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prostrakan, inc. - fentanyl citrate (unii: mun5lyg46h) (fentanyl - unii:uf599785jz) - fentanyl 100 ug - abstral (fentanyl) sublingual tablets are 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 opioid therapy for their underlying persistent cancer pain. patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or at least 25 mg oral oxymorphone daily, or an equianalgesic dose of another opioid medication daily for a week or longer. patients must remain on around-the-clock opioids when taking abstral. abstral is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could result at any dose in patients not on a chronic regimen of opioids. for this reason, abstral is contraindicated in the management of acute or postoperative pain,

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cephalon, llc - fentanyl citrate (unii: mun5lyg46h) (fentanyl - unii:uf599785jz) - fentanyl 200 ug - actiq 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 actiq. 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 and dental pain [see contraindications (4)] . - as a part of the tirf rems, actiq may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see  warnings and precautions  (5.7)] . for inpatient administration of actiq, patient and prescriber enrollment are not required. actiq is contraindicated in: - opioid non-tolerant patients: life-threatening respiratory depression and death could occur at any dose in opioid non-tolerant patients [see indications and usage (1), warnings and precautions (5.2)]. - significant respiratory depression [see warnings and precautions (5.2)]. - acute or postoperative pain including headache/migraine and dental pain, or acute pain in the emergency department [see indications and usage (1)] . - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.11 )]. - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings and precautions (5.15 )]. - known hypersensitivity to fentanyl or components of actiq (e.g., anaphylaxis, hypersensitivity) [see adverse reactions (6.2)]. risk summary use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.8)] . available data with actiq in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are risks to the mother and infant associated with use of actiq for an extended period of time during pregnancy (see clinical considerations). in animal reproduction studies, fentanyl administration to pregnant rats during organogenesis was embryocidal at doses within the range of the human recommended dosing. when administered during gestation through lactation fentanyl administration to pregnant rats resulted in reduced pup survival at doses within the range of the human recommended dosing. no evidence of malformations were noted in animal studies completed to date [see data] . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. the onset of neonatal withdrawal symptoms usually occurs in the first days after birth. the duration and severity of neonatal opioid withdrawal syndrome may vary. observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see warnings and precautions (5.8)] . labor or delivery opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. actiq is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. opioid analgesics, including actiq, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. however, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. data human data in women treated acutely with intravenous or epidural fentanyl during labor, symptoms of neonatal respiratory or neurological depression were no more frequent than would be expected in infants of untreated mothers. transient neonatal muscular rigidity has been observed in infants whose mothers were treated with intravenous fentanyl. animal data fentanyl (25, 50, or 100 mcg/kg) citrate was administered subcutaneously to pregnant rats during the period of organogenesis (gestation day, gd 6 to 17). maternal toxicity and a decrease in fetal weights were observed at 100 mcg/kg but no teratogenicity was seen in the study (the no observed effect level of 50 mcg/kg is equivalent to 0.7 times the exposure of a single human dose of 1600 mcg per pain episode, based on an auc comparison). fentanyl (50, 100, or 250 mcg/kg) was also administered subcutaneously to pregnant rabbits during the period of organogenesis (gd 6-18). maternal toxicity was noted at doses >100 mcg/kg. no teratogenicity was seen in the study (250 mcg/kg dose is equivalent to 3.5 times the exposure of a single human dose of 1600 mcg per pain episode, based on an auc comparison). fentanyl has been shown to be embryocidal in pregnant rats at doses of 30 mcg/kg intravenously (0.2 times the 1600 mcg dose of actiq on a mg/m2 basis) from gd 6 to 18 and 160 mcg/kg subcutaneously (1 times the 1600 mcg dose of actiq based on a mg/m2 basis). no evidence of teratogenicity was reported. no evidence of malformations or adverse effects on the fetus was reported in a published study in which pregnant rats were administered fentanyl continuously via subcutaneously implanted osmotic minipumps at doses of 10, 100, or 500 mcg/kg/day starting 2-weeks prior to breeding and throughout pregnancy. the high dose was approximately 3 times the human dose of 1600 mcg actiq per pain episode on a mg/m2 basis and produced mean steady-state plasma levels that are 3.4 times higher than the mean cmax observed following administration of 1600 mcg dose of actiq in humans. in a postnatal development study, pregnant rats were treated from gd 6 through lactation day (ld) 20 with subcutaneous doses of fentanyl (25, 50, 100, and 400 mcg/kg). maternal toxicity was noted at doses >100 mcg/kg. a reduction in pup growth and delayed attainment of developmental indices were observed at >100 mcg/kg. no difference in the number of live pups/litter was seen at birth, however, pup survival at ld 4 was reduced to 48% at 400 mcg/kg and by ld 21 pup survival was reduced to 30% and 26% at 100 and 400 mcg/kg, respectively. during lactation, fentanyl-related clinical signs (decreased activity, skin cold to touch, and moribund appearance) were noted in the f1 pups, most prominently in the 400 mcg/kg group. pups from this group also had significantly reduced body weights throughout the lactation period. the dose of fentanyl administered to rats at which no developmental toxicity in the f1 generation was seen was 50 mcg/kg which is 0.6 times the exposure of a single human dose of 1600 mcg per pain episode, based on an auc comparison. risk summary fentanyl is present in breast milk. one published lactation study reports a relative infant dose of fentanyl of 0.024%. however, there is insufficient information to determine the effects of fentanyl on the breastfed infant and the effects of fentanyl on milk production. because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with actiq. clinical considerations monitor infants exposed to actiq through breast milk for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breastfeeding is stopped. infertility use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [see adverse reactions ( 6.2), clinical pharmacology (12.2), nonclinical toxicology (13.1)] . safety and effectiveness in pediatric patients below 16 years of age have not been established. in a clinical study, 15 opioid-tolerant pediatric patients with breakthrough pain, ranging in age from 5 to 15 years, were treated with actiq. the study was too small to allow conclusions on safety and efficacy in this patient population. twelve of the fifteen opioid-tolerant children and adolescents aged 5 to 15 years in this study received actiq at doses ranging from 200 mcg to 600 mcg. the mean (cv%; range) dose-normalized (to 200 mcg) cmax and auc0-8 values were 0.87 ng/ml (51%; 0.42-1.30) and 4.54 ng. h/ml (42%; 2.37-6.0), respectively, for children ages 5 to <11 years old (n = 3) and 0.68 ng/ml (72%; 0.15-1.44) and 8.38 (192%; 0.84-50.78), respectively, for children ages ≥11 to <16 y (n = 9). of the 257 patients in clinical studies of actiq in breakthrough cancer pain, 61 (24%) were 65 years of age and older, while 15 (6%) were 75 years of age and older. those patients over the age of 65 years were titrated to a mean dose that was about 200 mcg less than the mean dose titrated to by younger patients. no difference was noted in the safety profile of the group over 65 years of age as compared to younger patients in actiq clinical trials. elderly patients have been shown to be more sensitive to the effects of fentanyl when administered intravenously, compared with the younger population. therefore, exercise caution when individually titrating actiq in elderly patients to provide adequate efficacy while minimizing risk. respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. titrate the dosage of actiq slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see warnings and precautions (5.11)] . fentanyl is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function. insufficient information exists to make recommendations regarding the use of actiq 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. both male and female opioid-tolerant patients with cancer were studied for the treatment of breakthrough cancer pain. no clinically relevant sex differences were noted either in dosage requirement or in observed adverse reactions. actiq contains fentanyl, a schedule ii controlled substance. actiq contains fentanyl, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings and precautions (5.1)]. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of actiq increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent abuse of actiq with alcohol and/or other cns depressants. abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. in addition, abuse of opioids can occur in the absence of addiction. all patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. patients at high risk of actiq abuse include those with a history of prolonged use of any opioid, including products containing fentanyl, those with a history of drug or alcohol abuse, or those who use actiq in combination with other abused drugs. “drug-seeking” behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. actiq, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of actiq abuse of actiq poses a risk of overdose and death. the risk is increased with concurrent use of actiq with alcohol and/or other cns depressants. actiq is approved for oral transmucosal use only. both tolerance and physical dependence can develop during use of opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see use in specific populations (8.1)].

