• Select a suitable body area: Apply the patch to dry, intact skin on or near the chest, back, or upper arm. Avoid applying the patch to cut, inflamed, red, or itchy skin. Peel and Stick: Remove the paper backing of the patch and apply the patch firmly to your skin for about 30 seconds to secure it properly.
• Wash Hands: After applying the patch, wash your hands immediately to avoid accidental exposure to fentanyl.
• Wear for 72 hours: The patch should be worn for 3 days. Do not remove it early unless directed by your healthcare provider.
• Dispose Properly: After removing the patch, fold it in half so that the sticky sides are together, and dispose of it according to local guidelines, away from children and pets.

If you forget a replacement of your patch on time, apply a new patch as soon as you remember. But never apply more than one patch at a time to make up for a missed dose. If the next patch replacement is imminent, simply wait until the next patch replacement.

Duragesic-100 works through its active ingredient, fentanyl, which is a synthetic opioid. The patch releases fentanyl slowly into the skin, and it is absorbed into the bloodstream to work on the central nervous system to create pain relief. This is how it works:

• Skin Absorption: Once you apply the Duragesic-100 patch on your skin, the medicine seeps gradually into the blood after some duration.
• Relief of Pain: Fentanyl produces effects on the opioid receptors inside the brain and the spinal cord involved in passing on pain impulses to the brain. When the fentanyl becomes attached to such receptors, transmission of pain signals gets blocked and a relief in pain is obtained.
• Continuous Effect: Because the patch delivers fentanyl continuously for 72 hours, it achieves long-term, consistent pain relief. That is, the patient doesn’t have to keep reminding himself to take several different drugs throughout the day, as the patch works to manage pain continuously throughout the treatment period.

Common side effects are:

• Sedation or Drowsiness: The drowsy effect of fentanyl, it is hard to remain wakeful and active.
• Constipation: Opioid-induced severe constipation from the use of opioids such as fentanyl may have to be medically rectified.
• Skin Irritation: Redness, itching, or irritation on the skin where the patch is placed occurs in some subjects.

Severe Side Effects:

• Overdose: Overdose can occur as drowsiness, decreased breathing, loss of consciousness, or even death. Medical attention should be sought immediately if overdose symptoms are seen.
• Allergic Reactions: Fentanyl allergic reactions are not likely but possible and might have effects like hives, swelling, or shortness of breath.
• Confusion or Mental Changes: Confusion, dizziness, and other changes in the mind are found in some individuals.

Duragesic-100 must be used cautiously since it is highly potent. The following are significant warnings and precautions:

• Risk of Abuse and Dependence: Fentanyl is a controlled substance since it will most probably be abused and result in addiction. It can only be utilized according to directions and in opioid-tolerant patients.
• Risk of Overdose: Misuse of Duragesic-100 will likely lead to overdose, especially if the patch is not used as directed. Do not use more patches than ordered.
• Avoid Heat: Applying heat to the patch, like a heating pad or hot shower, will increase the rate of absorption of fentanyl, increasing the risk for side effects.
• Children and Animals: Keep Duragesic-100 out of reach of children and animals. Accidental exposure, even skin contact, can be lethal.

• Duragesic-100 can interact with other medications, especially those that affect the central nervous system. Some of these interactions increase the risk of unwanted side effects, such as respiratory depression. The most critical interactions are:

• CNS Depressants: Administration of Duragesic with other sedatives, such as alcohol and benzodiazepines (e.g., diazepam) and other opioid medications increases the risk of protracted sedation and respiratory depression.
• CYP3A4 Inhibitors: Certain drugs, including antifungals (ketoconazole), HIV medications, and certain antibiotics, can affect the way your body metabolizes fentanyl and can increase the effect and side effect of fentanyl.

• The duration of Duragesic-100 will depend on the intensity of the patient’s pain and opioid history. In opioid patients, a dose of 25 mcg/hour can be utilized for initiation, and the dose is to be titrated as a function of tolerance and response by the physician. Duragesic-100 is to be used typically for 72 hours, and strict adherence to planned dosing is to be followed.

• Duragesic-100 is a prescription drug. It can only be prescribed by a doctor who knows the history of the patient and the patient’s requirement for pain relief. Due to the high potential for overdose and abuse, Duragesic-100 is a controlled drug and can only be obtained with a doctor’s prescription from a licensed physician.

• Prior to beginning treatment with Duragesic-100, your doctor will consider your history of substance abuse, respiratory illness, or other illness. Follow-up and monitoring is required to determine whether the medication is controlling pain adequately without leading to side effects.

1. What is Duragesic-100?
   Duragesic-100 is a transdermal skin patch that delivers fentanyl, a strong opioid pain medication, through the skin.

2. What is Duragesic-100 used for?
   It is prescribed for managing severe, chronic pain that requires long-term, continuous opioid treatment.

3. How does the Duragesic patch work?
   It slowly releases fentanyl into the bloodstream over 72 hours to provide consistent pain relief.

4. Who should use Duragesic-100?
   It is only for opioid-tolerant patients with ongoing severe pain.

5. How often is Duragesic-100 applied?
   Typically, a new patch is applied every 72 hours (3 days).

6. Where should the Duragesic patch be applied?
   On clean, dry, flat skin areas such as the chest, back, upper arm, or sides of the waist.

7. Can the patch be cut into smaller doses?
   No—cutting or dividing the patch can cause dangerous fentanyl release.

8. What precautions should be taken with Duragesic-100?
   Avoid heat sources (heating pads, hot tubs) because heat can increase drug absorption and risk overdose.

9. What are common side effects of Duragesic-100?
   Nausea, constipation, drowsiness, dizziness, sweating, and skin irritation at the patch site.

10. What are serious risks of Duragesic-100?
    Respiratory depression, overdose, addiction, and death if misused.

11. Can Duragesic-100 be used for short-term pain?
    No—it is not for acute or mild pain.

12. Is Duragesic-100 addictive?
    Yes, it has a high risk of dependence and misuse.

13. What should I do if a patch falls off?
    Apply a new patch to a different skin area and dispose of the old one safely.

14. How should used Duragesic patches be disposed of?
    Fold the patch with sticky sides together and flush it, or follow FDA/doctor disposal guidelines.

15. Can alcohol be consumed while using Duragesic-100?
    No—alcohol increases the risk of dangerous side effects like severe sedation and breathing problems.

16. Can Duragesic-100 interact with other medicines?
    Yes, especially sedatives, benzodiazepines, and other opioids—it may cause life-threatening effects.

17. Can Duragesic-100 be used in children?
    It is generally not recommended for children under 2 years.

18. What should I do if I miss changing a patch on time?
    Apply a new patch as soon as possible and follow your regular schedule.

19. Is Duragesic-100 available in different strengths?
    Yes, it comes in multiple strengths (12 mcg/hr, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, 100 mcg/hr).

20. When should I contact a doctor immediately while using Duragesic-100?
    If you experience slow or shallow breathing, extreme drowsiness, or inability to wake up.