fentanyl patch

The prescription fentanyl patch is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The fentanyl transdermal system is used for patients with severe chronic pain, for example, cancer pain.

Patients considered opioid-tolerant are those who are taking, for one 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.

Physical dependence occurs commonly during therapy with opiate agonists such as fentanyl. Abruptly stopping the drug in patients can precipitate a withdrawal reaction.

Symptoms of withdrawal include:

• Nausea
• Diarrhea
• Coughing
• Tearing
• Nasal discharge
• Profuse sweating
• Twitching muscles
• Yawning

Fentanyl can cause respiratory depression (decreased rate or depth of breathing), muscle rigidity, and slow heart rate. Nausea or vomiting, constipation, and itching can occur during treatment with fentanyl. Transdermal fentanyl can cause a variety of skin reactions. Commonly, redness occurs at the site of application and can last for 6 hours following removal of the patch.

Other side effects include:

• Dry mouth
• Abdominal pain
• Loss of appetite
• Drowsiness
• Confusion
• Headache
• Dizziness
• Nervousness
• Hallucinations
• Anxiety
• Depression
• Euphoria

Possible serious side effects include:

• Hallucinations
• Anxiety
• Depression
• Respiratory depression
• Death (overdose)
• Cardiac arrest
• Fainting
• Severe low blood pressure
• Seizures
• Slow heart rate
• Paralytic ileus
• Abuse
• Withdrawal symptoms

The FDA is investigating reports of deaths and other serious side effects from the use of the fentanyl transdermal system as well as overdoses.

Exposing the patch to heat can increase the amount of fentanyl released and may lead to an overdose. Some patches may cause burns of the skin if worn during an MRI (magnetic resonance imaging) scan. Patients should tell their health-care professional that they are using a medication patch prior to receiving an MRI scan.

• Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve fentanyl for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.ride

• Patches should be applied to a flat, non-irritated area on the upper torso.
• The area of application should be clean and washed with water only prior to application.
• The patch should be applied immediately after removing it from the package and pressed firmly against the skin for 10 to 20 seconds especially around the edges.
• Patches should never be cut or otherwise damaged.
• Doses required to control pain vary widely among patients.
• The recommended dose is 25 to 100 mcg/hour patch applied every 72 hours.
• The manufacturer considers a fentanyl transdermal dose of 100 µg/hour approximately equivalent to 360 mg/day of oral morphine.

The use of fentanyl with other central nervous system depressants can increase the ability of fentanyl to depress breathing, depress the brain, sedate, and lower blood pressure.

Other drugs that may result in slow heart rates in patients when used with fentanyl, and therefore, should be used cautiously include:

• Antipsychotics, for example, Thorazine and Stelazine, haloperidol (Haldol)
• Anxiolytics, for example, diazepam (Valium), lorazepam (Ativan), and zolpidem (Ambien)
• Certain antihistamines, for example, diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• Barbiturates, for example, phenobarbital (Donnatal)
• Tricyclic antidepressants, for example, amitriptyline (Elavil, Endep) and doxepin (Sinequan), ethanol
• Skeletal muscle relaxants, for example, carisoprodol (Soma), cyclobenzaprine (Flexeril), and baclofen (Lioresal). The use of fentanyl with amiodarone (Cordarone) may result in slow heart rates.

Cimetidine (Tagamet) when used with fentanyl can cause confusion, disorientation, or seizures due to impairment in breathing and brain function.

• The fentanyl transdermal system is not recommended for use during pregnancy; it may cause fetal harm.
• Fentanyl from the patch passes into breast milk and may cause undesirable side effects in a nursing infant. Breastfeeding is not recommended while using it.

What preparations of fentanyl transdermal system are available?

• Transdermal systems labeled as delivering 12, 25, 50, 37.5, 62.5, 75, 87.5, or 100 mcg/hour.

How should I keep fentanyl transdermal system stored?

• Patches should be stored at room temperature below 30 C (86 F). Used patches should be folded in half with the sticky sides together, and then flushed down the toilet.
• Patients must avoid exposing the patches to excessive heat as this promotes the release of fentanyl from the patch and increases the absorption of fentanyl through the skin which can result in fatal overdose.