FENTANYL TRANSDERMAL SYSTEM

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Overview

What is FENTANYL TRANSDERMAL SYSTEM?

What does FENTANYL TRANSDERMAL SYSTEM look like?

What are the available doses of FENTANYL TRANSDERMAL SYSTEM?

Fentanyl transdermal system is available as:

*

What should I talk to my health care provider before I take FENTANYL TRANSDERMAL SYSTEM?

How should I use FENTANYL TRANSDERMAL SYSTEM?

Fentanyl transdermal system is a transdermal formulation of fentanyl indicated for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age and older when a continuous, around-the-clock opioid analgesic is required for an extended period of time, and the patient cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.

Patients considered opioid-tolerant are those who are taking at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.

Abuse Potential

Assess patients for their clinical risks for opioid abuse or addiction prior to being prescribing fentanyl transdermal system .

Opioid Tolerance

Opioid tolerance to an opioid of comparable potency must be established before prescribing fentanyl transdermal system .

Patients considered opioid-tolerant are those who are taking at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

What interacts with FENTANYL TRANSDERMAL SYSTEM?

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What are the warnings of FENTANYL TRANSDERMAL SYSTEM?

Sorry No Records found

What are the precautions of FENTANYL TRANSDERMAL SYSTEM?

Sorry No Records found

What are the side effects of FENTANYL TRANSDERMAL SYSTEM?

Sorry No records found

What should I look out for while using FENTANYL TRANSDERMAL SYSTEM?

Fentanyl transdermal system is contraindicated in the following patients and situations due to the risk of fatal respiratory depression:

Fentanyl transdermal system is also contraindicated:

Abuse Potential

Fentanyl transdermal system

contains fentanyl, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics.

Fentanyl transdermal system

can be abused in a manner similar to other opioid agonists, legal or illicit. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Assess patients for their clinical risks for opioid abuse or addiction prior to prescribing

fentanyl transdermal system

and then routinely monitor all patients for signs of misuse, abuse and addiction during treatment

Respiratory Depression and Death

Respiratory depression and death may occur with use of fentanyl transdermal system, even when fentanyl transdermal system has been used as recommended and not misused or abused.

Proper dosing and titration are essential and fentanyl transdermal system

should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Fentanyl transdermal system is contraindicated for use in conditions in which the risk of life-threatening respiratory depression is significantly increased, including use as an as-needed analgesic, use in non-opioid tolerant patients, acute pain, and postoperative pain. Monitor for respiratory depression, especially during the first two applications following initiation of dosing, or following an increase in dosage

Accidental Exposure

Death and other serious medical problems have occurred when children and adults were accidentally exposed to fentanyl transdermal system. Advise patients about strict adherence to the recommended handling and disposal instructions in order to prevent accidental exposure

Cytochrome P450 3A4 Interaction

The concomitant use of

fentanyl transdermal system with

all cytochrome P450 3A4 inhibitors

may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Monitor patients receiving

fentanyl transdermal system and any CYP3A4 inhibitor .

Exposure To Heat

The fentanyl transdermal system application site and surrounding area must not be exposed to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds. Exposure to heat may increase fentanyl absorption and there have been reports of overdose and death as a result of exposure to heat. Patients wearing fentanyl transdermal systems who develop fever or increased core body temperature due to strenuous exertion are also at risk for increased fentanyl exposure and may require an adjustment in the dose of fentanyl transdermal system to avoid overdose and death .

What might happen if I take too much FENTANYL TRANSDERMAL SYSTEM?

How should I store and handle FENTANYL TRANSDERMAL SYSTEM?

Vials should be stored refrigerated at 2°-8°C (36°-46°F). Vials may be transferred to room temperature storage for a period not to exceed 2 months. Upon transfer, vial cartons must be marked by the dispensing pharmacist with a "DISCARD BY" date (2 months from the transfer date or the labeled expiration date, whichever comes first). Protect from light until administration.Vials should be stored refrigerated at 2°-8°C (36°-46°F). Vials may be transferred to room temperature storage for a period not to exceed 2 months. Upon transfer, vial cartons must be marked by the dispensing pharmacist with a "DISCARD BY" date (2 months from the transfer date or the labeled expiration date, whichever comes first). Protect from light until administration.Fentanyl Transdermal System is supplied in cartons containing 4 individually packaged systems. See chart for information regarding individual systems.Store in original unopened pouch. Store up to 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F).Fentanyl Transdermal System is supplied in cartons containing 4 individually packaged systems. See chart for information regarding individual systems.Store in original unopened pouch. Store up to 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F).

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Fentanyl is an opioid analgesic. Fentanyl interacts predominately with the opioid mu‑receptor. These mu-binding sites are distributed in the human brain, spinal cord, and other tissues.

Non-Clinical Toxicology

Fentanyl transdermal system is contraindicated in the following patients and situations due to the risk of fatal respiratory depression:

Fentanyl transdermal system is also contraindicated:

Abuse Potential

Fentanyl transdermal system

contains fentanyl, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics.

Fentanyl transdermal system

can be abused in a manner similar to other opioid agonists, legal or illicit. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Assess patients for their clinical risks for opioid abuse or addiction prior to prescribing

fentanyl transdermal system

and then routinely monitor all patients for signs of misuse, abuse and addiction during treatment

Respiratory Depression and Death

Respiratory depression and death may occur with use of fentanyl transdermal system, even when fentanyl transdermal system has been used as recommended and not misused or abused.

Proper dosing and titration are essential and fentanyl transdermal system

should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Fentanyl transdermal system is contraindicated for use in conditions in which the risk of life-threatening respiratory depression is significantly increased, including use as an as-needed analgesic, use in non-opioid tolerant patients, acute pain, and postoperative pain. Monitor for respiratory depression, especially during the first two applications following initiation of dosing, or following an increase in dosage

Accidental Exposure

Death and other serious medical problems have occurred when children and adults were accidentally exposed to fentanyl transdermal system. Advise patients about strict adherence to the recommended handling and disposal instructions in order to prevent accidental exposure

Cytochrome P450 3A4 Interaction

The concomitant use of

fentanyl transdermal system with

all cytochrome P450 3A4 inhibitors

may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Monitor patients receiving

fentanyl transdermal system and any CYP3A4 inhibitor .

Exposure To Heat

The fentanyl transdermal system application site and surrounding area must not be exposed to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds. Exposure to heat may increase fentanyl absorption and there have been reports of overdose and death as a result of exposure to heat. Patients wearing fentanyl transdermal systems who develop fever or increased core body temperature due to strenuous exertion are also at risk for increased fentanyl exposure and may require an adjustment in the dose of fentanyl transdermal system to avoid overdose and death .

Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when ivermectin was coadministered with warfarin.

Fentanyl transdermal system contains fentanyl, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. Schedule II opioid substances which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression. Fentanyl transdermal system can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing fentanyl transdermal system in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion .

Assess patients for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Routinely monitor all patients receiving opioids for signs of misuse, abuse and addiction since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients at increased risk may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction. Concerns about abuse, addiction, and diversion should not prevent the proper management of pain.

Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

The following serious adverse reactions are discussed elsewhere in the labeling:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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