INSOMNIACS place to talk in the wee hours

PATTY YOOHOO this is for you

Under construction

Your total body is wound tight in pain. An analogy : a toy airplane that you wind the propeller and the rubber band gets tighter and tighter. With pain the same thing can happen to the body. One turn it was as single area that the brain was responding too. But the messages from the brain &body can actually increase pain b/c it sends too many stimuli and releases chemicasl in the area. Then another turn of the propeller the tighter the band becomes. This continues till the rubber band is so tight. The tension is complete. The result is that when the propeller releases the airplane can fly. With the brain & body we need to find ways to release the tension.

Think of taking the pain away layer by layer. Orthodox medicine sometimes gets lost in pills and over technical treatments. I'm not saying that we can take away all the pain, but we can try to alleviate areas that only came to the pain party b/c of too much prodding by the brain and body.

Key to the understanding of pain is the PAIN CYCLE.  1. When pain starts there is signaling to the brain. The brain evaluates, stimulates many responses. Another portion of the brain is paying attention and starts to worry (anxiety). 2.The brain signaling to the pain site is actually protective. The brain and the body are working together to remove the pain. Think of putting your finger in a flame. Brain & body work together to remove the finger from the flame. Protective. The ideal is to stop pain between I &2. We stop the cycle from commencing. Each step along the way, if pain is not interrupted it will become more difficult to control.

                                                                                  1.  Pain

      4. Increase in Pain , anxiety, muscle spasm                                       2.   Increase in Pain , anxiety, muscle spasm

                                                            3. Increase in Pain , anxiety, muscle spasm

This is a repost from another thread I worked on. Including it here because in order to control pain we need to understand how to evaluate it.

Jun 21, 2011 01:22 am sas-schatzi wrote:

. This is going to be long, sorry folks. Generic description of how to evaluate pain and what to do.

First try to see if comfort measures will change level of pain---positioning change> if you have been in on position too long that can cause muscle fatigue which can lead to pain. When appropriate try warming up or mild stretching or getting up and walk around. In the hospital The first thing after asking what when where why , how long etc to determined what I was dealing with,  I'd then look at, is something to tight restricting etc. If the patient has pushed things too much, too fast and pain is caused by overuse---rest.   Bottom line is figure out what we are dealing with first. If this fails  go to meds

Using the pain scale. Research has shown that the worst judges of a patients pain are doctors and nurses. The best judge of the patient pain is there own self description. Everyones tolerance of pain and response to pain is different. No one should assume that anyonelses pain is like their own. If they do, they are arrogant and ignorant of the indepth research of the last 30 years.  If you have somatic pain which is physical body pain----taking medication is appropriate.

I know allot of people mock the pain scale ,but with adequate explanation it works. This is how I used to present it.

 0 --no pain.

1-3 is mild pain, generally tolerated well, but there are people that would like relief from that , so NSAIDS  like motrin ,advil, tylenol if tolerated usually work well.

4-5 and maybe 6 are moderate pain. The choice of pain reliever can be individual here too. Many people do not like taking a narcotic because of fear of getting hooked. So using the previously mentioned drugs are okay. Some people don't get relief with these drugs. Taking the lowest dose narcotic may be a better choice for this individual. Many of the narcotics are combined with the nsaids or tylenol. For example, tylenol 325 mg with oxycodone  5mg = percocet, tylenol 500mg + oyxcodone = Tylox, Hydrocone and tylenol 325mg =vicodin, Etc. Try one pill at lowest dose. If no relief or relief is not acceptable and the doc has said it's okay take the second one---do so.  The reason the drugs are combined is they hit different receptor sites and that will give more widespread relief.

7-10 is severe pain, if at home take the higher dose allowed and should expect pain level to decrease below at least a four or lower,  if no pain relief call doctor.

Don't exceed recommend doses without doctor being aware because it could be an indicator something serious is brewing.

NSAIDS and tylenol are not benign drugs. Taken in doses higher than recommended can cause damage to the liver and the kidney , that may not be reversible. NSAIDS and tylenol should never be taken with alcohol, because of this---Millions of people in the USA have done this for decades----many may have problems years later. Only in the last 15 years has the damage that the NSAIDS/tylenol in combination with alcohol become known, BUT the public has not been adequately informed.

In the hospital at a 6 or higher, I always recommended IV pain meds because------>5- 6 you start to see changes in blood pressure and heart rate,  and chemicals are produced in the body that will actually interfere with healing.

