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Basic Drug Info
Drug Name:Fentanyl
Manufacturer:Actavis South Atlantic LLC
Other Info:Full Prescribing InformationFOR USE IN OPIOID-TOLERANT PATIENTS ONLY



Clinical Trials:


Indications and Usage
Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that:requires continuous, around-the-clock opioid administration for an extended period of time, andcannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioidsFentanyl transdermal system should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg/hr (see DOSAGE AND ADMINISTRATION).  Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid.Because serious or life-threatening hypoventilation could result, fentanyl transdermal system is contraindicated for use on an as needed basis (i.e., prn), for the management of post-operative or acute pain, or in patients who are not opioid-tolerant or who require opioid analgesia for a short period of time (see BOX WARNING and CONTRAINDICATIONS).An evaluation of the appropriateness and adequacy of treating with immediate-release opioids is advisable prior to initiating therapy with any modified-release opioid.  Prescribers should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen, to opioids, in a plan of pain management such as outlined by the World Health Organization, the Agency for Health Research and Quality, the Federation of State Medical Boards Model Policy, or the American Pain Society.Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids.  Patients receiving opioids should be routinely monitored for signs of misuse, abuse, and addiction.  Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).  Patients at increased risk may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction.
Chronic pain -- Pain that can range from mild to severe, and persists or progresses over a long period of time.

Hypercapnic respiratory failure -- A reduction in the amount of air entering the pulmonary alveoli.

Acute onset pain -- Pain that comes on quickly, can be severe, but lasts a relatively short time.

Absence of pain sensation --

Disease Progression -- The worsening of a disease over time. This concept is most often used for chronic and incurable diseases where the stage of the disease is an important determinant of therapy and prognosis.

Physical findings -- Objective evidence of disease perceptible to the examining physician.

Contraindications
Because serious or life-threatening hypoventilation could occur, fentanyl transdermal system is contraindicated: in patients who are not opioid-tolerantin the management of acute pain or in patients who require opioid analgesia for a short period of timein the management of post-operative pain, including use after out-patient or day surgeries (e.g., tonsillectomies)in the management of mild painin the management of intermittent pain (e.g., use on an as needed basis [prn])in situations of significant respiratory depression, especially in unmonitored settings where there is a lack of resuscitative equipmentin patients who have acute or severe bronchial asthmaFentanyl transdermal system is contraindicated in patients who have or are suspected of having paralytic ileus.Fentanyl transdermal system is contraindicated in patients with known hypersensitivity to fentanyl or any component of this product.
Hypercapnic respiratory failure -- A reduction in the amount of air entering the pulmonary alveoli.

Acute onset pain -- Pain that comes on quickly, can be severe, but lasts a relatively short time.

Absence of pain sensation --

Pain, Postoperative -- Pain during the period after surgery.

