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Empagliflozin (Monograph)

Brand name: Jardiance
Drug class: Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors
Chemical name: (1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-d-glucitol
Molecular formula: C23H27ClO7
CAS number: 864070-44-0

Medically reviewed by Drugs.com on Dec 1, 2022. Written by ASHP.

Introduction

Antidiabetic agent; sodium-glucose cotransporter 2 (SGLT2) inhibitor.

Uses for Empagliflozin

Type 2 Diabetes Mellitus

Used as monotherapy as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Used to reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease.

May have beneficial effects on renal function; reduction of the risk of CKD progression demonstrated in clinical studies.

Used in combination with other antidiabetic agents (e.g., metformin, a sulfonylurea, a peroxisome proliferator-activated receptorγ [PPARγ] agonist [thiazolidinedione], a dipeptidylpeptidase-4 [DPP-4] inhibitor) or insulin as an adjunct to diet and exercise in patients with type 2 diabetes mellitus who have not achieved adequate glycemic control.

Used in fixed combination with immediate- or extended-release metformin hydrochloride or linagliptin as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus when treatment with both drugs is appropriate.

Current guidelines for the treatment of type 2 diabetes mellitus generally recommend metformin as first-line therapy in addition to lifestyle modifications in patients with recent-onset type 2 diabetes mellitus or mild hyperglycemia because of its well-established safety and efficacy (i.e., beneficial effects on glycosylated hemoglobin [hemoglobin A1c; HbA1c], weight, and cardiovascular mortality).

In patients with metformin contraindications or intolerance (e.g., risk of lactic acidosis, GI intolerance) or in selected other patients, some experts suggest that initial therapy with a drug from another class of antidiabetic agents (e.g., a glucagon-like peptide 1 [GLP-1] receptor agonist, SGLT2 inhibitor, DPP-4 inhibitor, sulfonylurea, thiazolidinedione, basal insulin) may be acceptable based on patient factors.

May need to initiate therapy with 2 agents (e.g., metformin plus another drug) in patients with high initial HbA1c (>7.5% or ≥1.5% above target). In such patients with metformin intolerance, some experts suggest initiation of therapy with 2 drugs from other drug classes with complementary mechanisms of action.

Consider early initiation of combination therapy for the treatment of type 2 diabetes mellitus to extend the time to treatment failure and more rapidly attain glycemic goals.

For patients with inadequate glycemic control on metformin monotherapy, consider patient comorbidities (e.g., atherosclerotic cardiovascular disease [ASCVD], established kidney disease, heart failure), hypoglycemia risk, impact on weight, cost, risk of adverse effects, and patient preferences when selecting additional antidiabetic agents for combination therapy.

Consider early introduction of insulin for severe hyperglycemia (e.g., blood glucose of ≥300 mg/dL or HbA1c >9–10%), especially if accompanied by catabolic manifestations (e.g., weight loss, hypertriglyceridemia, ketosis) or symptoms of hyperglycemia.

Experts recommend that patients with type 2 diabetes mellitus who have established (or are at a high risk for) ASCVD, established kidney disease, or heart failure receive a GLP-1 receptor agonist or SGLT2 inhibitor with demonstrated cardiovascular disease benefit. In patients with these comorbidities, consider GLP-1 receptor agonist or SGLT2 inhibitor therapy independently of patient's HbA1c.

In patients with type 2 diabetes mellitus and CKD, consider a GLP-1 receptor agonist or SGLT2 inhibitor shown to reduce the risk of CKD progression, cardiovascular events, or both, in addition to metformin therapy or in those in whom metformin cannot be used.

In patients on metformin monotherapy without established ASCVD or indicators of high ASCVD risk, heart failure, or CKD, base decision regarding addition of other antidiabetic agents on avoidance of adverse effects, cost, and individual patient factors.

Not indicated for treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Beneficial Effects on Renal Function

Some experts suggest that SGLT2 inhibitor therapy be considered to reduce risk of CKD progression, cardiovascular events, or both in patients with type 2 diabetes mellitus and diabetic kidney disease with albuminuria [off-label] (eGFR ≥30 mL/minute per 1.73 m2 and urinary albumin >30 mg/g [particularly >300 mg/g] creatinine).

