Dosing & Uses
Dosage Forms & Strengths
tablet
- 10mg
- 25mg
Type 2 Diabetes Mellitus
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
Also indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease
10 mg PO qDay
May increase to 25 mg/day if needed and tolerated
Heart Failure
Indicated to reduce the risk of cardiovascular death plus hospitalization in adults with heart failure and reduced ejection fraction (HFrEF)
10 mg PO qDay
Data are insufficient to provide dosing recommendations in patients with HFrEF with an eGFR <20 mL/min/1.73 m2
Dosage Modifications
Hepatic impairment: No dosage adjustment required
Renal Impairment
-
Type 2 diabetes mellitus
- eGFR 30-90 mL/min/1.73 m2: No dosage adjustment required
- eGFR <30 mL/min/1.73 m2 without cardiovascular risk factors: Not recommended
- Patients with end-stage renal disease or eGFR <30 mL/min/1.73 m2 with established cardiovascular disease or cardiovascular risk factors: Data are insufficient; no dosing recommendations available
- Patients on dialysis: Contraindicated
- Glucose lowering benefit of 25 mg/day decreased in patients with worsening renal function
- Risks of renal impairment, volume depletion adverse reactions and urinary tract infection-related adverse reactions increased with worsening renal function
-
HFrEF
- eGFR ≥20 mL/min/1.73 m2: No dosage adjustment required
- eGFR <20 mL/min/1.73 m2: Data are insufficient; no dosing recommendations available
- eGFR <30 mL/min/1.73 m2 in patients without established cardiovascular disease or cardiovascular risk factors: Not recommended
- Patients on dialysis: Contraindicated
Dosing Considerations
Limitations of use
- Not indicated for treatment of type 1 diabetes or diabetic ketoacidosis
- Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR <30 mL/min/1.73 m2
Before initiating therapy
- Assess renal function beforehand and periodically thereafter
- Correct condition in patients with volume depletion
<18 years: Safety and efficacy not established
No dosage change is recommended based on age; see Adult Dosing
Risk of volume depletion-related adverse reactions increased in patients who were ≥75 yr to 2.1%, 2.3%, and 4.4% for placebo, 10 mg, and 25 mg, respectively
Risk of urinary tract infections increased in patients who were ≥75 yr to 10.5%, 15.7%, and 15.1% in patients randomized to placebo, 10 mg, and 25 mg, respectively
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (39)
- amiloride
empagliflozin, amiloride. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of empagliflozin with diuretics results in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
- bendroflumethiazide
empagliflozin, bendroflumethiazide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of empagliflozin with diuretics results in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
- bumetanide
empagliflozin, bumetanide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of empagliflozin with diuretics results in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
- chlorothiazide
empagliflozin, chlorothiazide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of empagliflozin with diuretics results in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
- chlorpropamide
empagliflozin, chlorpropamide. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- chlorthalidone
empagliflozin, chlorthalidone. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of empagliflozin with diuretics results in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
- dulaglutide
dulaglutide, empagliflozin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- ethacrynic acid
empagliflozin, ethacrynic acid. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of empagliflozin with diuretics results in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
- furosemide
empagliflozin, furosemide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of empagliflozin with diuretics results in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
- glimepiride
empagliflozin, glimepiride. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- glipizide
empagliflozin, glipizide. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- glyburide
empagliflozin, glyburide. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- hydrochlorothiazide
empagliflozin, hydrochlorothiazide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of empagliflozin with diuretics results in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
- indapamide
empagliflozin, indapamide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of empagliflozin with diuretics results in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
- insulin aspart
empagliflozin, insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- insulin aspart protamine/insulin aspart
empagliflozin, insulin aspart protamine/insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin degludec
empagliflozin, insulin degludec. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- insulin degludec/insulin aspart
empagliflozin, insulin degludec/insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- insulin detemir
empagliflozin, insulin detemir. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- insulin glargine
empagliflozin, insulin glargine. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- insulin glulisine
empagliflozin, insulin glulisine. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- insulin inhaled
empagliflozin, insulin inhaled. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- insulin isophane human/insulin regular human
empagliflozin, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin lispro
empagliflozin, insulin lispro. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- insulin lispro protamine/insulin lispro
empagliflozin, insulin lispro protamine/insulin lispro. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin NPH
empagliflozin, insulin NPH. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- insulin regular human
empagliflozin, insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- letermovir
letermovir will increase the level or effect of empagliflozin by unspecified interaction mechanism. Use Caution/Monitor. Monitor glucose concentrations.
- lonapegsomatropin
lonapegsomatropin decreases effects of empagliflozin by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- methyclothiazide
empagliflozin, methyclothiazide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of empagliflozin with diuretics results in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
- metolazone
empagliflozin, metolazone. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of empagliflozin with diuretics results in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
- nateglinide
empagliflozin, nateglinide. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- repaglinide
empagliflozin, repaglinide. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- somapacitan
somapacitan decreases effects of empagliflozin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- spironolactone
empagliflozin, spironolactone. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of empagliflozin with diuretics results in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
- tolazamide
empagliflozin, tolazamide. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- tolbutamide
empagliflozin, tolbutamide. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with SGLT2 inhibitors.
