Biguanide

Diabetes Mellitus, Type 2

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>SEGLUROMET (ertugliflozin and metformin hydrochloride) tablet for oral use contains ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor, and metformin HCl, a member of the biguanide class.<div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a>ErtugliflozinThe chemical name of ertugliflozin L-pyroglutamic acid is (1S,2S,3S,4R,5S)-5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol, compound with (2S)-5-oxopyrrolidine-2-carboxylic acid. The molecular formula is C27H32ClNO10 and the molecular weight is 566.00.The chemical structure is:<img alt="Chemical Structure" src="segluromet-01.jpg"/>Ertugliflozin L-pyroglutamic acid is a white to off-white powder that is soluble in ethyl alcohol and acetone, slightly soluble in ethyl acetate and acetonitrile and very slightly soluble in water.</div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a>Metformin HClMetformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:<img alt="Chemical Structure" src="segluromet-02.jpg"/>Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.SEGLUROMET is available as film-coated tablets containing:<ul class="Disc"><li>3.24 mg ertugliflozin L-pyroglutamic acid equivalent to 2.5 mg of ertugliflozin and 500 mg metformin HCl (SEGLUROMET 2.5/500)</li><li>3.24 mg ertugliflozin L-pyroglutamic acid equivalent to 2.5 mg of ertugliflozin and 1,000 mg metformin HCl (SEGLUROMET 2.5/1000)</li><li>9.71 mg ertugliflozin L-pyroglutamic acid equivalent to 7.5 mg of ertugliflozin and 500 mg metformin HCl (SEGLUROMET 7.5/500)</li><li>9.71 mg ertugliflozin L-pyroglutamic acid equivalent to 7.5 mg of ertugliflozin and 1,000 mg metformin HCl (SEGLUROMET 7.5/1000)</li></ul>Inactive ingredients are povidone, microcrystalline cellulose, crospovidone, sodium lauryl sulfate, and magnesium stearate.The film coating contains: hypromellose, hydroxypropyl cellulose, titanium dioxide, iron oxide red, and carnauba wax.</div></section>

SEGLUROMET

ertugliflozin

ertugliflozin / metformin

ertugliflozin 2.5 MG / metformin hydrochloride 1000 MG Oral Tablet

Segluromet

ertugliflozin 2.5 MG / metformin hydrochloride 1000 MG Oral Tablet [Segluromet]

ertugliflozin 2.5 MG / metformin hydrochloride 500 MG Oral Tablet

ertugliflozin 2.5 MG / metformin hydrochloride 500 MG Oral Tablet [Segluromet]

ertugliflozin 7.5 MG / metformin hydrochloride 1000 MG Oral Tablet

ertugliflozin 7.5 MG / metformin hydrochloride 1000 MG Oral Tablet [Segluromet]

ertugliflozin 7.5 MG / metformin hydrochloride 500 MG Oral Tablet

ertugliflozin 7.5 MG / metformin hydrochloride 500 MG Oral Tablet [Segluromet]

metformin hydrochloride

metformin

Dipeptidyl Peptidase 4 Inhibitors

Dipeptidyl Peptidase 4 Inhibitor

Sodium-Glucose Transporter 2 Inhibitors

Sodium-Glucose Cotransporter 2 Inhibitor

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>TRIJARDY XR tablets for oral use contain: empagliflozin, linagliptin, and metformin HCl.<div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a>EmpagliflozinEmpagliflozin is an inhibitor of the SGLT2.The chemical name of empagliflozin is D-Glucitol,1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-, (1S).The molecular formula is C23H27ClO7 and the molecular weight is 450.91. The structural formula is:<img alt="Chemical Structure" src="trijardy-01.jpg"/>Empagliflozin is a white to yellowish, non-hygroscopic powder. It is very slightly soluble in water, sparingly soluble in methanol, slightly soluble in ethanol and acetonitrile, soluble in 50% acetonitrile/water, and practically insoluble in toluene.</div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a>LinagliptinLinagliptin is an inhibitor of the DPP-4 enzyme.The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-The molecular formula is C25H28N8O2 and the molecular weight is 472.54. The structural formula is:<img alt="Chemical Structure" src="trijardy-02.jpg"/>Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water. Linagliptin is soluble in methanol, sparingly soluble in ethanol, very slightly soluble in isopropanol, and very slightly soluble in acetone.</div><div class="Section" data-sectioncode="42229-5"><a name="section-10.3"></a>Metformin HClMetformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is:<img alt="Chemical Structure" src="trijardy-03.jpg"/></div><div class="Section" data-sectioncode="42229-5"><a name="section-10.4"></a>TRIJARDY XREach film-coated tablet of TRIJARDY XR consists of an extended-release metformin hydrochloride core tablet that is coated with the immediate-release drug substances: empagliflozin and linagliptin.TRIJARDY XR tablets for oral administration are available in four strengths containing:<ul class="Disc"><li>5 mg empagliflozin, 2.5 mg linagliptin, and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)</li><li>10 mg empagliflozin, 5 mg linagliptin, and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)</li><li>12.5 mg empagliflozin, 2.5 mg linagliptin, and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)</li><li>25 mg empagliflozin, 5 mg linagliptin, and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)</li></ul>Each film-coated tablet of TRIJARDY XR contains the following inactive ingredients: Tablet Core: hypromellose, magnesium stearate, and polyethylene oxide. Film Coatings and Printing Ink: ammonium hydroxide, arginine, carnauba wax, ferric oxide yellow and ferric oxide red (10 mg/5 mg/1,000 mg), ferrosoferric oxide and ferric oxide red (12.5 mg/2.5 mg/1,000 mg), ferrosoferric oxide and ferric oxide yellow (5 mg/2.5 mg/1,000 mg and 25 mg/5 mg/1,000 mg), hydroxypropyl cellulose, hypromellose, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, propylene glycol, purified water, shellac glaze, talc, and titanium dioxide.</div></section>