Empagliflozin Dosage and Administration

General

Administration

Oral Administration

Administer empagliflozin or the fixed combination of empagliflozin and linagliptin once daily in the morning, with or without food.

Administer the fixed combination of empagliflozin and immediate-release metformin hydrochloride twice daily with meals.

Administer the fixed combination of empagliflozin and extended-release metformin hydrochloride once daily with the morning meal; swallow tablet whole (do not crush, chew, or cut).

If a dose is missed, take missed dose as soon as it is remembered followed by resumption of the regular schedule. If the missed dose is not remembered until it is almost time for the next dose, skip the missed dose and resume the regular schedule; do not double the dose to replace a missed dose.

Dosage

Adults

Type 2 Diabetes Mellitus
Empagliflozin Monotherapy
Oral

Recommended dosage is 10 mg once daily in the morning.

If well tolerated, may increase dosage to 25 mg once daily in the morning.

Empagliflozin/Linagliptin Fixed-combination Therapy
Oral

Recommended dosage is 10 mg of empagliflozin and 5 mg of linagliptin once daily in the morning.

If well tolerated, may increase dosage to 25 mg of empagliflozin and 5 mg of linagliptin once daily in the morning.

Empagliflozin/Immediate-release Metformin Hydrochloride Fixed-combination Therapy
Oral

Individualize dosage of empagliflozin in fixed combination with immediate-release metformin hydrochloride based on the patient's current antidiabetic regimen. May increase dosage gradually based on effectiveness and tolerability up to a maximum daily dosage of 25 mg of empagliflozin and 2 g of immediate-release metformin hydrochloride.

Patients currently receiving metformin hydrochloride: Initially, 10 mg of empagliflozin and a total daily dosage of immediate-release metformin hydrochloride similar to the patient's existing dosage, administered in 2 divided doses.

Patients currently receiving empagliflozin: Initially, same daily dosage of empagliflozin and 1 g of immediate-release metformin hydrochloride, administered in 2 divided doses.

Patients currently receiving both empagliflozin and metformin hydrochloride: Initially, same daily dosage of empagliflozin and a total daily dosage of immediate-release metformin hydrochloride similar to the patient's existing dosage, administered in 2 divided doses.

Empagliflozin/Extended-release Metformin Hydrochloride Fixed-combination Therapy
Oral

Individualize dosage of empagliflozin in fixed combination with extended-release metformin hydrochloride based on the patient's current antidiabetic regimen. May increase dosage gradually based on effectiveness and tolerability up to a daily maximum of 25 mg of empagliflozin and 2 g of extended-release metformin hydrochloride.

Patients currently receiving metformin hydrochloride: Initially, 10 mg of empagliflozin and a total daily dosage of extended-release metformin hydrochloride similar to the patient's existing dosage, administered once daily in the morning.

Patients currently receiving empagliflozin: Initially, same daily dosage of empagliflozin and 1 g of extended-release metformin hydrochloride, administered once daily in the morning.

Patients currently receiving both empagliflozin and metformin hydrochloride: Initially, same daily dosage of empagliflozin and a total daily dosage of extended-release metformin hydrochloride similar to the patient's existing dosage, administered once daily in the morning.

Special Populations

Hepatic Impairment

Empagliflozin Monotherapy

Mild, moderate, or severe: No dosage adjustment necessary.

Empagliflozin/Linagliptin Fixed-combination Therapy

May be used in patients with hepatic impairment.

Empagliflozin/Metformin Hydrochloride Fixed-combination Therapy

Use of the fixed-combination preparation of empagliflozin and immediate- or extended-release metformin hydrochloride not recommended.

Renal Impairment

Empagliflozin Monotherapy

eGFR ≥45 mL/minute per 1.73 m2: No dosage adjustment necessary.

eGFR <45 mL/minute per 1.73 m2: Do not initiate drug. Discontinue drug if eGFR is persistently <45 mL/minute per 1.73 m2. (See Renal Impairment under Cautions.)

Empagliflozin/Linagliptin Fixed-combination Therapy

eGFR ≥45 mL/minute per 1.73 m2: No dosage adjustment necessary.

eGFR <45 mL/minute per 1.73 m2: Do not initiate drug. Discontinue drug if eGFR is persistently <45 mL/minute per 1.73 m2.

