Duragesic Patch Overview

What is  Duragesic?

Duragesic under the fentanyl transdermal system, is a skin patch belongs to narcotic analgesics or opoiod analgesic category which were developed as pain relievers or pain killers. This skin patch named as Duragesic aims at treating chronic pain, from moderate to severe ones, and which will last for several weeks or even longer.

Duragesic CII Patch is produced by ALZA Corporation and distributed by Janssen Pharmaceutica Products LP. Duragesic was granted its initial approval in 1990 by US Food and Drug Administration.

Fentanyl Patches Recalled

Painkiller patches with the prescription medicatiom fentanyl were recalled in February 12, 2008 because of the reports where there have been cut in the drug reservoir of the patch that may result to dangerous overdose of the painkiller. These patches are sold by PriCara under the brand name known as Duragesic. The generic model of these fentanyl patches were marketed by Sandoz Inc. The recall was true to all 25 microgram/hour fentanyl patches bearing the expiration dates on or before December 2009. The recalled skin patches must be disposed of properly and right away. PriCara advised the patients with the recalled 25 mcg/hr Duragesic patches to contact 800-547-6446 and those with recalled 25 mcg/hr from Sandoz Inc should call 800-901-7236.

Duragesic FD Alert – Narcotic Overdose and Death

US FDA gave a warning declaring that the agency was looking into some reports of death and adverse side effects from over dosages of narcotic fentanyl in patients using Duragesic skin patches for pain killer.

The instructions given on using the Duragesic skin patch must be adhered to religiously to avoid death or other adverse side effects from using too much or overdose of fentanyk. These instructions are given in the patient package from the FDA.

What should I know before using Duragesic skin patch?

Duragesic must not be the first narcotic pain medication prescribed for your pain. You must be using Duragesic only if you already have taken at least 60 milligrams(mg) of oral morphine every day, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equal strong dosage of another narcotic analgesic for at least one week or even longer before starting with Duragesic.

Duragesic is not recommended for patients who need narcotic painkillers for a short time only. The pain should be linked with surgery like tonsillectomies, medical or dental procedures like wisdom tooth removal.

Duragesic is also not recommended for occasional or “as needed” use only.

Duragesic may be applied to children with opioid-tolerance and who are of two years or older, who are already using other opioid narcotic pain killers. Pediatric patients below two years old or even older who are tolerant from opioid, and if they are at least 60 mg of oral morphine every day, or at lest 30 mg of oral oxycodone every day, or at least 8 mg of oral hydromorphone daily, or an equal dose of another opioid for one week or longer before using Duragesic.

Who should not use Duragesic?

You must avoid using Duragesic when you are in any of these conditions:

  • Need treatment for pain from surgery, medical or dental procedure
  • Need opioid  or narcotic pain killers for a short time
  • If you are not already using any other opioid narcotic medications
  • Suffered or suffering from gastrointestinal problems known as paralytic ileus
  • Suffering from pain that can easily be taken care of by occasional use of other pain killers
  • Experienced sudden and acute asthma

Children below two years old and children two years old and older who have not yet used or taken other opioid narcotic pain relievers must avoid using Duragesic.

Health Risks from using Duragesic Skin Patches

There are severe side effects associated with the use of Duragesic. Contact your healthcare provider immediately if you experience one or more of the following symptoms:

  • Difficulty in breathing
  • Intense drowsiness with slowed breathing
  • Shortness of breathing or slow chest movement with breathing
  • Feeling faintness, dizziness, confused, or other rare symptoms

These may be symptoms caused by overdose from Duragesic that may also lead to some severe health problems if they are not treated immediately. If you plan to discontinue using Duragesic skin patch abruptly may make you sick with withdrawal symptoms. Consult first with your healthcare provider and discuss about how you can stop using Duragesic.

There is also a chance when you may be addicted to Duragesic skin patch and the risks are greater if you have been addicted to other medicines, street drugs, or even alcohol, or if you have mental problem history.

Durgesic skin patches users may experience a reduced blood pressure and this can make you feel dizzy when you get up fast from sitting or lying down.

