Fentanyl – Novaplus

Fentanyl – Novaplus

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

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:

Fentanyl Structural Formula

The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n-octanol: water partition coefficient is 860:1. The pKa is 8.4.

System Components and Structure
The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/h per 10.5 cm2). The composition per unit area of all system sizes is identical.

Dose*
(mcg/h) 
Size
(cm2
Fentanyl Content
(mg) 
25 10 2.5 
50 22 
75 30 7.5 
100 40 10 

*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.

Diagram of Fentanyl transdermal system comprising of a protective liner and four functional layers.

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.

Fentanyl – Novaplus Manufacturers


  • Watson Laboratories, Inc.
    Fentanyl – Novaplus (Fentanyl) Patch, Extended Release [Watson Laboratories, Inc.]

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