If someone said "well my pains a 20 or 100". I would immediately contact the doc for a regimen change. For example, bone pain from neulasta I said" 100 and it feels like wolves gnawing at my bones and I'm alive" That's pretty descriptive that the meds weren't working.

When we talk of emotional pain.  That's where the doc or counselor ought to be looking at drugs like the benzodiazapines>>>>xanax, valium, ativan. An evaluation for depression is appropriate because  there are many good drugs that will alleviate this and take care of the physical pain as well. When our bodies are under to much pain stress for too long, we can get into the "chronic widespread pain syndrome cycle" Abbreviated CWP. Previously known as and still known as fibromyalgia, but the seriousness of it has only recently been taken accepted and treated seriously. Drugs like Savella and cymbalta and lyrica are good for this, but they do take several weeks to do there magic. Think of it as a logjam. Taking one log away isn't going to get the river flowing. BUT in the meantime we need relief. A combination of drugs to relieve the emotional stress >>benzo's and the physical pain>>i.e percocet may be appropriate. 

We each have to evaluate which it is emotional or physical and take steps to make sure we are safe, but getting some relief. Do all the comfort measures possible>>massage, adequate sleep, adequate hydration(lack of proper hydration will cause the muscles to ache/pain and fatigue faster). Get our cancer docs to make proper referrals for the emotional pain. The best resource to get this moving in a cancer center is through the social worker that can work the system. Get our docs to prescribed appropriate physical pain drug management.

Thyroid--Have a thyroid workup. Ask doc to consider getting you into the midrange to high range of normal lab values. Discuss use of LT4--synthroid,  levothyronine, levoxyl. Try and get them to consider T3 cytomel in a low dose range. Evidence based research is hard to come by. I intentionally stopped pain medicine in July 2014 to see what affect on pain and mood Thyroid meds had if any.  There was one published study that was done by an ENT doc.The dose range he used was 7.5 mcg-10 mcg.  Having difficulty retrieving it. The following link is an Evidence Based study on use of T3 with depression. The study used 100mcg of Cytomel-T3. Why they didn't use a lower dose--unknown.

http://www.ncbi.nlm.nih.gov/pubmed/19108898

Fentanyl--  is at the top of the heap in pain control. The monograph(drug info) describes that patient should have reached the point of failure to control pain with Morphine. Everything is relative. Ask your doc for a patch. Fentanyl 25 mcg to begin with. Some docs b/c of the problems with the Federal Govt. won't prescribe Fentanyl. You should have only one doc prescribing controlled substances. If your PCP won't do it. Ask the MO. Ask your pain mgt doc. Based on what you wrote before Fentanyl wasn't offered as an option. Pursue this vigorously. Because I understand the mechanism of pain and how drugs work I successfully used Fentanyl from Dec 2009 till I discontinued in 2011. I did not have to go through the idiocy of Morphine failure.

 You are Stage 4. Documented uncontrolled pain. The pain mgt. doc offered a pain pump. Duh, demand a trial with Fentanyl. Less costly as pumps cost in the six figures( friend quoted near 250, 000) and  less dangerous.

 In order to make this work, you need to start a pain chart ASAP. Use one of those black&white school notebooks.

Date/time         pain location           pain scale pre drug         drug & dose        pain scale post drug at 2hours     Last BM

Exercise--research has shown for decades that exercise can help pain. But it's not a one size fits all approach. Plus, any program needs to be started slowly.  Very slowly b/c it can increase pain if done too fast.

Posture should be good when doing any physical activity. The skeleton is designed to work well when everything is aligned properly. When our posture is off kilter, muscles have to work harder to keep the skeleton from becoming a problem. That increased tension on the muscles can increase pain.

Walking-This is likely the easiest to start immediately. Walk for 5 minutes a day in the house. Every third day add a minute. Max out at ten minutes. Then try to add a second walking period during the day. When adding the second period start it the same as the first. i.e 5 minutes. The advantage of doing it in the house is reduced risk of falls. Try and do the walking within one hour of waking.

 If your shoulders work. Put your arms through full range of motion for 30 seconds slowly, not like a fast windmill. Think medium. Don't increase for a week. Then max out at 1 minute over the next two weeks.

Hips & knees--Stairstepping if there's a two inch step around the house, start with one foot step up then down. Then alternate to the other foot. Do only 5 each foot for a week. Then the next week add another 5 up and down with each foot. Max out at 20 by four weeks. Make sure your posture is good during this exercise. If the hip is very out of condition, this may have to be done more slowly.

