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Fentanyl Citrate (Fentanyl Buccal)

Trade Name : Fentanyl Buccal

Mayne Pharma

TABLET

Strength 100 ug/1

FENTANYL CITRATE Full Opioid Agonists [MoA],Opioid Agonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fentanyl Citrate (Fentanyl Buccal) which is also known as Fentanyl Buccal and Manufactured by Mayne Pharma. It is available in strength of 100 ug/1 per ml. Read more

Fentanyl Citrate (Fentanyl Buccal) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; RISKS FROM CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; REMS; and NEONATAL OPIOID WITHDRAWAL SYNDROME
  • See full prescribing information for complete boxed warning
  • Serious, life-threatening, and/or fatal respiratory depression has occurred. Monitor closely, especially upon initiation or following a dose increase. Due to the risk of fatal respiratory depression, fentanyl buccal tablet is contraindicated in opioid non-tolerant patients () and in management of acute or postoperative pain, including headache/migraines. ()
  • Accidental ingestion of fentanyl buccal tablet, especially by children, can result in a fatal overdose of fentanyl. Keep out of reach of children. Ensure proper storage and disposal. ()
  • Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of fentanyl. (, , )
  • 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. 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. (, )
  • When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl product to fentanyl buccal tablet. ()
  • When dispensing, do not substitute with any other fentanyl products. ()
  • Fentanyl buccal tablet exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor closely for these behaviors and conditions. ()
  • Fentanyl buccal tablet is available only through a restricted program called the TIRF REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program. ()
  • Prolonged use of fentanyl buccal tablet during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. ()
  • No data
  • Fentanyl buccal tablet is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
  • Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg per hour of transdermal fentanyl, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablet.
  • Limitations of Use:
  • Fentanyl buccal tablet is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. ()
  • Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg per hour of transdermal fentanyl, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablet.
  • Limitations of Use:
  • Not for use in opioid non-tolerant patients.
  • Not for use in the management of acute or postoperative pain, including headache/migraine, or dental pain.
  • As a part of the TIRF REMS Access program, fentanyl buccal tablet may be dispensed only to patients enrolled in the TIRF REMS Access program. For inpatient administration of fentanyl buccal tablet (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required.
  • No data
  • Patients must require and use around-the-clock opioids when taking fentanyl buccal tablet. ()
  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. ()
  • Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. ()
  • Initial dose of fentanyl buccal tablet: 100 mcg. ()
  • Initiate titration using multiples of 100 mcg fentanyl buccal tablet. Limit patient access to only one strength of fentanyl buccal tablet at any one time. ()
  • Individually titrate to a tolerable dose that provides adequate analgesia using a single fentanyl buccal tablet. ()
  • No more than two doses can be taken per breakthrough pain episode. ()
  • Wait at least 4 hours before treating another episode of breakthrough pain with fentanyl buccal tablet. ()
  • Place entire tablet in buccal cavity or under the tongue; tablet is not to be split, crushed, sucked, chewed or swallowed whole. ()
  • When opioid therapy is no longer required, consider discontinuing fentanyl buccal tablet along with a gradual downward of other opioids to minimize possible withdrawal effects. ()
  • Fentanyl buccal tablets are flat-faced, round, beveled-edge in shape; are white in color; and are available in 100 mcg, 200 mcg, 400 mcg, 600 mcg, and 800 mcg strengths as fentanyl base. Each tablet strength is marked with a unique identifier .
  • Buccal Tablets: 100 mcg, 200 mcg, 400 mcg, 600 mcg, and 800 mcg strengths as fentanyl base. ()
  • Fentanyl Buccal Tablet is contraindicated in:
  • Opioid non-tolerant patients. ()
  • Management of acute or postoperative pain, including headache/migraine and dental pain. ()
  • Significant respiratory depression. ()
  • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ()
  • Known or suspected gastrointestinal obstruction, including paralytic ileus. ()
  • Known hypersensitivity to fentanyl or components of fentanyl buccal tablet. ()
  • No data
  • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients
  • Serotonin Syndrome
  • Adrenal Insufficiency
  • Severe Hypotension
  • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness
  • Application site reactions occurred in 10% of patients in clinical trials and ranged from paresthesia to ulceration and bleeding. ()
  • The following serious adverse reactions are described, or described in greater detail, in other sections:
