Dipeptidyl Peptidase 4 Inhibitors

Dipeptidyl Peptidase 4 Inhibitor

Sodium-Glucose Transporter 2 Inhibitors

Sodium-Glucose Cotransporter 2 Inhibitor

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>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

metformin hydrochloride

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]

metformin

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>JARDIANCE tablets for oral use contain empagliflozin, 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).Its molecular formula is C23H27ClO7 and the molecular weight is 450.91. The structural formula is:<img alt="Chemical Structure" src="jardiance-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.Each film-coated tablet of JARDIANCE contains 10 mg or 25 mg of empagliflozin (free base) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: hypromellose, polyethylene glycol, talc, titanium dioxide, and yellow ferric oxide.</section>

Jardiance

empagliflozin 10 MG Oral Tablet

empagliflozin 10 MG Oral Tablet [Jardiance]

empagliflozin 25 MG Oral Tablet

empagliflozin 25 MG Oral Tablet [Jardiance]

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.

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Instructions For Use: Type 2 Diabetes 

Jardiance (empagliflozin) is an FDA-approved tablet used to manage blood sugar levels in individuals aged 10 and above with type 2 diabetes. It is also employed to lower the risk of cardiovascular issues in adults with heart failure or cardiovascular disease and type 2 diabetes. Jardiance operates by reducing blood glucose levels (HbA1c) through increased glucose elimination in the urine. When prescribed for type 2 diabetes, it should be used alongside diet and exercise. Jardiance belongs to the SGLT-2 inhibitor class (sodium-glucose cotransporter-2 inhibitors). It functions by inhibiting SGLT-2 proteins found in the renal tubules of the kidneys, responsible for reabsorbing glucose into the bloodstream.

Jardiance is available in 10mg and 25mg tablet forms.

The mechanism through which Jardiance reduces the risk of cardiovascular problems or heart failure is believed to involve altering heart muscle metabolism. This shift favors a balanced combination of fatty acids, ketone bodies (ketones), branched-chain amino acids (BCAA), and glucose over relying solely on glucose. Jardiance also enhances the heart's diastolic stiffness and function.

Type 2 diabetes is a chronic condition where elevated blood sugar levels (HbA1c) result from the body's inability to produce or utilize insulin properly. Prolonged high blood sugar levels can lead to severe health issues, including heart disease, vision impairment, and kidney disease. Maintaining better control of blood sugar levels helps mitigate the risk of diabetes-related complications.

Trijardy XR®(metformin hydrochloride)	Jardiance®(empagliflozin)

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,...	Prescription Only Jardiance (empagliflozin) is an FDA-approved tablet used to manage blood sugar levels in individuals aged 10 and above with type 2 diabetes. It is also employed to lower the risk...
Dosage & Administration
Administration
Oral . Learn more.	Oral . Learn more.
Dosing
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.	Recommended dosage is 10 mg once daily in the morning, taken with or without food. For additional glycemic control, dosage may be increased to 25 mg.. Learn more.
Latin Shorthand
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.	Recommended: 10mg qd in AM, with or without food. May increase to 25mg for better glycemic control.. Learn more.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
$10. Learn more.	$10. Learn more.
Annual Cap
$175 per month. Learn more.	$175 per month. Learn more.
Assistance Expiration
12/31/23. Learn more.	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 upper respiratory tract infection, urinary tract infection, nasopharyngitis, diarrhea, constipation, headache, and gastroenteritis. . Learn more.	Most common adverse reactions (5% or greater incidence) were urinary tract infections and female genital mycotic infections. . Learn more.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

Trijardy XR® Alternatives