dapagliflozin (Rx)

Brand and Other Names:Farxiga

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet (Farxiga, generic)

  • 5mg
  • 10mg

Type 2 Diabetes Mellitus

Improve glycemic control

  • Indicated as an adjunct to diet and exercise to improve glycemic control with type 2 diabetes mellitus (T2DM)
  • Initial: 5 mg PO qDay in AM
  • May increase to 10 mg qDay in patients tolerating 5 mg/day who require additional glycemic control

Reduce risk of hospitalization for heart failure

  • Indicated to reduce hospitalization risk for heart failure in adults with T2DM and established cardiovascular disease (CVD) or multiple CV risk factors
  • 10 mg PO qDay in AM

Heart Failure

Indicated to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), and urgent heart failure visit in adults with HF; this indication includes HF with either reduced or preserved ejection fraction

10 mg PO qDay

Chronic Kidney Disease

Indicated to reduce risk of sustained eGFR decline, end-stage kidney disease (ESKD), cardiovascular death, and hospitalization for HF in adults with chronic kidney disease (CKD) who are at risk of progression

10 mg PO qDay

Dosage Modifications

Renal impairment

eGFR ≥45mL/min/1.73 m2: No dosage adjustment required

  • eGFR 25 to <45 mL/min/1.73 m2
    • T2DM: Not recommended
    • HF or CKD: No dosage adjustment required
  • eGFR <25 mL/min/1.73 m2
    • Initiation not recommended
    • Patients with HF or CKD may continue 10 mg/day to reduce risk of eGFR decline, ESKD, CV death, and HF hospitalization

​ESRD/dialysis: Contraindicated

Hepatic impairment

  • Mild or moderate: No dosage adjustment required
  • Severe: Not studied

Dosing Considerations

Limitations of use

  • Not for treatment of type 1 diabetes mellitus; may increase risk of diabetic ketoacidosis in these patients
  • Not recommended to improve glycemic control in adults with T2DM with eGFR <45 mL/min/1.73 m2; dapagliflozin likely to be ineffective owing to its mechanism of action
  • Not recommended for CKD in patients with polycystic kidney disease, or those requiring or with recent history of immunosuppressive therapy for kidney disease; dapagliflozin is likely to be ineffective in these populations

Before initiation

  • Assess renal function and periodically thereafter
  • Assess, and if needed, correct volume depletion

Safety and efficacy not established

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Interactions

Interaction Checker

and dapagliflozin

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                Monitor Closely (26)

                • chlorpropamide

                  chlorpropamide, dapagliflozin. 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 dapagliflozin.

                • dulaglutide

                  dulaglutide, dapagliflozin. 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.

                • glimepiride

                  glimepiride, dapagliflozin. 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 dapagliflozin.

                • glipizide

                  glipizide, dapagliflozin. 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 dapagliflozin.

                • glyburide

                  glyburide, dapagliflozin. 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 dapagliflozin.

                • insulin aspart

                  insulin aspart, dapagliflozin. 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 dapagliflozin.

                  dapagliflozin, 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 aspart protamine/insulin aspart

                  dapagliflozin, 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

                  dapagliflozin, insulin degludec. 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/insulin aspart

                  dapagliflozin, insulin degludec/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 detemir

                  insulin detemir, dapagliflozin. 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 dapagliflozin.

                  dapagliflozin, insulin detemir. 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 glargine

                  insulin glargine, dapagliflozin. 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 dapagliflozin.

                  dapagliflozin, insulin glargine. 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 glulisine

                  insulin glulisine, dapagliflozin. 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 dapagliflozin.

                  dapagliflozin, insulin glulisine. 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 inhaled

                  dapagliflozin, insulin inhaled. 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 isophane human/insulin regular human

                  dapagliflozin, 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

                  insulin lispro, dapagliflozin. 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 dapagliflozin.

                  dapagliflozin, 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 lispro protamine/insulin lispro

                  dapagliflozin, 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

                  insulin NPH, dapagliflozin. 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 dapagliflozin.

                  dapagliflozin, insulin NPH. 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 regular human

                  insulin regular human, dapagliflozin. 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 dapagliflozin.

                  dapagliflozin, 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.