Empagliflozin/Metformin Hydrochloride Fixed-combination Therapy

eGFR ≥45 mL/minute per 1.73 m2: No dosage adjustment necessary for fixed combination containing empagliflozin and immediate- or extended-release metformin hydrochloride.

eGFR <45 mL/minute per 1.73 m2: Contraindicated for fixed combination containing empagliflozin and immediate- or extended-release metformin hydrochloride.

Geriatric Patients

Monotherapy

No dosage adjustment necessary based solely on age.

Empagliflozin/Metformin Hydrochloride Fixed-combination Therapy

Monitor renal function frequently after initiating fixed-combination therapy.

Cautions for Empagliflozin

Contraindications

Warnings/Precautions

Ketoacidosis

Ketoacidosis (e.g., diabetic ketoacidosis, ketoacidosis, ketosis) requiring hospitalization reported with SGLT2 inhibitors; may occur without markedly elevated blood glucose concentrations (e.g., <250 mg/dL).

Evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing signs or symptoms of acidosis regardless of the patient's blood glucose concentration; discontinue SGLT2 inhibitor and initiate appropriate treatment to correct acidosis if confirmed. (See Advice to Patients.)

Prior to initiating empagliflozin therapy, consider factors that may predispose patients to ketoacidosis (e.g., pancreatic insulin deficiency, reduced caloric intake, alcohol abuse).

Consider discontinuing empagliflozin for ≥3 days prior to surgery for patients with scheduled surgery.

Consider temporarily discontinuing SGLT2 inhibitor in patients with other clinical situations known to predispose to ketoacidosis (e.g., prolonged fasting due to acute illness or post-surgery). Risk factors for ketoacidosis should be resolved prior to restarting empagliflozin.

Some clinicians suggest monitoring of urine and/or plasma ketone levels if patients feel unwell, regardless of ambient glucose concentrations.

Hypotension

May cause intravascular volume contraction. Symptomatic hypotension can occur, particularly in patients with impaired renal function, geriatric patients, patients receiving diuretics, or patients with low systolic BP. (See Specific Drugs and Laboratory Tests under Interactions.) Assess and correct intravascular volume status prior to initiating empagliflozin in patients.

Monitor patients for signs and symptoms of hypotension after initiating therapy; increase monitoring in clinical situations in which volume contraction is expected.

Renal Effects

Causes intravascular volume contraction and can cause renal impairment.

May increase Scr concentration and decrease eGFR; hypovolemic patients may be more susceptible. Renal function abnormalities can occur following initiation of therapy.

Consider factors that may predispose patients to acute kidney injury, such as hypovolemia, chronic renal insufficiency, heart failure, concomitant medications (e.g., diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIAs), prior to initiating empagliflozin therapy.

Consider temporarily discontinuing empagliflozin in any setting of reduced oral intake (e.g., acute illness, fasting) or fluid losses (e.g., GI illness, excessive heat exposure).

Monitor patients for acute kidney injury; monitor patients with an eGFR <60 mL/minute per 1.73 m2 more frequently. Discontinue empagliflozin and initiate appropriate therapy if such injury occurs.

Concomitant Therapy with Hypoglycemic Agents

When adding empagliflozin to therapy with an insulin secretagogue (e.g., a sulfonylurea) or insulin, consider reducing dosage of the concomitant insulin secretagogue or insulin to reduce the risk of hypoglycemia.

Fournier Gangrene

Fournier gangrene (necrotizing fasciitis of the perineum), a rare but serious or life-threatening bacterial infection requiring urgent surgical intervention, reported during postmarketing surveillance in men and women with type 2 diabetes mellitus receiving an SGLT2 inhibitor.

Assess for necrotizing fasciitis in patients receiving empagliflozin who develop pain or tenderness, erythema, or swelling in the genital or perineal area, in addition to fever or malaise. Discontinue empagliflozin if Fournier gangrene suspected; initiate treatment with broad-spectrum antibiotics and perform surgical debridement if necessary. Monitor blood glucose concentrations closely; initiate alternative antidiabetic agents to maintain glycemic control.

Genital Mycotic Infections

Possible increased risk of genital mycotic infections in males (e.g., balanitis, balanoposthitis) and females (e.g., vulvovaginitis). Patients with a history of chronic or recurrent genital mycotic infections more likely to develop such infections. Genital mycotic infections also occurred more frequently in female than in male patients.

