Sotagliflozin

Sotagliflozin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

Sotagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that is FDA approved for the prophylaxis of heart failure in patients with history of heart failure, type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.. Common adverse reactions include urinary tract infection, volume depletion, diarrhea, and hypoglycemia..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Sotagliflozin is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure in patients with history of heart failure or with underlying comorbidities like diabetes mellitus, chronic kidney disease and other cardiovascular risk factors

The recommended starting dose is 200mg mg administered orally once daily not more than one hour before the meal. It can up titrated to 400mg once daily as tolerated only after 2 weeks.

Always assess the volume status and renal function prior to administering the drug. If the patient has decompensated heart failure, Sotagliflozin is administered as soon as the patient in hemodynamically stable.

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Sotagliflozin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

Sotagliflozin is contraindicated in patients with hypersensitivity reaction to Sotagliflozin.

Warnings

1. Diabetic ketoacidosis

2. volume depleation'

3. Urosepsis

4. Hypoglycemia with concomitant usage of insulin and insulin secretagogues

5. Necrotizing Fasciitis of the Perineum (Fournier's Gangrene)

6. Genital Mycotic Infections

7. Avoid monitoring Glucose level through urine glucose test while on Sotagliflozin as SGLT2 inhibition leads to glucosuria casing Urine Glucose test to be positive.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Sotagliflozin Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Sotagliflozin Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Sotagliflozin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Sotagliflozin in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sotagliflozin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sotagliflozin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Sotagliflozin in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Sotagliflozin in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Sotagliflozin in geriatric settings.

Gender

There is no FDA guidance on the use of Sotagliflozin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sotagliflozin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sotagliflozin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sotagliflozin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sotagliflozin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sotagliflozin in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Sotagliflozin Administration in the drug label.

Monitoring

There is limited information regarding Sotagliflozin Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Sotagliflozin and IV administrations.

Overdosage

There is limited information regarding Sotagliflozin 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 Sotagliflozin Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Sotagliflozin Mechanism of Action in the drug label.

Structure

There is limited information regarding Sotagliflozin Structure in the drug label.

Pharmacodynamics

There is limited information regarding Sotagliflozin Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Sotagliflozin Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Sotagliflozin Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Sotagliflozin Clinical Studies in the drug label.

How Supplied

There is limited information regarding Sotagliflozin How Supplied in the drug label.

Storage

There is limited information regarding Sotagliflozin 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 Sotagliflozin Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Sotagliflozin interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

INPEFA

Look-Alike Drug Names

There is limited information regarding Sotagliflozin 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.