possibilities [30:<45 mL/minute/1.73 m 2 Dosing: Adult Note: If present, correct volume depletion prior to initiation Diabetes mellitus, type 2: Oral: Initial: 10 mg once daily; may increase to 25 mg once daily Dosing: Geriatric Refer to adult dosing. Dosing: Renal Impairment eGFR 45 mL/minute/1.73 m 2 : No dosage adjustment necessary. eGFR 30 to> <45 mL/minute/1.73 m 2 : The manufacturer recommends to not initiate therapy, or in patients already taking empagliflozin, discontinue therapy when eGFR is persistently> <45 mL/minute/1.73 m 2 . Empagliflozin, however, has been shown to have beneficial effects on preservation of renal function in select patients with an eGFR 30 mL/minute/1.73 m 2 (Wanner 2016). eGFR> <30 mL/minute/1.73 m 2 : Use is contraindicated. ESRD, dialysis: Use is contraindicated. Dosing: Hepatic Impairment There are no dosage adjustments provided in the manufacturer's labeling; may be used in patients with hepatic impairment. Administration Administer once daily in the morning, with or without food. Dietary Considerations Individualized medical nutrition therapy (MNT) based on ADA recommendations is an integral part of therapy Storage Store at 25 C (77 F); excursions are permitted between 15 C and 30 C (59 F and 86 F). Drug Interactions Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy Androgens: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Exceptions: Danazol. Monitor therapy Guanethidine: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy Insulins: Sodium-Glucose Cotransporter 2 (SLGT2) Inhibitors may enhance the hypoglycemic effect of Insulins. Management: Consider a decrease in insulin dose when initiating therapy with a sodium-glucose cotransporter 2 inhibitor and monitor patients for hypoglycemia. Consider therapy modification Loop Diuretics: Empagliflozin may enhance the hypotensive effect of Loop Diuretics. Monitor therapy Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy Pegvisomant: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy Prothionamide: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy Quinolones: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolones may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy Salicylates: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy Sulfonylureas: Sodium-Glucose Cotransporter 2 (SLGT2) Inhibitors may enhance the hypoglycemic effect of Sulfonylureas. Management: Consider a decrease in sulfonylurea dose when initiating therapy with a sodium-glucose cotransporter 2 inhibitor and monitor patients for hypoglycemia. Consider therapy modification Teriflunomide: May increase the serum concentration of OAT3 Substrates. Monitor therapy Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy Test Interactions Positive test for glucosuria; may interfere with 1,5-anhydroglucitol (1,5-AG) assay; use alternative methods to monitor glycemic control. Adverse Reactions >10%: Genitourinary: Urinary tract infection (9%; females: 18%; males: 4%) 1% to 10%: Endocrine & metabolic: Dyslipidemia (4%), increased thirst (2%) Gastrointestinal: Nausea (2%) Genitourinary: Increased urine output (3%) Hematologic & oncologic: Increased hematocrit (3% to 4%) Infection: Genitourinary fungal infection (4%; females: 5% to 6%; males: 2% to 3%) Frequency not defined: Endocrine & metabolic: Increased LDL cholesterol> <1%, postmarketing, and/or case reports: Acute renal failure, decreased estimated GFR (eGFR), hypotension, hypovolemia, increased serum creatinine, ketoacidosis, phimosis, pyelonephritis, urosepsis Warnings/Precautions Concerns related to adverse effects: Bone fractures: Increased incidence of bone fractures may occur. Genital mycotic infections: May increase the risk of genital mycotic infections (eg, vulvovaginal mycotic infection, vulvovaginal candidiasis, vulvovaginitis, candida balanitis, balanoposthitis). Patients with a history of these infections or uncircumcised males are at greater risk. Hypotension: May cause symptomatic hypotension due to intravascular volume depletion especially in patients with renal impairment (ie, eGFR> <60 mL/minute/1.73 m 2 ), elderly, patients on other antihypertensives (eg, diuretics, ACE inhibitors, angiotensin receptor blockers [ARBs]), or those with low systolic blood pressure. Assess volume status prior to initiation in patients at risk of hypotension and correct if depleted; monitor for signs and symptoms of hypotension after initiation. Ketoacidosis: Cases of ketoacidosis, a serious and life-threatening condition resulting in urgent hospitalization, have been reported in patients with type 1 and type 2 diabetes mellitus receiving sodium-glucose cotransporter 2 (SGLT2) inhibitors; in some cases, patients have presented with normal or only modestly elevated blood glucose (> <250 mg/dL) (Bobart 2016; FDA 2015; Handelsman 2016). Before initiating treatment, consider risk factors that may predispose to ketoacidosis (eg, pancreatic insulin deficiency, dose decreases or discontinuation of insulin, caloric restriction, alcohol abuse, extensive exercise, MI, stroke, severe infection, surgery, any other extreme stress event) (Handelsman 2016). The American Association of Clinical Endocrinologists and American College of Endocrinology recommend considering withholding of SGLT2 inhibitors for at least 24 hours prior to events that may precipitate diabetic ketoacidosis (Handelsman 2016), while