Empa 10 - Tablet Empagliflozin - 10mg 15 Tablet(s) / Strip NIPRO JMI Pharma Limited Introduction: Empa 10 is used alone or in combination with other medicines to treat type 2 diabetes mellitus. It helps control the high blood sugar levels seen in diabetes. This reduces the chances of serious complications of diabetes and also helps prevent heart disease. Empa 10 can be taken with or without food at any time of day but you should try to take it at the same time every day. The dose will be decided by your doctor. Do not stop taking it without asking your doctor. If you do, your blood sugar levels may increase and put you at... Uses of Empa 10: Type 2 diabetes mellitus Side effects of Empa 10: Frequent urge to urinateGenital fungal infectionIncreased thirstNauseaUrinary tract infection How to use Empa 10: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Empa 10 may be taken with or without food, but it is better to take it at a fixed time. How Empa 10 works: Empa 10 is an antidiabetic medication. It works by removing excess sugar from your body through urine. What if you forget to take Empa 10?: If you miss a dose of Empa 10, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose. Indication: Type 2 diabetes mellitus Administration: May be taken with or without food. Adult Dose: Oral Type 2 diabetes mellitus Adult: Initially, 10 mg once daily in the morning, may be increased to 25 mg once daily, if necessary for additional glycemic control. Renal Dose: CrCl (mL/min) <45 Contraindicated. <60 Max: 10 mg daily. Contraindication: As treatment for type 1 DM or diabetic ketoacidosis. Renal impairment (CrCl <45 mL/min), ESRD, or patients on haemodialysis. Lactation. Mode of Action: Empagliflozin is a reversible inhibitor of sodium-glucose co-transporter 2 (SGLT2), the main site of filtered glucose re-absorption in the renal proximal convoluted tubules. This reduces re-absorption of filtered glucose and lowers renal threshold for glucose, resulting in increased urinary glucose excretion, thereby reducing blood glucose concentration. Precaution: Hypotension: Before initiating Empagliflozin, volume status should be assessed and correction on hypovolemia should be made in the elderly, in patients with renal impairment, in patients with low systolic blood pressure and in patients on diuretics since Empagliflozin causes intravascular volume contraction. Impairment in Renal Function: Renal function should be evaluated prior to initiating Empagliflozin and periodically thereafter since Empagliflozin increases serum creatinine and decreases eGFR. Hypoglycemia: In patients taking insulin or an insulin secretagogue with Empagliflozin, a lower dose of insulin or the insulin secretagogue is considered to reduce the risk of hypoglycemia. Genital mycotic infections: Monitoring and treatment... Side Effect: 1-10% Urinary tract infection (7.6-9.3%) Female genital mycotic infections (5.4-6.4%) Upper respiratory tract infection (3.1-4%) Increased urination (3.2-3.4%) Dyslipidemia (2.3-2.4%) Male genital mycotic infections (1.6-3.1%) Nausea (1.1-2.3%) Polydipsia (1.5-1.7%) Pregnancy Category Note: Pregnancy Based on animal data showing adverse renal effects, use not recommended during the second and third trimesters of pregnancy Limited data available in pregnant women are insufficient to determine a drug-associated risk for major birth defects and miscarriage There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy Clinical considerations Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, still birth, and macrosomia related morbidity Lactation There is no information regarding presence in... Interaction: Additive hypoglycaemic effect if concomitantly used w/ insulin and insulin secretagogues (e.g. sulfonylureas). Increased risk of dehydration and hypotension when used w/ diuretics (e.g. thiazides, loop diuretics).