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Fentanyl Buccal

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Overview

What is Fentanyl Buccal?

Fentanyl buccal tablets are a potent opioid analgesic, intended for buccal mucosal administration. Fentanyl buccal tablets are formulated as a flat-faced, round, beveled-edge white to off-white tablet.

Fentanyl buccal tablets are designed to be placed and retained within the buccal cavity for a period sufficient to allow dissolution of the tablet and absorption of fentanyl across the oral mucosa.

Watson’s fentanyl buccal tablets employ immediate-release drug delivery technology which releases the drug substance upon dissolution.

Active Ingredient:

All tablet strengths are expressed as the amount of fentanyl free base, e.g., the 100 microgram strength tablet contains 100 micrograms of fentanyl free base.

Inactive Ingredients:



What does Fentanyl Buccal look like?



What are the available doses of Fentanyl Buccal?

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What should I talk to my health care provider before I take Fentanyl Buccal?

Sorry No records found

How should I use Fentanyl Buccal?

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Fentanyl buccal tablets are indicated only for the management of breakthrough pain in patients with cancer who are . Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer.

This product be used in opioid non-tolerant patients because life-threatening hypoventilation and death could occur at any dose in patients not on a chronic regimen of opioids.  For this reason, fentanyl buccal tablets are contraindicated in the management of acute or postoperative pain.

Fentanyl buccal tablets are intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.

Physicians should individualize treatment using a progressive plan of pain management.  Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring. (See and .)

It is important to minimize the number of strengths available to patients at any time to prevent confusion and possible overdose.


What interacts with Fentanyl Buccal?

Fentanyl buccal tablets are contraindicated in opioid non-tolerant patients. Fentanyl buccal tablets are contraindicated in the management of acute or postoperative pain including headache/migraine. Life-threatening respiratory depression and death could occur at any dose in opioid non-tolerant patients.


Fentanyl buccal tablets are contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug fentanyl.



What are the warnings of Fentanyl Buccal?

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.

Use with CNS Depressants

The concomitant use of other CNS depressants, including other opioids, sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines, potent inhibitors of cytochrome P450 3A4 isoform (e.g., erythromycin, ketoconazole, and certain protease inhibitors), and alcoholic beverages may produce increased depressant effects. Hypoventilation, hypotension, and profound sedation may occur.

Fentanyl buccal tablets are not recommended for use in patients who have received MAO inhibitors within 14 days, because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.

Pediatric Use:

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Drug Abuse, Addiction and Diversion of Opioids

Fentanyl buccal tablets contain fentanyl, a mu-opioid agonist and a Schedule II controlled substance with high potential for abuse similar to hydromorphone, methadone, morphine, oxycodone, and oxymorphone.  Fentanyl can be abused and is subject to misuse, and criminal diversion.

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.

Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations.  It is characterized by behaviors that include one or more of the following:  impaired control over drug use, compulsive use, continued use despite harm, and craving.  Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

“Drug-seeking” behavior is very common in addicts and drug abusers. Fentanyl buccal tablets should be prescribed with caution to patients who have a higher risk of substance abuse, including patients with bipolar disorder and/or schizophrenia.

Patients with chronic pain may be at a higher risk for suicide.

Abuse and addiction are separate and distinct from physical dependence and tolerance.  Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts.  In addition, abuse of opioids can occur in the absence of addiction and is characterized by misuse for nonmedical purposes, often in combination with other psychoactive substances.  Since fentanyl buccal tablets may be diverted for non-medical use, careful record keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Proper assessment of patients, 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 buccal tablets should be handled appropriately to minimize the risk of diversion, including restriction of access and accounting procedures as appropriate to the clinical setting and as required by law.

Healthcare 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.

Physical Dependence and Withdrawal

The administration of fentanyl buccal tablets should be guided by the response of the patient. Physical dependence, per se, is not ordinarily a concern when one is treating a patient with cancer and chronic pain, and fear of tolerance and physical dependence should not deter using doses that adequately relieve the pain.

