Absorption and Bioavailability of Oral Transmucosal Fentanyl Citrate

Streisand, James B.; Varvel, John R.; Stanski, Donald R.; Maire, Leon Le; Ashburn, Michael A.; Hague, Brian; Tarver, Stephen D.; Stanley, Theodore H.

doi:10.1097/00000542-199108000-00009

Cited by 223 publications

(77 citation statements)

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“…~-5 We believe absence of these problems is related to the fact that plasma fentanyl concentrations rise slowly after OTFC (compared to IV administration), do not peak until 20 to 30 rain after beginning OTFC administration and only reach 2.5 ng' ml-I. 7 Mild facial pruritus was the most common side-effecl in this study, occurring in 58 and 76 per cent of Groups I and 1I patients. Pruritus has been reported in adult volunteers and in all studies in which OTCF has been evaluated as a paediatric premedication.…”

Section: Discussionmentioning

confidence: 58%

Oral transmucosal fentanyl citrate for premedication in paediatric outpatients

et al. 1990

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Two doses (10)(11)(12)(13)(14)(15) Group I,(15)(16)(17)(18)(19)(20) Group II) Oral transmucosal fentanyl citrate produces dosedependent increases in sedation and analgesia in adult volunteers' and has proven safe and effective as a premedicant in studies involving mixtures of paediatric inpatients and outpatients. 2-5 At the present time most paediatric surgery in North America is performed in outpatients requiring rapid turnover. The purpose of this study was to evaluate two doses of oral transmucosal fentanyl citrate (OTFC) as a premedication in children CAN J ANAESTH 1990 / 37:8 / pp857-66

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Section: Discussionmentioning

confidence: 58%

Oral transmucosal fentanyl citrate for premedication in paediatric outpatients

et al. 1990

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“…Even with oral bioavailability of about 30%, each pill can readily deliver enough fentanyl to result in toxic serum concentrations. 19 Other medications such as promethazine were also found in our patients' biologic samples, which may have contributed to the patients' feelings of euphoria, but, because of their less severe toxicity profiles, those drugs likely played minimal roles in the fatalities or prolonged hospitalizations.…”

Section: Discussionmentioning

confidence: 83%

Fatal Fentanyl: One Pill Can Kill

Sutter

Gerona

Davis

et al. 2016

Academic Emergency Medicine

127

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Objective: The current national opioid epidemic is a public health emergency. We have identified an outbreak of exaggerated opioid toxicity caused by fentanyl adulterated tablets purchased on the street as hydrocodone/ acetaminophen.Methods: Over an 8-day period in late March 2016, a total of 18 patients presented to our institution with exaggerated opioid toxicity. The patients provided a similar history: ingesting their "normal dose" of hydrocodone/ acetaminophen tablets but with more pronounced symptoms. Toxicology testing and analysis was performed on serum, urine, and surrendered pills.Results: One of the 18 patients died in hospital. Five patients underwent cardiopulmonary resuscitation, one required extracorporeal life support, three required intubation, and two received bag-valve-mask ventilation. One patient had recurrence of toxicity after 8 hours after naloxone discontinuation. Seventeen of 18 patients required boluses of naloxone, and four required prolonged naloxone infusions (26-39 hours). All 18 patients tested positive for fentanyl in the serum. Quantitative assays conducted in 13 of the sera revealed fentanyl concentrations of 7.9 to 162 ng/mL (mean = 52.9 ng/mL). Pill analysis revealed fentanyl amounts of 600-6,900 lg/pill. The pills are virtually indistinguishable from authentic hydrocodone/acetaminophen tablets and are similar in weight. To date, our county has reported 56 cases of fentanyl opioid toxicity, with 15 fatalities. In our institution, the outbreak has stressed the capabilities and resources of the emergency department and intensive care units. Conclusions:A serious outbreak of exaggerated opioid toxicity caused by fentanyl-adulterated tablets purchased on the street as hydrocodone/acetaminophen is under way in California. These patients required higher dosing and prolonged infusions of naloxone. Additionally, observation periods off naloxone were extended due to delayed, recurrent toxicity. The outbreak has serious ramifications for public health and safety, law enforcement, and healthcare facilities and resources.

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“…76 The fentanyl Oralet™ was developed to take advantage of oral transmucosal absorption for the painless administration of an opioid in a formulation acceptable to children. [112][113][114][115][116][117] The administration of other medications by this route and with similar delivery systems is being investigated. 76,77,118,119 Most pediatric patients will swallow medications administered orally, potentially leading to drug degradation in the gastrointestinal system.…”

Section: Oral Transmucosal (Sublingual Buccal) Administrationmentioning

confidence: 99%

Alternative Routes of Drug Administration—Advantages and Disadvantages (Subject Review)

Berlin¹,

May-McCarver²,

Notterman³

et al. 1997

Pediatrics

100

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During the past 20 years, advances in drug formulations and innovative routes of administration have been made. Our understanding of drug transport across tissues has increased. These changes have often resulted in improved patient adherence to the therapeutic regimen and pharmacologic response. The administration of drugs by transdermal or transmucosal routes offers the advantage of being relatively painless.12 Also, the potential for greater flexibility in a variety of clinical situations exists, often precluding the need to establish intravenous access, which is a particular benefit for children. This statement focuses on the advantages and disadvantages of alternative routes of drug administration. Issues of particular importance in the care of pediatric patients, especially factors that could lead to drug-related toxicity or adverse responses, are emphasized.

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Absorption and Bioavailability of Oral Transmucosal Fentanyl Citrate

Cited by 223 publications

References 0 publications

Oral transmucosal fentanyl citrate for premedication in paediatric outpatients

Oral transmucosal fentanyl citrate for premedication in paediatric outpatients

Fatal Fentanyl: One Pill Can Kill

Alternative Routes of Drug Administration—Advantages and Disadvantages (Subject Review)

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