Biguanide

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><p></p><h1>11 DESCRIPTION</h1><p class="First">SYNJARDY and SYNJARDY XR tablets for oral use contain: empagliflozin and metformin HCl.</p><div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a><p></p><p class="First"><span class="Italics">Empagliflozin</span></p><p>Empagliflozin is an inhibitor of the SGLT2.</p><p>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).</p><p>Its molecular formula is C<span class="Sub">23</span>H<span class="Sub">27</span>ClO<span class="Sub">7</span> and the molecular weight is 450.91. The structural formula is:</p><p><img alt="Chemical Structure" src="synjardy-01.jpg"/></p><p>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.</p></div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a><p></p><p class="First"><span class="Italics">Metformin HCl</span></p><p>Metformin HCl (<span class="Italics">N,N</span>-dimethylimidodicarbonimidic diamide HCl) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C<span class="Sub">4</span>H<span class="Sub">11</span>N<span class="Sub">5</span>∙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:</p><p><img alt="Chemical Structure" src="synjardy-02.jpg"/></p></div><div class="Section" data-sectioncode="42229-5"><a name="section-10.3"></a><p></p><p class="First"><span class="Italics">SYNJARDY</span></p><p>SYNJARDY tablets for oral administration are available in four dosage strengths containing:</p><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><p>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.</p></div><div class="Section" data-sectioncode="42229-5"><a name="section-10.4"></a><p></p><p class="First"><span class="Italics">SYNJARDY XR</span></p><p>Each 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.</p><p>SYNJARDY XR tablets for oral administration are available in four dosage strengths containing:</p><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><p>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.</p></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

metformin hydrochloride

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">INVOKANA <span class="Sup">®</span>(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 <span class="Italics">S</span>)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C <span class="Sub">24</span>H <span class="Sub">25</span>FO <span class="Sub">5</span>S∙1/2 H <span class="Sub">2</span>O and 453.53, respectively. The structural formula for canagliflozin is: </p><div class="Figure"><img alt="Chemical Structure" src="invokana-01.jpg"/></div><p>Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9.</p><p>INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively.</p><p>Inactive ingredients of the core tablet are croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following excipients: polyvinyl alcohol (partially hydrolyzed), titanium dioxide, macrogol/PEG, talc, and iron oxide yellow, E172 (100 mg tablet only).</p></section>

INVOKANA

Invokana

canagliflozin

canagliflozin 100 MG Oral Tablet

canagliflozin 100 MG Oral Tablet [Invokana]

canagliflozin 300 MG Oral Tablet

canagliflozin 300 MG Oral Tablet [Invokana]

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 

Invokana, an oral medication for diabetes, plays a crucial role in regulating blood sugar levels. Canagliflozin, its active component, functions by facilitating the elimination of glucose from the bloodstream through the kidneys.

Invokana is prescribed in conjunction with dietary adjustments and physical activity to enhance blood sugar management in adults diagnosed with type 2 diabetes mellitus.

Moreover, Invokana serves as a preventative measure, reducing the risk of fatality resulting from heart attack, stroke, or heart failure in adults who have both type 2 diabetes and heart disease. It is also employed to mitigate the risk of end-stage kidney disease and the likelihood of hospitalization or mortality due to heart-related issues in adults with kidney complications linked to type 2 diabetes.

Please note that Invokana is not suitable for the treatment of type 1 diabetes.

Synjardy®(metformin hydrochloride)	Invokana®(canagliflozin)

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 Invokana, an oral medication for diabetes, plays a crucial role in regulating blood sugar levels. Canagliflozin, its active component, functions by facilitating the elimination of...
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.	The recommended starting dose is 100 mg once daily, taken before the first meal of the day. Dose can be increased to 300 mg once daily in patients tolerating 100 mg once daily who have an eGFR of 60 mL/min/1.73 m2 or greater.. Learn more.
Latin Shorthand
Take PO BID with meals, titrate dose gradually to mitigate metformin GI SE.. Learn more.	Starting dose: 100 mg daily before 1st meal. Increase to 300 mg daily if tolerating 100 mg daily with eGFR ≥ 60 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.	$3000 and $200 per month. Learn more.
Assistance Expiration
Learn more.	Calendar year. 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 (5% or greater incidence): female genital mycotic infections, urinary tract infection, and increased urination. . Learn more.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

Synjardy® Alternatives