Opioid analgesics may cause physical dependence. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity, e.g., naloxone, nalmefene, or mixed agonist/antagonist analgesics (pentazocine, butorphanol, buprenorphine, nalbuphine).

Physical dependence usually does not occur to a clinically significant degree until after several weeks of continued opioid usage. Tolerance, in which increasingly larger doses are required in order to produce the same degree of analgesia, is initially manifested by a shortened duration of analgesic effect, and subsequently, by decreases in the intensity of analgesia.

Respiratory Depression

Respiratory depression is the chief hazard of opioid agonists, including fentanyl, the active ingredient in fentanyl buccal tablets. Respiratory depression is more likely to occur in patients with underlying respiratory disorders and elderly or debilitated patients, usually following large initial doses in opioid 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.


What are the precautions of Fentanyl Buccal?

General

Opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery). Patients taking fentanyl buccal tablets should be warned of these dangers and should be counseled accordingly.

The use of concomitant CNS active drugs requires special patient care and observation. (See .)

Chronic Pulmonary Disease

Because potent opioids can cause respiratory depression, fentanyl buccal tablets should be titrated with caution in patients with chronic obstructive pulmonary disease or pre-existing medical conditions predisposing them to respiratory depression. In such patients, even normal therapeutic doses of fentanyl buccal tablets may further decrease respiratory drive to the point of respiratory failure.

Head Injuries and Increased Intracranial Pressure

Fentanyl buccal tablets should only be administered with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO retention such as those with evidence of increased intracranial pressure or impaired consciousness. Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted.

Application Site Reactions

In clinical trials, 10% of all patients exposed to fentanyl buccal tablets reported application site reactions. These reactions ranged from paresthesia to ulceration and bleeding. Application site reactions occurring in ≥ 1% of patients were pain (4%), ulcer (3%), and irritation (3%).

Application site reactions tended to occur early in treatment, were self-limited and only resulted in treatment discontinuation for 2% of patients.

Cardiac Disease

Intravenous fentanyl may produce bradycardia. Therefore, fentanyl buccal tablets should be used with caution in patients with bradyarrhythmias.

Hepatic or Renal Disease

Insufficient information exists to make recommendations regarding the use of fentanyl buccal tablets in patients with impaired renal or hepatic function.  Fentanyl is metabolized primarily via human cytochrome P450 3A4 isoenzyme system and mostly eliminated in urine. If the drug is used in these patients, it should be used with caution because of the hepatic metabolism and renal excretion of fentanyl.

Information for Patients and Caregivers

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Disposal of Unopened Fentanyl Buccal Tablets Blister Packages When No Longer Needed

Patients and members of their household must be advised to dispose of any unopened blister packages remaining from a prescription as soon as they are no longer needed.

To dispose of unused fentanyl buccal tablets, remove fentanyl buccal tablets from blister packages and flush down the toilet. Do not flush the fentanyl buccal tablets blister packages or cartons down the toilet. (See .)

Detailed instructions for the proper storage, administration, disposal, and important instructions for managing an overdose of fentanyl buccal tablets are provided in the fentanyl buccal tablets Medication Guide. Patients should be encouraged to read this information in its entirety and be given an opportunity to have their questions answered.

In the event that a caregiver requires additional assistance in disposing of excess unusable tablets that remain in the home after a patient has expired, they should be instructed to call the Watson toll-free number (1-866-510-7780) or seek assistance from their local DEA office.

Laboratory Tests

The effects of fentanyl buccal tablets on laboratory tests have not been evaluated.

Drug Interactions

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Fentanyl is metabolized mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4); therefore potential interactions may occur when fentanyl buccal tablets are given concurrently with agents that affect CYP3A4 activity. The concomitant use of fentanyl buccal tablets with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, and nefazadone) or moderate CYP3A4 inhibitors (e.g., amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, and verapamil) may result in increased fentanyl plasma concentrations, potentially causing serious adverse drug effects including fatal respiratory depression. Patients receiving fentanyl buccal tablets concomitantly with moderate or strong CYP3A4 inhibitors should be carefully monitored for an extended period of time. Dosage increase should be done conservatively. (See and .)