  • Most common (frequency u226510%): nausea, dizziness, vomiting, fatigue, anemia, constipation, edema peripheral, asthenia, dehydration and headache. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Table 4 includes clinically significant drug interactions with fentanyl buccal tablet.
  • Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
  • 7
  • No data
  • Pregnancy:
  • Lactation
  • Renal and Hepatic Impairment
  • No data
  • No data
  • Fentanyl buccal tablet is an opioid agonist, intended for buccal mucosal administration.
  • Fentanyl buccal tablet is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of fentanyl across the oral mucosa.
  • Fentanyl buccal tablet employs the OraVescentdrug delivery technology, which generates a reaction that releases carbon dioxide when the tablet comes in contact with saliva. It is believed that transient pH changes accompanying the reaction may optimize dissolution (at a lower pH) and membrane permeation (at a higher pH) of fentanyl through the buccal mucosa.
  • 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:
  • No data
  • No data
  • The efficacy of fentanyl buccal tablet was demonstrated in a double-blind, placebo-controlled, cross-over study in opioid tolerant patients with cancer and breakthrough pain. Patients considered opioid tolerant were those who were taking at least 60 mg of oral morphine daily, at least 25 mcg/hour of transdermal fentanyl, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer.
  • In this trial, patients were titrated in an open-label manner to a successful dose of fentanyl buccal tablet. A successful dose was defined as the dose in which a patient obtained adequate analgesia with tolerable side effects. Patients who identified a successful dose were randomized to a sequence of 10 treatments with 7 being the successful dose of fentanyl buccal tablet and 3 being placebo. Patients used one tablet of study drug (either fentanyl buccal tablet or placebo) per breakthrough pain episode.
  • Patients assessed pain intensity on a scale that rated the pain as 0=none to 10=worst possible pain. With each episode of breakthrough pain, pain intensity was assessed first and then treatment was administered. Pain intensity (0-10) was then measured at 15, 30, 45, and 60 minutes after the start of administration. The sum of differences in pain intensity scores at 15 and 30 minutes from baseline (SPID) was the primary efficacy measure.
  • Sixty-five percent (65%) of patients who entered the study achieved a successful dose during the titration phase. The distribution of successful doses is shown in Table 8. The median dose was 400 mcg.
  • The LS mean (SE) SPID for fentanyl buccal tablet-treated episodes was 3.0 (0.12) while for placebo-treated episodes it was 1.8 (0.18).
  • PID=pain intensity difference; SEM=standard error of the mean
  • Fentanyl buccal tablets are supplied in individually sealed, child-resistant blister packages. Each carton contains 7 blister cards with 4 white tablets in each card. The blisters are child-resistant, encased in peelable foil, and provide protection from moisture. Each tablet is debossed on one side with , and the other side of each dosage strength is uniquely identified by the debossing on the tablet as described in the table below. In addition, the dosage strength is indicated on the blister package and the carton. See blister package and carton for product information.
  • Note:
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide)n
  • 400-33-100054.03Distributed By:n Greenville, NC 27834
  • How should I store fentanyl buccal tablets?
  • How should I dispose of unused fentanyl buccal tablets when they are no longer needed?
  • General information about fentanyl buccal tablet
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Use fentanyl buccal tablet only for the purpose for which it was prescribed. Do not give fentanyl buccal tablet to other people, even if they have the same symptoms you have. Fentanyl buccal tablet can harm other people and even cause death. Sharing fentanyl buccal tablet is against the law.
  • This Medication Guide summarizes the most important information about fentanyl buccal tablet. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your pharmacist or healthcare provider for information about fentanyl buccal tablet that is written for health professionals.
  • For more information about the TIRF REMS Access program, go to or call 1-866-822-1483.
  • What are the ingredients in fentanyl buccal tablet?
  • Active Ingredient: fentanyl citrate
  • Inactive Ingredients: mannitol, sodium starch glycolate, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate.
  • Before you use fentanyl buccal tablet, it is important that you read the Medication Guide and these Instructions for Use. Be sure that you read, understand, and follow these Instructions for Use so that you use fentanyl buccal tablet the right way. Ask your healthcare provider or pharmacist if you have any questions about the right way to use fentanyl buccal tablet.
  • When you get an episode of breakthrough cancer pain, use the dose of fentanyl buccal tablet prescribed by your healthcare provider as follows:
