GLIFLOZAMET XR 25/1000MG 30TAB

Description of GLIFLOZAMET XR 25/1000MG 30TAB:

Extended Release Film Coated Tablets Contain Empagliflozin 25 mg & Metformin Hydrochloride 1000 mg Used For Treatment Of Diabetes Mellitus Type 2.

type 2 Diabetes Mellitus

Indicated as adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus (T2DM) when treatment with both empagliflozin and metformin is appropriate

Individualize starting dose based on the patient’s current drug regimen

Empagliflozin, when used in combination with metformin, is also indicated in T2DM to reduce risk of

• Cardiovascular death in adults with established cardiovascular disease
• Cardiovascular death and hospitalization for heart failure in adults with heart failure

Active ingredients:

tablet, extended-release

• 25mgEmpagliflozin/1000mg Metformin Hydrochloride

Dosing Considerations

Before initiation

• Assess renal function and periodically, thereafter
• Correct volume depletion before initiating if not previously treated with empagliflozin

Limitations of use

• Not for patients with type 1 diabetes; it may increase risk of diabetic ketoacidosis in these patients

Adverse effects:

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

Contraindications

Moderate-to-severe renal disease (eGFR <45 mL/min/1.73 m²), end-stage renal disease, or dialysis

Acute or chronic metabolic acidosis, including diabetic ketoacidosis (treat ketoacidosis with insulin)

History of serious hypersensitivity reaction to empagliflozin or metformin

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

Mechanism 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

Related drugs:

JARDIANCE 25MG

SYNJARDY