Fentanyl Citrate (Fentanyl Citrate)

Trade Name : Fentanyl Citrate

Teva Pharmaceuticals USA, Inc.

LOZENGE

Strength 200 ug/1

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

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fentanyl Citrate (Fentanyl Citrate) which is also known as Fentanyl Citrate and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 200 ug/1 per ml. Read more

Fentanyl Citrate (Fentanyl Citrate) 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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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
  • No data
  • Arrayn- Life-Threatening Respiratory Depression
  • Serious, life-threatening and/or fatal respiratory depression has occurred in patients treated with Oral Transmucosal Fentanyl Citrate (OTFC), including following use in opioid non-tolerant patients and improper dosing. Monitor for respiratory depression, especially during initiation of OTFC or following a dose increase . The substitution of OTFC for any other fentanyl product may result in fatal overdose .
  • Due to the risk of respiratory depression, OTFC is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients .
  • Arrayn- Accidental Ingestion
  • Accidental ingestion of even one dose of OTFC, especially by children, can result in a fatal overdose of fentanyl n .
  • Death has been reported in children who have accidentally ingested OTFC. OTFC must be kept out of reach of children n .
  • Arrayn- Cytochrome P450 3A4 Interaction
  • The concomitant use of OTFC with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving OTFC and any CYP3A4 inhibitor or inducer n .
  • Arrayn- 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 n .
  • Arrayn- Risk of Medication Errors
  • Substantial differences exist in the pharmacokinetic profile of OTFC compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl and that could result in fatal overdose .
  • Arrayn- Addiction, Abuse, and Misuse
  • OTFC exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patientu2019s risk prior to prescribing OTFC, and monitor all patients regularly for the development of these behaviors and conditions n .
  • Arrayn- Risk Evaluation and Mitigation Strategy (REMS) Access Program
  • Because of the risk for misuse, abuse, addiction, and overdose, OTFC is available only through a restricted program required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program . Further information is available at www.TIRFREMSAccess.com or by calling 1-866-822-1483.
  • Arrayn- Neonatal Opioid Withdrawal Syndrome
  • Prolonged use of OTFC 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. 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 n .
  • 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, OTFC is contraindicated in opioid non-tolerant patients () and in management of acute or postoperative pain, including headache/migraines. ()
  • Accidental ingestion of OTFC, 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 OTFC. ()
  • When dispensing, do not substitute with any other fentanyl products. ()
  • OTFC exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patientu2019s risk before prescribing and monitor closely for these behaviors and conditions. ()
  • OTFC 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 OTFC 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. ()
  • Oral Transmucosal Fentanyl Citrate (OTFC) is indicated for the management of breakthrough pain in cancer patients 16 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 of transdermal fentanyl per hour, 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 when taking OTFC.
  • Limitations of Use:
  • OTFC is an opioid agonist indicated for the management of breakthrough pain in cancer patients 16 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 of transdermal fentanyl per hour, 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 oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking OTFC.
  • 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, OTFC may be dispensed only to outpatients enrolled in the program. () For inpatient administration of OTFC (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 OTFC. ()
  • 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 OTFC: 200 mcg. Prescribe an initial supply of six 200 mcg OTFC units. ()
  • Individually titrate to a tolerable dose that provides adequate analgesia using single OTFC dosage unit per breakthrough cancer pain episode. ()
  • 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 OTFC. (, )
  • Limit consumption to four or fewer units per day once successful dose is found. ()
  • When opioid therapy is no longer required, consider discontinuing OTFC along with a gradual downward of other opioids to minimize possible withdrawal effects. ()
  • Solid oral transmucosal lozenge: Each dosage unit has white to off-white color and is a solid drug matrix on a handle. Each strength is marked on the individual solid drug matrix and the handle tag. Oral Transmucosal Fentanyl Citrate (OTFC) is available in 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg and 1600 mcg strengths .
