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>SYNJARDY and SYNJARDY XR tablets for oral use contain: empagliflozin 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).Its molecular formula is C23H27ClO7 and the molecular weight is 450.91. The structural formula is:<img alt="Chemical Structure" src="synjardy-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>Metformin HClMetformin HCl (N,N-dimethylimidodicarbonimidic diamide HCl) 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 HCl is 6.68. The structural formula is:<img alt="Chemical Structure" src="synjardy-02.jpg"/></div><div class="Section" data-sectioncode="42229-5"><a name="section-10.3"></a>SYNJARDYSYNJARDY tablets for oral administration are available in four dosage strengths containing:<ul class="Disc"><li>5 mg empagliflozin and 500 mg metformin HCl (equivalent to 389.93 mg of metformin)</li><li>5 mg empagliflozin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)</li><li>12.5 mg empagliflozin and 500 mg metformin HCl (equivalent to 389.93 mg of metformin)</li><li>12.5 mg empagliflozin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)</li></ul>Each film-coated tablet of SYNJARDY contains the following inactive ingredients: colloidal silicon dioxide, copovidone, corn starch, and magnesium stearate. Film-coating: black ferrosoferric oxide and ferric oxide red (12.5 mg/500 mg, 12.5 mg/1,000 mg) or ferric oxide yellow (5 mg/500 mg, 5 mg/1,000 mg), hypromellose, polyethylene glycol 400, talc and titanium dioxide.</div><div class="Section" data-sectioncode="42229-5"><a name="section-10.4"></a>SYNJARDY XREach film-coated tablet of SYNJARDY XR consists of an extended-release metformin HCl core tablet that is coated with the immediate-release drug substance empagliflozin.SYNJARDY XR tablets for oral administration are available in four dosage strengths containing:<ul class="Disc"><li>5 mg empagliflozin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)</li><li>10 mg empagliflozin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)</li><li>12.5 mg empagliflozin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)</li><li>25 mg empagliflozin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)</li></ul>Each film-coated tablet of SYNJARDY XR contains the following inactive ingredients: Tablet Core: hypromellose, magnesium stearate, and polyethylene oxide. Film-coatings and Printing Ink: carnauba wax, FD&amp;C blue#2/indigo carmine aluminum lake (12.5 mg/1,000 mg, 25 mg/1,000 mg), ferric oxide red (10 mg/1,000 mg), ferric oxide yellow (5 mg/1,000 mg, 10 mg/1,000 mg, 25 mg/1,000 mg), ferrosoferric oxide, hypromellose, isopropyl alcohol, polydextrose, polyethylene glycol, propylene glycol, purified water, talc, and titanium dioxide.</div></section>

Synjardy

empagliflozin

empagliflozin / metformin

empagliflozin 5 MG / metformin hydrochloride 500 MG Oral Tablet

empagliflozin 5 MG / metformin hydrochloride 500 MG Oral Tablet [Synjardy]

empagliflozin 12.5 MG / metformin hydrochloride 500 MG Oral Tablet

empagliflozin 12.5 MG / metformin hydrochloride 500 MG Oral Tablet [Synjardy]

empagliflozin 5 MG / metformin hydrochloride 1000 MG Oral Tablet

empagliflozin 5 MG / metformin hydrochloride 1000 MG Oral Tablet [Synjardy]

empagliflozin 12.5 MG / metformin hydrochloride 1000 MG Oral Tablet

empagliflozin 12.5 MG / metformin hydrochloride 1000 MG Oral Tablet [Synjardy]

metformin hydrochloride

metformin

<section class="Section" data-sectioncode="34089-3"><a name="ID_fd36fb00-7c31-4b1a-ad48-5d227ed82c01"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>Dapagliflozin, an inhibitor of SGLT2, is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1). The empirical formula is C21H25ClO6•C3H8O2•H2O and the molecular weight is 502.98. The structural formula is:<div class="Figure"><a name="id6857421"></a><img alt="Dapagliflozin Chemical Structure" src="dapagliflozin_struct.jpg"/></div>FARXIGA is available as a film-coated tablet for oral administration containing the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol or the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol, and the following inactive ingredients: anhydrous lactose, crospovidone, magnesium stearate, microcrystalline cellulose, and silicon dioxide. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.</section>

FARXIGA

Farxiga

dapagliflozin 10 MG Oral Tablet [Farxiga]

dapagliflozin 5 MG Oral Tablet [Farxiga]

dapagliflozin

dapagliflozin 10 MG Oral Tablet

dapagliflozin 5 MG Oral Tablet

Synjardy is a medication that combines empagliflozin and metformin, both of which are oral drugs designed to regulate blood sugar levels. Empagliflozin functions by assisting the kidneys in removing glucose from the bloodstream, while metformin reduces glucose production in the liver and reduces glucose absorption in the intestines.

This medication is prescribed in conjunction with dietary and exercise measures to enhance blood sugar management in individuals aged 10 years and older diagnosed with type 2 diabetes mellitus. Additionally, Synjardy is utilized to reduce the risk of mortality from heart attacks, strokes, or heart failure in adults who have both type 2 diabetes and heart disease.

Please note that Synjardy is not intended for the treatment of type 1 diabetes.

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Instructions For Use: Diabetes 

Farxiga (dapagliflozin) is an oral medication prescribed for individuals with diabetes, heart disease, or kidney disease to enhance their health outcomes. Here's how Farxiga is utilized:

Farxiga is employed in adults with type 2 diabetes mellitus, complementing dietary and exercise measures to regulate blood sugar levels.

It helps lower the likelihood of hospitalization due to heart failure in adults with type 2 diabetes who have either cardiovascular disease or multiple cardiovascular risk factors.

Farxiga reduces the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults already dealing with heart failure.

It also diminishes the risk of further deterioration in kidney function, progression to end-stage kidney disease (ESKD), cardiovascular-related deaths, and hospitalization due to heart failure in adults with chronic kidney disease who are at risk. 

Farxiga operates by inhibiting the sodium-glucose cotransporter 2 (SGLT2) found in the kidneys' proximal renal tubules. This inhibition prevents the reabsorption of glucose, causing it to be excreted in the urine. Additionally, Farxiga reduces sodium reabsorption in the kidneys, affecting various physiological functions. These include reducing the heart's preload and afterload, regulating sympathetic activity, and decreasing renal pressure.

Farxiga received FDA approval on January 8, 2014, and belongs to the class of medications known as selective sodium-glucose cotransporter-2 inhibitors.

Synjardy®(metformin hydrochloride)	Farxiga®(dapagliflozin)

Prescription Only Synjardy is a medication that combines empagliflozin and metformin, both of which are oral drugs designed to regulate blood sugar levels. Empagliflozin functions by assisting the...	Prescription Only Farxiga (dapagliflozin) is an oral medication prescribed for individuals with diabetes, heart disease, or kidney disease to enhance their health outcomes. Here's how Farxiga is...
Dosage & Administration
Administration
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Dosing
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Latin Shorthand
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Financial Assistance
Out-Of-Pocket Costs With Copay Card
$10. Learn more.	$0. Learn more.
Annual Cap
$175 per month . Learn more.	$175 per month. Learn more.
Assistance Expiration
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Generics
No lower-cost generic available	No lower-cost generic available
Physician Advisory
Adverse Reactions
Most common adverse reactions associated with empagliflozin (5% or greater incidence) were urinary tract infection and female genital mycotic infections. Most common adverse reactions associated with metformin (>5%) are diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache.. Learn more.	Most common adverse reactions (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections. . Learn more.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

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