Monitor patients for genital mycotic infections and institute appropriate treatment if these infections occur.

Urosepsis and Pyelonephritis

May increase the risk of serious urinary tract infections (e.g., urosepsis, pyelonephritis requiring hospitalization). Patients with a history of chronic or recurrent urinary tract infections more likely to develop such infections.

Urinary tract infections also occurred more frequently in female than in male patients, and risk of urinary tract infections increased in patients ≥75 years of age. Prior to initiating empagliflozin therapy, consider patient factors that may predispose to serious urinary tract infections (e.g., history of difficulty urinating; infection of the bladder, kidneys, or urinary tract).

Monitor patients for urinary tract infections and initiate treatment if indicated.

Effects on Lipoproteins

Dose-related increases in LDL-cholesterol concentration can occur. Monitor serum LDL-cholesterol concentrations and treat such lipid elevations according to standard of care.

Potential Risk of Bone Fracture

Increased risk of bone fracture, along with dose-related decreases in bone mineral density in older adults, observed in patients receiving another SGLT2 inhibitor (canagliflozin). FDA continuing to evaluate bone fracture risk with SGLT2 inhibitors.

Sensitivity Reactions

Serious hypersensitivity reactions (e.g., angioedema, urticaria) reported. Discontinue drug if hypersensitivity reaction occurs, institute appropriate treatment, and monitor patients until signs and symptoms resolve.

Use of Fixed Combinations

When empagliflozin is used in fixed combination with metformin hydrochloride, linagliptin, or other drugs, consider the cautions, precautions, contraindications, and interactions associated with the concomitant agent(s) in addition to those associated with empagliflozin.

Specific Populations

Pregnancy

No adequate and well-controlled studies using empagliflozin in pregnant women.

Studies in animals indicate that empagliflozin use during pregnancy may affect renal development and maturation.

Not recommended for use in the second or third trimesters of pregnancy.

Lactation

Distributed into milk in rats; not known whether distributed into human milk. Discontinue nursing or the drug.

Pediatric Use

Safety and efficacy not established in pediatric patients <18 years of age.

Geriatric Use

Geriatric patients with renal impairment expected to experience reduced efficacy.

Risk of volume depletion-related adverse effects and urinary tract infections increased in patients ≥75 years of age.

Hepatic Impairment

No dosage adjustment necessary for patients with mild, moderate, or severe hepatic impairment.

Renal Impairment

Glucose-lowering effect of empagliflozin 25 mg was reduced in patients with worsening renal function in a clinical study. In addition, risk of renal impairment and of volume depletion-related and urinary tract infection-related adverse effects increased with worsening renal function.

Efficacy and safety not established in patients with severe renal impairment, end-stage renal disease, or in those receiving dialysis; empagliflozin is not expected to be effective in these patients and is contraindicated in such patients.

Do not initiate drug in patients with eGFR <45 mL/minute per 1.73 m2. Discontinue drug if eGFR is persistently <45 mL/minute per 1.73 m2.

Assess renal function before initiating empagliflozin and during therapy. More frequent monitoring recommended in patients with eGFR <60 mL/minute per 1.73 m2.

Common Adverse Effects

Empagliflozin: Urinary tract infection, female genital mycotic infections, upper respiratory tract infection, increased urination, dyslipidemia, arthralgia, male genital mycotic infections, and nausea.

Empagliflozin and linagliptin therapy: Urinary tract infection, nasopharyngitis, upper respiratory tract infection.

Empagliflozin, metformin, and sulfonylurea combination therapy: Hypoglycemia, urinary tract infection, nasopharyngitis.

Drug Interactions

Metabolized principally by glucuronidation via uridine diphosphate-glucuronosyltransferase (UGT) isoenzymes 2B7, 1A3, 1A8, and 1A9.

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Did not inhibit, inactivate, or induce CYP isoforms in vitro; no effect of empagliflozin expected on concomitantly administered drugs that are substrates of the major CYP isoforms.

Drugs Affecting or Affected by Organic Anion Transporters

Substrate of organic anion transporter (OAT) 3 and organic anion transport proteins (OATP) 1B1 and 1B3. Not a substrate of OAT1. Does not inhibit any of these transporters at clinically relevant plasma concentrations; no effect of empagliflozin expected on concomitantly administered drugs that are substrates of these transporters.

