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SEGLUROMET
Diabetes
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Drug Name:

SEGLUROMET Rx

Generic Name and Formulations:
Ertugliflozin, metformin HCl; 2.5mg/500mg, 2.5mg/1000mg, 7.5mg/500mg, 7.5mg/1000mg; tabs.

Company:
Merck & Co., Inc.

Therapeutic Use:

Indications for SEGLUROMET:

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 ertugliflozin or metformin, or in patients already treated with both ertugliflozin and metformin.

Limitations Of use:

Not for treating type 1 diabetes mellitus or diabetic ketoacidosis.

Adult:

See full labeling. Individualize. Swallow whole. Take twice daily with meals. Increase dose gradually as tolerated. Maximum daily dose: 15mg/2000mg. Renal impairment: if eGFR 30–<60mL/min/1.73m2: do not initiate; if persistently between 30–<60mL/min/1.73m2: continued use is not recommended.

Children:

<18yrs: not established.

Contraindications:

Severe renal impairment (eGFR <30mL/min/1.73m2), ESRD, or on dialysis. Metabolic acidosis, diabetic ketoacidosis.

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. Monitor for symptomatic hypotension in renal impairment (eGFR <60mL/min/1.73m2), elderly, low systolic BP, or on diuretics. 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). Assess renal function prior to starting and periodically thereafter; more frequently in elderly. Consider factors that may predispose to acute kidney injury including hypovolemia, chronic renal insufficiency, CHF, and on concomitant drugs (eg, diuretics, ACEIs, ARBs, NSAIDs). Consider temporarily discontinuing in reduced oral intake or fluid losses; monitor for acute kidney injury; discontinue and treat if occurs. Elderly, debilitated, uncompensated strenuous exercise, malnourished or deficient caloric intake, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Monitor for genital mycotic infections, UTIs (including urosepsis, pyelonephritis), hematology (esp. serum Vit. B12 in susceptible patients), increases in LDL-C; treat if needed. Before initiating, consider factors that may increase risk of amputation (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. Hepatic impairment: not recommended. Pregnancy (2nd & 3rd trimesters), nursing mothers: not recommended.

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. Consider a lower dose of concomitant insulin/insulin secretagogue to reduce risk of hypoglycemia. β-blockers may mask hypoglycemia. May cause false (+) urine glucose tests or unreliable measurements of 1, 5-AG assay; use alternative methods to monitor glycemic control.

Pharmacological Class:

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

Adverse Reactions:

Genital mycotic infections (esp. females), UTIs, headache, vaginal pruritus, increased urination, thirst, diarrhea, nausea, vomiting, flatulence, abdominal discomfort, indigestion, asthenia; hypotension, ketoacidosis, lower limb amputation, hypoglycemia, increases in LDL-C; rare: lactic acidosis.

Generic Availability:

NO

How Supplied:

Tabs—60, 180, 500

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