Empaa-L Tablets 25Mg/5Mg (1 Strip = 14 Tablets)

Requires Prescription (YES/NO)

Yes

Generics

Empagliflozin + Linagliptin

Used For

Diabetes

How it works

Empagliflozin Sodium-glucose co-transporter 2 (SGLT2) is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Empagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, Empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Linagliptin Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, Linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation. Both incretin hormones are involved in the physiological regulation of glucose homeostasis. GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels. Furthermore, GLP-1 also reduces glucagon secretion from pancreatic alpha cells, resulting in a reduction in hepatic glucose output.

Dosage

Empagliflozin + Linagliptin

Side Effects

Common: Urinary tract infection (including pyelonephritis and urosepsis), vaginal moniliasis, vulvovaginitis, balanitis and other genital infections, nasopharyngitis, hypoglycaemia (when used with sulphonylurea or insulin), thirst, cough, pruritus, rash, increased urination, amylase increased and lipase increased. Uncommon: Hypersensitivity, angioedema, urticarial, pancreatitis, volume depletion, dysuria, hematocrit increased, serum lipids increased and blood creatinine increased/glomerular filtration rate decreased. Not known: Necrotising fasciitis of the perineum (Fournier´s gangrene) and bullous pemphigoid.

Drug Interactions

Diuretics : Coadministration of Empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion. Before initiating Empagliflozin + Linagliptin , assess volume status and renal function. In patients with volume depletion, correct this condition before initiating therapy. Monitor for signs and symptoms of volume depletion and renal function after initiating therapy. Interference with 1,5-anhydroglucitol (1,5-AG) Assay Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Monitoring glycemic control with 1,5-AG assay is not recommended. Use alternative methods to monitor glycemic control. Inducers of P-glycoprotein or CYP3A4 Enzymes Rifampin decreased Linagliptin exposure, suggesting that the efficacy of Linagliptin may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer. Use of alternative treatments is strongly recommended when Linagliptin is to be administered with a strong P-gp or CYP3A4 inducer.

Indication

Empagliflozin + Linagliptin are indicated as an adjunct to diet and exercise in adults aged 18 years and older with type 2 diabetes mellitu s: to improve glycemic control when metformin and/or sulphonylurea (SU) and monotherapy of either of Empagliflozin and Linagliptin do not provide adequate glycemic control. - when already being treated with the free combination of Empagliflozin and Linagliptin. Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.

When not to Use

The combination of Empagliflozin + Linagliptin is contraindicated in patients with hypersensitivity to the active substances, to any other Sodium-Glucose-Co-Transporter-2 (SGLT2) inhibitor, to any other Dipeptidyl-Peptidase-4 (DPP-4) inhibitor, or to any of the excipients of the product.

Precaution

Use of dipeptidyl peptidase-4 (DPP-4) inhibitors has been associated with a risk of developing acute pancreatitis. Acute pancreatitis has been observed in patients taking Linagliptin. If pancreatitis is suspected, Empagliflozin + Linagliptin Tablets should be discontinued; if acute pancreatitis is confirmed, Empagliflozin + Linagliptin should not be restarted. Caution should be exercised in patients with a history of pancreatitis.

Warning 1

Caution should be exercised in patients for whom an Empagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti-hypertensive therapy (e.g. thiazide and loop diuretics with a history of hypotension or patients aged 75 years and older).

Warning 2

An increase in cases of lower limb amputation (primarily of the toe) has been observed. Like for all diabetic patients it is important to counsel patients on routine preventative foot-care.

Warning 3

Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated .

Pregnancy category

Always consult your physician before using any medicine.

Storage (YES/NO)

Store this medicine at room temperature, away from direct light and heat.