Grapefruit and grapefruit juice decrease CYP3A4 activity, increasing blood concentrations of fentanyl, thus should be avoided.

Drugs that induce cytochrome P450 3A4 activity may have the opposite effects.

Concomitant use of fentanyl buccal tablets with an MAO inhibitor, or within 14 days of discontinuation, is not recommended.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of fentanyl.

Fentanyl citrate was not mutagenic in the Ames reverse mutation assay in or , or the mouse lymphoma mutagenesis assay. Fentanyl citrate was not clastogenic in the mouse micronucleus assay.

Fentanyl impairs fertility in rats at doses of 30 mcg/kg IV and 160 mcg/kg SC. Conversion to human equivalent doses indicates this is within the range of the human recommended dosing for fentanyl buccal tablets.

Pregnancy-Category C

There are no adequate and well-controlled studies in pregnant women. Fentanyl buccal tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. No epidemiological studies of congenital anomalies in infants born to women treated with fentanyl during pregnancy have been reported.

Chronic maternal treatment with fentanyl during pregnancy has been associated with transient respiratory depression, behavioral changes, or seizures characteristic of neonatal abstinence syndrome in newborn infants. Symptoms of neonatal respiratory or neurological depression were no more frequent than expected in most studies of infants born to women treated acutely during labor with intravenous or epidural fentanyl. Transient neonatal muscular rigidity has been observed in infants whose mothers were treated with intravenous fentanyl.

Fentanyl is embryocidal as evidenced by increased resorptions in pregnant rats at doses of 30 mcg/kg IV or 160 mcg/kg SC. Conversion to human equivalent doses indicates this is within the range of the human recommended dosing for fentanyl buccal tablets.

Fentanyl citrate was not teratogenic when administered to pregnant animals. Published studies demonstrated that administration of fentanyl (10, 100, or 500 mcg/kg/day) to pregnant rats from day 7 to 21, of their 21 day gestation, via implanted microosmotic minipumps was not teratogenic (the high dose was approximately 3-times the human dose of 1600 mcg per pain episode on a mg/m basis). Intravenous administration of fentanyl (10 or 30 mcg/kg) to pregnant female rats from gestation day 6 to 18, was embryo or fetal toxic, and caused a slightly increased mean delivery time in the 30 mcg/kg/day group, but was not teratogenic.

Labor and Delivery

Fentanyl readily passes across the placenta to the fetus; therefore fentanyl buccal tablets are not recommended for analgesia during labor and delivery.

Nursing Mothers

Fentanyl is excreted in human milk; therefore fentanyl buccal tablets should not be used in nursing women because of the possibility of sedation and/or respiratory depression in their infants. Symptoms of opioid withdrawal may occur in infants at the cessation of nursing by women using fentanyl buccal tablets.

Pediatric Use

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Geriatric Use

Of the 304 patients with cancer in clinical studies of fentanyl buccal tablets, 69 (23%) were 65 years of age and older.

Patients over the age of 65 years tended to titrate to slightly lower doses than younger patients.

Patients over the age of 65 years reported a slightly higher frequency for some adverse events specifically vomiting, constipation, and abdominal pain.  Therefore, caution should be exercised in individually titrating fentanyl buccal tablets in elderly patients to provide adequate efficacy while minimizing risk.


What are the side effects of Fentanyl Buccal?

Pre-Marketing Clinical Trial Experience

The safety of fentanyl buccal tablets has been evaluated in 304 opioid tolerant cancer patients with breakthrough pain. The average duration of therapy was 76 days with some patients being treated for over 12 months.

The most commonly observed adverse events seen with fentanyl buccal tablets are typical of opioid side effects. Opioid side effects should be expected and managed accordingly.

