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>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 / 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

metformin hydrochloride

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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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.

Jardiance®(empagliflozin)	Synjardy®(metformin hydrochloride)

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 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 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.	Take orally twice daily with meals, with gradual dosage escalation to reduce the gastrointestinal side effects due to metformin.. Learn more.
Latin Shorthand
Recommended: 10mg qd in AM, with or without food. May increase to 25mg for better 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
$10. 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 urinary tract infections and female genital mycotic 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

Jardiance® Alternatives