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lake erie medical dba quality care products llc - fentanyl citrate (unii: mun5lyg46h) (fentanyl - unii:uf599785jz) - fentanyl 800 ug

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janssen pharmaceuticals, inc. - fentanyl (unii: uf599785jz) (fentanyl - unii:uf599785jz) - fentanyl 12.5 ug in 1 h - duragesic is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see warnings and precautions (5.1)] , reserve duragesic for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide suffi

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actavis pharma, inc. - fentanyl (unii: uf599785jz) (fentanyl - unii:uf599785jz) - fentanyl 25 ug in 1 h

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insys therapeutics, inc. - fentanyl (unii: uf599785jz) (fentanyl - unii:uf599785jz) - fentanyl 0.1 mg - subsys 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 of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. patients must remain on around-the-clock opioids when taking subsys. 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, dental pain, or in the emergency room [see contraindications ( 4)]. - as part of the transmuc

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bryant ranch prepack - fentanyl (unii: uf599785jz) (fentanyl - unii:uf599785jz) - fentanyl 100 ug in 1 h

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depomed, inc. - fentanyl citrate (unii: mun5lyg46h) (fentanyl - unii:uf599785jz) - fentanyl 100 ug - lazanda 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, 25 mcg of transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60mg oral hydrocodone per day, or an equianalgesic dose of another opioid for a week or longer. patients must remain on around-the-clock opioids when taking lazanda. 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, dental pain, or in the emergency department [see contraindications (4)]. - as a part of the tirf rems access program, lazanda may be disp

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archimedes pharma us inc. - fentanyl citrate (unii: mun5lyg46h) (fentanyl - unii:uf599785jz) - fentanyl 100 ug - lazanda (fentanyl) nasal spray 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 opioid therapy for their underlying persistent cancer pain. patients considered opioid tolerant are those who are taking at least: 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for a week or longer. patients must remain on around-the-clock opioids when taking lazanda. lazanda is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could occur in patients not taking chronic opioids. for this reason, lazanda is contraindicated in the management of acute or postoperative pain, including headache/migraine, or dental pain. [4] lazanda is intended to be prescribed only by healthcare professionals who are knowledgeable of and

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watson laboratories, inc. - fentanyl citrate (unii: mun5lyg46h) (fentanyl - unii:uf599785jz) - fentanyl 100 ug