Duragesic

DRUG DESCRIPTION

DURAGESIC® (fentanyl transdermal system) is a transdermal system providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is:

DURAGESIC® CII (Fentanyl) Structural Formula Illustration

The molecular weight of fentanyl base is 336.5, and the empirical 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 cm?). The composition per unit area of all system sizes is identical.

Dose* (mcg/h) Size (cm?) Fentanyl Content (mg)
12** 5.25 2.1
25 10.5 4.2
50 21 8.4
75 31.5 12.6
100 42 16.8
*Nominal delivery rate per hour
**Nominal delivery rate is 12.5 mcg/hr

DURAGESIC® (fentanyl transdermal) is a rectangular transparent unit comprising a protective liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are:

1) a backing layer of polyester/ethyl vinyl acetate film; 2) a drug-in-adhesive layer. Before use, a protective liner covering the adhesive layer is removed and discarded.

Layers of Duragesic - illustration

The active component of the system is fentanyl. The remaining components are pharmacologically inactive.

What are the possible side effects of a fentanyl transdermal skin patch?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Remove the skin patch and call your doctor at once if you have any of these serious side effects:

  • weak, shallow breathing;
  • severe weakness, feeling light-headed or fainting;
  • cold, clammy skin; or
  • pale skin, easy bruising or bleeding.

Less serious side effects may include:

  • nausea, vomiting,...

Read All Potential Side Effects and See Pictures of Duragesic »

What are the precautions when taking fentanyl transdermal (Duragesic)?

Before using fentanyl, tell your doctor or pharmacist if you are allergic to it; or to adhesives; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus),...

Read All Potential Precautions of Duragesic »


Duragesic Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or headache may occur. Mild irritation, itching, or redness at the application site may also occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating.

Get medical help right away if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using fentanyl, tell your doctor or pharmacist if you are allergic to it; or to adhesives; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Tell your doctor promptly if you develop a fever, since this rise in body temperature may cause overdose (see also Warning section).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially dizziness, drowsiness, or urinary problems.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of the potential for harm to the unborn baby. Discuss the risks and benefits with your doctor. Babies born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. If you notice any of these symptoms in your newborn, tell the doctor promptly.

This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.


Duragesic Patient Information Including Side Effects

Brand Names: Duragesic, Duragesic-100, Duragesic-12, Duragesic-25, Duragesic-50, Duragesic-75

Generic Name: fentanyl transdermal (skin patch) (Pronunciation: FEN ta nil trans DERM al)

  • What is fentanyl transdermal (Duragesic)?
  • What are the possible side effects of a fentanyl transdermal skin patch?
  • What is the most important information I should know about a fentanyl transdermal skin patch?
  • What should I discuss with my healthcare provider before using a fentanyl transdermal skin patch?
  • How should I use fentanyl transdermal skin patches?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while using a fentanyl transdermal patch?
  • What other drugs will affect fentanyl transdermal?
  • Where can I get more information?

What is fentanyl transdermal (Duragesic)?

Fentanyl is a narcotic (opioid) pain medicine.

The fentanyl skin patch is used to treat moderate to severe chronic pain.

Fentanyl transdermal may also be used for other purposes not listed in this medication guide.

What are the possible side effects of a fentanyl transdermal skin patch?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Remove the skin patch and call your doctor at once if you have any of these serious side effects:

  • weak, shallow breathing;
  • severe weakness, feeling light-headed or fainting;
  • cold, clammy skin; or
  • pale skin, easy bruising or bleeding.

Less serious side effects may include:

  • nausea, vomiting, stomach pain, constipation, gas;
  • dizziness, drowsiness, anxiety, sleep problems (insomnia);
  • muscle stiffness, back pain;
  • itching, blistering, redness, or swelling where the patch was worn; or
  • increased sweating, urinating less than usual.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about a fentanyl transdermal skin patch?

MISUSE OF THIS MEDICATION CAN CAUSE HARMFUL OR FATAL SIDE EFFECTS.

Do not use this medication unless you are already being treated with a similar opioid (narcotic) pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Do not expose the skin patch to heat while you are wearing it. This includes a hot tub, heating pad, sauna, or heated water bed. Heat can increase the amount of drug you absorb through your skin and may cause harmful effects.

Fentanyl may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Store the medication in a secure place where others cannot get to it.

Keep both used and unused fentanyl transdermal patches out of the reach of children or pets. The amount of fentanyl in a used skin patch could be fatal to a child or pet who accidentally sucks on or swallows the unit. Seek emergency medical attention if this happens.

Avoid drinking alcohol, or using other medicines that make you sleepy (such as cold medicine, other pain medication, muscle relaxers, and medicine for depression or anxiety). They can add to extreme drowsiness or breathing problems caused by fentanyl.

The fentanyl transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

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