FENTANYL TRANSDERMAL 62.5 ug/h
fentanyl transdermal · PATCH, EXTENDED RELEASE · SpecGx LLC
Fentanyl Transdermal is a prescription patch that delivers the opioid pain medication fentanyl through your skin over an extended period to treat moderate to severe chronic pain. This medication is typically prescribed when other pain treatments have not been effective enough.
Key Facts
- Brand Name
- FENTANYL TRANSDERMAL
- Generic Name
- fentanyl transdermal
- NDC Code (Product)
0406-9062- Manufacturer
- SpecGx LLC
- Strength
- 62.5 ug/h
- Dosage Form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA077154
- Drug Class
- Opioid Agonist [EPC]
- Marketing Start
- 02/28/2020
Recall History
Alvogen, Inc
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Alvogen, Inc
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Actavis
Subpotent; some patches may not contain fentanyl gel
Actavis
Failed Impurities/Degradation Specifications
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid-tolerant patients that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. 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. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ] , reserve opioid analgesics, including fentanyl transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic. Fentanyl transdermal system contains fentanyl, an opioid agonist, and is i…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Fentanyl transdermal system should be prescribed only by healthcare providers who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. ( 2.1 ) Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of fentanyl transdermal system for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 ) Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. ( 5.1 ) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with fentanyl transdermal system. Consider this risk when selecting an initial dose and when making dose adjustments. ( 2.1 , 5.2 ) Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when in…
Contraindications
4 CONTRAINDICATIONS Fentanyl transdermal system is contraindicated in: patients who are not opioid-tolerant. the management of acute or intermittent pain, or in patients who require opioid analgesia for a short period of time. the management of post-operative pain, including use after out-patient or day surgeries, (e.g., tonsillectomies). the management of mild pain. patients with significant respiratory depression [see Warnings and Precautions (5.12) ] . in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.12) ] . in patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.19) ] . in patients with hypersensitivity to fentanyl (e.g., anaphylaxis) or any components of the transdermal system [see Adverse Reactions (6.2) ] . Opioid non-tolerant patients. ( 4 ) Acute or intermittent pain, postoperative pain, mild pain. ( 4 ) Significant respiratory depression. ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) Known or suspected gastrointestinal obstruction, inc…
Drug Interactions
7 DRUG INTERACTIONS Table 6 includes clinically significant drug interactions with fentanyl transdermal system. Table 6. Clinically Significant Drug Interactions with Fentanyl Transdermal System Inhibitors of CYP3A4 Clinical Impact: The concomitant use of fentanyl transdermal system and CYP3A4 inhibitors can increase the plasma concentration of fentanyl, resulting in increased or prolonged opioid effects particularly when an inhibitor is added after a stable dose of fentanyl transdermal system is achieved [see Warnings and Precautions (5.7) ] . After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the fentanyl transdermal system plasma concentration will decrease [see Clinical Pharmacology (12.3 ) ] , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to fentanyl. Intervention: If concomitant use is necessary, consider dosage reduction of fentanyl transdermal system until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation. If a CYP3A4 inhibitor is discontinued, consider increasing the fentanyl transdermal system dosage until stable drug…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] Accidental Exposure [see Warnings and Precautions (5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5) ] Interactions with Benzodiazepines or Other Central Nervous System Depressants [see Warnings and Precautions (5.4) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.10) ] Serotonin Syndrome [see Warnings and Precautions (5.11) ] Adrenal Insufficiency [see Warnings and Precautions (5.13) ] Severe Hypotension [see Warnings and Precautions (5.14) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.19) ] Seizures [see Warnings and Precautions (5.20) ] Withdrawal [see Warnings and Precautions (5.21) ] Most common adverse reactions (≥5%) are nausea, vomiting, somnolence, dizziness, insomnia, constipation, hyperhidrosis, fatigue, feeling cold, anorexia, headache, and diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt at 1-800-778-7898 or FDA at 1-800…
Frequently Asked Questions
What is FENTANYL TRANSDERMAL used for?
Fentanyl Transdermal is a prescription patch that delivers the opioid pain medication fentanyl through your skin over an extended period to treat moderate to severe chronic pain. This medication is typically prescribed when other pain treatments have not been effective enough.
Is FENTANYL TRANSDERMAL a controlled substance?
Yes, FENTANYL TRANSDERMAL is classified as CII under the DEA Controlled Substances Act.
What is the generic name for FENTANYL TRANSDERMAL?
The generic name for FENTANYL TRANSDERMAL is fentanyl transdermal. There are no other listed brand versions of fentanyl transdermal.
What is the NDC code for FENTANYL TRANSDERMAL 62.5 ug/h?
The NDC (National Drug Code) for FENTANYL TRANSDERMAL 62.5 ug/h is 0406-9062, listed by SpecGx LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)