Drugs Affecting or Affected by Organic Cation Transporters

Not a substrate of organic cation transporter (OCT)2; does not inhibit OCT2 at clinically relevant plasma concentrations. No effect of empagliflozin expected on concomitantly administered drugs that are substrates of this transporter.

Drugs Affecting or Metabolized by Uridine Diphosphate-glucuronosyltransferase

Does not inhibit UGT1A1, 1A3, 1A8, 1A9, or 2B7; no effect of empagliflozin expected on concomitantly administered drugs that are substrates of these UGT isoenzymes. Manufacturer states effect of UGT induction on empagliflozin exposure has not been studied.

Drugs Affecting or Affected by P-glycoprotein Transport

Substrate of P-glycoprotein (P-gp); does not inhibit P-gp at therapeutic doses. Considered unlikely to cause interactions with drugs that are P-gp substrates based on in vitro studies.

Drugs Affecting or Affected by Breast Cancer Resistance Protein

Substrate of breast cancer resistance protein (BCRP); does not inhibit BCRP at therapeutic doses.

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Comments

Antidiabetic agents

Increased risk of hypoglycemia when used concomitantly with insulin or insulin secretagogues (e.g., sulfonylurea)

Reduced dosage of insulin or insulin secretagogue may be required to reduce risk of hypoglycemia

Digoxin

No clinically relevant effect on digoxin pharmacokinetics

No adjustment of digoxin dosage necessary

Diuretics

Concomitant use may increase urine volume and frequency of voids, which may increase risk of volume depletion

Assess for volume contraction and correct prior to initiating empagliflozin; monitor for manifestations of hypotension after initiating therapy; increase monitoring in situations in which volume contraction expected

Gemfibrozil

Increased empagliflozin AUC; however, effect not clinically relevant

No adjustment of empagliflozin dosage necessary

Glimepiride

No clinically relevant effect on pharmacokinetics of glimepiride or empagliflozin

No adjustment of either drug dosage necessary

Hormonal contraceptives

No clinically relevant effect on pharmacokinetics of ethinyl estradiol or levonorgestrel

No adjustment of ethinyl estradiol or levonorgestrel dosage necessary

Hydrochlorothiazide

No clinically relevant effect on pharmacokinetics of hydrochlorothiazide or empagliflozin

No adjustment of either drug dosage necessary

Linagliptin

No clinically relevant effect on pharmacokinetics of linagliptin or empagliflozin

No adjustment of either drug dosage necessary

Metformin

No clinically relevant effect on pharmacokinetics of metformin or empagliflozin

No adjustment of either drug dosage necessary

Pioglitazone

No clinically relevant effect on pharmacokinetics of empagliflozin or pioglitazone

No adjustment of empagliflozin dosage necessary

Probenecid

Increased empagliflozin AUC; however, effect not clinically relevant

Concomitant use decreased fraction of empagliflozin excreted in urine by 30% without affecting 24-hour urinary glucose excretion in patients with normal renal function

No adjustment of empagliflozin dosage necessary

Ramipril

No clinically relevant effect on pharmacokinetics of ramipril, ramiprilat (metabolite), or empagliflozin

No adjustment of ramipril or empagliflozin dosage necessary

Rifampin

Increased empagliflozin AUC; however, effect not clinically relevant

No adjustment of empagliflozin dosage necessary

Simvastatin

No clinically relevant effect on pharmacokinetics of simvastatin, simvastatin acid (metabolite), or empagliflozin

No adjustment of either drug dosage necessary

Sitagliptin

No clinically relevant effect on pharmacokinetics of sitagliptin or empagliflozin

No adjustment of either drug dosage necessary

Torsemide

No clinically relevant effect on pharmacokinetics of torsemide or empagliflozin

No adjustment of either drug dosage necessary

Urine glucose tests (e.g., 1,5-anhydroglucitol assay)

SGLT2 inhibitors increase urinary glucose excretion and will result in false-positive urine glucose tests

Elevation in urinary glucose excretion approaches baseline in approximately 3 days following a single 10- or 25-mg dose

Use alternative methods to monitor glycemic control

Verapamil

No clinically relevant effect on pharmacokinetics of empagliflozin

No adjustment of verapamil dosage necessary

Warfarin

No clinically relevant effect on pharmacokinetics of warfarin or empagliflozin

No adjustment of either drug dosage necessary

Empagliflozin Pharmacokinetics

Absorption

Bioavailability

Peak plasma concentration usually attained within 1 hour after oral dosing in fasted state. Empagliflozin exposure increases in proportion to the dose.

