Sodium-Glucose Cotransporter 2 Inhibitor

Sodium-Glucose Transporter 2 Inhibitors

Type 2 Diabetes Mellitus

<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: microcrystalline cellulose, anhydrous lactose, crospovidone, silicon dioxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and yellow iron oxide.</section>

FARXIGA

Farxiga

dapagliflozin

dapagliflozin 10 MG Oral Tablet

dapagliflozin 10 MG Oral Tablet [Farxiga]

dapagliflozin 5 MG Oral Tablet

dapagliflozin 5 MG Oral Tablet [Farxiga]

Biguanide

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>SYNJARDY tablets for oral use contain: empagliflozin and metformin hydrochloride.<div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a>EmpagliflozinEmpagliflozin is an inhibitor of the sodium-glucose co-transporter 2 (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 hydrochlorideMetformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin hydrochloride 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. 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 5 mg empagliflozin and 500 mg metformin hydrochloride, 5 mg empagliflozin and 1000 mg metformin hydrochloride, 12.5 mg empagliflozin and 500 mg metformin hydrochloride, or 12.5 mg empagliflozin and 1000 mg metformin hydrochloride.Each film-coated tablet of SYNJARDY contains the following inactive ingredients: copovidone, corn starch, colloidal silicon dioxide, magnesium stearate. Film-coating: hypromellose, titanium dioxide, talc, polyethylene glycol 400, and yellow ferric oxide (5 mg/500 mg, 5 mg/1000 mg) or red ferric oxide and black ferrosoferric oxide (12.5 mg/500 mg, 12.5 mg/1000 mg).</div></section>

Synjardy

empagliflozin

empagliflozin / metformin

empagliflozin 12.5 MG / metformin hydrochloride 1000 MG Oral Tablet

empagliflozin 12.5 MG / metformin hydrochloride 1000 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 5 MG / metformin hydrochloride 500 MG Oral Tablet

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

metformin

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.

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Prescribing Information

Medication Guide 

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Pharmacy List 

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Farxiga Support 

Other HCP Resources: Video

Other HCP Resources 

Wallet Card 

Farxiga Newly Diagnosed CKD Patient Tear Sheet 

What is CKD & How Farxiga May Help - Brochure 

What is CKD & How Farxiga May Help - Brochure (Spanish)

Side Effects 

FAQs: Diabete, CKD & Heart Failure 

Instructions For Use: Diabetes

Instructions For Use: CKD

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.

Farxiga®(dapagliflozin)	Synjardy®(empagliflozin / metformin)

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...	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...
Dosage & Administration
Administration
Oral . Learn more.	Oral . Learn more.
Dosing
Recommended starting dose is 5 mg orally once daily. Dose can be increased to 10 mg orally once daily for additional glycemic control. . Learn more.	Take orally twice daily with meals, with gradual dosage escalation to reduce the gastrointestinal side effects due to metformin.. Learn more.
Latin Shorthand
Starting Dose: 5mg PO qd. Can be increased to 10mg PO qd for additional glycemic control.. Learn more.	Take PO BID with meals, titrate dose gradually to mitigate metformin GI SE.. Learn more.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$10. Learn more.
Annual Cap
$175 per month. Learn more.	$175 per month . Learn more.
Assistance Expiration
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 female genital mycotic infections, nasopharyngitis, and urinary tract infections. . Learn more.	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.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

Farxiga® Alternatives