New sandoz fentanyl patch

Fentanyl is an opioid pain medication that is times more powerful than morphine. It is used to treat patients suffering from moderate to severe chronic pain. The patch is most often prescribed for people with cancer or severe long-term injury. Sandoz is a transdermal patch, which contains a three-day dose of fentanyl gel that is sealed in a reservoir and released at a steady rate over 72 hours. The FDA has received hundreds of reports of fatalities linked to Sandoz fentanyl patch use.

Patients and caregivers who come in contact with a leaking patch may experience severe side effects or potentially be victims of a fatal overdose. In addition to reports of leaking patches, the FDA has investigated deaths and life-threatening side effects in patients who never should have been prescribed the patch.

According to the FDA, patients using the fentanyl patch who experience those symptoms should get medical attention right away. Fentanyl treatment 0. Both the mid-dose and high-dose of fentanyl animals demonstrated alterations in some physical landmarks of development delayed incisor eruption and eye opening and transient behavioral development decreased locomotor activity at Day 28 which recovered by Day The mid-dose and the high-dose are 0.

Fentanyl is excreted in human milk; therefore, fentanyl transdermal system is not recommended for use in nursing women because of the possibility of effects in their infants. Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with fentanyl transdermal system.

Monitor infants exposed to fentanyl through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped.

Due to effects of androgen deficiency, chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [see Adverse Reactions 6. The safety of fentanyl transdermal system was evaluated in three open-label trials in pediatric patients with chronic pain, 2 years of age through 18 years of age.

The safety and effectiveness of fentanyl transdermal system in children under 2 years of age have not been established. To guard against excessive exposure to fentanyl transdermal system by young children, advise caregivers to strictly adhere to recommended fentanyl transdermal system application and disposal instructions [see Dosage and Administration 2.

Clinical studies of fentanyl transdermal system did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Data from intravenous studies with fentanyl suggest that the elderly patients may have reduced clearance and a prolonged half-life.

Moreover, elderly patients may be more sensitive to the active substance than younger patients. A study conducted with the fentanyl transdermal system in elderly patients demonstrated that fentanyl pharmacokinetics did not differ significantly from young adult subjects, although peak serum concentrations tended to be lower and mean half-life values were prolonged to approximately 34 hours [see Clinical Pharmacology Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration.

Titrate the dosage of fentanyl transdermal system slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see Warnings and Precautions 5. Fentanyl is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

The effect of hepatic impairment on the pharmacokinetics of fentanyl transdermal system has not been fully evaluated. Because there is in vitro and in vivo evidence of extensive hepatic contribution to the elimination of fentanyl transdermal system, hepatic impairment would be expected to have significant effects on the pharmacokinetics of fentanyl transdermal system.

Avoid use of fentanyl transdermal system in patients with severe hepatic impairment [see Dosage and Administration 2. The effect of renal impairment on the pharmacokinetics of fentanyl transdermal system has not been fully evaluated.

Because there is in vivo evidence of renal contribution to the elimination of fentanyl transdermal system, renal impairment would be expected to have significant effects on the pharmacokinetics of fentanyl transdermal system. Avoid the use of fentanyl transdermal system in patients with severe renal impairment [see Dosage and Administration 2. Fentanyl transdermal system contains fentanyl, a substance with a high potential for abuse similar to other opioids including hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol.

Fentanyl transdermal system can be abused and is subject to misuse, addiction, and criminal diversion [see Warnings and Precautions 5. The high drug content in long-acting formulations adds to the risk of adverse outcomes from abuse and misuse. All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes physical withdrawal.

Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare providers should be aware that addiction may be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction. Fentanyl transdermal system, like other opioids, can be diverted for non-medical use into illicit channels of distribution.

Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Fentanyl transdermal system is intended for transdermal use only. Abuse of fentanyl transdermal system poses a risk of overdose and death. This risk is increased with concurrent abuse of fentanyl transdermal system with alcohol and other central nervous system depressants [see Warnings and Precautions 5. Intentional compromise of the transdermal delivery system may result in the uncontrolled delivery of fentanyl and pose a significant risk to the abuser that could result in overdose and death [see Warnings and Precautions 5.

Abuse may occur by applying the transdermal system in the absence of legitimate purpose, or by swallowing, snorting or injecting fentanyl extracted from the transdermal system. Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia in the absence of disease progression or other external factors. Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.

Physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug.

Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity e. Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. Rapid tapering of fentanyl transdermal system in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide.

When discontinuing fentanyl transdermal system, gradually taper the dosage using a patient-specific plan that considers the following: the dose of fentanyl transdermal system the patient has been using, the duration of treatment, and the physical and psychological attributes of the patient. To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient.

In patients taking opioids for a long duration at high doses, ensure that a multimodal approach to pain management, including mental health support if needed , is in place prior to initiating an opioid analgesic taper [see Dosage and Administration 2. Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms [see Use in Specific Populations 8.

Clinical Presentation: Acute overdose with fentanyl transdermal system can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death.

Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology Treatment of Overdose: Give primary attention to the reestablishment of a patent airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures including oxygen and vasopressors in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques. Once stable, examine the patient and ensure that all fentanyl transdermal systems have been removed.

Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid antagonist. Because the duration of opioid reversal is expected to be less than the duration of action of fentanyl in fentanyl transdermal system, carefully monitor the patient until spontaneous respiration is reliably reestablished.

Therefore, management of an overdose must be monitored accordingly, at least 72 to 96 hours beyond the overdose. In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome.

The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.

The system contains fentanyl, an opioid agonist, for transdermal administration. The composition per unit area of all transdermal system sizes is identical. The molecular weight of fentanyl base is The pKa is 8. The chemical name is N-Phenyl-N-[1- 2-phenylethyl piperidinyl] propanamide.

The structural formula is:. Fentanyl transdermal system is a rectangular translucent system with rounded corners. Each system is comprised of a polyester release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are:. Before use, a polyester release liner covering the drug-in-adhesive layer is removed and discarded.

Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use. 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. Fentanyl produces respiratory depression by direct action on brain stem respiratory centers.

The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation.

Fentanyl causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic e.

Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations. In clinical trials of non-opioid tolerant subjects treated with fentanyl transdermal system, 13 subjects experienced hypoventilation. In these studies, the incidence of hypoventilation was higher in nontolerant women 10 than in men 3 and in subjects weighing less than 63 kg 9 of Although subjects with prior impaired respiration were not common in the trials, they had higher rates of hypoventilation.

In addition, post-marketing reports have been received that describe opioid-naive post-operative patients who have experienced clinically significant hypoventilation and death with fentanyl transdermal system. Hypoventilation can occur throughout the therapeutic range of fentanyl serum concentrations, especially for patients who have an underlying pulmonary condition or who receive concomitant opioids or other CNS drugs associated with hypoventilation.

The use of fentanyl transdermal system is contraindicated in patients who are not tolerant to opioid therapy. Fentanyl causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.

Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm, resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase. Fentanyl produces peripheral vasodilation, which may result in orthostatic hypotension or syncope.

Histamine assays and skin wheal testing in clinical studies indicate that clinically significant histamine release rarely occurs with fentanyl administration. They also stimulate prolactin, growth hormone GH secretion, and pancreatic secretion of insulin and glucagon.

Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.

The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see Adverse Reactions 6. Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models. The clinical significance of these findings is unknown.

Overall, the effects of opioids appear to be modestly immunosuppressive. The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids.

There is a relationship between increasing fentanyl plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression. In opioid-tolerant patients, the situation may be altered by the development of tolerance to opioid-related adverse reactions [see Dosage and Administration 2. Fentanyl transdermal system is a drug-in-adhesive matrix designed formulation.