Bioequivalence studies: Fixed-combination tablets of empagliflozin and immediate-release metformin hydrochloride or empagliflozin and linagliptin are bioequivalent to individual tablets of empagliflozin, metformin hydrochloride, or linagliptin administered concomitantly in equivalent doses.

Food

Administration with a high-fat and high-calorie meal decreased peak concentration and AUC by approximately 37 and 16%, respectively, compared with fasting condition. These changes not considered clinically relevant; administer empagliflozin with or without food.

Special Populations

Mild hepatic impairment (Child-Pugh class A): AUC and peak plasma concentration increased by 23 and 4%, respectively, compared with that in individuals with normal hepatic function.

Moderate hepatic impairment (Child-Pugh class B): AUC and peak plasma concentration increased by 47 and 23%, respectively, compared with that in individuals with normal hepatic function.

Severe hepatic impairment (Child-Pugh class C): AUC and peak plasma concentration increased by 75 and 48%, respectively, compared with that in individuals with normal hepatic function.

Mild renal impairment (eGFR 60 to <90 mL/minute per 1.73 m2): AUC and peak plasma concentration increased by approximately 18 and 20%, respectively, compared with that in individuals with normal renal function.

Moderate renal impairment (eGFR 30 to <60 mL/minute per 1.73 m2): AUC increased by 20% and peak plasma concentrations were similar compared with that in individuals with normal renal function.

Severe renal impairment (eGFR <30 mL/minute per 1.73 m2): AUC and peak plasma concentration increased by approximately 66 and 20%, respectively, compared with that in individuals with normal renal function.

Patients with renal failure/end-stage renal disease: AUC increased by approximately 48% and peak plasma concentrations were similar compared with that in individuals with normal renal function.

Distribution

Plasma Protein Binding

86.2%

Elimination

Metabolism

Metabolized principally via glucuronidation by UGT isoenzymes 2B7, 1A3, 1A8, and 1A9.

Elimination Route

Following administration of radiolabeled dose of empagliflozin, eliminated in feces (41.2%) and urine (54.4%).

Half-life

Approximately 12.4 hours

Special Populations

Apparent oral clearance of empagliflozin decreases with a reduction in eGFR. Fraction of empagliflozin excreted unchanged in urine and urinary glucose excretion decline with decrease in eGFR.

Gender, race, and body weight have no clinically meaningful effect on pharmacokinetics of empagliflozin.

Stability

Storage

Oral

Tablets

Empagliflozin, fixed combination of empagliflozin and linagliptin, and fixed combination of empagliflozin and metformin hydrochloride: 25°C (may be exposed to 15–30°C).

Actions

Advice to Patients

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Empagliflozin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

10 mg

Jardiance

Boehringer Ingelheim

25 mg

Jardiance

Boehringer Ingelheim

Empagliflozin Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, extended-release

5 mg with Extended-release Metformin Hydrochloride 1 g

Synjardy XR

Boehringer Ingelheim

10 mg with Extended-release Metformin Hydrochloride 1 g

Synjardy XR

Boehringer Ingelheim

12.5 mg with Extended-release Metformin Hydrochloride 1 g

Synjardy XR

Boehringer Ingelheim

25 mg with Extended-release Metformin Hydrochloride 1 g

Synjardy XR

Boehringer Ingelheim

Tablets, film-coated

5 mg with Metformin Hydrochloride 500 mg

Synjardy

Boehringer Ingelheim

5 mg with Metformin Hydrochloride 1 g

Synjardy

Boehringer Ingelheim

10 mg with Linagliptin 5 mg

Glyxambi

Boehringer Ingelheim

12.5 mg with Metformin Hydrochloride 500 mg

Synjardy

Boehringer Ingelheim

12.5 mg with Metformin Hydrochloride 1 g

Synjardy

Boehringer Ingelheim

25 mg with Linagliptin 5 mg

Glyxambi

Boehringer Ingelheim

AHFS DI Essentials™. © Copyright 2024, Selected Revisions December 1, 2022. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

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