IMPORTANT SAFETY INFORMATION
- 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.
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.
- Taking DURAGESIC® with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) may cause severe drowsiness, decreased awareness, breathing difficulties, with slow or shallow breathing, coma, and death. Do not take these medicines with DURAGESIC® without talking to and following any instructions by your healthcare provider. If you don't know if the medicine you are taking is one that will interact with DURAGESIC®, contact your healthcare professional.
- 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 from the patches, 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®.
- Taking DURAGESIC® may lead to a rare, but serious condition called adrenal insufficiency in which the adrenal glands do not produce adequate amounts of the steroid hormone, cortisol, particularly during stressful conditions. Seek medical attention if you experience symptoms of adrenal insufficiency such as:
- Nausea or vomiting
- Loss of appetite
- Low blood pressure
- DURAGESIC® may cause you to feel dizzy or faint, which may be symptoms of low blood pressure. If you experience one of these symptoms, sit or lie down. To help prevent these symptoms, carefully rise from a sitting or lying position.
- DURAGESIC® may cause anaphylaxis (a type of allergic reaction), including anaphylactic shock. Get emergency help right away if you have any of these symptoms when taking DURAGESIC®: trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat.
- DURAGESIC® may cause reduced fertility in men and women. It is not known if this is reversible. Inform your healthcare professional if you experience signs or symptoms of decreased sex hormone levels such as low libido, impotence, erectile dysfunction, lack of menstruation, or infertility.
- Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including DURAGESIC®. Talk to your healthcare provider about dietary changes, and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while using DURAGESIC®. Tell your healthcare provider if you have severe constipation or stomach pain that gets worse or does not go away.
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:
- 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.
Tell your healthcare provider if you:
- have a fever.
- are pregnant or planning to become pregnant. DURAGESIC® can cause fetal harm if used during pregnancy. Using DURAGESIC® during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
- are breastfeeding. Breastfeeding is not recommended during treatment with DURAGESIC®. It 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.
- are taking or plan on taking selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), triptans, or tricyclic antidepressants (TCAs). Using these medicines during treatment with DURAGESIC® may cause serotonin syndrome, a rare but potentially life-threatening increase of serotonin in the brain, which may lead to symptoms such as feeling confused or restless, sweating, shivering, muscle jerks, fast heartbeat, nausea, vomiting or diarrhea. Get emergency medical help right away if you experience these symptoms while taking DURAGESIC®.
- are taking or plan on taking monoamine oxidase inhibitors (MAOIs), mixed agonist/antagonist opioid analgesics, muscle relaxants, or anticholinergics.
When using DURAGESIC®:
- Do not change your dose. Apply DURAGESIC® exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
- 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.
- Do not cut, break, chew, crush, dissolve, snort, or inject DURAGESIC® because this may cause you to overdose and die.
- 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.
- Do not 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.
- Do not 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.
- Do not take DURAGESIC® if you have taken monoamine oxidase inhibitors (MAOIs) within the last 14 days. Do not take DURAGESIC® while using any drugs that inhibit monoamine oxidase.
What are the possible side effects of DURAGESIC®?
- Constipation (which may be severe), nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, 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, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes
such as confusion.
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, call 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.
Please see full Prescribing Information, including Boxed Warnings, Medication Guide, and Instructions for Use.