Empagliflozin

Empagliflozin
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: Rabin Bista, M.B.B.S. [2]

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Overview

Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that is FDA approved for the treatment of adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Common adverse reactions include urinary tract infections and female genital mycotic infections.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indicatios

ARDIANCE is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)].

1.1 Limitation of Use JARDIANCE is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Dosage

The recommended dose of JARDIANCE is 10 mg once daily in the morning, taken with or without food. In patients tolerating JARDIANCE, the dose may be increased to 25 mg [see Clinical Studies (14)].

In patients with volume depletion, correcting this condition prior to initiation of JARDIANCE is recommended [see Warnings and Precautions (5.1), Use in Specific Populations (8.5), and Patient Counseling Information (17)].

2.2 Patients with Renal Impairment Assessment of renal function is recommended prior to initiation of JARDIANCE and periodically thereafter.

JARDIANCE should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m2.

No dose adjustment is needed in patients with an eGFR greater than or equal to 45 mL/min/1.73 m2.

JARDIANCE should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m2

DOSAGE FORMS AND STRENGTHS

• JARDIANCE (empagliflozin) 10 mg tablets are pale yellow, round, biconvex and bevel-edged, film-coated tablets debossed with “S 10” on one side and the Boehringer Ingelheim company symbol on the other side.

JARDIANCE (empagliflozin) 25 mg tablets are pale yellow, oval, biconvex, film-coated tablets debossed with “S 25” on one side and the Boehringer Ingelheim company symbol on the other side.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Empagliflozin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Empagliflozin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Empagliflozin in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Empagliflozin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Empagliflozin in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Empagliflozin in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

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

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Empagliflozin in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Empagliflozin with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Empagliflozin with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Empagliflozin with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Empagliflozin in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Empagliflozin in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Empagliflozin in the drug label.

Pharmacology

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

Mechanism of Action

Structure

File:Empagliflozin01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Empagliflozin in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Empagliflozin in the drug label.

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Precautions with Alcohol

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

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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