Fentanyl - NOVAPLUS

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Overview

What is Fentanyl - NOVAPLUS?

Fentanyl transdermal system is a transdermal system containing fentanyl. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is:

The molecular weight of fentanyl base is 336.5, and the molecular formula is CHNO. The n-octanol: water partition coefficient is 860:1. The pKa is 8.4.

System Components and Structure

*Nominal delivery rate per hour.

Fentanyl transdermal system is a rectangular transparent unit comprising a protective liner and four functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are:

1) a backing layer of polyester film; 2) a drug reservoir of fentanyl and alcohol USP gelled with hydroxyethyl cellulose; 3) an ethylene-vinyl acetate copolymer membrane that controls the rate of fentanyl delivery to the skin surface; and 4) a fentanyl containing silicone adhesive. Before use, a protective liner covering the adhesive layer is removed and discarded.

The active component of the system is fentanyl. The remaining components are pharmacologically inactive. Less than 0.2 mL of alcohol is also released from the system during use.

What does Fentanyl - NOVAPLUS look like?

What are the available doses of Fentanyl - NOVAPLUS?

Fentanyl transdermal system is available as:

What should I talk to my health care provider before I take Fentanyl - NOVAPLUS?

How should I use Fentanyl - NOVAPLUS?

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.

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 - NOVAPLUS?

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What are the warnings of Fentanyl - NOVAPLUS?

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What are the precautions of Fentanyl - NOVAPLUS?

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What are the side effects of Fentanyl - NOVAPLUS?

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What should I look out for while using Fentanyl - NOVAPLUS?

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 PotentialFentanyl 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 DeathRespiratory 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 ExposureDeath 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 InteractionThe 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 HeatThe 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 system 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 - NOVAPLUS?

How should I store and handle Fentanyl - NOVAPLUS?

Storage:[See USP controlled room temperature]Protect from moisture.Storage:[See USP controlled room temperature]Protect from moisture.Storage:[See USP controlled room temperature]Protect from moisture.Fentanyl transdermal system is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems. Store in original unopened pouch. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Bioclusive™ is a trademark of Ethicon, Inc.Tegaderm™ is a trademark of 3MFentanyl transdermal system is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems. Store in original unopened pouch. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Bioclusive™ is a trademark of Ethicon, Inc.Tegaderm™ is a trademark of 3MFentanyl transdermal system is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems. Store in original unopened pouch. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Bioclusive™ is a trademark of Ethicon, Inc.Tegaderm™ is a trademark of 3MFentanyl transdermal system is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems. Store in original unopened pouch. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Bioclusive™ is a trademark of Ethicon, Inc.Tegaderm™ is a trademark of 3M

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Clinical Information

Chemical Structure

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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 PotentialFentanyl 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 DeathRespiratory 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 ExposureDeath 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 InteractionThe 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 HeatThe 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 system 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 .

When protriptyline is given with anticholinergic agents or sympathomimetic drugs, including epinephrine combined with local anesthetics, close supervision and careful adjustment of dosages are required.

Hyperpyrexia has been reported when tricyclic antidepressants are administered with anticholinergic agents or with neuroleptic drugs, particularly during hot weather.

Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants, thereby delaying elimination and increasing steady-state concentrations of these drugs. Clinically significant effects have been reported with the tricyclic antidepressants when used concomitantly with cimetidine. Increases in plasma levels of tricyclic antidepressants, and in the frequency and severity of side-effects, particularly anticholinergic, have been reported when cimetidine was added to the drug regimen. Discontinuation of cimetidine in well-controlled patients receiving tricyclic antidepressants and cimetidine may decrease the plasma levels and efficacy of the antidepressants.

Tricyclic antidepressants may enhance the seizure risk in patients taking ULTRAM (tramadol hydrochloride).

Protriptyline may enhance the response to alcohol and the effects of barbiturates and other CNS depressants.

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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