Fentanyl (sublingual)

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Fentanyl (sublingual)
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: Chetan Lokhande, M.B.B.S [2]

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Overview

Fentanyl (sublingual) is an analgesic opioid that is FDA approved for the {{{indicationType}}} of breakthrough cancer pain, in opioid-tolerant patients, pain, chronic (severe), in opioid-tolerant patients requiring a long-term daily around-the-clock opioid analgesic.. Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Fentanyl (sublingual) FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Fentanyl in adult patients.

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Fentanyl in pediatric patients.

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Fentanyl (sublingual) Contraindications in the drug label.

Warnings

There is limited information regarding Fentanyl (sublingual) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Fentanyl (sublingual) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Fentanyl (sublingual) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Fentanyl (sublingual) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

There is no FDA guidance on use of Fentanyl (sublingual) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Fentanyl (sublingual) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Fentanyl (sublingual) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Fentanyl (sublingual) in geriatric settings.

Gender

There is no FDA guidance on the use of Fentanyl (sublingual) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Fentanyl (sublingual) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Fentanyl (sublingual) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Fentanyl (sublingual) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Fentanyl (sublingual) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Fentanyl (sublingual) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Fentanyl (sublingual) Administration in the drug label.

Monitoring

There is limited information regarding Fentanyl (sublingual) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Fentanyl (sublingual) and IV administrations.

Overdosage

There is limited information regarding Fentanyl (sublingual) 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 Fentanyl (sublingual) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Fentanyl (sublingual) Mechanism of Action in the drug label.

Structure

There is limited information regarding Fentanyl (sublingual) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Fentanyl (sublingual) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Fentanyl (sublingual) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Fentanyl (sublingual) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Fentanyl (sublingual) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Fentanyl (sublingual) How Supplied in the drug label.

Storage

There is limited information regarding Fentanyl (sublingual) 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 Fentanyl (sublingual) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Fentanyl 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 Fentanyl (sublingual) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Fentanyl (sublingual) 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.