- torsemide
empagliflozin, torsemide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of empagliflozin with diuretics results in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
- triamterene
empagliflozin, triamterene. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of empagliflozin with diuretics results in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
Minor (0)
Adverse Effects
1-10%
Urinary tract infection (7.6-9.3%)
Female genital mycotic infections (5.4-6.4%)
Upper respiratory tract infection (3.1-4%)
Increased urination (3.2-3.4%)
Dyslipidemia (2.9-3.9%)
Male genital mycotic infections (1.6-3.1%)
Arthralgia (2.3-2.4%)
Nausea (1.1-2.3%)
Polydipsia (1.5-1.7%)
<1%
Adverse reactions related to volume depletion (eg, blood pressure [ambulatory] decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolemia, orthostatic hypotension, and syncope)
Increased urination (eg, nocturia)
Postmarketing reports
Ketoacidosis
Urosepsis and pyelonephritis
Necrotizing fasciitis of the perineum (Fournier’s gangrene)
Angioedema
Skin reactions
Warnings
Contraindications
Serious hypersensitivity to empagliflozin (eg, anaphylaxis, angioedema)
Patients on dialysis
Cautions
Increases serum creatinine and decreases eGFR; risk increased in elderly or those with moderate renal impairment
Increased incidence of bone fractures reported; American Diabetes Association recommends avoiding sodium glucose cotransporter-2 inhibitors in patients with fracture risk factors
Genital mycotic infections may occur; patients with history of genital mycotic infections and uncircumcised males are more susceptible
Increases risk of urinary tract infections (UTIs), including life-threatening urosepsis and pyelonephritis that started as UTIs
Dose-related increases in LDL-C reported
No conclusive evidence of macrovascular risk reduction with antidiabetic agent
Serious hypersensitivity reactions (eg, angioedema) reported; if a hypersensitivity reaction occurs, discontinue treatment; treat promptly per standard of care, and monitor until signs and symptoms resolve
Volume depletion
- Intravascular volume depletion, which may manifest as symptomatic hypotension or acute changes in creatinine, occurred
- Acute kidney injury, some requiring hospitalization and dialysis, in patients with T2DM receiving SGLT2 inhibitors reported
- Patients with impaired renal function (eGFR <60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension
- Before initiating therapy in patients with one or more of these characteristics, assess volume status and renal function; in patients with volume depletion, correct this condition before initiating treatment; monitor for signs and symptoms of volume depletion, and renal function after initiating therapy
Renal function
- Acute kidney injury reported
- Consider risk factors, including hypovolemia, heart failure, and chronic renal insufficiency or use of medications, including diuretics, ACE inhibitors, NSAIDs, or angiotensin receptor blockers
- Correct volume status before initiating if needed and monitor renal function periodically thereafter
Necrotizing fasciitis
- Necrotizing fasciitis of the perineum (Fournier gangrene) reported with SGLT2 inhibitors
- Signs and symptoms include pain or tenderness, erythema, or swelling in genital or perineal area, along with fever or malaise
- If suspected, discontinue SGLT2 inhibitor and start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary
Ketoacidosis
- Ketoacidosis, including fatal cases, reported in patients treated with SGLT2 inhibitors
- Not indicated for treatment of type 1 diabetes mellitus
- Before initiating therapy, consider factors in patient history that may predispose to ketoacidosis, including pancreatic insulin deficiency from any cause, caloric restriction, and alcohol abuse
- Consider temporarily discontinuing therapy for at least 3 days for patients who undergo scheduled surgery
- Consider monitoring for ketoacidosis and temporarily discontinuing therapy in other clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or post-surgery); ensure risk factors for ketoacidosis are resolved prior to restarting therapy
- Restart once the patient’s oral intake is back to baseline and any other risk factors for ketoacidosis (blood acid buildup) are resolved
Drug interactions overview
- Hypoglycemia risk increased with insulin and insulin secretagogues (eg, sulfonylureas); a lower dose of insulin or insulin secretagogue may be required
-
Laboratory testing
- Urine glucose tests is not recommended in patients taking SGLT2 inhibitors, as SGLT2 inhibitors, increase urinary glucose excretion and lead to positive urine glucose tests; use alternative methods to monitor glycemic control
- 1,5-AG assay is not recommended, as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors; use alternative methods to monitor glycemic control
Pregnancy & Lactation
Pregnancy
Based on animal data showing adverse renal effects, use not recommended during the second and third trimesters of pregnancy
Limited data available in pregnant women are insufficient to determine a drug-associated risk for major birth defects and miscarriage
There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy
Animal data
- In animal studies, adverse renal changes were observed in rats when empagliflozin was administered during period of renal development corresponding to the late second and third trimesters of human pregnancy
- Doses ~13-times the maximum clinical dose caused renal pelvic and tubule dilatations were reversible
- Not teratogenic in rats and rabbits up to 300 mg/kg/day, which approximates 48-times and 128-times, respectively, the maximum clinical dose of 25 mg when administered during organogenesis
Clinical considerations
- Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, still birth, and macrosomia related morbidity
Lactation
There is no information regarding presence in human milk, the effects on breastfed infant or on milk production