others have suggested withholding for 3 to 5 days (Bobart 2016). Patients presenting with nausea/vomiting, abdominal pain, generalized malaise, and/or shortness of breath should be assessed immediately for ketoacidosis; if indicated, consider interruption or discontinuation of therapy. Lipid abnormality: May cause low-density lipoprotein cholesterol (LDL-C) elevation; monitor LDL-C and treat as needed. Renal effects: Acute kidney injury has been reported. Prior to initiation, consider risk factors for acute kidney injury (eg, hypovolemia, chronic renal insufficiency, heart failure, use of concomitant medications [eg, diuretics, ACE inhibitors, angiotensin receptor blockers, or NSAIDs]). Temporarily discontinue use with reduced oral intake or fluid losses; discontinue use if acute kidney injury occurs. Additional abnormalities in renal function (decreased eGFR, increased serum creatinine) and adverse effects related to renal function may occur. Assess renal function prior to initiation and periodically during treatment. Urinary tract infection: Serious urinary infections including urosepsis and pyelonephritis requiring hospitalization have been reported; treatment with SGLT2 inhibitors increases the risk for urinary tract infection (UTI); monitor for signs and symptoms of UTI and treat as needed. Disease-related concerns: Renal impairment: Glycemic efficacy may be decreased in renal impairment. Assess renal function prior to initiation and periodically during treatment. Empagliflozin should not be initiated in patients with eGFR> <45 mL/minute/1.73 m 2 and should be discontinued when eGFR is persistently> <45 mL/minute/1.73 m 2 . Use is contraindicated in severe renal impairment (eGFR> <30 mL/minute/1.73 m 2 ), ESRD, and in dialysis patients. Empagliflozin has been shown to reduce the occurrence of incident or worsening nephropathy in select diabetic patients receiving standard care with an eGFR 30 mL/minute/1.73 m 2 and high cardiovascular risk over a period of approximately 3.1 years (Wanner 2016). Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations: Elderly: Risk of intravascular volume depletion, renal impairment, and UTI may be increased in elderly patients. Other warnings/precautions: Appropriate use: Not for use in patients with diabetic ketoacidosis (DKA) or patients with type 1 diabetes mellitus (insulin-dependent, IDDM). Monitoring Parameters Blood glucose, HbA 1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change (ADA 2017a); renal function (baseline and periodically during treatment); volume status (eg, blood pressure, hematocrit, electrolytes); LDL-C; monitor for genital mycotic infections and UTI; blood pressure; ketoacidosis Pregnancy Considerations Adverse events were observed in some animal reproduction studies. Use is not recommended during the second and third trimesters. In women with diabetes, maternal hyperglycemia can be associated with congenital malformations as well as adverse effects in the fetus, neonate, and the mother (ACOG 2005; ADA 2017c; Kitzmiller 2008; Metzger 2007). To prevent adverse outcomes prior to conception and throughout pregnancy, maternal blood glucose and HbA 1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ACOG 2013; ADA 2017c; Blumer 2013; Kitzmiller 2008). Agents other than empaglifozin are currently recommended to treat diabetes in pregnant women (ADA 2017c). Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Have patient report immediately to prescriber signs of fluid and electrolyte problems (mood changes, confusion, muscle pain or weakness, abnormal heartbeat, severe dizziness, passing out, tachycardia, increased thirst, seizures, loss of strength and energy, lack of appetite, urinary retention or change in amount of urine passed, dry mouth, dry eyes, or nausea or vomiting), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of acidosis (confusion, fast breathing, tachycardia, abnormal heartbeat, severe abdominal pain, nausea, vomiting, fatigue, shortness of breath, or loss of strength and energy), signs of a urinary tract infection (hematuria, burning or painful urination, polyuria, fever, lower abdominal pain, or pelvic pain), signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating), signs of vaginal yeast infection, or signs of penile yeast infection (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about empagliflozin Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 59 Reviews Add your own review/rating Drug class: SGLT-2 inhibitors Consumer resources Empagliflozin Empagliflozin (Advanced Reading) Professional resources Empagliflozin (AHFS Monograph) Other brands: Jardiance Related treatment guides Cardiovascular Risk Reduction Diabetes, Type 2> ]} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Empagliflozin Rating 59 User Reviews 6.6 /10 59 User Reviews 6.6 Rate it! Drug Class SGLT-2 inhibitors Related Drugs SGLT-2 inhibitors Invokana , Jardiance , Farxiga , canagliflozin , dapagliflozin Diabetes, Type 2 metformin , insulin aspart , glipizide , glimepiride , Januvia , pioglitazone , Victoza , Actos , Tradjenta , Glucophage , glyburide , Janumet , More... Cardiovascular Risk Reduction simvastatin , Zocor , ramipril , Victoza , telmisartan , Altace , Micardis , Jardiance , liraglutide , Praluent , simvastatin / sitagliptin , alirocumab , More...} } you obtain
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