Author: John Carter

Fentanyl transdermal route

Opioids increase the tone and decrease the propulsivecontractions of the smooth muscle of the gastrointestinal tract. The resultantprolongation in gastrointestinal transit time may be responsible for theconstipating effect of fentanyl. Because opioids may increase biliary tract pressure,some patients with biliary colic may experience worsening rather than relief ofpain. In clinical trials of 357 non-opioid tolerant subjectstreated with DURAGESIC, 13 subjects experienced hypoventilation.Hypoventilation was manifested by respiratory rates of less than 8breaths/minute or a pCO2 greater than 55 mm Hg. In these studies, the incidenceof hypoventilation was higher in nontolerant women (10) than in men (3) and insubjects weighing less than 63 kg (9 of 13).

What may interact with this medication?

When discontinuing DURAGESIC and not converting toanother opioid, use a gradual downward titration, such as halving the doseevery 6 days, in order to reduce the possibility of withdrawal symptoms seeWARNINGS AND PRECAUTIONS. It is not known at what dose level DURAGESIC maybe discontinued without producing the signs and symptoms of opioid withdrawal. To convert patients to another opioid, remove DURAGESICand titrate the dose of the new analgesic based upon the patient’s report ofpain until adequate analgesia has been attained. Upon system removal, 17 hoursor more are required for a 50% decrease in serum fentanyl concentrations. Withdrawal symptoms are possible in some patients after conversion or dose adjustmentsee WARNINGS AND PRECAUTIONS. It may take up to 6 days for fentanyl levels to reachequilibrium on a new dose see CLINICAL PHARMACOLOGY.

Report Problems to the Food and Drug Administration

Frequent communication is importantamong the prescriber, other members of the healthcare team, the patient, andthe caregiver/family during periods of changing analgesic requirements,including initial titration. During chronic therapy, periodically reassess thecontinued need for opioid analgesics. When an opioid medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, under the close supervision of a healthcare provider, people who have continuing pain should not let the fear of dependence keep them from using opioids to relieve their pain. Mental dependence (addiction) is less likely to occur when opioids are used for this purpose.

Do not let children see you apply the patch and do not apply it where children can see it. Do not call the patch a sticker, tattoo, or bandage, as this could encourage the child to mimic your actions. Children or pets can have serious side effects or die from putting used patches in their mouth or on their bodies. Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there.

  1. In addition, opioids may obscurethe clinical course of patients with head injury.
  2. Enter other medications to view a detailed interaction report.
  3. Ask your pharmacist which type of laxative is right for you.
  4. Many people using this medication do not have serious side effects.

Do not use Table 1 to convert from DURAGESIC toother therapies because this conversion to DURAGESIC is conservative and willoverestimate the dose of the new agent. Discontinue all other around-the-clock opioid drugs whenDURAGESIC therapy is initiated. Throw away any DURAGESIC® patches that are left over from your prescription as soon as they are no longer needed. Remove the leftover patches from their protective pouch and remove the release liner. Fold the patches in half with the sticky sides together, and flush the patches down the toilet. Do not flush the pouch or the release liner down the toilet.

Precautions

This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval. Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits.

Fentanyl side effects

Fentanyl may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. These effects usually go away after a few days of treatment, when your body gets used to the medicine. However, check with your doctor if drowsiness that is severe enough to interfere with your activities continues for more than a few days. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fentanyl skin patch in the elderly. However, elderly patients are more likely to have drowsiness and age-related lung, kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving fentanyl skin patch.

Cardiac arrest orarrhythmias will require advanced life support techniques. Monitor patients withbradyarrhythmias closely for changes in heart rate, particularly wheninitiating therapy with DURAGESIC. Since the CYP3A4 isoenzyme plays a major role in the metabolism of DURAGESIC, drugs that alter CYP3A4 activity may cause changes inclearance of fentanyl which could lead to changes in fentanyl plasmaconcentrations. Hypotension, profound sedation, coma, respiratorydepression, and death may result if DURAGESIC is used concomitantly withalcohol or other central nervous system (CNS) depressants (e.g., sedatives,anxiolytics, hypnotics, neuroleptics, other opioids). Abuse or misuse of DURAGESIC by placing it in the mouth,chewing it, swallowing it, or using it in ways other than indicated may cause choking, overdose, and death see OVERDOSAGE.

In the female fertility study, female rats weretreated with fentanyl (0, 0.025, 0.1 or 0.4 mg/kg/day) via continuousintravenous infusion for 14 days prior to mating until day 16 of pregnancy;male rats were not treated. In a separate study, a single daily bolus dose of fentanylwas shown to impair fertility in rats when given in intravenous doses of 0.3times the human dose for a period of 12 days. A considerable amount of active fentanyl remains inDURAGESIC even after use as directed. Death and other serious medical problemshave occurred when children and adults were accidentally exposed to DURAGESIC.Accidental or deliberate application or ingestion by a child or adolescent willcause respiratory depression that can result in death.

Alcohol may interfere with the effect of this medication. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Take the patch out of its wrapper, and take off the protective strip over the sticky part. Do not use a patch if the packaging or backing is damaged.

Medical Professionals

While this medication may be prescribed for children as young as 2 years old for selected conditions, precautions do apply. Using opioids for a long time may cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems. Use the patch-disposal unit that was provided with your prescription to dispose of the patches. Read and follow the printed instructions on the disposal unit and use one unit for each patch.

Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, dispose of any unused skin patches in the same folded manner. Do not flush the foil pouch or patch liners; place them in a trash container out of the reach of children and pets. You will probably need to take a faster-acting opioid by mouth to relieve pain during the first few days of using fentanyl skin patch. You may also need another opioid while your dose of fentanyl is being adjusted, and to relieve any “breakthrough” pain that occurs later on. Be sure you do not take more of the other opioid, and do not take it more often than directed.