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

P-Glycoprotein Inhibitors

<section class="Section" data-sectioncode="34089-3"><a name="s41"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>INPEFA tablets for oral administration contain sotagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor.The chemical name of sotagliflozin is (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol.Its molecular formula is C21H25ClO5S and the molecular weight is 424.94. The structural formula is:<a name="f01"></a><img alt="Structural Formula
" src="sot00-0008-01.jpg"/>Sotagliflozin is a white to off-white solid. It is practically insoluble in water.Each film-coated tablet of INPEFA contains 200 mg or 400 mg of sotagliflozin and the following inactive ingredients. The core of the tablet contains colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and talc. The film coating for the 200 mg tablet contains: indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol (partly hydrolyzed), talc, and titanium dioxide. The film coating for the 400 mg tablet contains: hypromellose, lactose monohydrate, titanium dioxide, triacetin, and yellow iron oxide. The 200 mg printed tablet also includes black ink which contains: ammonium hydroxide, black iron oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac.</section>

INPEFA

sotagliflozin

sotagliflozin 200 MG Oral Tablet

Inpefa

sotagliflozin 200 MG Oral Tablet [Inpefa]

sotagliflozin 400 MG Oral Tablet

sotagliflozin 400 MG Oral Tablet [Inpefa]

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 

Inpefa is an oral tablet taken once daily, and it contains sotagliflozin. It can be used to lower the chances of cardiovascular death, hospitalization due to heart failure, and urgent heart failure-related visits in adults dealing with heart failure, type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

Inpefa received approval on May 26, 2023.

Synjardy®(metformin hydrochloride)	Inpefa®(sotagliflozin)

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 Inpefa is an oral tablet taken once daily, and it contains sotagliflozin. It can be used to lower the chances of cardiovascular death, hospitalization due to heart failure, and...
Dosage & Administration
Administration
Oral . Learn more.	Oral . Learn more.
Dosing
Take orally twice daily with meals, with gradual dosage escalation to reduce the gastrointestinal side effects due to metformin.. Learn more.	200 mg daily and titrate to 400 mg as tolerated.. Learn more.
Latin Shorthand
Take PO BID with meals, titrate dose gradually to mitigate metformin GI SE.. Learn more.	Take 200 mg qd, increase to 400 mg qd if tolerated.. Learn more.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
$10. Learn more.	$10. Learn more.
Annual Cap
$175 per month . Learn more.	$2,600. Learn more.
Assistance Expiration
Learn more.	12/31/25. Learn more.
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 (incidence ≥ 5%) are urinary tract infection, volume depletion, diarrhea, and hypoglycemia. . Learn more.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

Synjardy® Alternatives