Fentanyl (sublingual)
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.