Hips & knees continued--stand at counter with hands on counter. Perfect posture--chin up, back straight up and down.  Only a few inches from counter. Weight on one knee and bend at the knee. Only slightly 5-10 degrees. Repeat 1-3 times. Alternate to other leg. Increase after third day only by 1-3 times This one will come back to bite you in the ass if you try to increase the reps too fast. Think small. Reduces hip and knee pain. But too many reps done too early will increase pain, Think small

Warm moist heat. Has been used for centuries, but is probably most noted for it's use in polio. As stated above pain can cause other areas of the body to become painful b/c of too much stimuli. With the muscles that are at maximum tension, we can help them relax with warm moist heat. How to do it? Set aside a bed in the house if you can for this purpose. If not be creative. The reason I say set aside a bed is you will need at least three large long heating pads(one for each leg  and one for the torso. Three hand towels( same--each leg and torso). A plug strip that you can plug all the heating pads into and leave plugged into. How to use. Turn heating pads to low heat maybe medium. Key is they can not make the skin feel hot (burns). After pads are preheated on bed i.e warming the bed. Wet towels with medium hot water (heat will be lost when getting them set up on you in bed). The key is you want them warm to start. Lay on back in bed. Place one warm towel over leg and put one heating pad over top, repeat with other leg. Tuck the heating pad down the side of the leg. Then place last towel over torso followed by pad. Rest in place for minimum 20-30 minutes. Suggest setting an alarm at the beginning of set up. This will be so comforting you may fall asleep. SAFETY: use low setting to prevent burns. Flip over and do the other side, but will need help to position equipment.  

Avoid massage in a hyper pain state. Possibility of causing more pain. Try skin Brushing. Different definition than what's on the net. Lay fingers flat on the skin. With a light sweep, brush as if picking up a particle. Do this lightly over surface. Stimulates circulation of the area. Very light. have your DH do this for you.

Savella ; repost from another thread I worked on .

In Dec. 2009, I asked my PCP for an antidepressant. I told her that I was pretty distrustful of the side effects of all the psych drugs. From her experience, what did she perceive as the least problematic of all the drugs available. She suggested Savella(trade name in USA--Forrest Pharmaceuticals). It had recently been approved in spring of 2009 in the USA for use in fibromyalgia. It was recognized as having only mild to moderate antidepressant indications.

I have post polio and met the diagnostic criteria for fibromyalgia. Significantly made worse by Arimedex. The Arimedex, I quit in Nov. 2009 b/c the pain increase was unbearable. Subsequently, I tried Femara  and Aromasin.

I am, also, cautious about new drugs. Savella--Milnacipran--generic name, has been available in Europe since the mid 90's. Not a new drug, just a new drug in the USA. For me it was a home run. Not a new drug, good for depression and fibro.  Did a relook at the monograph(drug info). I forgot in the USA it was only approved by FDA for Fibromyalgia. Memories a little fuzzy, but I think it had to do with having to repeat clinical trials for depression, if it was going to be approved for that in the USA. Check your countries for approval use.

Before I started writing here, I did an Evidence Based Search for publications. There are numerous studies. I chose this meta-analysis study b/c I felt most lay people  could read it and understand it. When as a lay person reading studies, over-read(skip) the statistical info--it just makes you confused.--me too sometimes. I have included here the conclusion of the study. The bolding emphasis will be mine.  I will also link to the whole study b/c each section of the study compares Milnacipran to other psych drugs. It may be of interest to others that are on different TCA's and SSRI's, other SNRI's. In reading the study if you need to translate the name of the drug or drug class look at the list I posted on page 1.

For those in the USA, the reason you haven't heard of it much is Forrest Pharm was granted proprietary rights by the FDA as a trade name drug until 2021. It can't be produced or dispensed as a generic drug. It's expensive. My PCP doc kept me in samples from 2009 until I discontinued it in 2013. Bless her. Also, there was a conception I think that it wasn't of value in major depression, only mild to moderate. This study from 2010 clearly disproves that misconception, as some of the other studies do too. I do encourage you to read the entire study, it truly is worth the time. You'll like the info regarding weight loss Study below.

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Milnacipran: a unique antidepressant?

Whether or not the profile described above justify referring to milnacipran as a unique antidepressant, it is clear that this agent has a distinct combination of characteristics.