Trijardy XR

linagliptin

empagliflozin

empagliflozin / linagliptin / metformin

24 HR empagliflozin 10 MG / linagliptin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

Trijardy

24 HR empagliflozin 10 MG / linagliptin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Trijardy]

24 HR empagliflozin 12.5 MG / linagliptin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

24 HR empagliflozin 12.5 MG / linagliptin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Trijardy]

24 HR empagliflozin 25 MG / linagliptin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

24 HR empagliflozin 25 MG / linagliptin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Trijardy]

24 HR empagliflozin 5 MG / linagliptin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

24 HR empagliflozin 5 MG / linagliptin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Trijardy]

Segluromet is a medication that combines ertugliflozin and metformin to regulate blood sugar levels. Ertugliflozin aids the kidneys in removing glucose from the bloodstream, while metformin reduces the amount of sugar released by the liver into the blood.

This medication is prescribed alongside diet and exercise to enhance blood sugar management in adults diagnosed with type 2 diabetes mellitus. It's important to note that Segluromet is not intended for the treatment of type 1 diabetes.

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Instructions For Use: Type 2 Diabetes 

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Trijardy XR tablets combine empagliflozin, linagliptin, and metformin, which are all oral medications for managing blood sugar levels.

This prescription medication, Trijardy XR, is employed in conjunction with dietary and exercise measures to enhance blood sugar regulation in adults diagnosed with type 2 diabetes mellitus. Additionally, it is utilized to reduce the risk of mortality resulting from heart attack, stroke, or heart failure in adults who have both type 2 diabetes and heart disease.

It's important to note that Trijardy XR is not intended for the treatment of type 1 diabetes.

Segluromet®(metformin hydrochloride)	Trijardy XR®(metformin hydrochloride)

Prescription Only Segluromet is a medication that combines ertugliflozin and metformin to regulate blood sugar levels. Ertugliflozin aids the kidneys in removing glucose from the bloodstream, while...	Prescription Only Trijardy XR tablets combine empagliflozin, linagliptin, and metformin, which are all oral medications for managing blood sugar levels. This prescription medication, Trijardy XR,...
Dosage & Administration
Administration
Oral . Learn more.	Oral . Learn more.
Dosing
Maximum recommended dose is 7.5 mg ertugliflozin/1,000 mg metformin twice daily. Take twice daily with meals, with gradual dose escalation. Do not use in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m2 . . Learn more.	The maximum recommended dose of TRIJARDY XR is 25 mg empagliflozin, 5 mg linagliptin and 2000 mg metformin HCl. Take once daily with a meal in the morning. Swallow whole; do not split, crush, dissolve, or chew.. Learn more.
Latin Shorthand
Max dose: 7.5 mg ertugliflozin / 1000 mg metformin BID. Take with meals, gradual dose increase. Avoid if eGFR < 30 mL/min/1.73 m².. Learn more.	Max dose TRIJARDY XR: 25 mg empagliflozin, 5 mg linagliptin, 2000 mg metformin HCl. Take 1x daily with AM meal. Swallow whole; no splitting, crushing, dissolving, or chewing.. Learn more.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$10. Learn more.
Annual Cap
$583 per fill . Learn more.	$175 per month. Learn more.
Assistance Expiration
12 uses. Learn more.	12/31/23. Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Physician Advisory
Adverse Reactions
Most common adverse reactions associated with ertugliflozin (incidence ≥5%) were female genital mycotic infections. Most common adverse reactions associated with metformin (incidence ≥5%) were diarrhea, nausea, vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. . Learn more.	Most common adverse reactions (5% or greater incidence) were upper respiratory tract infection, urinary tract infection, nasopharyngitis, diarrhea, constipation, headache, and gastroenteritis. . Learn more.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

Segluromet® Alternatives