The Full US Prescribing Information is available for download as a Portable Document Format (PDF) file below:
PDF documents require Adobe®
to download Adobe Reader for free.
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, in people who are already regularly using opioid pain medicine, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
- A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
- Not for use to treat pain that is not around-the-clock.
IMPORTANT SAFETY INFORMATION
What is the most important information I need to know about DURAGESIC®?
- Get emergency help right away if you use too much DURAGESIC® (overdose). When you first start taking DURAGESIC®, when your dose is changed, or if you take too much (overdose), serious or life threatening breathing problems that can lead to death may occur.
- Never give anyone else your DURAGESIC®. They could die from using it. Store DURAGESIC® in a secure place away from children (because of the high risk of respiratory depression or death) and in a safe place to prevent stealing or abuse. Selling or giving away DURAGESIC® is against the law.
- DURAGESIC® can be accidentally transferred to children or another family member while in close contact. Take special precautions to avoid accidental contact when holding or caring for children. If the patch accidentally sticks to the skin of another person, take the patch off immediately, wash the area with water, and get emergency help right away because an accidental exposure to DURAGESIC® can lead to death or other serious medical problems.
- Properly dispose of DURAGESIC® after use or if you have unused patches that are no longer needed. Fold the sticky sides of a used patch together and immediately flush down the toilet. Dispose of any unused patches remaining from a prescription as soon as they are no longer needed. Unused patches should be removed from the pouches, the protective liners removed, folded so the sticky sides of each patch are together, and immediately flushed down the toilet. Do not put patches in a trash can.
- DURAGESIC® is a long-acting (extended-release) opioid pain medicine (narcotic) that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to overdose or death.
- Serious or life-threatening breathing problems that can lead to death can occur when using DURAGESIC® even if you take your dose correctly as prescribed. The risk is greatest when starting DURAGESIC® or when the dose is increased.
- Call your healthcare provider if you develop a high fever while using DURAGESIC®.
Who should not use DURAGESIC®:
Do not use DURAGESIC®
if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
What should I tell my healthcare professional before applying DURAGESIC®?
Tell your healthcare provider if you have a history of:
Tell your healthcare provider if you:
- head injury, seizures.
- liver, kidney, thyroid problems.
- problems urinating.
- pancreas or gallbladder problems.
- abuse of street or prescription drugs, alcohol addiction, or mental health problems.
- have a fever.
- are pregnant or planning to become pregnant. Prolonged use of DURAGESIC® during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
- are breastfeeding. DURAGESIC® passes into breast milk and may harm your baby.
- are taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking DURAGESIC® with certain other medicines can cause serious side effects that could lead to death.
When using DURAGESIC®:
- Do not change your dose. Apply DURAGESIC® exactly as prescribed by your healthcare provider.
- See the detailed Instructions for Use for information about how to apply and dispose of the DURAGESIC® patch.
- Do not apply more than 1 patch at the same time unless your healthcare provider tells you to.
- You should wear the DURAGESIC® patch continuously for 3 days, unless advised otherwise by your healthcare provider.
- Call your healthcare provider if the dose you are using does not control your pain or if you develop a high fever.
- Do not stop using DURAGESIC® without talking to your healthcare provider. When no longer needed, talk to your doctor about slowly stopping DURAGESIC® to avoid getting sick with withdrawal symptoms.
While using DURAGESIC® DO NOT:
- Take hot baths or sunbathe, use hot tubs, saunas, heating pads, electric blankets, heated waterbeds, or tanning lamps, or engage in activities (such as strenuous exercise) that increases your body temperature. These can cause an overdose that can lead to death.
- Drive or operate heavy machinery when starting or changing the dose of DURAGESIC® until you know how DURAGESIC® affects you. DURAGESIC® can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using these products containing alcohol during treatment with DURAGESIC® may cause you to overdose and die.
What are the possible side effects of DURAGESIC®?
- Constipation (which may be severe), nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, or itching, redness, or rash where the patch is applied. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, or you are feeling faint.
These are not all the possible side effects of DURAGESIC®. Call your healthcare professional for medical advice about side effects.
You may report side effects to FDA, visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Click here for link to FDA website for information on Postmarket Drug Safety Information for Patients and Providers.
Please see full Prescribing Information, including Boxed Warnings, Medication Guide, and Instructions for Use.