It is the only SNRI with a balanced (1:1) activity on NE and 5-HT reuptake inhibition. Its efficacy in mild, moderate, and severe depression and a good overall tolerability are combined with a low risk of causing pharmacokinetic drug- drug interactions, sexual dysfunction, minimal effects on body weight in normal-weight patients, and a lack of toxicity in overdose. This particular profile qualifies milnacipran as a first-line antidepressant for many depressed patients. Milnacipran may be particularly well-suited for low-energy, slowed-down patients. Patients who have been withdrawn from SSRIs or other antidepressants due to lack of efficacy or intolerance may find milnacipran to be an effective therapeutic option.

Note that this overview highlights what we consider to be the most interesting and relevant points of the profile of milnacipran and does not claim to be exhaustive. Approved indications and safety recommendations may vary between countries, so prescribers should check on the summary of product characteristics in their own country.

Link to entire study;

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2938282/

Abstract link  http://www.ncbi.nlm.nih.gov/pubmed/20856597

---------------------------------

Link to my favorite drug site. It's run by the government, surprising it's great.  Monograph on Milnacipran as written for the USA. Check your country's source for monographs.

http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d37684d6-5134-49e6-9867-5fd67c9dfd90 

Benzodiazapines: The below is a repost from yet another thread.  For pain I recommend consideration of Valium and Ativan. Key in on the descriptions of Ativan and Valium. I've left the other benzo's here just because it's a nice little explanation of the family group and each drugs particular benefit. Valium will help interrupt the pain cycle b/c of it's affect on anxiety and muscle spasm. Ativan interrupts the anxiety cycle and when combined with melatonin is great as a sleeper combo. BUT you wouldn't take them together. Valium would be good in your scenario, taken in the am. Ativan with melatonin for sleep.

Each benzo has it's own particular little nitch in this family of drugs.

1. Xanax-aprazolam-antianxiety, but I have found that people tend to end up having physical dependence problems. This is from long term personal observation versus scientific reporting. I dislike the drug intensely.

2. Restoril-temazapam-sleeper. I respect restoril allot. Never had a negative patient experience with it. But my experience of use with it was in standard patient population, NOT with patients on oncology drugs, Tamox, or AI's. So even though I respect the drug allot, it may not be a good choice with oncology drugs. I would suggest a first try at it, but if it doesn't work ask for Ativan. (Rose had a negative experience with it)

2. Valium-diazapam-antianxiety and muscle relaxer. There is NO drug that compares to this drug for relieving skeletal muscle spasms. The pain caused by skeletal muscle spasms causes allot of anxiety. Valium interrupts the cycle of muscle spasms and anxiety. It's a two for one drug. I respect Valium very much. It used to be used as Versed is used now. But when Versed was introduced, it replaced valium. It commonly is used now for minor procedures or for patients that are claustrophobic with CT scans and MRI's

4. Versed-midazolam-used for surgery/procedures, all levels from general anesthesia to twilight, because of it's amnesic quality i.e. from the time it's administered it causes the patient to forget until it wears off. It also has a delicious skeletal muscle relaxtion quality. Versed is a very strong drug that cannot be used without direct supervision by qualified personnell with monitoring of all vital signs--BP/R/P/EKG and O2 saturation. Oxygen at 2 liters is the usual adjunct when Versed is used. I respect Versed allot. It was a major leap forward when it was introduced in the late 80's.

5. Ativan-Lorazapam-great drug for anxiety. Minimal side effects. Dose 0.5mg to 4mg. Taken in combo with low dose OXY for pain, or when  Fentanyl patch on it works well. Taken only with melatonin for ins useful for sleep

Sleep-- Interrupted sleep does all kinds of things to the body & brain. Sounds crazy, but evaluate your bed. Consumer Reports Best buy memory foam mattress can be bought for under 700$. A side affect of memory foam that I didn't plan on was the warming affect on the muscles A two for one Comfort and warmth are great for stressed tension filled muscles.

 Patty I think this is it. I may tweak this a bit and revise as opinions are offered. I'm going to take off the UNDER CONSTRUCTION off the intro. The best person to get some level of pain control for you is YOU. Do what you individually can do and then get the docs to do what they can. OOPs forgot opiods BBL

I'm putting two links here. One was from a thread I worked on before Christmas. The second link is from a thread I worked on a few years ago

https://community.breastcancer.org/forum/102/topic/826526?page=1

https://community.breastcancer.org/forum/8/topic/770655?page=1

Well Patty you are going to have a book.

