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Duragesic (fentanyl transdermal system): Headache and Migraine Drug Profiles

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Updated: July 7, 2006

Duragesic (fentanyl transdermal system)

Duragesic® (fentanyl transdermal system)

Type of medication: Rx, opioid agonist analgesic.

General Principles:
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
  • cannot be managed by other means such as non-steroidal 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/h. 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 oral hydromorphone daily, or an equianalgesic dose of another opioid.1

How supplied: transdermal patches-- 25, 50, 75, or 100mcg/hour dosages.

Pregnancy and Breastfeeding:

  • FDA pregnancy category C. This means that it is not known whether this drug will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.
  • It is not known whether this medication passes into breast milk. Do not take without talking to your doctor if you are breast-feeding a baby.

DEA/FDA:

  • Schedule II: Requires prescription; high abuse potential; no refills or verbal orders allowed; some states require triplicate Rx and may impose other restrictions.

Contraindications:
Because serious or life-threatening hypoventilation could occur, DURAGESIC® (fentanyl transdermal system) 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])
  • in situations of significant respiratory depression, especially in unmonitored settings where there is a lack of resuscitative equipment
  • in patients who have acute or severe bronchial asthma
  • DURAGESIC® (fentanyl transdermal system) is contraindicated in patients who have or are suspected of having paralytic ileus.
  • DURAGESIC® (fentanyl transdermal system) is contraindicated in patients with known hypersensitivity to fentanyl or any components of this product.

Warnings:

  • All patients and their caregivers should be advised to avoid exposing the DURAGESIC® application site to direct external heat sources, such as heating pads or electric blankets, heat lamps, saunas, hot tubs, and heated water beds, etc., while wearing the system. There is a potential for temperature-dependent increases in fentanyl released from the system resulting in possible overdose and death (see full prescribing information: PRECAUTIONS - Patients with Fever/External Heat).
  • Death and other serious medical problems have occurred when people were accidentally exposed to DURAGESIC®. Examples of accidental exposure include transfer of a DURAGESIC® patch from an adult’s body to a child while hugging, accidental sitting on a patch and possible accidental exposure of a caregiver’s skin to the medication in the patch while the caregiver was applying or removing the patch.
  • Placing DURAGESIC® in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking or overdose that could result in death.

Please see the full prescribing information for the complete listing of contraindications and warnings.

Other medical conditions:
Make sure you tell your doctor if you have any other medical problems, especially those listed below.

  • alcohol abuse
  • brain tumor
  • diarrhea caused by antibiotic treatment or poisoning
  • drug dependence, especially narcotic abuse or dependence, or history of
  • emotional problems
  • emphysema, asthma, or other chronic lung disease
  • enlarged prostate or problems with urination
  • gallbladder disease or gallstones
  • intestinal problems such as colitis or Crohn's disease
  • kidney disease
  • liver disease
  • slow heartbeat
  • underactive thyroid

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