Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0027497 (nausea)
 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Fentanyl citrate is a synthetic narcotic 1,000 times as potent as meperidine. It produces minimal hemodynamic effects and is characterized by a rapid onset of sedation and analgesia, a relatively short duration of action (approximately 30 to 40 minutes), and rapid reversal with opiate antagonists. These properties make fentanyl an ideal drug for emergency department use. The safety of fentanyl use in an adult ED population has not previously been studied. We retrospectively reviewed the charts of 841 patients who received fentanyl at the University of Cincinnati Center for Emergency Care between January 1985 and June 1988. The study population included 497 (59%) men and 344 (41%) women, with an average age of 33 years. The average dose of fentanyl was 180 micrograms (range, 25 to 1,400 micrograms). Six patients (1%) experienced mild side effects including nausea (one), emesis (two), urticaria (one), and pruritus (two). Nine patients (1%) developed more serious complications including six cases (0.7%) of respiratory depression and three cases (0.4%) of hypotension. Two of 183 patients (1%) who received midazolam and two of nine patients (22%) who received haloperidol developed respiratory depression. Four of the six patients with respiratory depression and two of the three patients with hypotension were intoxicated. All of the complications were transient, and none resulted in hospitalization. We conclude that fentanyl is a safe drug for use in the ED. To maximize safety, we recommend careful dosing and titration, close patient monitoring, and the availability of naloxone hydrochloride and resuscitation equipment.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:The safety of fentanyl use in the emergency department. 238 73

Fentanyl citrate is a potent short-acting narcotic reported to cause less nausea and sedation than morphine or meperidine hydrochloride. The purpose of this prospective investigation was to determine whether a safe but adequate intrapartum dosing schedule is possible. A total of 137 women with uncomplicated term pregnancies were offered a standard intravenous dose (50 mcg or 100 mcg hourly as needed) of fentanyl citrate during active labor. Temporary analgesia and mild sedation were apparent in each case. The cumulative dose varied in accordance with maternal needs (mean, 140 +/- 42 micrograms; range, 50 mcg to 600 micrograms). Apart from a brief decrease in fetal heart rate variability that lasted 30 minutes, no worrisome pattern was apparent from exposure to fentanyl citrate. Pediatric examinations were performed without knowledge of analgesic therapy on infants exposed to fentanyl citrate and those not exposed to analgesics. No differences were found in frequencies of newborn depressed respirations, low Apgar scores, or neurologic and adaptive capabilities at two hours and 24 hours postnatally. With the use of the described dosing schedule, fentanyl citrate was helpful during labor and did not cause immediate or prolonged hazards to the mother and unborn infant.
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PMID:Fentanyl citrate analgesia during labor. 275 Aug 5

Fentanyl buccal tablet (FBT) is indicated for the treatment of breakthrough pain in patients who are already receiving, and who are tolerant to, opioid therapy for underlying, persistent cancer pain. Breakthrough pain may be severe or excruciating, and some patients may require high doses of rapid-onset opioids to obtain adequate analgesia. The objective of this study was to assess the dose proportionality of FBT over a range of 600-1300 microg in healthy subjects. This was a randomized, open-label, four-period, crossover, single-centre study of FBT (Fentora) conducted in healthy adult subjects who were not tolerant to opioids. The study included 120 men and women aged 18-45 years with a body mass index of 20-30 kg/m2 who had no clinically significant findings on medical and psychiatric histories, physical examination, ECG or standard clinical laboratory tests, and who had a negative urine screen for drugs and alcohol. Eligible subjects were randomized to one of four dose sequences: ABDC, BCAD, CDBA and DACB, where A, B, C and D were FBT doses from lowest to highest (600, 1000, 1200 and 1300 microg). Each dose of FBT was separated by a minimum of 7 days. Naltrexone 50 mg was administered to block the opioid receptor-mediated effects of fentanyl. Plasma fentanyl concentration was measured through 72 hours after placement of FBT. The main outcome measures, maximum plasma fentanyl concentration (C(max)) and area under the plasma drug concentration versus time curve from time zero to infinity (AUC(infinity)), were analysed to determine dose proportionality. Other pharmacokinetic parameters were also evaluated. Dose proportionality was concluded if the two-sided 90% confidence intervals (CIs) for the slopes of the C(max) versus dose and AUC(infinity) versus dose curves were completely contained within the range of 0.711-1.289. The safety and tolerability of FBT were assessed throughout the study. The slope for C(max) versus dose was 0.8627 (90% CI 0.7730, 0.9525), and the slope for AUC(infinity) versus dose was 0.9330 (90% CI 0.8738, 0.9922). Given that the CIs for C(max) and AUC(infinity) were within the predefined range of 0.711-1.289, dose proportionality was concluded over the 600-1300 microg range. The mean dose-normalized plasma fentanyl concentration reached 80% of C(max) within 25 minutes; plasma fentanyl concentration was maintained at this level for 3 hours after dose. No unexpected safety or tolerability concerns were noted in the naltrexone-blocked healthy subjects. Seventy-four subjects (68%) experienced adverse events (AEs); all were mild (56 [51%]) or moderate (18 [17%]). The most common AEs were nausea, dizziness and headache. No serious AEs were reported. The dose proportionality of FBT from 600-1300 microg was shown in healthy subjects. Based on the data, when FBT is titrated up to 1300 microg, a predictable and linear increase in systemic exposure can be expected. Currently, FBT is approved up to 800 microg. This study provides pharmacokinetic data to support a potential, expanded therapeutic dose range of FBT.
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PMID:Dose proportionality of fentanyl buccal tablet in doses ranging from 600 to 1300 microg in healthy adult subjects: a randomized, open-label, four-period, crossover, single-centre study. 2044 Dec 45