Fentanyl is released from the matrix at a nearly constant amount per unit time. The concentration gradient existing between the matrix and the lower concentration in the skin, drives drug release. Fentanyl moves in the direction of the lower concentration at a rate determined by the matrix and the diffusion of fentanyl through the skin layers.

While the actual rate of fentanyl delivery to the skin varies over the hour application period, each system is labeled with a nominal flux which represents the average amount of drug delivered to the systemic circulation per hour across average skin. While there is variation in dose delivered among patients, the nominal flux of the systems Following fentanyl transdermal system application, the skin under the system absorbs fentanyl, and a depot of fentanyl concentrates in the upper skin layers.

Fentanyl then becomes available to the systemic circulation. Serum fentanyl concentrations increase gradually following initial fentanyl transdermal system application, generally leveling off between 12 and 24 hours and remaining relatively constant, with some fluctuation, for the remainder of the hour application period.

Peak serum concentrations of fentanyl generally occurred between 20 and 72 hours after initial application see Table 7. Serum fentanyl concentrations achieved are proportional to the fentanyl transdermal system delivery rate.

With continuous use, serum fentanyl concentrations continue to rise for the first two system applications. By the end of the second hour application, a steady-state serum concentration is reached and is maintained during subsequent applications of a patch of the same size see Figure 1. Patients reach and maintain a steady-state serum concentration that is determined by individual variation in skin permeability and body clearance of fentanyl. Fentanyl plasma protein binding capacity decreases with increasing ionization of the drug.

Alterations in pH may affect its distribution between plasma and the central nervous system. Fentanyl accumulates in the skeletal muscle and fat and is released slowly into the blood. Fentanyl is metabolized primarily via human cytochrome P 3A4 isoenzyme system. Skin does not appear to metabolize fentanyl delivered transdermally.

Moreover elderly patients may be more sensitive to the active substance than younger patients. A study conducted with the fentanyl transdermal system in elderly patients demonstrated that fentanyl pharmacokinetics did not differ significantly from young adult subjects, although peak serum concentrations tended to be lower and mean half-life values were prolonged to approximately 34 hours. In older pediatric patients, the pharmacokinetic parameters were similar to that of adults.

However, these findings have been taken into consideration in determining the dosing recommendations for opioid-tolerant pediatric patients 2 years of age and older. For pediatric dosing information, refer to [see Dosage and Administration 2. Information on the effect of hepatic impairment on the pharmacokinetics of fentanyl transdermal system is limited.

Avoid use of fentanyl transdermal system in patients with severe hepatic impairment [see Dosing and Administration 2. Information on the effect of renal impairment on the pharmacokinetics of fentanyl transdermal system is limited. An inverse relationship between blood urea nitrogen level and fentanyl clearance was found.

Avoid the use of fentanyl transdermal system in patients with severe renal impairment [see Dosing and Administration 2. The interaction between ritonavir, a CPY3A4 inhibitor, and fentanyl was investigated in eleven healthy volunteers in a randomized crossover study.

Subjects received oral ritonavir or placebo for 3 days. The ritonavir dose was mg three times a day on Day 1 and mg three times a day on Day 2 followed by one morning dose of mg on Day 3. Naloxone was administered to counteract the side effects of fentanyl. The concomitant use of transdermal fentanyl with all CYP3A4 inhibitors such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, or grapefruit juice may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression.

Carefully monitor patients receiving fentanyl transdermal system and any CYP3A4 inhibitor for signs of respiratory depression for an extended period of time and adjust the dosage if warranted [see Boxed Warning and Warnings and Precautions 5. Co-administration with agents that induce CYP3A4 activity may reduce the efficacy of fentanyl transdermal system.

The potential effects of fentanyl on male and female fertility were examined in the rat model via two separate experiments. In the male fertility study, male rats were treated with fentanyl 0, 0. In the female fertility study, female rats were treated with fentanyl 0, 0. Analysis of fertility parameters in both studies indicated that an intravenous dose of fentanyl up to 0. In a separate study, a single daily bolus dose of fentanyl was shown to impair fertility in rats when given in intravenous doses of 0.

