Biguanide

Type 2 Diabetes Mellitus

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>INVOKAMET ®(canagliflozin and metformin HCl) and INVOKAMET ®XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. <div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a>CanagliflozinCanagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is: <div class="Figure"><img alt="Chemical Structure" src="invokamet-01.jpg"/></div>Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9.</div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a>Metformin HClMetformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C 4H 11N 5∙ HCl and 165.62, respectively. The structural formula for metformin HCl is: <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>INVOKAMET and INVOKAMET XRINVOKAMET 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).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).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).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).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.</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

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>STEGLATRO (ertugliflozin) tablets for oral use contain ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor.The chemical name of ertugliflozin L-pyroglutamic acid is (1S,2S,3S,4R,5S)-5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol, compound with (2S)-5-oxopyrrolidine-2-carboxylic acid. The molecular formula is C27H32ClNO10 and the molecular weight is 566.00.The chemical structure is:<img alt="Chemical Structure" src="steglatro-01.jpg"/>Ertugliflozin L-pyroglutamic acid is a white to off-white powder that is soluble in ethyl alcohol and acetone, slightly soluble in ethyl acetate and acetonitrile and very slightly soluble in water.STEGLATRO is supplied as film-coated tablets, containing 6.48 or 19.43 mg of ertugliflozin L-pyroglutamic acid, which is equivalent to 5 and 15 mg of ertugliflozin.Inactive ingredients are microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, and magnesium stearate.The film coating contains: hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide and iron oxide red.</section>

STEGLATRO

Steglatro

ertugliflozin

ertugliflozin 15 MG Oral Tablet

ertugliflozin 15 MG Oral Tablet [Steglatro]

ertugliflozin 5 MG Oral Tablet

ertugliflozin 5 MG Oral Tablet [Steglatro]

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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About Invokamet XR

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Instructions For Use: Diabetes

Steglatro is an oral medication designed to regulate blood sugar levels. Its active component, ertugliflozin, functions by facilitating the removal of glucose from the bloodstream through the kidneys.

It is prescribed in conjunction with dietary and exercise measures to enhance blood sugar management in adults diagnosed with type 2 diabetes mellitus. It's essential to note that Steglatro is not intended for the treatment of type 1 diabetes.

Invokamet XR ®(metformin hydrochloride)	Steglatro®(ertugliflozin)

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 Steglatro is an oral medication designed to regulate blood sugar levels. Its active component, ertugliflozin, functions by facilitating the removal of glucose from the bloodstream...
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.	Recommended starting dose is 5 mg once daily, taken in the morning, with or without food. Increase dose to 15 mg once daily in those tolerating STEGLATRO and needing additional glycemic control.. Learn more.
Latin Shorthand
2 tabs, 1x daily with AM meal. Swallow whole, do not crush, cut, or chew.. Learn more.	Starting dose: 5mg qd (morning, with or without food). Increase to 15mg daily if tolerated and requiring more glycemic control.. Learn more.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$0. Learn more.
Annual Cap
$3000 and $200 per month. Learn more.	$583 per fill . Learn more.
Assistance Expiration
Calendar year. Learn more.	12 uses. 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 (incidence ≥ 5%) were female genital mycotic infections. . Learn more.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

Invokamet XR ® Alternatives