FENTANYL 62.5 ug/h
FENTANYL · PATCH, EXTENDED RELEASE · Aveva Drug Delivery Systems Inc.
FENTANYL is a patch, extended release containing fentanyl at 62.5 ug/h, taken transdermal. Manufactured by Aveva Drug Delivery Systems Inc..
Key Facts
- Brand Name
- FENTANYL
- Generic Name
- FENTANYL
- NDC Code (Product)
3215-7705- Manufacturer
- Aveva Drug Delivery Systems Inc.
- Strength
- 62.5 ug/h
- Dosage Form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA077449
- Drug Class
- Opioid Agonist [EPC]
- Marketing Start
- 02/10/2025
Recall History
Pharmedium Services, LLC
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
SCA Pharmaceuticals
cGMP deviations: due to shipment of rejected units.
SterRx, LLC
Lack of Assurance of Sterility
Apollo Care, LLC
Lack of Assurance of Sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Central Admixture Pharmacy Services Inc
Lack of assurance of sterility:
Pharmedium Services, LLC
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Teva Pharmaceuticals USA Inc
Labeling: Incorrect or Missing Package Insert
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Central Admixture Pharmacy Services Inc
Lack of assurance of sterility:
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 Citrate Injection is indicated for: • analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. • use as a narcotic analgesic supplement in general or regional anesthesia. • administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. • use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures. Fentanyl Citrate Injection is indicated for: • analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. • use as an opioid analgesic supplement in general or regional anesthesia. • administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. • use as an anesthetic agent with …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Fentanyl Citrate Injection should be administered only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids. • Ensure that an opioid antagonist, resuscitative and intubation equipment, and oxygen are readily available ( 2.1 ). • Individualize dosing based on the factors such as age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and the surgical procedure involved. ( 2.1 ) • Initiate treatment in adults with 50 mcg to 100 mcg. ( 2.2 ) • Initiate treatment in children 2 to 12 years of age, with a reduced dose as low as 2 mcg/kg to 3 mcg/kg. ( 2.2 ) 2.1 Important Dosage and Administration Instructions Fentanyl Citrate Injection should be administered only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids. • Ensure that an opioid antagonist, resuscitative and intubation equipment, and oxygen are readily available. • Individualize dosage based on factors such as age, body weight, physical status, underlying pathological condition, use…
Contraindications
4 CONTRAINDICATIONS Fentanyl Citrate Injection is contraindicated in patients with: • Hypersensitivity to fentanyl (e.g., anaphylaxis) [See Adverse Reactions ( 6 )] • Hypersensitivity to fentanyl ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 2 includes clinically significant drug interactions with Fentanyl Citrate Injection. Table 2: Clinically Significant Drug Interactions with Fentanyl Citrate Injection Inhibitors of CYP3A4 Clinical Impact: The concomitant use of Fentanyl Citrate Injection 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 Citrate Injection is achieved [see Warnings and Precautions ( 5.4 )] . After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the fentanyl 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 Citrate Injection until stable drug effects are achieved [see Dosage and Administration ( 2.1 )] . Monitor patients at frequent intervals for respiratory depression and sedation. If a CYP3A4 inhibitor is discontinued, consider increasing the Fentanyl Citrate Injection dosage …
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.1 )] • Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.2 )] • Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions ( 5.3 )] • Severe Cardiovascular Depression [see Warnings and Precautions ( 5.6 )] • Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions ( 5.7 )] • Serotonin Syndrome [see Warnings and Precautions ( 5.8 )] • Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.11 )] • Seizures [see Warnings and Precautions ( 5.12 )] The following adverse reactions associated with the use of fentanyl were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. As with other opioid agonists, the most common serious adverse reactions reported to occur with fentanyl are respiratory depression, apn…
Frequently Asked Questions
What is FENTANYL used for?
FENTANYL contains FENTANYL. It is a patch, extended release taken transdermal. Consult your doctor for specific uses.
Is FENTANYL a controlled substance?
Yes, FENTANYL is classified as CII under the DEA Controlled Substances Act.
What is the generic name for FENTANYL?
The generic name for FENTANYL is FENTANYL. There are 7 other brand versions of FENTANYL.
What is the NDC code for FENTANYL 62.5 ug/h?
The NDC (National Drug Code) for FENTANYL 62.5 ug/h is 3215-7705, listed by Aveva Drug Delivery Systems Inc..