Linagliptin and Metformin hydrochloride

Linagliptin and Metformin hydrochloride
Black Box Warning
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];

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Black Box Warning

WARNING: RISK OF LACTIC ACIDOSIS See full prescribing information for complete Boxed Warning. Risk oflactic acidosis:* Lactic acidosis is a rare, but serious, complication that can occur due to metformin accumulation. The risk increases with conditions such as renal impairment, sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute congestive heart failure. The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate. If acidosis is suspected, JENTADUETO should be discontinued and the patient hospitalized immediately.

Overview

Linagliptin and Metformin hydrochloride is a hypoglycemic agent that is FDA approved for the treatment of type 2 diabetes mellitus. There is a Black Box Warning for this drug as shown here. Common adverse reactions include nasopharyngitis and diarrhea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Linagliptin and Metformin hydrochloride FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Linagliptin and Metformin hydrochloride in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Linagliptin and Metformin hydrochloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Linagliptin and Metformin hydrochloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Linagliptin and Metformin hydrochloride in pediatric patients.

Contraindications

There is limited information regarding Linagliptin and Metformin hydrochloride Contraindications in the drug label.

Warnings

WARNING: RISK OF LACTIC ACIDOSIS See full prescribing information for complete Boxed Warning. Risk oflactic acidosis:* Lactic acidosis is a rare, but serious, complication that can occur due to metformin accumulation. The risk increases with conditions such as renal impairment, sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute congestive heart failure. The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate. If acidosis is suspected, JENTADUETO should be discontinued and the patient hospitalized immediately.

There is limited information regarding Linagliptin and Metformin hydrochloride Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Linagliptin and Metformin hydrochloride Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Linagliptin and Metformin hydrochloride Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Linagliptin and Metformin hydrochloride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

There is no FDA guidance on use of Linagliptin and Metformin hydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Linagliptin and Metformin hydrochloride in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Linagliptin and Metformin hydrochloride in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Linagliptin and Metformin hydrochloride in geriatric settings.

Gender

There is no FDA guidance on the use of Linagliptin and Metformin hydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Linagliptin and Metformin hydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Linagliptin and Metformin hydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Linagliptin and Metformin hydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

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

Immunocompromised Patients

There is no FDA guidance one the use of Linagliptin and Metformin hydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Linagliptin and Metformin hydrochloride Administration in the drug label.

Monitoring

There is limited information regarding Linagliptin and Metformin hydrochloride Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Linagliptin and Metformin hydrochloride and IV administrations.

Overdosage

There is limited information regarding Linagliptin and Metformin hydrochloride 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 Linagliptin and Metformin hydrochloride Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Linagliptin and Metformin hydrochloride Mechanism of Action in the drug label.

Structure

There is limited information regarding Linagliptin and Metformin hydrochloride Structure in the drug label.

Pharmacodynamics

There is limited information regarding Linagliptin and Metformin hydrochloride Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Linagliptin and Metformin hydrochloride Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Linagliptin and Metformin hydrochloride Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Linagliptin and Metformin hydrochloride Clinical Studies in the drug label.

How Supplied

There is limited information regarding Linagliptin and Metformin hydrochloride How Supplied in the drug label.

Storage

There is limited information regarding Linagliptin and Metformin hydrochloride 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 Linagliptin and Metformin hydrochloride Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Linagliptin and Metformin hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Linagliptin and Metformin hydrochloride Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Linagliptin and Metformin hydrochloride 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.