The clinical trials of fentanyl buccal tablets were designed to evaluate safety and efficacy in treating patients with cancer and breakthrough pain; all patients were taking concomitant opioids, such as sustained-release morphine, sustained-release oxycodone or transdermal fentanyl, for their persistent pain.

The adverse event data presented here reflect the actual percentage of patients experiencing each adverse effect among patients who received fentanyl buccal tablets for breakthrough pain along with a concomitant opioid for persistent pain.  There has been no attempt to correct for concomitant use of other opioids, duration of fentanyl buccal tablets therapy or cancer-related symptoms.

Table 5 lists, by maximum dose received, adverse events with an overall frequency of 5% or greater within the total population that occurred during titration.  The ability to assign a dose-response relationship to these adverse events is limited by the titration schemes used in these studies.

Table 6 lists, by successful dose, adverse events with an overall frequency of ≥ 5% within the total population that occurred after a successful dose had been determined.

In addition, a small number of patients (n=11) with Grade 1 mucositis were included in clinical trials designed to support the safety of fentanyl buccal tablets. There was no evidence of excess toxicity in this subset of patients.

The duration of exposure to fentanyl buccal tablets varied greatly, and included open-label and double-blind studies. The frequencies listed below represent the ≥1% of patients from three clinical trials (titration and post-titration periods combined) who experienced that event while receiving fentanyl buccal tablets. Events are classified by system organ class.

Adverse Events (≥1%) 

Blood and Lymphatic System Disorders:

Cardiac Disorders:

Gastrointestinal Disorders:

General Disorders and Administration Site Conditions:

Hepatobiliary Disorders:

Infections and Infestations:

Injury, Poisoning and Procedural Complications:

Investigations:

Metabolism and Nutrition Disorders:

Musculoskeletal and Connective Tissue Disorders:

Nervous System Disorders:

Psychiatric Disorders:

Renal and Urinary Disorders:

Respiratory, Thoracic and Mediastinal Disorders:

Skin and Subcutaneous Tissue Disorders:

Vascular Disorders:

Table 5. Adverse Events Which Occurred During Titration at a Frequency of ≥ 5%
 * Three hundred and two (302) patients were included in the safety analysis.
             
 Nausea  4 (9)  5 (15)  10 (19)  13 (23)  18 (16)  50 (17)
 Vomiting  0  2 (6)  2 (4)  7 (13)  3 (3)  14 (5)
 Fatigue  3 (7)  1 (3)  9 (17)  1 (2)  5 (4)  19 (6)
  Dizziness  5 (11)  2 (6)  12 (23)  18 (32)  21 (19)  58 (19)
  Somnolence  2 (4)  2 (6)  6 (12)  7 (13)  3 (3)  20 (7)
  Headache  1 (2)  3 (9)  4 (8)  8 (14)  10 (9)  26 (9)
Table 6. Adverse Events Which Occurred During Long-Term Treatment at a Frequency of ≥ 5%
             
      Anemia  6 (32) 4 (13)  4 (9)  5 (10)   7 (13)  26 (13)
      Neutropenia   0 2 (6) 1 (2)  4 (8)  4 (7)  11 (6)
      Nausea  8 (42) 5 (16) 14 (32)  13 (27)  17 (31)  57 (29)
      Vomiting  7 (37) 5 (16) 9 (20)  8 (17)  11 (20)  40 (20)
      Constipation  5 (26) 4 (13) 5 (11)  4 (8)  6 (11)  24 (12)
      Diarrhea  3 (16) 0 4 (9)  3 (6)  5 (9)  15 (8)
  Abdominal pain  2 (11) 1 (3) 4 (9)  7 (15)  4 (7)  18 (9)
      Edema peripheral  6 (32) 5 (16) 4 (9)  5 (10)  3 (5)  23 (12)
      Asthenia  3 (16) 5 (16) 2 (5)  3 (6)  8 (15)  21 (11)
      Fatigue  3 (16) 3 (10) 9 (20)  9 (19)  8 (15)  32 (16)
      Pneumonia  1 (5) 5 (16) 1 (2)  1 (2)  4 (7)  12 (6)
        