LUNG FUNCTION DECREASED --

Paralytic Ileus --

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings
Fentanyl transdermal systems are intended for transdermal use (on intact skin) only.  Using damaged or cut fentanyl transdermal systems can lead to the rapid release of the contents of the fentanyl transdermal system and absorption of a potentially fatal dose of fentanyl.The safety of fentanyl transdermal system has not been established in children under 2 years of age.  Fentanyl transdermal system should be administered to children only if they are opioid-tolerant and 2 years of age or older (see PRECAUTIONS - Pediatric Use).Fentanyl transdermal system is ONLY for use in patients who are already tolerant to opioid therapy of comparable potency.  Use in non-opioid tolerant patients may lead to fatal respiratory depression.  Overestimating the fentanyl transdermal system dose when converting patients from another opioid medication can result in fatal overdose with the first dose.  The mean elimination half-life of fentanyl transdermal system is 17 hours.  Therefore, patients who have experienced serious adverse events, including overdose, will require monitoring for at least 24 hours after fentanyl transdermal system removal since serum fentanyl concentrations decline gradually and reach an approximate 50% reduction in serum concentrations 17 hours after system removal.Fentanyl transdermal system should be prescribed only by persons knowledgeable in the continuous administration of potent opioids, in the management of patients receiving potent opioids for treatment of pain, and in the detection and management of hypoventilation including the use of opioid antagonists.All patients and their caregivers should be advised to avoid exposing the fentanyl transdermal system application site to direct external heat sources, such as heating pads or electric blankets, heat lamps, saunas, hot tubs, and heated water beds, etc., while wearing the system.  There is a potential for temperature-dependent increases in fentanyl released from the system resulting in possible overdose and death (see PRECAUTIONS - Patients with Fever/External Heat).Death and other serious medical problems have occurred when people were accidentally exposed to fentanyl transdermal system.  Examples of accidental exposure include transfer of a fentanyl transdermal system from an adult’s body to a child while hugging, accidental sitting on a patch and possible accidental exposure of a caregiver’s skin to the medication in the patch while the caregiver was applying or removing the patch.Placing fentanyl transdermal system in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking or overdose that could result in death.Misuse, Abuse and Diversion of OpioidsFentanyl is an opioid agonist of the morphine-type.  Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.Fentanyl can be abused in a manner similar to other opioids, legal or illicit.  This should be considered when prescribing or dispensing fentanyl transdermal system in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.Fentanyl transdermal system has been reported as being abused by other methods and routes of administration.  These practices will result in uncontrolled delivery of the opioid and pose a significant risk to the abuser that could result in overdose and death (see WARNINGS and DRUG ABUSE AND ADDICTION).Concerns about abuse, addiction and diversion should not prevent the proper management of pain.  However, all patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use.Health care professionals should contact their state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.Hypoventilation (Respiratory Depression) Serious or life-threatening hypoventilation may occur at any time during the use of fentanyl transdermal system especially during the initial 24 to 72 hours following initiation of therapy and following increases in dose.Because significant amounts of fentanyl are absorbed from the skin for 17 hours or more after the system is removed, hypoventilation may persist beyond the removal of fentanyl transdermal system.  Consequently, patients with hypoventilation should be carefully observed for degree of sedation and their respiratory rate monitored until respiration has stabilized.The use of concomitant CNS active drugs requires special patient care and observation.Respiratory depression is the chief hazard of opioid agonists, including fentanyl, the active ingredient in fentanyl transdermal system.  Respiratory depression is more likely to occur in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other drugs that depress respiration.Respiratory depression from opioids is manifested by a reduced urge to breathe and a decreased rate of respiration, often associated with the “sighing” pattern of breathing (deep breaths separated by abnormally long pauses).  Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.  This makes overdoses involving drugs with sedative properties and opioids especially dangerous.Fentanyl transdermal system should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression.  In such patients, even usual therapeutic doses of fentanyl transdermal system may decrease respiratory drive to the point of apnea.  In these patients, alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.Chronic Pulmonary Disease Because potent opioids can cause serious or life-threatening hypoventilation, fentanyl transdermal system should be administered with caution to patients with pre-existing medical conditions predisposing them to hypoventilation.  In such patients, normal analgesic doses of opioids may further decrease respiratory drive to the point of respiratory failure.Head Injuries and Increased Intracranial Pressure Fentanyl transdermal system should not be used in patients who may be particularly susceptible to the intracranial effects of CO2 retention such as those with evidence of increased intracranial pressure, impaired consciousness, or coma.  Opioids may obscure the clinical course of patients with head injury.  Fentanyl transdermal system should be used with caution in patients with brain tumors.Interactions with Other CNS DepressantsThe concomitant use of fentanyl transdermal system with other central nervous system depressants, including but not limited to other opioids, sedatives, hypnotics, tranquilizers (e.g., benzodiazepines), general anesthetics, phenothiazines, skeletal muscle relaxants, and alcohol, may cause respiratory depression, hypotension, and profound sedation or potentially result in coma.  When such combined therapy is contemplated, the dose of one or both agents should be significantly reduced.Interactions with Alcohol and Drugs of AbuseFentanyl may be expected to have additive CNS depressant effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.Interactions with CYP3A4 InhibitorsThe concomitant use of fentanyl transdermal system with potent cytochrome P450 3A4 inhibitors (ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, and nefazodone) may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression.  Patients receiving fentanyl transdermal system and potent CYP3A4 inhibitors should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted.  (See BOX WARNING, CLINICAL PHARMACOLOGY - Drug Interactions, PRECAUTIONS and DOSAGE AND ADMINISTRATION for further information.)
Branded Drugs
The following US Branded drugs contain Fentanyl


DURAGESIC-100 -- ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC

DURAGESIC-12 -- ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC

DURAGESIC-25 -- ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC

DURAGESIC-50 -- ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC

DURAGESIC-75 -- ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC

FENTANYL-100 -- ACTAVIS SOUTHATLANTIC LLC

FENTANYL-100 -- LAVIPHARM LABORATORIES INC

FENTANYL-100 -- MYLAN TECHNOLOGIES INC

FENTANYL-100 -- TEVA PHARMACEUTICALS USA

FENTANYL-100 -- WATSON LABORATORIES INC

FENTANYL-12 -- MYLAN TECHNOLOGIES INC

FENTANYL-25 -- ACTAVIS SOUTHATLANTIC LLC

FENTANYL-25 -- LAVIPHARM LABORATORIES INC

FENTANYL-25 -- MYLAN TECHNOLOGIES INC

FENTANYL-25 -- TEVA PHARMACEUTICALS USA

FENTANYL-25 -- WATSON LABORATORIES INC

FENTANYL-50 -- ACTAVIS SOUTHATLANTIC LLC

FENTANYL-50 -- LAVIPHARM LABORATORIES INC

FENTANYL-50 -- MYLAN TECHNOLOGIES INC

FENTANYL-50 -- TEVA PHARMACEUTICALS USA

FENTANYL-50 -- WATSON LABORATORIES INC

FENTANYL-75 -- ACTAVIS SOUTHATLANTIC LLC

FENTANYL-75 -- LAVIPHARM LABORATORIES INC

FENTANYL-75 -- MYLAN TECHNOLOGIES INC

FENTANYL-75 -- TEVA PHARMACEUTICALS USA

FENTANYL-75 -- WATSON LABORATORIES INC


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