Empagliflozin

Empagliflozin - Precautions | Dosage | Interaction

Empagliflozin is a medicine that acts by blocking sodium-glucose co-transporter 2 (the so-called SGLT2 inhibitors) in kidneys which result in decrease in glucose reabsorption and is used in the treatment of diabetes mellitus type 2. This drug is 5000 times more selective for SGLT2 than for SGLT1 which is responsible for glucose absorption in the intestines. Given that glucose reabsorption in the proximal renal tubule is more pronounced in patients with type 2 diabetes mellitus, Empagliflozin contributes to better glycemic control in diabetics.

Because of its characteristic mechanism of action, this medicine exhibits a low risk of developing hypoglycaemia compared to other anti-diabetic agents.

It is used as monotherapy or in combination with other oral anti-diabetic drugs or insulin.

Precautions

Empagliflozin should be used with caution in patients who have impaired renal function since its mechanism of action is primarily based on glucose reabsorption in the kidneys. The renal function should be checked, before starting therapy with this medicine. Regular control of renal function during therapy is also recommended.

This medicine can lower blood pressure, and should be used cautiously in patients who have hypotension or are on antihypertensive therapy.

Clinical trials have shown that patients who are on therapy with this medicine have an increased risk of developing urinary tract infections. If you notice signs and symptoms of a urinary infection, you should inform your doctor.

Patients who are taking this medication have an increased risk of developing genital fungal infections, and if you notice symptoms and signs of genital infections, you should inform your doctor.

Empagliflozin, pregnancy and lactation

Studies in animals have shown that this drug can be toxic if applied during pregnancy, as it may disrupt the development of renal tissue in the fetus. Studies conducted in rats and rabbits did not demonstrate the teratogenic effect of this drug when administered at doses of 300 mg / kg / day, which is 48-128 times higher than the therapeutic dose.

For this reason, the FDA classified this drug in pregnancy category C and advises that it should only be used if the benefit to the mother is greater than the risk to the fetus.

Since the kidneys develop during the first two years of life, the use of this medication while breastfeeding must be avoided.

Dosage

The usual dose is 10 mg once a day. It is best taken in the morning with or without food.

The dose may be increased to a maximum of 25 mg daily.

Interactions

Empagliflozin should not be administered concurrently or can be administered with extra precautions with the following drugs:

  • (e.g. bumetanide and furosemide). Simultaneous administration with these medicines increases the risk of dehydration and hypotension.
  • Insulin. Simultaneous administration with insulin increases the risk of hypoglycaemia, so your doctor may reduce your insulin dose.
  • Gatifloxacin.

No other, clinically significant interactions were observed.

Adverse reactions

Empagliflozin may cause the following adverse reactions:

  • Genital fungal infections (e.g. vulvovaginal candidiasis)
  • Balanitis (infection and inflammation of the glans, or the head of the penis)
  • Volume depletion (vascular instability resulting from sodium loss, accompanied by vomiting and diarrhea)
  • Polyuria (excessive urination)
  • Painful or difficulty urinating (dysuria)
  • Hypoglycaemia
  • Orthostatic hypotension
  • Syncope

References

  1. accessdata link
  2. PIL