Hilton Pharma (Pvt) Ltd.

Xenglu-Met Tablets 12.5 Mg/1000Mg

Xenglu-Met Tablets 12.5 Mg/1000Mg

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SPECIFICATION

Requires Prescription (YES/NO)

Yes

Generics

Empagliflozin , Metformin HCl

Used For

Diabetes

How it works

Metformin hydrochloride is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. 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.

USAGE AND SAFETY

Dosage

Empagliflozin , Metformin HCl

Side Effects

Most common adverse reactions associated with empagliflozin (5% or greater incidence) were urinary tract infection and female genital mycotic infections. Most common adverse reactions associated with metformin (>5%) are diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache.

Drug Interactions

Diuretics , Positive Urine Glucose Test , Interference with 1,5-anhydroglucitol (1,5-AG) Assay , ranolazine, vandetanib, dolutegravir, and cimetidine , zonisamide, acetazolamide or dichlorphenamide , corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid , Nifedipine

Indication

It is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing empagliflozin or metformin, or in patients already being treated with both empagliflozin and metformin.

When not to Use

It should not be used when Renal Impairment, ESRD, or on dialysis, Metabolic acidosis, including diabetic ketoacidosis, History of serious hypersensitivity reaction to empagliflozin or metformin.

PRECAUTIONS

Precaution

Keep all medicines out of the reach and sight of children. Store in a cool, dry place, away from direct heat and light.

WARNINGS

Warning 1

Lactic Acidosis: There have been postmarketing cases of Metformin-associated lactic acidosis, including fatal cases. These cases had a subtle onset and were accompanied by nonspecific symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypothermia, hypotension, and resistant bradyarrhythmias have occurred with severe acidosis.

Warning 2

Hypotension: Empagliflozin causes intravascular volume contraction. Symptomatic hypotension may occur after initiating Empagliflozin particularly in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Before initiating this medicine , assess for volume contraction and correct volume status if indicated. Monitor for signs and symptoms of hypotension after initiating therapy and increase monitoring in clinical situations where volume contraction is expected.

Warning 3

Ketoacidosis: Ketoacidosis, a serious life-threatening condition require urgent hospitalization in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose co-transporter-2 (SGLT2) inhibitors, including Empagliflozin. Fatal cases of ketoacidosis have been reported in patients taking Empagliflozin.These medicines are not indicated for the treatment of patients with type 1 diabetes mellitus.

ADDITIONAL INFORMATION

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.

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