Biguanide

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">INVOKAMET <span class="Bold"><span class="Sup">®</span></span>(canagliflozin and metformin HCl) and INVOKAMET <span class="Bold"><span class="Sup">®</span></span>XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. </p><div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a><p></p><p class="First"><span class="Underline">Canagliflozin</span></p><p>Canagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin 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="invokamet-01.jpg"/></div><p>Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9.</p></div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a><p></p><p class="First"><span class="Underline">Metformin HCl</span></p><p>Metformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C <span class="Sub">4</span>H <span class="Sub">11</span>N <span class="Sub">5</span>∙ HCl and 165.62, respectively. The structural formula for metformin HCl is: </p><div class="Figure"><img alt="Chemical Structure" src="invokamet-02.jpg"/></div></div><div class="Section" data-sectioncode="42229-5"><a name="section-10.3"></a><p></p><p class="First"><span class="Underline">INVOKAMET and INVOKAMET XR</span></p><p>INVOKAMET or INVOKAMET XR are supplied as film-coated tablets for oral administration. Each 50 mg/500 mg tablet and 50 mg/1,000 mg tablet contains 51 mg of canagliflozin equivalent to 50 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively).</p><p>Each 150 mg/500 mg tablet and 150 mg/1,000 mg tablet contains 153 mg of canagliflozin equivalent to 150 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively).</p><p>INVOKAMET contains the following inactive ingredients: croscarmellose sodium, hypromellose, 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 inactive ingredients: macrogol/PEG3350, polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide, iron oxide yellow (50 mg/1,000 mg and 150 mg/500 mg tablets only), iron oxide red (50 mg/1,000 mg, 150 mg/500 mg and 150 mg/1,000 mg tablets only), and iron oxide black (150 mg/1,000 mg tablets only).</p><p>INVOKAMET XR contains the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate (vegetable-sourced), microcrystalline cellulose, polyethylene oxide, and silicified microcrystalline cellulose (50 mg/500 mg and 50 mg/1,000 mg tablets only). The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350, polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide, iron oxide red, iron oxide yellow, and iron oxide black (50 mg/1,000 mg and 150 mg/1,000 mg tablets only).</p><p>INVOKAMET XR tablets provide canagliflozin for immediate-release and metformin HCl for extended-release. Each bilayer tablet is compressed from two separate granulates, one for each active ingredient of the tablet, and finished with a film-coating. The metformin HCl extended-release layer is based on a polymer matrix which controls the drug release by passive diffusion through the swollen matrix in combination with tablet erosion.</p></div></section>

INVOKAMET

24 HR canagliflozin 150 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

24 HR canagliflozin 150 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Invokamet]

24 HR canagliflozin 150 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet

24 HR canagliflozin 150 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [Invokamet]

24 HR canagliflozin 50 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

24 HR canagliflozin 50 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Invokamet]

24 HR canagliflozin 50 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet

24 HR canagliflozin 50 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [Invokamet]

Invokamet

canagliflozin

canagliflozin / metformin

canagliflozin 150 MG / metformin hydrochloride 1000 MG Oral Tablet

canagliflozin 150 MG / metformin hydrochloride 1000 MG Oral Tablet [Invokamet]

canagliflozin 150 MG / metformin hydrochloride 500 MG Oral Tablet

canagliflozin 150 MG / metformin hydrochloride 500 MG Oral Tablet [Invokamet]

canagliflozin 50 MG / metformin hydrochloride 1000 MG Oral Tablet

canagliflozin 50 MG / metformin hydrochloride 1000 MG Oral Tablet [Invokamet]

canagliflozin 50 MG / metformin hydrochloride 500 MG Oral Tablet

canagliflozin 50 MG / metformin hydrochloride 500 MG Oral Tablet [Invokamet]

metformin

metformin hydrochloride

Sodium-Glucose Cotransporter 2 Inhibitor

Sodium-Glucose Transporter 2 Inhibitors

<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]

Invokamet XR is a medication that, when combined with dietary and exercise measures, is prescribed to enhance blood sugar management in adults diagnosed with type 2 diabetes mellitus.

Additionally, Invokamet XR serves as a preventive measure to reduce the risk of fatality due to heart attack, stroke, or heart failure in adults who have type 2 diabetes and coexisting heart disease. It is also employed to diminish the likelihood of end-stage kidney disease and hospitalization or fatality stemming from heart issues in individuals with kidney problems linked to type 2 diabetes.

It's important to note that Invokamet XR is not intended for the treatment of type 1 diabetes.

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Instructions For Use: Diabetes

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.

Invokamet XR ®(metformin hydrochloride)	Synjardy®(metformin hydrochloride)

Prescription Only Invokamet XR is a medication that, when combined with dietary and exercise measures, is prescribed to enhance blood sugar management in adults diagnosed with type 2 diabetes...	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
INVOKAMET XR: two tablets, once daily with the morning meal. Swallow whole. Never crush, cut, or chew. . 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
2 tabs, 1x daily with AM meal. Swallow whole, do not crush, cut, or chew.. 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
$3000 and $200 per month. Learn more.	$175 per month . Learn more.
Assistance Expiration
Calendar year. Learn more.	Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Physician Advisory
Adverse Reactions
Most common adverse reactions associated with canagliflozin (5% or greater incidence): female genital mycotic infections, urinary tract infection, and increased urination. Most common adverse reactions associated with metformin HCl (5% or greater incidence) are diarrhea, nausea, vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache.. 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

Invokamet XR ® Alternatives