      Weight decreased  1 (5) 1 (3) 3 (7)  2 (4)  6 (11)  13 (7)
      Dehydration  4 (21) 0 4 (9)  6 (13)  7 (13)  21 (11)
      Anorexia   1 (5) 2 (6) 4 (9)  3 (6)  6 (11)  16 (8)
      Hypokalemia   0 2 (6) 0  1 (2)  8 (15)  11 (6)
      Back pain  2 (11) 0 2 (5)  3 (6)  2 (4)  9 (5)
      Arthralgia   0 1 (3) 3 (7)  4 (8)  3 (5)  11 (6)
      Cancer pain  3 (16) 1 (3) 3 (7)  2 (4)  1 (2)  10 (5)
      Dizziness  5 (26) 3 (10) 5 (11)  6 (13)  6 (11)  25 (13)
      Headache  2 (11) 1 (3) 4 (9)  5 (10)  8 (15)  20 (10)
      Somnolence   0 1 (3) 4 (9)  4 (8)  8 (15)  17 (9)
      Confusional state  3 (16) 1 (3) 2 (5)  3 (6)  5 (9)  14 (7)
      Depression  2 (11) 1 (3) 4 (9)  3 (6)  5 (9)  15 (8)
      Insomnia  2 (11) 1 (3) 3 (7)  2 (4)  4 (7)  12 (6)
     Cough  1 (5) 1 (3) 2 (5)  4 (8)  5 (9)  13 (7)
     Dyspnea  1 (5) 6 (19) 0  7 (15)  4 (7)  18 (9)



What should I look out for while using Fentanyl Buccal?

Fentanyl buccal tablets are contraindicated in opioid non-tolerant patients. Fentanyl buccal tablets are contraindicated in the management of acute or postoperative pain including headache/migraine. Life-threatening respiratory depression and death could occur at any dose in opioid non-tolerant patients.

Fentanyl buccal tablets are contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug fentanyl.

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When prescribing, DO NOT convert a patient from Actiq

to fentanyl buccal tablets without following the instructions found in the prescribing information

When dispensing, DO NOT substitute a fentanyl buccal tablets prescription for an Actiq

prescription under any circumstances. Fentanyl buccal tablets and Actiq

are not equivalent.

As a result of these differences, the substitution of the same dose of fentanyl buccal tablets for the same dose of Actiq

or any other fentanyl product may result in a fatal overdose.

There are no safe conversion directions available for patients on any other fentanyl products. (Note: This includes oral, transdermal, or parenteral formulations of fentanyl.)

.


What might happen if I take too much Fentanyl Buccal?


How should I store and handle Fentanyl Buccal?