Side Effects of Duragesic

The common side effects using Duragesic are as follows:

  • Vomiting
  • Nausea
  • Sleepiness
  • Confusion
  • Dry mouth
  • Constipation
  • Weakness
  • Sweating

Constipation is considered as the most common side effect of opioids such as Duragesic skin patch but may disappear without treating it. Consult with your healthcare provider about using laxatives, medicines to cure constipation, and stool softeners to avoid or treat constipation while using Duragesic.

Duragesic skin patch may make you sleepy and therefore, it is strongly recommended that you do not drive, operate heavy equipment, or do some dangerous activities until you are determine about how Duragesic works for you.

And although rare, there were reports that children experienced trouble in sleeping and seizures.

What should I tell my healthcare provider?

Inform your healthcare provider about all your medical issues before using Duragesic:

  • If you have seizures, convulsions or fits
  • If you have low thyroid level or hypothyroidism
  • If you have difficulty in breathing and lung problems like wheezing, asthma, shortness of breath
  • If you have bradycardia, a condition characterized by slow heart beat
  • If you have low blood pressure
  • If you have  brain problems  or head injury
  • If you have liver and/or kidney problems
  • If you have gallbladder problems
  • If you have some gland problems like Addison’s disease
  • If you have some problems in urinating
  • If you have experienced intense depression
  • If you have  suffered from hallucinations, a condition characterized by seeing or hearing things which are unseen by others
  • If you have history of drinking problems or alcoholism, if you have past and present problems on alcoholism
  • If you have a family history of drug abuse or addiction, past and present experience on these problems
  • If you have some skin reactions or allergies against adhesives used in Duragesic skin patch
  • If you are breastfeeding your baby because the components in the Duragesic skin patch passes to your milk and can harm your baby
  • If you are pregnant or planning to be pregnant since Durageisc skin patch may harm you unborn child
  • If you are using heating sources including electric blankets, heat lamps, heating pads, heated waterbeds, and hot tubs. Avoid taking long baths or sun bath because these activities increase your temperature that can lead to less effectiveness of the medicines in the Duragesic skin patch.

Can other medicines of foods affect the Duragesic skin patch?

Duragesic skin patch and some other medications can interact with one another. Inform your healthcare provider regarding all the medicines you have and/or are taking, the prescription and non-prescription medicines, vitamins, and herbal supplements that can make you sleep such as:

  • Tranquilizers
  • Anxiety medications
  • Sleeping pills
  • Antihistamines
  • And other pain killers

Do not begin using any new prescription medicines, non-prescription medicines, or herbal supplements while you are using the Duragesic skin patch until you have thoroughly consulted with your healthcare provider.

What are other things I should know about the Duragesic skin patch?

Consult your healthcare provider immediately if you have fever above 102 degrees Fahrenheit.  The fever may indicate an overdose of the components in the Duragesic skin patch. The healthcare provider may prescribe a lower dose while you have still have fever.

Avoid using Duragesic skin patch when the seal is broken or when the patch is already cut, damaged,or altered in any form. Using Duragesic skin patch which has cut, or damaged, or altered in any form may subject you to the ingredients of the skin patch which has fatal dose of the medicine.

Do not alter your dose or discontinue using the Durgesic skin patch unless the healthcare provider instructs you to do so.

Refrain from using the Duragesic skin patch more than what is prescribed.

Avoid wearing more than one Duragesic skin patch at a time, unless healthcare provider instructed you to do so.

Once you have discontinued using the patch, make sure that the sticky sides of the skin patch are folded together and flush it in the toilet. Refrain from throwing used Duragesic skin patch in a garbage can.

If the healthcare provider instructs you to discontinue using the Duragesic skin patch, throw away the unused packages. Open the unused skin patches and fold the sticky sides of the patches together and flush them down the toilet.

Duragesic and Getting Legal Help

Since all medicines have certain side effects, the drug manufacturer has an obligation to make their products as reasonably safe, and to inform the medical community and the general public about the potential health risks associated with the use of these skin patches. When the manufacturer fails to do so, then they can be help legally liable when the patients get injured as a result of insufficient warnings or the unreasonably harmful nature of the drug, under the legal theory known as “product liability.”

If you or any of your family members experienced any of the harmful symptoms or rare medical conditions while using Duragesic skin patches, call immediately a doctor or healthcare providers. Then, you may want to look for an experienced lawyer whom you can discuss with about some legal options you can take for the injuries sustained caused by the Duragesic skin patches.


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