  • Solid oral transmucosal lozenge: 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, and 1600 mcg. ()
  • Oral Transmucosal Fentanyl Citrate (OTFC) is contraindicated in:
  • Opioid non-tolerant patients. ()
  • Significant respiratory depression. ()
  • Management of acute or postoperative pain including headache/migraines and dental pain. ()
  • 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 OTFC. ()
  • 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
  • The following serious adverse reactions are described, or described in greater detail, in other sections:
  • Most common (frequency u22655%): nausea, dizziness, somnolence, vomiting, asthenia, and headache, dyspnea, constipation, anxiety, confusion, depression, rash, and insomnia. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or .
  • Table 3 includes clinically significant drug interactions with Oral Transmucosal Fentanyl Citrate (OTFC).
  • Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
  • 7
  • No data
  • Pregnancy:
  • Lactation
  • Renal and Hepatic Impairment
  • No data
  • Clinical Presentation
  • Acute overdose with Oral Transmucosal Fentanyl Citrate (OTFC) 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 .
  • Treatment of Overdose
  • In case of overdose, priorities are: removal of the OTFC unit, if still in the mouth, the reestablishment of a patent and protected 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.
  • The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to fentanyl overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to fentanyl overdose.
  • Because the duration of opioid reversal is expected to be less than the duration of action of fentanyl in OTFC, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the productu2019s prescribing information.
  • 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 begun with care and by titration with smaller than usual doses of the antagonist.
  • Oral Transmucosal Fentanyl Citrate (OTFC) (fentanyl citrate) oral transmucosal lozenge is a solid formulation of fentanyl, an opioid agonist, intended for oral transmucosal administration. OTFC is formulated as a white to off-white solid drug matrix on a handle that is fracture resistant (ABS plastic) under normal conditions when used as directed.
  • OTFC is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the OTFC unit to be removed from the mouth if signs of excessive opioid effects appear during administration.
  • Active Ingredient:
  • Inactive Ingredients:
  • No data
  • Carcinogenesis
  • Fentanyl was evaluated for carcinogenic potential in a 104-week rat study and in a 6-month Tg.AC transgenic mouse study. In rats, doses up to 50 mcg/kg in males and 100 mcg/kg in females were administered subcutaneously and no treatment-related neoplasms were observed (doses are equivalent to 1.13 and 2.7 times the exposure of a single human dose of 1600 mcg per pain episode, respectively, based on an AUC comparison). In a 26-week transgenic mice model (Tg.AC), at topical doses up to 50 mcg/dose/day, no increase in the occurrence of treatment-related neoplasms was observed.
  • Mutagenesis
  • Fentanyl citrate was not mutagenic in the in vitro Ames reverse mutation assay in or , or the mouse lymphoma mutagenesis assay, and was not clastogenic in the in vivo mouse micronucleus assay.
  • Impairment of Fertility
  • In a fertility study, female rats were administered fentanyl subcutaneously for 14 days prior to mating with untreated males at doses up to 300 mcg/kg and no effects on female fertility were observed. The systemic exposure at the dose of 300 mcg/kg was approximately 4.0-times the exposure of a single human dose of 1600 mcg per pain episode, based on an AUC comparison. Males were administered fentanyl subcutaneously for 28 days prior to mating with untreated females at doses up to 300 mcg/kg. At 300 mcg/kg, adverse effects on sperm parameters, which affected fertility, were observed. These effects included decreased percent mobile sperm, decreased sperm concentrations as well as an increase in the percent abnormal sperm. The dose in males at which no effects on fertility were observed was 100 mcg/kg, which is approximately 2.7 times the exposure of a single human dose of 1600 mcg per pain episode, based on an AUC comparison.
  • Fentanyl has been shown to impair fertility in rats at doses of 30 mcg/kg IV and 160 mcg/kg subcutaneously. Conversion to the human equivalent doses indicates that this is within the range of the human recommended dosing for OTFC.
  • Oral Transmucosal Fentanyl Citrate (OTFC) was investigated in clinical trials involving 257 opioid tolerant adult cancer patients experiencing breakthrough cancer pain. Breakthrough cancer pain was defined as a transient flare of moderate-to-severe pain occurring in cancer patients experiencing persistent cancer pain otherwise controlled with maintenance doses of opioid medications including at least 60 mg morphine/day, 50 mcg transdermal fentanyl/hour, or an equianalgesic dose of another opioid for a week or longer.