  • Figure 1
  • Figure 2
  • Figure 3
  • OR,
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Revised 10/2019400-33-100054.03Printed in USA
  • NDC 51862-634-28
  • FENTANYL Buccal Tablets CII
  • Equivalent to 100 mcg fentanyl base
  • 28 Buccal Tablets (4 tablets x 7 cards)
  • Information for Pharmacist:
  • u25a1 Counsel the patient about the use of this product including maximum dosing during a single breakthrough pain episode
  • u25a1 Instruct patients to read the enclosed fentanyl buccal tablets Medication Guide
  • u25a1 Fentanyl buccal tablets must only be supplied through the TIRF REMS Access restricted program. For more information call 1-866-822-1483 or visit www.TIRFREMSAccess.com.
  • WARNING: Keep out of the reach of children PATIENTS MUST BE TOLERANT TO AROUND-THE-CLOCK OPIOID THERAPY DO NOT SUBSTITUTE FENTANYL BUCCAL TABLETS FOR OTHER FENTANYL PRODUCTS Fentanyl buccal tablets can be harmful or fatal if given to someone for whom it was not prescribed
  • For Buccal or Sublingual Administration. Do NOT Split, Crush, Suck, Chew, or Swallow Tablet.
  • Distributed by: Mayne Pharma Greenville, NC 27834
  • mayne pharma
  • NDC 51862-635-28
  • FENTANYL Buccal Tablets CII
  • Equivalent to 200 mcg fentanyl base
  • 28 Buccal Tablets (4 tablets x 7 cards)
  • Information for Pharmacist:
  • u25a1 Counsel the patient about the use of this product including maximum dosing during a single breakthrough pain episode
  • u25a1 Instruct patients to read the enclosed fentanyl buccal tablets Medication Guide
  • u25a1 Fentanyl buccal tablets must only be supplied through the TIRF REMS Access restricted program. For more information call 1-866-822-1483 or visit www.TIRFREMSAccess.com.
  • WARNING: Keep out of the reach of children PATIENTS MUST BE TOLERANT TO AROUND-THE-CLOCK OPIOID THERAPY DO NOT SUBSTITUTE FENTANYL BUCCAL TABLETS FOR OTHER FENTANYL PRODUCTS Fentanyl buccal tablets can be harmful or fatal if given to someone for whom it was not prescribed
  • For Buccal or Sublingual Administration. Do NOT Split, Crush, Suck, Chew, or Swallow Tablet.
  • Distributed by: Mayne Pharma Greenville, NC 27834
  • mayne pharma
  • NDC 51862-636-28
  • FENTANYL Buccal Tablets CII
  • Equivalent to 400 mcg fentanyl base
  • 28 Buccal Tablets (4 tablets x 7 cards)
  • Information for Pharmacist:
  • u25a1 Counsel the patient about the use of this product including maximum dosing during a single breakthrough pain episode
  • u25a1 Instruct patients to read the enclosed fentanyl buccal tablets Medication Guide
  • u25a1 Fentanyl buccal tablets must only be supplied through the TIRF REMS Access restricted program. For more information call 1-866-822-1483 or visit www.TIRFREMSAccess.com.
  • WARNING: Keep out of the reach of children PATIENTS MUST BE TOLERANT TO AROUND-THE-CLOCK OPIOID THERAPY DO NOT SUBSTITUTE FENTANYL BUCCAL TABLETS FOR OTHER FENTANYL PRODUCTS Fentanyl buccal tablets can be harmful or fatal if given to someone for whom it was not prescribed
  • For Buccal or Sublingual Administration. Do NOT Split, Crush, Suck, Chew, or Swallow Tablet.
  • Distributed by: Mayne Pharma Greenville, NC 27834
  • mayne pharma
  • NDC 51862-637-28
  • FENTANYL Buccal Tablets CII
  • Equivalent to 600 mcg fentanyl base
  • 28 Buccal Tablets (4 tablets x 7 cards)
  • Information for Pharmacist:
  • u25a1 Counsel the patient about the use of this product including maximum dosing during a single breakthrough pain episode
  • u25a1 Instruct patients to read the enclosed fentanyl buccal tablets Medication Guide
  • u25a1 Fentanyl buccal tablets must only be supplied through the TIRF REMS Access restricted program. For more information call 1-866-822-1483 or visit www.TIRFREMSAccess.com.
  • WARNING: Keep out of the reach of children PATIENTS MUST BE TOLERANT TO AROUND-THE-CLOCK OPIOID THERAPY DO NOT SUBSTITUTE FENTANYL BUCCAL TABLETS FOR OTHER FENTANYL PRODUCTS Fentanyl buccal tablets can be harmful or fatal if given to someone for whom it was not prescribed
  • For Buccal or Sublingual Administration. Do NOT Split, Crush, Suck, Chew, or Swallow Tablet.
  • Distributed by: Mayne Pharma Greenville, NC 27834
  • mayne pharma
  • NDC 51862-638-28
  • FENTANYL Buccal Tablets CII
  • Equivalent to 800 mcg fentanyl base
  • 28 Buccal Tablets (4 tablets x 7 cards)
  • Information for Pharmacist:
  • u25a1 Counsel the patient about the use of this product including maximum dosing during a single breakthrough pain episode
  • u25a1 Instruct patients to read the enclosed fentanyl buccal tablets Medication Guide
  • u25a1 Fentanyl buccal tablets must only be supplied through the TIRF REMS Access restricted program. For more information call 1-866-822-1483 or visit www.TIRFREMSAccess.com.
  • WARNING: Keep out of the reach of children PATIENTS MUST BE TOLERANT TO AROUND-THE-CLOCK OPIOID THERAPY DO NOT SUBSTITUTE FENTANYL BUCCAL TABLETS FOR OTHER FENTANYL PRODUCTS Fentanyl buccal tablets can be harmful or fatal if given to someone for whom it was not prescribed
  • For Buccal or Sublingual Administration. Do NOT Split, Crush, Suck, Chew, or Swallow Tablet.
  • Distributed by: Mayne Pharma Greenville, NC 27834
  • mayne pharma

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