Chevy don't save until I take off the UNDER CONSTRUCTION.  LOL still writing. Using lots of old posts. It's funny how I use the same phrasing for things

Rosie, one thing I have been amazed at in the threads is the different pain responses with bone mets. The first person to enlighten me regarding this was ChrissyB. What's blown me away with the thyroid meds is pain I accepted from age 30 on is gone with the meds. In studying the thyroid info, different material suggested a connection. But orthodox medicine would deny the relationship. That's why I specifically stopped pain meds in early July 2014, my own little experiment. Glad your plan is working. The advantage we have as nurses is knowing stuff. Hey, it follows the Kenny Rogers Gambler song lyrics.

Haven't caught up in reading, just snippets

HI1 saw your treasure-----cool. I got multiple things yesterday. Lab visit followed by three thrift stores.:)

Listed as high as  35.00$----Indiana Glass  fairy lamp. Now have two. Overpriced but I got mine for 1.25$

High list about 7-8 $ per bowl. Mine 1.25 for one. AH Wexford

Hi1 you think of me when you thrift and I think of you LOL. YAY

Sweet puppies  the guys aren't bad either LOL YUM.

Patty it's done.......................Fentanyl.

I'm including the black box warning in it's entirety. Not sure as yet, how I will annotate it. But will reinforce the last paragraph regarding heat sources since you will be using the heating pads. The statement at the very end is very well written. If you start using Fentanyl, you would have to discontinue the total body warm moist heat. But if the trade off is better pain control, it doesn't matter how you get there as long as you get there.

Not sure what your MO knows about the drug, if he thinks it only works for a small area. All Opiods work by affecting the opiod receptors in the brain which positively affects the whole body. Plus, Fentanyl has a positive serotonergic affect. That means it mimics the positive affect of increasing serotonin availibility( mechanism I'm not sure of). The antidepressants SSRI's & SSNRI's(see fentanyl thread for list if questions) increase serotonin. Fentanyl is the only opiod that has a positive serotonergic affect. It's two for one drug.

What's different about fentanyl from the other opiods is it doesn't space you out unless the dose is too high. My pain was the entire musculoskeletal system. Post polio & fibromyalgia  induced by the Aromatase inhibitors. The day I started, I was a pain scale of 10. Like you the tears were flowing. I was WORN out by pain. It was heaven as the drug started to take effect.+- 18 hours. The pain melted away. Memory on pain scale with it on, is sketchy. I was so used to living my life with a 5-7(predominantly 5). For the duration that I was on Fentanyl, pain control was effective enough that I rarely took meds for breakthrough. I had an OXY script of 120 pills prescribed to be taken every 4-6 hours for breakthrough. If you calculate that out, it was enough for a month. That script lasted 18 months versus 1 month.

The lovely positive serontonergic effect was one of mellow well being for the duration. Not High. Not spacey. With Oxy 10 mg,  I'm spacey without great pain control and a bit spacey on 5 mg. I much preferred Fentanyl over Oxy.

In the Duragesic monograph below you will see the discussion regarding 3A4. All opiods go through 3A4. My 3A4 is a intermediate metabolizer which means I process it slowly. At the time I was using it, we didn't know that. You've read the "Panicking about Pain" thread. I developed a 7 day plan. I won't restate it here. What it means for you is that you should have your genetics done. I'm taking an educated guess here that you are a rapid metabolizer at 3A4, b/c you are taking high dose without relief but are symptomatic with negative s.e.'s. Doesn't matter if I'm wrong or right. Testing of your 3A4 is critical to your pain control. Depending if there is an aberration in the metabolism, dosing of anything going through 3A4 should be adjusted. Likely hood if I hadn't developed my 7 day plan, I would have been overdosed if I had changed the patch every 3 days

With Genelex testing for the panel is as cheap as testing for one.(see Fentanyl thread). For completeness her the panel includes 2D6, 2C9, 2C19, 3A4, 3A5, Vkroc1.

Dosing: Ask for the 25 mcg patch to start.. They come in a box of 5. If after one week of use pain is not in target range and s.e's none to minimal discuss using 50 mcg. But as you go up in dose s.e's will become more prominent as is the case with all drugs. Once they screwed up my script and gave me 50 mcg. I used them , but was spacey.

Skin prep: Wash application site with non oily soap and dry well. Patch will fall off if the skin is oily. Avoid cleaning skin with alcohol before application. Might set you up for skin irritation. Application site should be moved around to avoid skin from becoming irritated from the adhesive. If a patch comes off, it's designed to not be able to be reapplied.