  • In two dose titration studies 95 of 127 patients (75%) who were on stable doses of either long-acting oral opioids or transdermal fentanyl for their persistent cancer pain titrated to a successful dose of OTFC to treat their breakthrough cancer pain within the dose range offered (200, 400, 600, 800, 1200, and 1600 mcg). A u201csuccessfulu201d dose was defined as a dose where one unit of OTFC could be used consistently for at least two consecutive days to treat breakthrough cancer pain without unacceptable side effects. In these studies 11% of patients withdrew due to adverse reactions and 14% withdrew due to other reasons.
  • The successful dose of OTFC for breakthrough cancer pain was not predicted from the daily maintenance dose of opioid used to manage the persistent cancer pain and is thus best determined by dose titration.
  • A double-blind placebo controlled crossover study was performed in cancer patients to evaluate the effectiveness of OTFC for the treatment of breakthrough cancer pain. Of 130 patients who entered the study 92 patients (71%) achieved a successful dose during the titration phase. The distribution of successful doses is shown in Table 5.
  • On average, patients over 65 years of age titrated to a mean dose that was about 200 mcg less than the mean dose to which younger adult patients were titrated.
  • OTFC was administered beginning at Time 0 minutes and produced more pain relief compared with placebo at 15, 30, 45, and 60 minutes as measured after the start of administration (see Figure 2). The differences were statistically significant.
  • Figure 2. Pain Relief (PR) Scores (MeanSD) During the Double-Blind Phase - Allu00a0n- Patients with Evaluable Episodes on Both OTFC and Placebo (N=86)u00a0
  • Oral Transmucosal Fentanyl Citrate (OTFC) is supplied in six dosage strengths. Each unit is individually wrapped in a child-resistant, protective blister package. These blister packages are packed 30 per shelf carton for use when patients have been titrated to the appropriate dose.
  • Each dosage unit has a white to off-white color. Each individual solid drug matrix is marked with u201cFENTANYLu201d and the strength of the unit (u201c200u201d, u201c400u201d, u201c600u201d, u201c800u201d, u201c1200u201d, or u201c1600u201d). The dosage strength is also marked on the handle tag, the blister package and the carton. See blister package and carton for product information.
  • Note: Colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.
  • Store at 20-25u00baC (68-77u00baF) with excursions permitted between 15u00b0 and 30u00b0C (59u00b0 to 86u00b0F) until ready to use. (See USP Controlled Room Temperature.) Protect OTFC from freezing and moisture. Do not use if the blister package has been opened.
  • Store OTFC securely and dispose of properly n
  • Advise the patient to read the FDA-approved patient labeling .
  • Storage and Disposal of Unused and Used OTFCn- [see Medication Guide / Instructions for Use].
  • Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store OTFC securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home Inform patients that leaving OTFC 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. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.
  • Disposal of Used OTFC Units: Instruct patients on proper disposal of completely used and partially used OTFC units as follows:
  • If the patient does not entirely consume the unit and the remaining drug cannot be immediately dissolved under hot running water, the patient or caregiver must temporarily store the OTFC unit in the specially provided child-resistant container out of the reach of children until proper disposal is possible.
  • Disposal of Unopened OTFC Units When No Longer Needed: Patients and members of their household must be advised to dispose of any unopened units remaining from a prescription as soon as they are no longer needed.
  • To dispose of the unused OTFC units:
  • Do not flush the entire OTFC units, OTFC handles, blister packages, or cartons down the toilet. Dispose of the handle where children cannot reach it.
  • Detailed instructions for the proper storage, administration, disposal, and important instructions for managing an overdose of OTFC are provided in the OTFCu00a0. Encourage patients to read this information in its entirety and give them an opportunity to have their questions answered.
  • In the event that a caregiver requires additional assistance in disposing of excess unusable units that remain in the home after a patient has expired, instruct them to call the toll-free number for Teva Pharmaceuticals (1-888-483-8279) or seek assistance from their local DEA office.
  • Life-Threatening Respiratory Depression
  • Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Oral Transmucosal Fentanyl Citrate (OTFC) or when the dosage is increased, and that it can occur even at recommended dosages . Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
  • Accidental Ingestion
  • Interactions with Benzodiazepines and Other CNS Depressants (including Alcohol)
  • Inform patients and caregivers that potentially fatal additive effects may occur if OTFC is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider.
  • Addiction, Abuse, and Misuse
