Dafoxa 10 mg

Dapagliflozin should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Renal Impairment

Treatment of diabetes mellitus.

The glycemic efficacy of dapagliflozin is dependent on renal function and efficacy is reduced in patients who have moderate renal impairment and is likely absent in patients with severe renal impairment. In patients with moderate renal impairment (GFR <60 ml/minute), a higher proportion of patients treated with dapagliflozin had adverse reation of increase in creatinine, phosphorus, parathyroid hormone and hypotension. To improve glycemic effect is dependent on renal function, dapagliflozin should not be initiated to improve glycemic control in patients with GFR <60 ml/minute and should be discontinued at GFR persistently below 45 ml/minute. Dapagliflozin has not been studied for glycemic control in patients with severe renal impairment (GFR <30 ml/menit) or end stage renal disease (ESRD). Monitoring of renal function is recommende as follow:

• prior to initiation of dapagliflozin and at least yearly thereafter.
• prior to initiation of concomitant medicinal products that may reduce renal function and periodically therafter.
• for renal function with gfr <60 ml/minute, at least 2 to 4 times per year

Hepatic Impairment

Dapagiflozin exposure is increaased in patients with severe hepatic impairment.

Ketoacidosis

Patients treated with dapagliflozin who present with signs and symptoms consistent with ketoacidosis, including nausea, vomiting, abdominal oain, malaise and shortness of breath, should be assessed for ketoacidosis, even if blood glucose levels are below 14 mmol/l (250 mg/dl). If ketoacidosis is suspected, discontinuation or temporary interruption of dapagliflozin should be considered and the patient shoudl be promptly evaluated.

Urinary Tract Infection

Urinary glucose excretion may be associated with an increased risk of urinary tract infection; therfore. temporary interruption of dapagliflozin should be considered when treating pyelonephritis or urosepsis.

Use in patients at risk for volume depletion and/or hypotension

Due to its mechanism of action, dapagliflozin increases diuresis which may lead to modest decrease in blood pressure, which may be more pronounced in patients with very high blood glucose concentrations. Caution should be excercise in patients for whom dapafliflozin induced drop in blood pressure could pose a risk, such as patients on antihypertensive therapy with a history of hypotension or elderly patients.

Elderly Patients

Elderly patients may be at a greater risk for volume depletion and are more likely to be treated with diuretics. Elderly patients are more likely to have impaired renal function, and/or to be treated with antihypertensive medicinal product that may cause change in renal function such as angiotensin-converting enzyme inhibitors (ACEI) and angiotensin II type 1 receptor blockers (ARB).

• Elevated hematocrit was observed with dapagliflozine treatment
• Dapagliflozine has not been studied in combination with glucagon-like-peptide 1 (GLP-1)
• The film coated tablets contain lactose anhydrous. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency,or glucose-galactose malabsorption should not take this medicinal product.