Indications for: SEGLUROMET

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

Not recommended in those with type 1 diabetes; may increase risk of diabetic ketoacidosis.

Adult Dosage:

See full labeling. Swallow whole. Take twice daily with meals. Individualize. Base dose on patient's current regimen. Increase dose gradually as tolerated. Maximum daily dose: 15mg/2000mg. Renal impairment (eGFR <45mL/min/1.73m2): not recommended.

Children Dosage:

<18yrs: not established.

SEGLUROMET Contraindications:

Severe renal impairment (eGFR <30mL/min/1.73m2), ESRD, or on dialysis. Metabolic acidosis, diabetic ketoacidosis, with or without coma.

Boxed Warning:

Lactic acidosis.

SEGLUROMET Warnings/Precautions:

Increased risk of metformin-associated lactic acidosis in renal or hepatic impairment, concomitant use of certain drugs (eg, carbonic anhydrase inhibitors), ≥65yrs of age, undergoing radiological contrast study, surgery and other procedures, hypoxic states, and excessive alcohol intake; discontinue if lactic acidosis occurs. Discontinue at time of, or prior to intravascular iodinated contrast imaging in patients with eGFR <60mL/min/1.73m2, history of hepatic impairment, alcoholism, heart failure, or will be given intra-arterial contrast; reevaluate eGFR 48hrs after procedure and restart therapy if renally stable. Correct volume depletion before initiating. Increased risk for volume depletion or hypotension in those with renal impairment (eGFR <60mL/min/1.73m2), elderly, low systolic BP, or on loop diuretics. Assess volume status and renal function prior to initiation; monitor during therapy and more frequently in elderly. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, evaluate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Consider temporarily discontinuing prior to scheduled surgery (for ≥4 days) or other clinical situations (eg, prolonged fasting due to illness or post-surgery). Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Increased risk of genital mycotic infections, UTIs (including urosepsis, pyelonephritis); monitor and treat appropriately. Prior to initiation, consider factors that may predispose to need for amputations (eg, history of prior amputation, peripheral vascular disease, neuropathy, diabetic foot ulcers). Monitor for infection (including osteomyelitis), new pain/tenderness, sores or ulcers of the lower limbs; discontinue if occur. Measure hematologic parameters annually and Vit. B12 levels at 2–3 year intervals. Hepatic impairment: not recommended. Pregnancy (2nd & 3rd trimesters), nursing mothers: not recommended.

SEGLUROMET Classification:

Sodium-glucose co-transporter 2 (SGLT2) inhibitor + biguanide.

SEGLUROMET Interactions:

Increased risk of lactic acidosis with topiramate, other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide); monitor. Concomitant cationic drugs that interfere with renal tubular transport systems (eg, ranolazine, vandetanib, dolutegravir, cimetidine) may increase metformin levels. Diuretics, steroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, CCBs, and isoniazid may cause hyperglycemia. Avoid excessive alcohol. Greater potential for volume depletion or hypotension with concomitant diuretics. β-blockers may mask hypoglycemia. May need a lower dose of concomitant insulin or insulin secretagogue (eg, sulfonylurea) to reduce risk of hypoglycemia. Ertugliflozin may antagonize serum lithium concentrations; monitor levels more frequently. Ertugliflozin will lead to false (+) urine glucose tests or unreliable measurements of 1, 5-AG assay; use alternative methods to monitor glycemic control.

Adverse Reactions:

Genital mycotic infections (esp. females), UTIs, headache, vaginal pruritus, increased urination, thirst, diarrhea, nausea, vomiting, flatulence, abdominal discomfort, indigestion, asthenia; hypoglycemia, ketoacidosis, lower limb amputation; rare: lactic acidosis, Fournier's gangrene.

Generic Drug Availability:


How Supplied:

Tabs—60, 180, 500