Before OpeningEach carton contains 7 blister cards with 4 round, white to off-white uncoated tablets in each card. The blisters are child-resistant, encased in peel/push foil, and provide protection from moisture.Each tablet is debossed on one side with “WPI”, and the other side of each dosage strength is uniquely identified by the debossing on the tablet as described in the table below.  The dosage strength of each tablet is marked on the blister package and the carton.  See blister package and carton for product information.Note: Carton/blister package colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.Rx only.DEA ORDER FORM REQUIRED. A SCHEDULE CII NARCOTIC. Manufactured by: Corona, CA 92880Revised: January 2011Each carton contains 7 blister cards with 4 round, white to off-white uncoated tablets in each card. The blisters are child-resistant, encased in peel/push foil, and provide protection from moisture.Each tablet is debossed on one side with “WPI”, and the other side of each dosage strength is uniquely identified by the debossing on the tablet as described in the table below.  The dosage strength of each tablet is marked on the blister package and the carton.  See blister package and carton for product information.Note: Carton/blister package colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.Rx only.DEA ORDER FORM REQUIRED. A SCHEDULE CII NARCOTIC. Manufactured by: Corona, CA 92880Revised: January 2011Each carton contains 7 blister cards with 4 round, white to off-white uncoated tablets in each card. The blisters are child-resistant, encased in peel/push foil, and provide protection from moisture.Each tablet is debossed on one side with “WPI”, and the other side of each dosage strength is uniquely identified by the debossing on the tablet as described in the table below.  The dosage strength of each tablet is marked on the blister package and the carton.  See blister package and carton for product information.Note: Carton/blister package colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.Rx only.DEA ORDER FORM REQUIRED. A SCHEDULE CII NARCOTIC. Manufactured by: Corona, CA 92880Revised: January 2011Each carton contains 7 blister cards with 4 round, white to off-white uncoated tablets in each card. The blisters are child-resistant, encased in peel/push foil, and provide protection from moisture.Each tablet is debossed on one side with “WPI”, and the other side of each dosage strength is uniquely identified by the debossing on the tablet as described in the table below.  The dosage strength of each tablet is marked on the blister package and the carton.  See blister package and carton for product information.Note: Carton/blister package colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.Rx only.DEA ORDER FORM REQUIRED. A SCHEDULE CII NARCOTIC. Manufactured by: Corona, CA 92880Revised: January 2011Each carton contains 7 blister cards with 4 round, white to off-white uncoated tablets in each card. The blisters are child-resistant, encased in peel/push foil, and provide protection from moisture.Each tablet is debossed on one side with “WPI”, and the other side of each dosage strength is uniquely identified by the debossing on the tablet as described in the table below.  The dosage strength of each tablet is marked on the blister package and the carton.  See blister package and carton for product information.Note: Carton/blister package colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.Rx only.DEA ORDER FORM REQUIRED. A SCHEDULE CII NARCOTIC. Manufactured by: Corona, CA 92880Revised: January 2011Each carton contains 7 blister cards with 4 round, white to off-white uncoated tablets in each card. The blisters are child-resistant, encased in peel/push foil, and provide protection from moisture.Each tablet is debossed on one side with “WPI”, and the other side of each dosage strength is uniquely identified by the debossing on the tablet as described in the table below.  The dosage strength of each tablet is marked on the blister package and the carton.  See blister package and carton for product information.Note: Carton/blister package colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.Rx only.DEA ORDER FORM REQUIRED. A SCHEDULE CII NARCOTIC. Manufactured by: Corona, CA 92880Revised: January 2011Each carton contains 7 blister cards with 4 round, white to off-white uncoated tablets in each card. The blisters are child-resistant, encased in peel/push foil, and provide protection from moisture.Each tablet is debossed on one side with “WPI”, and the other side of each dosage strength is uniquely identified by the debossing on the tablet as described in the table below.  The dosage strength of each tablet is marked on the blister package and the carton.  See blister package and carton for product information.Note: Carton/blister package colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.Rx only.DEA ORDER FORM REQUIRED. A SCHEDULE CII NARCOTIC. Manufactured by: Corona, CA 92880Revised: January 2011Each carton contains 7 blister cards with 4 round, white to off-white uncoated tablets in each card. The blisters are child-resistant, encased in peel/push foil, and provide protection from moisture.Each tablet is debossed on one side with “WPI”, and the other side of each dosage strength is uniquely identified by the debossing on the tablet as described in the table below.  The dosage strength of each tablet is marked on the blister package and the carton.  See blister package and carton for product information.Note: Carton/blister package colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.Rx only.DEA ORDER FORM REQUIRED. A SCHEDULE CII NARCOTIC. Manufactured by: Corona, CA 92880Revised: January 2011


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Fentanyl is a pure opioid agonist whose principal therapeutic action is analgesia. Other members of the class known as opioid agonists include substances such as morphine, oxycodone, hydromorphone, codeine, and hydrocodone. Pharmacological effects of opioid agonists include anxiolysis, euphoria, feelings of relaxation, respiratory depression, constipation, miosis, cough suppression, and analgesia. Like all pure opioid agonist analgesics, with increasing doses there is increasing analgesia, unlike with mixed agonist/antagonists or non-opioid analgesics, where there is a limit to the analgesic effect with increasing doses. With pure opioid agonist analgesics, there is no defined maximum dose; the ceiling to analgesic effectiveness is imposed only by side effects, the more serious of which may include somnolence and respiratory depression.