                • letermovir

                  letermovir will increase the level or effect of dapagliflozin by unspecified interaction mechanism. Use Caution/Monitor. Monitor glucose concentrations.

                • lithium

                  dapagliflozin decreases levels of lithium by Other (see comment). Use Caution/Monitor. Comment: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations; monitor serum lithium concentration more frequently during therapy initiation and dosage changes.

                • lonapegsomatropin

                  lonapegsomatropin decreases effects of dapagliflozin 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.

                • nateglinide

                  nateglinide, dapagliflozin. 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 dapagliflozin.

                • repaglinide

                  repaglinide, dapagliflozin. 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 dapagliflozin.

                • somapacitan

                  somapacitan decreases effects of dapagliflozin 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. .

                • tolazamide

                  tolazamide, dapagliflozin. 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 dapagliflozin.

                • tolbutamide

                  tolbutamide, dapagliflozin. 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 dapagliflozin.

                Minor (1)

                • patiromer

                  patiromer, dapagliflozin. cation binding in GI tract. Minor/Significance Unknown. No observed clinically important interaction. No separation of dosing required.

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                Adverse Effects

                >10%

                Renal impairment

                • Overall (1.8-6.7%)
                • Age ≥65 yr (3.1-14%)
                • eGFR 30-60 mL/min (8-28.3%)
                • Age ≥65 yr and eGFR 30-60 mL/min (7-35.1%)

                1-10%

                Female genital mycotic infections (6.9-8.4%)

                Nasopharyngitis (6.3-6.6%)

                Urinary tract infection (4.3-5.7%)

                Back pain (3.1-4.2%)

                Increased urination (2.9-3.8%)

                Male genital mycotic infections (2.7-2.8%)

                Nausea (2.5-2.8%)

                Influenza (2.3-2.7%)

                Dyslipidemia (2.1-2.5%)

                Constipation (1.9-2.2%)

                Discomfort with urination (2.1-2.6%)

                Extremity pain (1.7-2%)

                Volume depletion

                • Overall (0.6-1.1%)
                • Patients on loop diuretics (0-9.7%; 1.8-2.5%)
                • Patients with moderate renal impairment, GFR 30-60 mL/min (0.9-1.9%)
                • Age ≥65 yr (0.5-1.7%)

                <1%

                Hypersensitivity (0.3%)

                Postmarketing Reports

                Rash

                Ketoacidosis

                Acute kidney injury and renal impairment

                Urosepsis and pyelonephritis

                Necrotizing fasciitis of the perineum

                Hypoglycemia

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                Warnings

                Contraindications

                Serious hypersensitivity to dapagliflozin (eg, anaphylaxis, angioedema)

                Patients on dialysis

                Cautions

                Genital mycotic infections may occur; patients with history of genital mycotic infections and uncircumcised males are more susceptible

                Serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization reported in patients receiving SGLT2 inhibitors

                Necrotizing fasciitis of the perineum (Fournier gangrene) reported with SGLT2 inhibitors; signs and symptoms include tenderness, redness or swelling of the genitals, or area from the genitals to the rectum, and have a fever >100.4ºF or generally feeling unwell; if suspected, discontinue SGLT2 inhibitor and start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary

                Intravascular volume contraction

                • Patients with diabetes and renal impairment may be more likely to experience hypotension and may be at higher risk for acute kidney injury secondary to volume depletion
                • Symptomatic hypotension may occur after initiating, particularly in patients with renal impairment (eGFR <60 mL/min/1.73 m2), with low systolic blood pressure, taking loop diuretics, or who are elderly
                • Renal impairment may occur owing to intravascular volume contraction; before initiating, consider factors that may predispose patients to acute kidney injury, including hypovolemia, chronic renal insufficiency, CHF, and concomitant medications (eg, diuretics, ACE inhibitors, ARBs, NSAIDs); consider temporarily discontinuing dapagliflozin in any setting of reduced oral intake or fluid loss; monitor for signs and symptoms of acute kidney injury, and, if evident, discontinue drug promptly and institute treatment

