Brand Name: Diaflazin
Generic Name: Empagliflozin
Preparations: 5/10/25 mg Tablets
Pharmacological category: SGLT2 inhibitor (Antidiabetic)

Absorption: Readily absorbed from gastrointestinal tract
Peak Plasma Time: 1.5 hours
Protein Binding: 86.2%
Metabolism: Liver via glucuronidation
Elimination Half-life: 12.4 hours
Excretion: Urine (54.4%), faeces (41.2%)

Mechanism of Action (MOA)
DIAFLAZIN (Empagliflozin) selectively inhibits sodium glucose transporter-2 (SGLT2) present in the proximal renal tubules that is responsible for the majority of reabsorption of filtered glucose from the tubular lumen. Thus, DIAFLAZIN reduces glucose reabsorption and lowers the renal threshold for glucose, thereby increasing urinary glucose excretion.
Several theories have been posited for mechanism of action of DIAFLAZIN in the prevention of heart failure including the potential inhibition of NHE (Na+/H+ exchanger) 1 in the myocardium and NHE3 in the proximal tubule, reduction of preload via diuretic/natriuretic effects and reduction of blood pressure, prevention of cardiac fibrosis via suppression of profibrotic markers, and reduction of pro-inflammatory adipokines.

Indications and Dosage
• Type 2 Diabetes, to reduce the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease: 10 mg daily; may increase to 25 mg/day if needed and tolerated.
• Heart Failure (to reduce the risk of CV death plus hospitalization in adults with heart failure and reduced ejection fraction): 10 mg daily

Administration: DIAFLAZIN can be taken with or without food. Patients are advised to take adequate fluid intake to reduce risk of hypotension.

Dosage Modifications
Hepatic Impairment: No dosage adjustment is required.

Renal Impairment:
• eGFR 30-90 mL/min/1.73 m2: No dosage adjustment required.
• eGFR<30 mL/min/1.73 m2 without cardiovascular risk factors: Not recommended
• Patients with end-stage renal disease or eGFR<30 mL/min/1.73 m2 with established cardiovascular disease or cardiovascular risk factors: Data are insufficient; no dosing recommendations available
• Patients on dialysis: Contraindicated

Heart Failure with reduced ejection fraction (HFrEF):
• eGFR³20 mL/min/1.73 m2: No dosage adjustment required
• eGFR<20 mL/min/1.73 m2: Data are insufficient; no dosing recommendations available
• eGFR<30 mL/min/1.73 m2 in patients without established cardiovascular disease or cardiovascular risk factors: Not recommended
• Patients on dialysis: Contraindicated

Side effects
1-10%: Urinary tract infection, female genital mycotic infections, upper respiratory tract infection, increased urination, dyslipidemia, male genital mycotic infections, arthralgia, nausea, and polydipsia
<1%: Decreased ambulatory blood pressure, decreased systolic blood pressure, dehydration, hypotension, hypovolemia, orthostatic hypotension, syncope, and increased urination
POSTMARKETING REPORTS: Ketoacidosis, urosepsis, pyelonephritis, necrotizing fascilitis of perineum, angioedema, and skin reactions

Hypersensitivity, severe renal impairment, end-stage renal disease or patient on dialysis

Pregnancy Category: To be avoided during pregnancy and lactation.

• Causes intravascular volume contraction; symptomatic hypotension may occur after initiating, particularly in patients with renal impairment, low systolic blood pressure, on diuretics, or in the elderly
• Increases serum creatinine and decreases eGFR; risk increases in elderly or those with moderate renal impairment
• Increased incidence of bone fractures has been reported.
• Genital mycotic infections may occur.
• Increases risk of urinary tract infections (UTIs), including life-threatening urosepsis and pyelonephritis that started as UTIs.
• Dose-related increase in LDL-C has been reported.
• Acute kidney injury has been reported.
• Consider risk factors, including hypovolemia, heart failure, and chronic renal insufficiency or use of medications, including diuretics, ACE inhibitors, NSAIDs, or angiotensin receptor blockers
• Correct volume status before initiating if needed and monitor renal function periodically thereafter
• Necrotizing fasciitis of the perineum (Fournier gangrene) has been reported with SGLT2 inhibitors
• Signs and symptoms include tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4ºF or a general feeling of being unwell. If suspected, discontinue SGLT2 inhibitor and start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary
• Before initiating therapy, consider factors in patient history that may predispose to ketoacidosis, including pancreatic insulin deficiency from any cause, caloric restriction, and alcohol abuse
• Consider temporarily discontinuing therapy for at least 3 days for patients who undergo scheduled surgery
• Consider monitoring for ketoacidosis and temporarily discontinuing therapy in other clinical situations known to predispose to ketoacidosis. Restart once the patient’s oral intake is back to baseline and any other risk factors for ketoacidosis (blood acid buildup) are resolved
• Urine glucose tests and 1,5-AG assay are not recommended in patients taking SGLT2 inhibitors

Drug Interactions
• Drugs that may enhance the hypoglycemic effect of empagliflozin includes alpha lipoic acid, androgens, direct acting antiviral agents, guanethidine, maitake mushroom, monoamine oxidase inhibitors, pegvisomant, prothionamide, salicylates, selective serotonin reuptake inhihitors
• Hyperglycemia-associated agents may diminish the therapeutic effect of empagliflozin.
• Antidiabetic agents may enhance the hypoglycemic effect of Hypoglycemia-associated agents.
• May enhance the hypoglycemic effect of Insulins.
• May enhance the hypotensive effect of loop diuretics.
• Quinolones may diminish the therapeutic effect of empagliflozin.
• May enhance the hypoglycemic effect of Sulfonylureas.
• Thiazide and Thiazide-like diuretics may diminish the therapeutic effect of empagliflozin.

DIAFLAZIN 5 : 10 X 10’s
DIAFLAZIN 10: 10 X 10’s
DIAFLAZIN 25: 10 X 10’s