Jardiamet

Jardiamet - Precautions | Dosage | Effects

This article was medically reviewed by M.Pharm, Marko Tanaskovic on August 12, 2018. To read more about an author, click here.

Jardiamet is a medicine that contains two active substances: metformin and empagliflozin. There are four different dosage forms:

  • 5/500 mg tablets containing 5 mg of empagliflozin and 500 mg of metformin
  • 5/1000 mg tablets containing 5 mg of empagliflozin and 1000 mg of metformin
  • 12.5/500 mg tablets containing 12.5 mg of empagliflozin and 500 mg of metformin
  • 12.5/1000 mg tablets containing 12.5 mg of empagliflozin and 1000 mg of metformin.

Empagliflozin belongs to a group of reversible, selective and competitive sodium-glucose co-transporter-2 (SGLT 2) inhibitors, while metformin belongs to the biguanide hypoglycemic agents.

Both drugs are used in the treatment of type 2 diabetes mellitus, along with lifestyle modifications.

This drug combination is used in the treatment of diabetes mellitus type 2, when lifestyle changes or monotherapy with empagliflozin or metformin have not provided adequate glycemic control.

Precautions

Jardiamet can cause lactic acidosis - a condition characterized by an increased lactic acid concentration in the blood, causing the following symptoms:

  • Muscle aches.
  • Decreased gas exchange at the alveolar level and difficulty breathing (so called respiratory distress).
  • Drowsiness and lack of interest in the surrounding events.
  • Malaise.

If you are experiencing any of abovementioned symptoms, you should contact your doctor immediately! Lactic acidosis may have a fatal outcome.

Patients with impaired renal function, impaired hepatic function, sepsis, dehydration, or congestive heart failure have an increased risk of accumulation of metformin which causes lactic acidosis. The risk of lactic acidosis is increased if you consume large amounts of alcoholic beverages with Jardiamet. With that said, you should avoid alcoholic beverages while using Jardiamet.

Jardiamet is contraindicated in patients with diabetic ketoacidosis, metabolic acidosis, and in patients with type 1 diabetes.

Jardiamet is contraindicated in patients who have kidney disease and / or impaired renal function.

Patients who have hypotension or are taking diuretics to treat hypertension should use this medicine only under strict medical supervision.

It is desirable to monitor kidney function periodically during the therapy.

Patients undergoing radiological imaging and who should receive iodinated contrast materials, must inform their doctor that they are taking this medicine.

Cases of vaginal candidiasis (vaginal yeast infection) and urinary infections due to the use of empagliflozin have been reported in more than 5% of patients. You should contact your doctor if you are experiencing symptoms of these infections.

Jardiamet may increase the level of LDL cholesterol (so-called bad cholesterol) in the blood, and it is desirable to monitor LDL blood levels periodically.

The most common adverse effects of metformin include diarrhea, flatulence, indigestion, headache and chronic fatigue. These side effects occur in > 5% of patients.

It should not be used in patients under the age of 18 because there are insufficient data available regarding safety of Jardiamet at this age.

Vitamin B12 deficiency has been reported in 7% of patients taking metformin.

Jardiamet, pregnancy and breastfeeding

According to the FDA, Jardiamet belongs to group C, which means that it can be used during pregnancy only if your gynecologist estimates that the potential benefit of using the medicine is greater than the potential risk to the fetus. There are no clinical studies on its use during pregnancy.

Empagliflozin and metformin have not demonstrated a teratogenic effect, although there is evidence that empagliflozin may affect kidney development in the fetus.

It is not known whether empagliflozin is excreted in breast milk, while metformin is excreted in small amounts. There are no studies on the effects of Jardiamet on infants. Therefore, your doctor must decide whether you should discontinue breastfeeding or use Jardiamet based on a benefit / risk assessment.

Dosage

Jardiamet treatment should be initiated only when attempts of monotherapy with empagliflozin or metformin have not resulted in adequate glycemic control. Patients on empagliflozin should switch to Jardiamet tablets containing a similar dose of empagliflozin and 500 mg of metformin, while patients on metformin should switch to Jardiamet tablets containing a similar dose of metformin and 5 mg of empagliflozin.

It is recommended to take tablets twice a day with a meal.

The maximum daily dose is 25/2000 mg.

It is necessary to adjust the dose in patients who have renal impairment.

Never change the dose prescribed by your doctor.

Interactions

Jardiamet should not be used concomitantly with the following medicines:

  • Diuretics, such as: hydrochlorothiazide, furosemide, spironolactone, triamterene, amiloride and bumetanide. Simultaneous administration with these medicines increases the risk of dehydration and hypoglycaemia.
  • Insulin. Simultaneous administration increases the risk of hypoglycaemia.
  • Cardiac glycosides (such as digoxin).
  • Antiarrhythmic drugs, such as: procainamide and quinidine.
  • Ranitidine - a medicine used to treat heartburn and stomach ulcers.
  • Morphine - a medicine used to treat severe pain.
  • Topiramate - a medicine used to prevent epilepsy and migraine. Simultaneous administration increases the risk of lactic acidosis.
  • Antipsychotics known as phenothiazines, such as: fluphenazine, thioridazine, promazine, levopromazine and others.
  • Corticosteroids (prednisone, hydrocortisone and others). These medications can cause hyperglycaemia and concomitant use is therefore not recommended.
  • Oral contraceptives. These medications can cause hyperglycaemia, therefore you should avoid concomitant use.

Tell your doctor about all medicines and herbal remedies you are taking.

Side effects

Jardiamet can cause the following side effects:

  • High levels of LDL cholesterol.
  • Lactic acidosis (symptoms: malaise, pain in muscles and difficulty breathing).
  • Low blood sugar.
  • Vaginal candidiasis as well as genital yeast infections in men.
  • Urinary infections.
  • Vitamin B12 deficiency.
  • Kidney impairment.
  • Liver impairment.
  • Inflammation/infection of the nose and pharynx.
  • Nausea.
  • Pain in the joints.

Tell your doctor if you are experiencing any side effects.

References

  1. FDA

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