Sodium-Glucose Cotransporter 2 Inhibitor

Sodium-Glucose Transporter 2 Inhibitors

Type 2 Diabetes Mellitus

<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

empagliflozin 10 MG Oral Tablet

empagliflozin 10 MG Oral Tablet [Jardiance]

empagliflozin 25 MG Oral Tablet

empagliflozin 25 MG Oral Tablet [Jardiance]

Biguanide

<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

Segluromet

ertugliflozin

ertugliflozin / metformin

ertugliflozin 2.5 MG / metformin hydrochloride 1000 MG Oral Tablet

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

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.

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Managing Multiple Medications

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.

Jardiance®(empagliflozin)	Segluromet®(ertugliflozin / metformin)

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...	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...
Dosage & Administration
Administration
Oral . Learn more.	Oral . Learn more.
Dosing
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.	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.
Latin Shorthand
Recommended: 10mg qd in AM, with or without food. May increase to 25mg for better glycemic control.. Learn more.	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.
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 and female genital mycotic infections. . Learn more.	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.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

Jardiance® Alternatives