Emparol Tablet
Empagliflozin + Metformin
5mg + 500mg
Drug International Ltd.
| Pack size | 14's Pack |
|---|---|
| Unite Price | 15.00 BDT |
Indications
Emparol Tablet is used for:
Type 2 Diabetes Mellitus
Adult Dose
Oral
Type 2 diabetes mellitus
Adult:
Immediate-release tablet
Take 1 tab twice daily with meals, with gradual dose escalation to reduce the GI adverse effects due to metformin
Extended-release tablet
Take 1 tab once daily with a meal in the morning, with gradual dose escalation to reduce the GI adverse effects due to metformin
Max: Empagliflozin 25 mg and metformin 2,000 mg daily.
Hepatic impairment
Avoid use in patients with clinical or laboratory evidence of hepatic disease
Use of metformin in patients with hepatic impairment has been associated with lactic acidosis
Child Dose
Renal Dose
Renal impairment
eGFR <45 mL/min/1.73 m2: Contraindicated
Administration
Should be taken with food. Take w/ meals to reduce GI discomfort.
Contra Indications
Diabetic pre-coma, acute or chronic metabolic acidosis (e.g. diabetic ketoacidosis, lactic acidosis), alcoholism or acute alcohol intoxication, acute or chronic disease that may cause hypoxia (e.g. cardiac or respiratory failure, recent MI, shock), conditions which may alter renal function (e.g. severe infection, dehydration). Intravascular administration of iodinated contrast agents. Hepatic and severe renal impairment (GFR <30 mL/min), ESRD, patient on dialysis. Lactation.
Precautions
Patient with risk factors for acute kidney injury, congestive heart failure, history of pancreatitis, and those who are exposed to stress (e.g. infection, fever, trauma, surgery). Pregnancy. Not intended for the treatment of diabetic ketoacidosis or type 1 diabetes mellitus.
Pregnancy-Lactation
Pregnancy
Not recommended during second and third trimester of pregnancy based on animal data
Limited available data with use in pregnant women is not sufficient to determine a drug-associated risk for major birth defects and miscarriages
Metformin may result in ovulation in some anovulatory women; discuss the potential for unintended pregnancy with premenopausal women
Animal data
In animal studies, adverse renal changes were observed in rats when empagliflozin was administered during period of renal development corresponding to the late second and third trimesters of human pregnancy
Doses ~13-times the maximum clinical dose caused renal pelvic and tubule dilatations were reversible
Not teratogenic in rats and rabbits up to 300 mg/kg/day, which approximates 48-times and 128-times, respectively, the maximum clinical dose of 25 mg when administered during organogenesis
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 human milk, the effects on breastfed infant or on milk production
Empagliflozin is present in the milk of lactating rats
Owing to the potential for serious adverse reactions in a breastfed infant, advise women that it is not recommended while breastfeeding
Interactions
Empagliflozin: May potentiate diuretic effect and increased risk of hypotension with thiazides and loop diuretics. Increased plasma concentration with UGT enzyme inhibitor (e.g. probenecid). Increased risk of hypoglycaemia with insulin and sulfonylureas.
Metformin: Reduced efficacy with verapamil. Increased gastrointestinal absorption and efficacy with rifampicin. Increased plasma concentration with organic cation transporters (OCT) inhibitors (e.g. ranolazine, vandetanib, dolutegravir, cimetidine). Altered renal elimination with olaparib. Increased risk of lactic acidosis with topiramate or other carbonic anhydrase inhibitors (e.g. zonisamide, acetazolamide, dichlorphenamide), NSAIDs, ACE inhibitors, angiotensin II receptor antagonists, diuretics. May impair vitamin B12 absorption.
Potentially Fatal: Intravascular administration of iodinated contrast may cause nephropathy and increased risk of metformin-induced lactic acidosis.
Side Effects
Side effects of Empagliflozin + Metformin :
1-10%
Urinary tract infection (7.6-9.3%)
Decreased vitamin B12 levels (7%)
Increased LDL-C (4.6-6.5%)
Female genital mycotic infections (5.4-6.4%)
Dyslipidemia (2.9-3.9%)
Increased urination (3.2-3.4%)
Male genital mycotic infections (1.6-3.1%)
Nausea (1.1-2.3%)
Hypoglycemia, with monotherapy (1.4-1.8%)
<1%
Volume depletion
Impaired renal function
Mode of Action
Empagliflozin: Selective sodium-glucose transporter-2 (SGLT2) inhibitor; SGLT2 is expressed in the proximal renal tubules and is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen; SGLT2 inhibitors reduce glucose reabsorption and lower the renal threshold for glucose, thereby increasing urinary glucose excretion
Metformin: Decreases hepatic glucose production; decreases GI glucose absorption; increases target cell insulin sensitivity
Note
Emparol 5mg + 500mg Tablet generic name is Empagliflozin + Metformin. Emparol 5mg + 500mg Tablet is manufactured by Drug International Ltd.Emparol is availble in all over Bangladesh.
Mes BD drug index information on Emparol Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.