Empagliflozin is present in the milk of lactating rats
Because of potential for serious adverse reactions in a breastfed infant, advise women that it is not recommended while breastfeeding
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Selective sodium-glucose transporter-2 (SGLT2) inhibitor
SGLT2 is expressed in the proximal renal tubules and is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen; SGLT2 inhibitors reduce glucose reabsorption and lower the renal threshold for glucose, thereby increasing urinary glucose excretion
Absorption
Peak plasma time: 1.5 hr
Peak plasma concentration: 259 nmol/L (10 mg/day); 687 nmol/L (25 mg/day)
AUC: 1870 nmol•hr/L (10 mg/day); 4740 nmol•hr/L (25 mg/day)
Distribution
Protein bound: 86.2%
Red blood cell partitioning: 36.8%
Vd: 73.8 L
Metabolism
Primary route of metabolism is glucuronidation by the uridine 5'-diphospho-glucuronosyltransferases UGT2B7, UGT1A3, UGT1A8, and UGT1A9
No major metabolites were detected and the most abundant metabolites were 3 glucuronide conjugates (2-O-, 3-O-, and 6-O-glucuronide)
Systemic exposure of each metabolite was <10%
Elimination
Half-life: 12.4 hr
Clearance: 10.6 L/hr
Excretion: 54.4% urine; 41.2% feces
Administration
Oral Administration
May take with or without food
Advise patient to have adequate fluid intake to decreased risk of hypotension
Storage
Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Jardiance oral - | 25 mg tablet |  | |
| Jardiance oral - | 10 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
empagliflozin oral
EMPAGLIFLOZIN - ORAL
(EM-pa-gli-FLOE-zin)
COMMON BRAND NAME(S): Jardiance
USES: Empagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Empagliflozin is also used in patients with type 2 diabetes and heart disease to lower the risk of death from heart attack or stroke. Empagliflozin works by increasing the removal of sugar by your kidneys.Empagliflozin is also used to treat heart failure. It may help you live longer and lower your risk of going to the hospital for heart failure. Empagliflozin works by increasing the removal of sodium by your kidneys.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking empagliflozin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. The dosage is based on your medical condition and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: Frequent urination, dizziness, or lightheadedness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: signs of a urinary tract infection (such as burning/painful/frequent/urgent urination, pink/bloody urine), signs of kidney problems (such as change in the amount of urine).Get medical help right away if you have any very serious side effects, including: unusual tiredness, nausea/vomiting, stomach/abdominal pain, trouble breathing.This medication may cause a new yeast infection in the vagina or the penis. It may also cause a rare but very serious bacterial infection in the genital/anal area (Fournier's gangrene) in people with type 2 diabetes. Tell your doctor right away if you have signs of a yeast infection in the vagina (such as unusual vaginal discharge/burning/itching/odor) or in the penis (such as redness/itching/swelling of the penis, unusual discharge from the penis). However, get medical help right away if you have any pain/redness/swelling in or around the genital/anal area, along with a fever or feeling unwell.This medication may cause you to become dehydrated. This can lead to serious kidney damage. Drink plenty of fluids to prevent dehydration. Tell your doctor or pharmacist right away if you are not able to drink fluids as usual, or losing fluid (such as due to vomiting, diarrhea, or heavy sweating). Also, tell your doctor right away if you have any signs of dehydration, such as urinating less than usual, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness/fainting.If you are taking empagliflozin for diabetes, empagliflozin does not usually cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other diabetes medications, or if you do not consume enough calories from food, or if you do unusually heavy exercise. Talk with your doctor or pharmacist about whether the dose of your other diabetes medication needs to be lowered. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your doctor may need to adjust your diabetes medications.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking empagliflozin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems (such as kidney dialysis), liver problems, dehydration, use/abuse of alcohol, low blood pressure, high cholesterol, history of yeast infections in the vagina or penis.If you have diabetes, you may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar and a high ketone level.If you have diabetes, it may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Also, if you are eating less or not able to eat due to these conditions or any illness, this can lead to a high ketone level while you are taking this medication. Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar or ketone testing.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially dehydration, kidney problems, and dizziness/fainting (usually when standing).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.Many drugs can affect blood sugar, making it harder to control in people with diabetes. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar if you have diabetes. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.Your urine will test positive for glucose. Make sure laboratory personnel and all your doctors know you use this drug.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as kidney function, blood pressure, blood sugar, cholesterol, ketones) may be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.If you have diabetes, attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams. Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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