath
• sleepiness
• slurred speech
• unusual tiredness or weakness

• Bad-smelling discharge from the penis
• itching of the vagina or genitals
• itching, stinging, or redness of the vaginal area
• redness, itching, swelling, or pain of the penis
• thick, white vaginal discharge with mild or no odor

• Blurred vision
• dark-colored urine
• decreased frequency or amount of urine
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• increased thirst
• light-colored stools
• loss of appetite
• loss of consciousness
• stomach pain, continuing
• swelling of the face, fingers, or lower legs
• unexplained weight loss
• vomiting
• weight gain
• yellow eyes or skin

Minor Side Effects

Some Empagliflozin (Jardiamet) / Metformin (Jardiamet) side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:

• Diarrhea
• flatulence
• indigestion
• stomach discomfort