  • Inform patients that the use of OTFC, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death . Instruct patients not to share OTFC with others and to take steps to protect OTFC from theft or misuse.
  • Transmucosal Immediate-Release Fentanyl (TIRF) REMS
  • Advise patients of the following information pertaining to the TIRF REMS
  • 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 of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their physicians if they are taking, or plan to take serotonergic medications .
  • MAOI Interaction
  • Inform patients to avoid taking OTFC while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking OTFC n
  • 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 .
  • Important Administration Instructions n- [see Dosage and Administration (2)]
  • Hypotension
  • Inform patients that OTFC 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.g., sit or lie down, carefully rise from a sitting or lying position) n
  • Anaphylaxis
  • Inform patients that anaphylaxis have been reported with ingredients contained in OTFC. Advise patients how to recognize such a reaction and when to seek medical attention n
  • Pregnancy
  • Neonatal Opioid Withdrawal Syndromen n- [see Warnings and Precautions (), Use in Specific Populations ()].n n- Embryo-Fetal Toxicityn n- [see Use in Specific Populations ()]
  • Lactation
  • Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs.
  • Infertility
  • Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible n
  • Driving or Operating Heavy Machinery
  • Inform patients that OTFC 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 n
  • Constipation
  • Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention .
  • Dental Decay
  • Because each OTFC unit contains approximately 2 grams of sugar (hydrated dextrates), frequent consumption may increase the risk of dental decay. The occurrence of dry mouth associated with the use of opioid medications (such as fentanyl) may add to this risk.
  • Post-marketing reports of dental decay have been received in patients taking OTFC . In some of these patients, dental decay occurred despite reported routine oral hygiene. As dental decay in cancer patients may be multi-factorial, patients using OTFC should consult their dentist to ensure appropriate oral hygiene.
  • Diabetic Patients
  • Advise diabetic patients that OTFC contains approximately 2 grams of sugar per unit.
  • OTF-014
  • Distributed By:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • u00a92019 Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved.
  • Oral Transmucosal Fentanyl Citrate (OTFC) is:
  • Important information about Oral Transmucosal Fentanyl Citrate (OTFC):
  • Do not take Oral Transmucosal Fentanyl Citrate (OTFC) if:
  • Before taking Oral Transmucosal Fentanyl Citrate (OTFC), tell your healthcare provider if you have a history of:
  • Tell your healthcare provider if you are:
  • When taking Oral Transmucosal Fentanyl Citrate (OTFC):
  • The possible side effects of Oral Transmucosal Fentanyl Citrate (OTFC):
  • Get emergency medical help if you have:
  • These are not all the possible side effects of OTFC. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. n
  • How should I store Oral Transmucosal Fentanyl Citrate (OTFC)?
  • The OTFC Child Safety Kit contains important information on the safe storage and handling of OTFC.
  • The Child Safety Kit includes:
  • Figure 1
  • Figure 2
  • Figure 3
  • How should I dispose of Oral Transmucosal Fentanyl Citrate (OTFC) units when they are no longer needed?
  • Disposing of OTFC units after use:
  • Partially used OTFC units may contain enough medicine to be harmful or fatal to a child or other adults who have not been prescribed OTFCn n
  • After you have finished the OTFC unit and the medicine is totally gone, throw the handle away in a place that is out of the reach of children.
  • If medicine remains on the used OTFC unit after you have finished:
  • Figure 4
  • Arrayn- Temporary Storage of Used OTFC Units
  • Figure 5
  • Arrayn- Disposing of Used OTFC Units from the Temporary Storage Bottle
  • You mustn- at least one time each day
  • 1. To open the temporary storage bottle, push down on the cap until you are able to twist the cap to the left to remove it (See Figure 6).
  • Figure 6
  • 2. Remove one OTFC unit from the temporary storage bottle. Hold the OTFC by its handle over the toilet bowl.3. Using wire-cutting pliers, cut the medicine end off so that it falls into the toilet.4. Throw the handle away in a place that is out of the reach of children.5. Repeat these 3 steps for each OTFC handle that is in the storage bottle. There should not be more than 4 handles in the temporary storage bottle for 1 day.6. Flush the toilet twice.
  • Do not flush entire unused OTFC units, OTFC handles, or blister packages down the toilet.
  • Disposing of unopened OTFC units:
  • 1. Remove all OTFC from the locked storage space (See Figure 7).
  • Figure 7
  • 2. Remove one OTFC unit from its blister package by using scissors to cut off the marked end and then peel back the blister backing (See Figures 8A and 8B).
  • Figure 8AtFigure 8Bn