Fentanyl transdermal system as therapy for pain due to cancer has been studied in patients. Individual patients have used fentanyl transdermal system continuously for up to days.

At one month after initiation of fentanyl transdermal system therapy, patients generally reported lower pain intensity scores as compared to a pre-study analgesic regimen of oral morphine. Twenty-five patients were treated with fentanyl transdermal system for at least 4 months and 9 patients for more than 9 months. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch.

The pouch is labeled with the lot number and expiration date. They are available as follows:. The Store in original unopened pouch. Store fentanyl transdermal system securely and dispose of properly [see Patient Counseling Information 17 ].

Storage and Disposal: Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store fentanyl transdermal system securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home [see Warnings and Precautions 5.

Inform patients that leaving fentanyl transdermal system unsecured can pose a deadly risk to others in the home. Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly.

Expired, unwanted, or unused fentanyl transdermal systems should be disposed of by folding the patch so that the adhesive side of the patch adheres to itself, and immediately flushing down the toilet if a drug take-back option is not readily available [see Instructions for Use ].

Inform patients that they can visit www. Addiction, Abuse, and Misuse: Inform patients that the use of fentanyl transdermal system, even when used as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions 5.

Instruct patients not to share fentanyl transdermal system with others and to take steps to protect fentanyl transdermal system from theft or misuse. Life-Threatening Respiratory Depression: Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting fentanyl transdermal system or when the dosage is increased, and that it can occur even at recommended dosages.

Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling or getting emergency medical help right away in the event of a known or suspected overdose [see Warnings and Precautions 5. Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose: Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with fentanyl transdermal system.

Accidental Exposure: Inform patients that accidental exposure, especially in children, may result in respiratory depression or death [see Warnings and Precautions 5. Fentanyl transdermal system can be accidentally transferred to children.

Instruct patients to take special precautions to avoid accidental contact when holding or caring for children. Instruct patients that, if the patch dislodges and accidentally sticks to the skin of another person, to immediately take the patch off, wash the exposed area with water and seek medical attention for the accidentally exposed individual as accidental exposure may lead to death or other serious medical problems.

Interactions with Benzodiazepines and Other CNS Depressants: Inform patients and caregivers that potentially fatal additive effects may occur if fentanyl transdermal system is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions 5.

Serotonin Syndrome: Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms and signs of serotonin syndrome, and to seek medical attention right away if symptoms develop.

Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications [see Warnings and Precautions 5. MAOI Interaction: Inform patients to avoid using fentanyl transdermal system while taking any drugs that inhibit monoamine oxidase.

Adrenal Insufficiency: Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.

Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions 5.

Important Administration Instructions: Advise patients never to change the dose of fentanyl transdermal system or the number of patches applied to the skin unless instructed to do so by the prescribing healthcare professional.

Important Discontinuation Instructions: In order to avoid developing withdrawal symptoms, instruct patients not to discontinue fentanyl transdermal system without first discussing a tapering plan with the prescriber [see Dosage and Administration 2. Warnings About Heat: Warn patients of the potential for temperature-dependent increases in fentanyl release from the patch that could result in an overdose of fentanyl.

Instruct patients to contact their healthcare provider if they develop a high fever. Instruct patients to:. Hypotension: Inform patients that fentanyl transdermal system may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur e. Anaphylaxis: Inform patients that anaphylaxis, including anaphylactic shock, has been reported with ingredients contained in fentanyl transdermal system.

Advise patients how to recognize such a reaction and when to seek medical attention [see Contraindications 4 , Adverse Reactions 6 ].

Pregnancy: Neonatal Opioid Withdrawal Syndrome: Inform female patients of reproductive potential that prolonged use of fentanyl transdermal system during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see Warnings and Precautions 5. Embryo-Fetal Toxicity: Inform female patients of reproductive potential that fentanyl can cause fetal harm and to inform their healthcare provider of known or suspected pregnancy [see Use in Specific Populations 8.

