Bexagliflozin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
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Overview
Bexagliflozin is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of Type 2 Diabetes mellitus. Common adverse reactions include female genital mycotic infections, urinary tract infection and increased urination.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Bexagliflozin is indicated to improve the glycemic control in type 2 diabetes mellitus in adjunct to diet and exercise.
Recommended dosage in one tablet 20mg taken orally once daily with or without meal in the morning. Always assess the renal function prior to initiating the drug. Bexagliflozin is not recommended if eGFR less than 30 mL/min/1.73 m2.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Bexagliflozin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
Hypersensitivity to bexagliflozin or any excipient in bexagliflozin tablets. Anaphylaxis and angioedema has been reported in patients taking SGLT2 inhibitors.
Warnings
1. Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: always assess the ketones even if the patient maintains normal blood glucose and discontinue Bexagliflozin if ketoacidosis is present. monitor the patients for ketone resolution prior to resuming Bexagliflozin
2.Lower limb amputation: Bexagliflozin increases the rsik of lower limb amputation. So monitor patients for signs and symptoms of infection, or ulcers of the lower limbs, and discontinue if these occur.
3.Volume depletion: It may cause Acute kidney injury, So always assess and correct volume status in patients with impaired renal function or low systolic blood pressure, elderly patients or patients on diuretics prior to starting Bexagliflozin.
4.Urosepsis and pyelonephritis
5.Hypoglycemia
6.Necrotizing fasciitis of the perineum Template:(Fournier’s Gangrene)
7.Gegintal mycotic infection
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Bexagliflozin Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Bexagliflozin Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Bexagliflozin Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Bexagliflozin in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bexagliflozin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Bexagliflozin during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Bexagliflozin in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Bexagliflozin in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Bexagliflozin in geriatric settings.
Gender
There is no FDA guidance on the use of Bexagliflozin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Bexagliflozin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Bexagliflozin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Bexagliflozin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Bexagliflozin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Bexagliflozin in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Bexagliflozin Administration in the drug label.
Monitoring
There is limited information regarding Bexagliflozin Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Bexagliflozin and IV administrations.
Overdosage
There is limited information regarding Bexagliflozin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Bexagliflozin Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Bexagliflozin Mechanism of Action in the drug label.
Structure
There is limited information regarding Bexagliflozin Structure in the drug label.
Pharmacodynamics
There is limited information regarding Bexagliflozin Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Bexagliflozin Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Bexagliflozin Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Bexagliflozin Clinical Studies in the drug label.
How Supplied
There is limited information regarding Bexagliflozin How Supplied in the drug label.
Storage
There is limited information regarding Bexagliflozin Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Bexagliflozin Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Bexagliflozin interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Bexagliflozin Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Bexagliflozin Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.