Dipeptidyl Peptidase 4 Inhibitors

Dipeptidyl Peptidase 4 Inhibitor

Sodium-Glucose Transporter 2 Inhibitors

Sodium-Glucose Cotransporter 2 Inhibitor

Diabetes Mellitus, Type 2

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>GLYXAMBI tablets for oral use contain: empagliflozin and linagliptin.<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="glyxambi-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="glyxambi-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>GLYXAMBIGLYXAMBI tablets are available in two dosage strengths containing 10 mg or 25 mg empagliflozin in combination with 5 mg linagliptin. The inactive ingredients of GLYXAMBI are the following: Tablet Core: copovidone, corn starch, crospovidone, magnesium stearate, mannitol, pregelatinized starch, and talc. Coating: ferric oxide yellow (10 mg/5 mg) or ferric oxide red (25 mg/5 mg), hypromellose, mannitol, polyethylene glycol, talc, and titanium dioxide.</div></section>

Glyxambi

linagliptin

empagliflozin

empagliflozin / linagliptin

empagliflozin 10 MG / linagliptin 5 MG Oral Tablet

empagliflozin 10 MG / linagliptin 5 MG Oral Tablet [Glyxambi]

empagliflozin 25 MG / linagliptin 5 MG Oral Tablet

empagliflozin 25 MG / linagliptin 5 MG Oral Tablet [Glyxambi]

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>STEGLATRO (ertugliflozin) tablets for oral use contain ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor.The 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="steglatro-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.STEGLATRO is supplied as film-coated tablets, containing 6.48 or 19.43 mg of ertugliflozin L-pyroglutamic acid, which is equivalent to 5 and 15 mg of ertugliflozin.Inactive ingredients are microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, and magnesium stearate.The film coating contains: hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide and iron oxide red.</section>

STEGLATRO

ertugliflozin

ertugliflozin 5 MG Oral Tablet

Steglatro

ertugliflozin 5 MG Oral Tablet [Steglatro]

ertugliflozin 15 MG Oral Tablet

ertugliflozin 15 MG Oral Tablet [Steglatro]

Glyxambi is a medication that combines empagliflozin and linagliptin, both of which are oral drugs designed to manage blood sugar levels. Empagliflozin operates by aiding the kidneys in removing excess glucose from the bloodstream, while linagliptin works to regulate insulin production in response to meals.

Glyxambi is prescribed alongside a balanced diet and regular exercise to enhance blood sugar management in adults dealing with type 2 diabetes mellitus. Additionally, it is employed to reduce the risk of mortality due to heart attack, stroke, or heart failure in adults who have both type 2 diabetes and heart disease.

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

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Instructions For Use: Diabetes 

Steglatro is an oral medication designed to regulate blood sugar levels. Its active component, ertugliflozin, functions by facilitating the removal of glucose from the bloodstream through the kidneys.

It is prescribed in conjunction with dietary and exercise measures to enhance blood sugar management in adults diagnosed with type 2 diabetes mellitus. It's essential to note that Steglatro is not intended for the treatment of type 1 diabetes.

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Glyxambi®(empagliflozin / linagliptin)	Steglatro®(ertugliflozin)

Prescription Only Glyxambi is a medication that combines empagliflozin and linagliptin, both of which are oral drugs designed to manage blood sugar levels. Empagliflozin operates by aiding the...	Prescription Only Steglatro is an oral medication designed to regulate blood sugar levels. Its active component, ertugliflozin, functions by facilitating the removal of glucose from the bloodstream...
Dosage & Administration
Administration
Oral . Learn more.	Oral. Learn more.
Dosing
The recommended dose of GLYXAMBI is 10 mg empagliflozin and 5 mg linagliptin once daily, taken in the morning, with or without food. Dose may be increased to 25 mg empagliflozin and 5 mg linagliptin once daily.. Learn more.	Recommended starting dose is 5 mg once daily, taken in the morning, with or without food. Increase dose to 15 mg once daily in those tolerating STEGLATRO and needing additional glycemic control.. Learn more.
Latin Shorthand
Recommended GLYXAMBI dose: 10mg empagliflozin + 5mg linagliptin qd in the AM, with or without food. May increase to 25mg empagliflozin + 5mg linagliptin qd.. Learn more.	Starting dose: 5mg qd (morning, with or without food). Increase to 15mg daily if tolerated and requiring more glycemic control.. Learn more.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
$10. Learn more.	$0. Learn more.
Annual Cap
$175 per month. Learn more.	$583 per fill . Learn more.
Assistance Expiration
Learn more.	12 uses. Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Physician Advisory
Adverse Reactions
Most common adverse reactions (5% or greater incidence) were urinary tract infections, nasopharyngitis, and upper respiratory tract infections.. Learn more.	Most common adverse reactions (incidence ≥ 5%) were female genital mycotic infections. . Learn more.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

Glyxambi® Alternatives