Lactation: Advise patients that breastfeeding is not recommended during treatment with fentanyl transdermal system [see Use in Specific Populations 8. Infertility: Inform patients that chronic use of opioids may cause reduced fertility.

It is not known whether these effects on fertility are reversible [see Use in Specific Populations 8. Driving or Operating Heavy Machinery: Inform patients that fentanyl transdermal system may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication [see Warnings and Precautions 5.

Constipation: Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see Adverse Reactions 6 , Clinical Pharmacology Important information about fentanyl transdermal system:. Before applying fentanyl transdermal system, tell your healthcare provider if you have a history of:. The possible side effects of fentanyl transdermal system are:.

These are not all the possible side effects of fentanyl transdermal system. Call your doctor for medical advice about side effects. For more information go to dailymed. Be sure that you read, understand, and follow these Instructions for Use before you apply fentanyl transdermal system patch. Talk to your healthcare provider or pharmacist if you have any questions. Important information about the fentanyl transdermal system patch appearance:. Manufactured for: Mylan Pharmaceuticals Inc.

Morgantown, WV U. For Opioid-Tolerant Patients Only. Usual Dosage: For information for use, see accompanying product literature. Apply immediately upon removal from pouch and after removal of the protective liner. Do not expose area to heat. If this is a medical emergency, please call Five In vivo delivery of DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.

DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage , we no longer display the RxImage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.

Drug Label Info. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. Drug Label Information Updated March 25, If you are a consumer or patient please visit this version. Approval: Monitor closely, especially upon initiation or following a dose increase. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Warn patients to avoid exposing the fentanyl transdermal system application site and surrounding area to direct external heat sources. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. Warn patients to avoid strenuous exertion that may lead to increased body temperature.

Avoid use of fentanyl transdermal system in patients with impaired consciousness or coma. Life-threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of fentanyl transdermal system.

Accidental Exposure Accidental exposure to even one dose of fentanyl transdermal system, especially in children, can result in a fatal overdose of fentanyl. Neonatal Opioid Withdrawal Syndrome Prolonged use of fentanyl transdermal system during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.

Cytochrome P 3A4 Interaction The concomitant use of fentanyl transdermal system with all cytochrome P 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Risk of Increased Fentanyl Absorption with Application of External Heat Exposure of the fentanyl transdermal system application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds may increase fentanyl absorption and has resulted in fatal overdose of fentanyl.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions 5.

Use of Table 1 for conversion to other analgesic therapies can overestimate the dose of the new agent. Overdosage of the new analgesic agent is possible [see Dosage and Administration 2. Use of Table 2 for conversion to other analgesic therapies can overestimate the dose of the new agent.

In young children and persons with cognitive impairment, adhesion should be monitored and the upper back is the preferred location to minimize the potential of inappropriate patch removal. Hair at the application site may be clipped not shaved prior to system application.

If the site of fentanyl transdermal system application must be cleansed prior to application of the patch, do so with clear water. Do not use soaps, oils, lotions, alcohol, or any other agents that might irritate the skin or alter its characteristics. Allow the skin to dry completely prior to patch application. The patch must not be altered e. Fentanyl transdermal system should not be used if the pouch seal is broken or if the patch is cut or damaged.

The next patch is applied to a different skin site after removal of the previous transdermal system. If problems with adhesion persist, the patch may be overlayed with a transparent adhesive film dressing. A new patch may be applied to a different skin site. Avoidance of Heat Instruct patients to avoid exposing the fentanyl transdermal system application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds, while wearing the system [see Warnings and Precautions 5.

Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with fentanyl transdermal system. Patients with Chronic Pulmonary Disease Fentanyl transdermal system-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of fentanyl transdermal system [see Warnings and Precautions 5.