                Ketoacidosis

                • Sodium-glucose cotransporter 2 (SGLT2) inhibitors increase risk of ketoacidosis in patients with type 1 and type 2 diabetes mellitus
                • Before initiating therapy, consider factors that may predispose patients to ketoacidosis, including pancreatic insulin deficiency from any cause, caloric restriction, and alcohol abuse
                • Consider temporarily discontinuing dapagliflozin for at least 3 days before undergoing scheduled surgery to avoid euglycemic ketoacidosis
                • 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 before resumption

                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

                • Increase in LDL-cholesterol compared with placebo
                • 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

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                Pregnancy & Lactation

                Pregnancy

                Based on animal data showing adverse renal effects drug is not recommended during second and third trimesters of pregnancy

                Limited data in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy

                In animal studies, adverse renal pelvic and tubule dilatations, that were not fully reversible, were observed in rats when administered during a period of renal development corresponding to late second and third trimesters of human pregnancy, at all doses tested

                Clinical considerations

                • Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, still birth and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, stillbirth, and macrosomia related morbidity

                Lactation

                There is no information regarding presence of dapagliflozin in human milk, effects on breastfed infant, or on milk production; drug is present in milk of lactating rats; however, due to species-specific differences in lactation physiology, clinical relevance of these data are not clear

                Since human kidney maturation occurs in utero and during first 2 years of life when lactational exposure may occur, there may be risk to developing human kidney; because of potential for serious adverse reactions in breastfed infants, advise women that therapy 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.

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                Pharmacology

                Mechanism of Action

                Selective sodium-glucose transporter-2 (SGLT2) inhibitor

                SGLT-2, expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen; SGLT2 inhibitors will reduce glucose reabsorption and lower the renal threshold for glucose, thereby increasing urinary glucose excretion

                Also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule; this may influence several physiological functions, such as lowering both pre-and afterload of the heart and downregulating sympathetic activity

                Absorption

                Bioavailability: 78%

                Peak plasma time: 2 hr (fasting); ~3 hr (with high fat meal)

                High fat meal decreases peak plasma concentration by up to 50%

                Distribution

                Protein bound: 91%

                Metabolism

                Metabolism primarily mediated by UGT1A9

                CYP-mediated metabolism is a minor clearance pathway in humans

                Extensively metabolized, primarily to yield dapagliflozin 3-O-glucuronide (inactive metabolite)

                Elimination

                Half-life: 12.9 hr

                Excretion: 75% urine; 21% feces

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                Administration

                Oral Administration

                Administer in the morning, with or without food

                Storage

                Store at room temperature at 20-25°C (68-77°F)

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Farxiga oral
                -
                10 mg tablet
                Farxiga oral
                -
                5 mg tablet

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                dapagliflozin propanediol oral

                DAPAGLIFLOZIN - ORAL

                (DAP-a-gli-FLOE-zin)

                COMMON BRAND NAME(S): Farxiga

                USES: Dapagliflozin 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. Proper control of diabetes may also lessen your risk of a heart attack or stroke. This medication is also used in people with type 2 diabetes and heart disease to lower the risk of going to the hospital for heart failure. Dapagliflozin works by increasing the removal of sugar by your kidneys.Dapagliflozin is also used to treat kidney disease and heart failure. It may help you live longer and lower your risk of going to the hospital for heart failure. Dapagliflozin works by increasing the removal of sodium by your kidneys.

                HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking dapagliflozin 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. 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 last or get worse, 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, swelling legs/feet).Get medical help right away if you have any very serious side effects, including: unusual tiredness, nausea/vomiting, stomach/abdominal pain, trouble breathing.Dapagliflozin can sometimes cause painful urination or pink/bloody urine that are usually signs of a urinary tract infection, but they may also be signs of a rare condition (bladder cancer). Bladder cancer may or may not be caused by dapagliflozin. Tell your doctor right away if you develop these symptoms.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 dapagliflozin for diabetes, dapagliflozin 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 dapagliflozin, 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 disease/failure (dialysis), dehydration, use/abuse of alcohol, low blood pressure, 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 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 dizziness/fainting (usually when standing), dehydration, and kidney disease.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, liver function, blood sugar, hemoglobin A1c, complete blood counts, cholesterol tests, 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 May 2023. Copyright(c) 2023 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.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.