Skin site selection: Most practioners recommend the upper back area. I recommend anterior upper chest. Reason is if you become unconscious for any reason the upper chest area is exposed by EMT's/doc's to evaluate breathing. In an unconscious state the patch would be identified and removed. If the patch is on the back it may be missed.  Long term use, consider a Medic Alert bracelet.

Initiating drug: Ask for a HomeHealth Referral for "Evaluation of Medication" change. There's an ICDM-9 code for it that the HHA will use. It's covered by insurance. The importance of this is that the nurse will evaluate how you are responding to the drug. It's necessary to be done in your surroundings versus going to the docs office. This evaluation is usually done over 1-2 weeks. Should be repeated if there is a dosage change. review the monograph to educate yourself about the drugs workings.

Storage and disposal: Keep in a secure area from children and pets. Dispose of in the trash that is then secured. Disposal is controversial as it is with all drugs now. Drugs used to be recommended to be put done the toilet. Drugs were affecting the environment. In the trash it goes to the landfill. Communities have developed drug disposal plans.

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Drug Monograph 

Black box warning for Fentanyl( black box warnings means that these are serious considerations regarding a drug).

DURAGESIC^® (fentanyl transdermal system) CII contains a high concentration of a potent Schedule II opioid agonist, fentanyl. Schedule II opioid substances which include fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone have the highest potential for abuse and associated risk of fatal overdose due to respiratory depression. Fentanyl can be abused and is subject to criminal diversion. The high content of fentanyl in the patches (DURAGESIC^®) may be a particular target for abuse and diversion.

DURAGESIC^® is indicated for management of persistent, moderate to severe chronic pain that:

• Requires continuous, around-the-clock opioid administration for an extended period of time, and
• Cannot be managed by other means such as nonsteroidal analgesics, opioid combination products, or immediate-release opioids

DURAGESIC^® should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to DURAGESIC^® 25 mcg/hr. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, 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.

Because serious or life-threatening hypoventilation could occur, DURAGESIC^®is contraindicated:

• In patients who are not opioid-tolerant
• In the management of acute pain or in patients who require opioid analgesia for a short period of time
• In the management of post-operative pain, including use after out-patient or day surgeries (e.g., tonsillectomies)
•    In the management of mild pain
• In the management of intermittent pain (e.g., use on an as needed basis [prn])

(See CONTRAINDICATIONS section of the full Prescribing Information for further information.)

Since the peak fentanyl concentrations generally occur between 20 and 72 hours of treatment, prescribers should be aware that serious or life-threatening hypoventilation may occur, even in opioid-tolerant patients, during the initial application period.

The concomitant use of DURAGESIC^®with all cytochrome P450 3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Patients receiving DURAGESIC^®and any CYP3A4 inhibitors should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted. (See CLINICAL PHARMACOLOGY-Drug Interactions, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of the full Prescribing Information for further information.)

The safety of DURAGESIC^®has not been established in children under 2 years of age. DURAGESIC^®should be administered to children only if they are opioid-tolerant and 2 years of age or older. (See PRECAUTIONS - Pediatric Use section of the full Prescribing Information.)

DURAGESIC^® is ONLY for use in patients who are already tolerant to opioid therapy of comparable potency. Use in non-opioid tolerant patients may lead to fatal respiratory depression. Overestimating the DURAGESIC^® dose when converting patients from another opioid medication can result in fatal overdose with the first dose (see DOSAGE and ADMINISTRATION – Initial DURAGESIC^® Dose Selection - section of full Prescribing Information for further information). Due to the mean elimination half-life of approximately 20-27 hours, patients who are thought to have had a serious adverse event, including overdose, will require monitoring and treatment for at least 24 hours.

DURAGESIC^® can be abused in a manner similar to other opioid agonists, legal or illicit. This risk should be considered when administering, prescribing, or dispensing DURAGESIC^® in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion.

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 should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse, abuse, and addiction. Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however, these patients will require intensive monitoring for signs of misuse, abuse, or addiction.

DURAGESIC^® patches are intended for transdermal use (on intact skin) only. Do not use a DURAGESIC^® patch if the seal is broken or the patch is cut, damaged, or changed in any way.

Avoid exposing the DURAGESIC^® application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, saunas, hot tubs and heated water beds, while wearing the system. Avoid taking hot baths or sunbathing. There is a potential for temperature-dependant increases in fentanyl released from the system resulting in possible overdose and death. Patients wearing DURAGESIC^® systems who develop fever or increased core body temperature due to strenuous exertion should be monitored for opioid side effects and the DURAGESIC^® dose should be adjusted if necessary.