Elderly, Cachectic, or Debilitated Patients Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see Warnings and Precautions 5. Cardiac Disorders: tachycardia, bradycardia Eye Disorders: vision blurred Gastrointestinal Disorders: ileus, dyspepsia General Disorders and Administration Site Conditions: pyrexia, application site erosion and application site ulcer Investigations: weight decreased Nervous System Disorders: convulsions including clonic convulsions and grand mal convulsion , amnesia, depressed level of consciousness, loss of consciousness Psychiatric Disorders: agitation Respiratory, Thoracic, and Mediastinal Disorders: respiratory distress, apnea, bradypnea, hypoventilation, dyspnea Vascular Disorders: hypotension, hypertension Serotonin Syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

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.

Intervention: If concomitant use is necessary, consider dosage reduction of fentanyl transdermal system until stable drug effects are achieved. Examples: Macrolide antibiotics e.

Intervention: If concomitant use is necessary, consider increasing the fentanyl transdermal system dosage until stable drug effects are achieved. Examples: Rifampin, carbamazepine, phenytoin Benzodiazepines and Other Central Nervous System CNS Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.

Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome [see Warnings and Precautions 5. Intervention: If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment.

Intervention: The use of fentanyl transdermal system is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Fentanyl transdermal system may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Diuretics Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Intervention: Monitor patients for signs of urinary retention or reduced gastric motility when fentanyl transdermal system is used concomitantly with anticholinergic drugs.

Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Data Human Data There are no adequate and well-controlled studies in pregnant women. Clinical Considerations Monitor infants exposed to fentanyl through breast milk for excess sedation and respiratory depression. Risks Specific to the Abuse of Fentanyl Transdermal System Fentanyl transdermal system is intended for transdermal use only. Effects on the Gastrointestinal Tract and Other Smooth Muscle Fentanyl causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.

Effects on the Cardiovascular System Fentanyl produces peripheral vasodilation, which may result in orthostatic hypotension or syncope. Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models.

Concentration—Efficacy Relationships The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids.

Concentration—Adverse Reaction Relationships There is a relationship between increasing fentanyl plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression. NOTE: Information on volume of distribution and half-life not available for renally impaired patients.

Distribution Fentanyl plasma protein binding capacity decreases with increasing ionization of the drug. Elimination Metabolism Fentanyl is metabolized primarily via human cytochrome P 3A4 isoenzyme system. Specific Populations Age Geriatric Population Data from intravenous studies with fentanyl suggest that the elderly patients may have reduced clearance and a prolonged half-life.

Age Pediatric Population In 1. Hepatic Impairment Information on the effect of hepatic impairment on the pharmacokinetics of fentanyl transdermal system is limited. Renal Impairment Information on the effect of renal impairment on the pharmacokinetics of fentanyl transdermal system is limited.

Impairment of Fertility The potential effects of fentanyl on male and female fertility were examined in the rat model via two separate experiments. They are available as follows: NDC carton containing 5 transdermal systems The Educate patients and caregivers on how to recognize the signs and symptoms of an overdose.

Emphasize the importance of doing this before an opioid emergency happens, so the patient and caregiver will know what to do. Even if you use your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. When you first start using fentanyl transdermal system, when your dose is changed, or if you use too many overdose , serious or life-threatening breathing problems that can lead to death may occur.

Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. They could die from using it. Selling or giving away fentanyl transdermal system is against the law. Visit www. Prolonged use of fentanyl transdermal system during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

Not recommended during treatment with fentanyl transdermal system. It may harm your baby. Using fentanyl transdermal system with certain other medicines can cause serious side effects that could lead to death. Apply fentanyl transdermal system exactly as prescribed by your healthcare provider.

Use the lowest dose possible for the shortest time needed. These can cause an overdose that can lead to death. Fentanyl transdermal system can make you sleepy, dizzy, or lightheaded. Using products containing alcohol during treatment with fentanyl transdermal system may cause you to overdose and die. Call your healthcare provider if you have any of these symptoms and they are severe.

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