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What is DURAGESIC?
DURAGESIC (fentanyl transdermal system) contains fentanyl, an opioid agonist, available as a patch for transdermal administration. 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.
The molecular weight of fentanyl base is 336.5, and the empirical formula is CHNO. The n-octanol: water partition coefficient is 860:1. The pKa is 8.4.
The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is:
DURAGESIC is a rectangular transparent unit comprised of a clear siliconized polyethylene terephthalate protective liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are:
1) a transparent backing layer of polyester/ethylene vinyl acetate film with green print; 2) a drug-in-adhesive layer. Before use, a protective liner covering the adhesive layer is removed and discarded.
What does DURAGESIC look like?
What are the available doses of DURAGESIC?
Transdermal system: 12 mcg/hour, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour, 100 mcg/hour. ()
What should I talk to my health care provider before I take DURAGESIC?
How should I use DURAGESIC?
DURAGESIC is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
DURAGESIC should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
Due to the risk of respiratory depression, DURAGESIC is only indicated for use in patients who are already opioid-tolerant. Discontinue or taper all other extended-release opioids when beginning DURAGESIC therapy. As DURAGESIC is only for use in opioid-tolerant patients, do not begin any patient on DURAGESIC as the first opioid .
What interacts with DURAGESIC?
Sorry No Records found
What are the warnings of DURAGESIC?
Sorry No Records found
What are the precautions of DURAGESIC?
Sorry No Records found
What are the side effects of DURAGESIC?
Sorry No records found
What should I look out for while using DURAGESIC?
DURAGESIC is contraindicated in:
What might happen if I take too much DURAGESIC?
How should I store and handle DURAGESIC?
DURAGESIC (fentanyl transdermal system) is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems.
Chemical StructureNo Image found
Fentanyl is an opioid agonist. Fentanyl interacts predominately with the opioid mu-receptor. These mu-binding sites are distributed in the human brain, spinal cord, and other tissues.
Non-Clinical ToxicologyDURAGESIC is contraindicated in:
Use with Allopurinol
One of the pathways for inactivation of azathioprine is inhibited by allopurinol. Patients receiving azathioprine tablets and allopurinol concomitantly should have a dose reduction of azathioprine tablets, to approximately ⅓ to ¼ the usual dose. It is recommended that a further dose reduction or alternative therapies be considered for patients with low or absent TPMT activity receiving azathioprine tablets and allopurinol because both TPMT and XO inactivation pathways are affected (see and sections).
Use with Aminosalicylates
Use with Other Agents Affecting Myelopoesis
Drugs which may affect leukocyte production, including co-trimoxazole, may lead to exaggerated leukopenia, especially in renal transplant recipients.
Use with Angiotensin-Converting Enzyme Inhibitors
The use of angiotensin-converting enzyme inhibitors to control hypertension in patients on azathioprine has been reported to induce anemia and severe leukopenia.
Use with Warfarin
Azathioprine tablets may inhibit the anticoagulant effect of warfarin.
Use with ribavirin
The use of ribavirin for hepatitis C in patients receiving azathioprine has been reported to induce severe pancytopenia and may increase the risk of azathioprine-related myelotoxicity. Inosine monophosphate dehydrogenase (IMDH) is required for one of the metabolic pathways of azathioprine. Ribavirin is known to inhibit IMDH, thereby leading to accumulation of an azathioprine metabolite, 6-methylthioionosine monophosphate (6MTITP), which is associated with myelotoxicity (neutropenia, thrombocytopenia, and anemia). Patients receiving azathioprine with ribavirin should have complete blood counts, including platelet counts, monitored weekly for the first month, twice monthly for the second and third months of treatment, then monthly or more frequently if dosage or other therapy changes are necessary.
Carcinogenesis, Mutagenesis, Impairment of Fertility
DURAGESIC contains fentanyl, an opioid agonist and a Schedule II controlled substance. As an opioid, DURAGESIC exposes users to the risks of addiction, abuse, and misuseBecause modified-release products such as DURAGESIC deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of fentanyl present .
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed DURAGESIC. Addiction can occur at recommended doses and if the drug is misused or abused.
Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing DURAGESIC, and monitor all patients receiving DURAGESIC for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as DURAGESIC, but use in such patients necessitates intensive counseling about the risks and proper use of DURAGESIC along with intensive monitoring for signs of addiction, abuse, and misuse.
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
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing DURAGESIC. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drugContact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
The following serious adverse reactions are discussed elsewhere in the labeling:
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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