Non-Clinical Toxicology
Fentanyl buccal tablets are contraindicated in opioid non-tolerant patients. Fentanyl buccal tablets are contraindicated in the management of acute or postoperative pain including headache/migraine. Life-threatening respiratory depression and death could occur at any dose in opioid non-tolerant patients.

Fentanyl buccal tablets are contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug fentanyl.

See

When prescribing, DO NOT convert a patient from Actiq

to fentanyl buccal tablets without following the instructions found in the prescribing information

When dispensing, DO NOT substitute a fentanyl buccal tablets prescription for an Actiq

prescription under any circumstances. Fentanyl buccal tablets and Actiq

are not equivalent.

As a result of these differences, the substitution of the same dose of fentanyl buccal tablets for the same dose of Actiq

or any other fentanyl product may result in a fatal overdose.

There are no safe conversion directions available for patients on any other fentanyl products. (Note: This includes oral, transdermal, or parenteral formulations of fentanyl.)

.

Opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery). Patients taking fentanyl buccal tablets should be warned of these dangers and should be counseled accordingly.

The use of concomitant CNS active drugs requires special patient care and observation. (See .)

Pre-Marketing Clinical Trial Experience

The safety of fentanyl buccal tablets has been evaluated in 304 opioid tolerant cancer patients with breakthrough pain. The average duration of therapy was 76 days with some patients being treated for over 12 months.

The most commonly observed adverse events seen with fentanyl buccal tablets are typical of opioid side effects. Opioid side effects should be expected and managed accordingly.

The clinical trials of fentanyl buccal tablets were designed to evaluate safety and efficacy in treating patients with cancer and breakthrough pain; all patients were taking concomitant opioids, such as sustained-release morphine, sustained-release oxycodone or transdermal fentanyl, for their persistent pain.

The adverse event data presented here reflect the actual percentage of patients experiencing each adverse effect among patients who received fentanyl buccal tablets for breakthrough pain along with a concomitant opioid for persistent pain.  There has been no attempt to correct for concomitant use of other opioids, duration of fentanyl buccal tablets therapy or cancer-related symptoms.

Table 5 lists, by maximum dose received, adverse events with an overall frequency of 5% or greater within the total population that occurred during titration.  The ability to assign a dose-response relationship to these adverse events is limited by the titration schemes used in these studies.

Table 6 lists, by successful dose, adverse events with an overall frequency of ≥ 5% within the total population that occurred after a successful dose had been determined.

In addition, a small number of patients (n=11) with Grade 1 mucositis were included in clinical trials designed to support the safety of fentanyl buccal tablets. There was no evidence of excess toxicity in this subset of patients.

The duration of exposure to fentanyl buccal tablets varied greatly, and included open-label and double-blind studies. The frequencies listed below represent the ≥1% of patients from three clinical trials (titration and post-titration periods combined) who experienced that event while receiving fentanyl buccal tablets. Events are classified by system organ class.

Adverse Events (≥1%) 

Blood and Lymphatic System Disorders:

Cardiac Disorders:

Gastrointestinal Disorders:

General Disorders and Administration Site Conditions:

Hepatobiliary Disorders:

Infections and Infestations:

Injury, Poisoning and Procedural Complications:

Investigations:

Metabolism and Nutrition Disorders:

Musculoskeletal and Connective Tissue Disorders:

Nervous System Disorders:

Psychiatric Disorders:

Renal and Urinary Disorders:

Respiratory, Thoracic and Mediastinal Disorders:

Skin and Subcutaneous Tissue Disorders:

Vascular Disorders:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).