  • Figure 9Au00a0n- Figure 9Bn
  • Figure 10
  • 5. Repeat steps 1 through 4 for each OTFC unit.6. Flush the toilet twice after the medicine ends from 5 OTFC units have been cut off (See Figure 11). Do not flush more than 5 OTFC units at a time.
  • Figure 11
  • If you need help with disposal of OTFC, call Teva Pharmaceuticals at 1-888-483-8279, or call your local Drug Enforcement Agency (DEA) office.
  • General information about Oral Transmucosal Fentanyl Citrate (OTFC)
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. OTFC can harm other people and even cause death. Sharing OTFC is against the law.
  • This Medication Guide summarizes the most important information about OTFC. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your pharmacist or healthcare provider for information about OTFC that is written for healthcare professionals.
  • For more information about the TIRF REMS Access program, go to www.TIRFREMSAccess.com or call 1-866-822-1483.
  • What are the ingredients of Oral Transmucosal Fentanyl Citrate (OTFC)?
  • Active Ingredient:
  • Inactive Ingredients:
  • Patient Instructions for Use
  • Before you use OTFC, it is important that you read the Medication Guide and these Patient Instructions for Use. Be sure that you read, understand, and follow these Patient Instructions for Use so that you use OTFC the right way. Ask your healthcare provider or pharmacist if you have any questions about the right way to use OTFC.
  • When you get an episode of breakthrough cancer pain, use the dose of OTFC prescribed by your healthcare provider as follows:
  • Figure 12
  • Figure 13AtFigure 13B
  • Figure 14
  • 1. Place the medicine end of the OTFC unit in your mouth between your cheeks and gums and actively suck on the medicine.2. Move the medicine end of the OTFC unit around in your mouth, especially along the inside of your cheeks (See Figure 15).
  • Figure 15
  • 3. Twirl the handle often.4. Finish the OTFC unit completely over 15 minutes to get the most relief. If you finish OTFC too quickly, you will swallow more of the medicine and get less relief.5.u00a0n
  • Figure 16
  • See u201cu201d for proper disposal of OTFC.
  • NDCn- 7865n- Oral Transmucosalu00a0n- Fentanyl Citrate (OTFC)u00a0n- CIIn n- 200 mcg
  • Only for patients already taking around-the-clock opioids (narcotics) such as fentanyl or morphine.n
  • u00a0n- PATIENTS MUST BE TOLERANT TO AROUND-THE-CLOCK OPIOID THERAPYn n- DO NOT SUBSTITUTE OTFC FOR OTHER FENTANYL PRODUCTS
  • WARNING: Keep out of the reach of children.
  • u00a0n- Rx onlyn n- 30 Unitsn n- TEVA
  • NDCn- 7866n- Oral Transmucosalu00a0n- Fentanyl Citrate (OTFC)u00a0n- CIIn n- 400 mcg
  • Only for patients already taking around-the-clock opioids (narcotics) such as fentanyl or morphine.
  • PATIENTS MUST BE TOLERANT TO AROUND-THE-CLOCK OPIOID THERAPYn n- DO NOT SUBSTITUTE OTFC FOR OTHER FENTANYL PRODUCTS
  • WARNING: Keep out of the reach of children.
  • u00a0
  • Arrayn- Array
  • NDCn- 7867n- Oral Transmucosalu00a0n- Fentanyl Citrate (OTFC)u00a0n- CIIn n- 600 mcg
  • Only for patients already taking around-the-clock opioids (narcotics) such as fentanyl or morphine.
  • PATIENTS MUST BE TOLERANT TO AROUND-THE-CLOCK OPIOID THERAPY
  • DO NOT SUBSTITUTE OTFC FOR OTHER FENTANYL PRODUCTS
  • WARNING: Keep out of the reach of children.
  • Arrayn- Array
  • NDCn- 7868n- Oral Transmucosalu00a0n- Fentanyl Citrate (OTFC)u00a0n- CIIn n- 800 mcg
  • Only for patients already taking around-the-clock opioids (narcotics) such as fentanyl or morphine.
  • PATIENTS MUST BE TOLERANT TO AROUND-THE-CLOCK OPIOID THERAPYn n- DO NOT SUBSTITUTE OTFC FOR OTHER FENTANYL PRODUCTS
  • WARNING: Keep out of the reach of children.
  • NDCn- 7869n- Oral Transmucosalu00a0n- Fentanyl Citrate (OTFC)u00a0n- CIIn n- 1200 mcg
  • Only for patients already taking around-the-clock opioids (narcotics) such as fentanyl or morphine.
  • PATIENTS MUST BE TOLERANT TO AROUND-THE-CLOCK OPIOID THERAPYn n- DO NOT SUBSTITUTE OTFC FOR OTHER FENTANYL PRODUCTS
  • WARNING: Keep out of the reach of children.
  • NDCn- 7870n- Oral Transmucosalu00a0n- Fentanyl Citrate (OTFC)u00a0n- CIIn n- 1600 mcg
  • Only for patients already taking around-the-clock opioids (narcotics) such as fentanyl or morphine.
  • PATIENTS MUST BE TOLERANT TO AROUND-THE-CLOCK OPIOID THERAPYn n- DO NOT SUBSTITUTE OTFC FOR OTHER FENTANYL PRODUCTS
  • WARNING: Keep out of the reach of children.

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

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Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

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Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

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Dossiers and Stability Studies

Dossiers and Stability Studies

STABILITY STUDIES STABILITY, BA / BE STUDIES Due to our active

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Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

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Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

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