Articles: acetaminophen.
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Recently, the U. S. Food and Drug Administration (FDA) approved Zohydro(®), an extended release formulation of the opioid analgesic hydrocodone that contains no acetaminophen. ⋯ Subsequently, both chronic pain advocates and anti-drug abuse advocates have steadfastly expressed their support of, or astonishment at this decision. Here, we review the pharmacokinetics, pharmacodynamics, safety and abuse liability of this hydrocodone formulation and how it relates to the Expert Panel's opinion and the FDA decision. We discuss the important issues, risk mitigation, potential use of abuse deterrents, and how the different viewpoints of the Expert Panel and FDA decision makers resulted in the approval and subsequent controversy.
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Clin Toxicol (Phila) · Jan 2015
Multicenter Study Observational StudyAcetaminophen concentrations prior to 4 hours of ingestion: impact on diagnostic decision-making and treatment.
Consensus recommendations for acute acetaminophen exposure include plotting an acetaminophen concentration at ≥ 4 h post ingestion on the Rumack-Matthew nomogram to determine the need for acetylcysteine treatment. We studied the frequency of acetaminophen concentrations drawn within 4 h post ingestion and whether the Rumack-Matthew nomogram was properly used in making acetylcysteine treatment decisions. ⋯ Patients with a known exposure time and presenting within 4 h of acetaminophen ingestion had a pre-4-hour acetaminophen concentration obtained 62% of the time. Pre-4-hour acetaminophen concentrations cannot be used to determine the need for acetylcysteine therapy and are associated with an increased likelihood of not obtaining optimally timed acetaminophen concentrations and acetylcysteine management not based on the proper application of the Rumack-Matthew nomogram. Current practice results in additional cost, unnecessary treatment, potential adverse medication effects, and the possibility of non-treatment of patients at risk of hepatotoxicity.
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Postgraduate medicine · Jan 2015
Randomized Controlled TrialHuman abuse potential of immediate-release/extended-release versus immediate-release hydrocodone bitartrate/acetaminophen: a randomized controlled trial in recreational users of prescription opioids.
The abuse potential of prescription opioids is well established. This study compared positive, subjective drug effects of single, equal doses of biphasic immediate release (IR)/extended release (ER) hydrocodone bitartrate (HB)/acetaminophen (acetyl-p-aminophenol [APAP]) 7.5/325 mg tablets versus IR HB/APAP 7.5/325-mg tablets and placebo. ⋯ This Phase I clinical trial conducted in the USA was not registered.
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Randomized Controlled Trial Comparative Study
Pharmacokinetics of hydrocodone extended-release tablets formulated with different levels of coating to achieve abuse deterrence compared with a hydrocodone immediate-release/acetaminophen tablet in healthy subjects.
A hydrocodone extended-release (ER) formulation employing the CIMA(®) Abuse-Deterrence Technology platform was developed to provide resistance against rapid release of hydrocodone when tablets are comminuted or taken with alcohol. This study evaluated the pharmacokinetics of three hydrocodone ER tablet prototypes with varying levels of polymer coating to identify the prototype expected to have the greatest abuse deterrence potential based on pharmacokinetic characteristics that maintain systemic exposure to hydrocodone comparable to that of a commercially available hydrocodone immediate-release (IR) product. ⋯ All three hydrocodone ER tablet prototypes (low-, intermediate-, and high-level polymer coating) demonstrated ER pharmacokinetic characteristics. The hydrocodone ER tablet prototype with the high-level coating was selected for development because of its comparable exposure to the hydrocodone IR/APAP formulation and potentially increased ability to resist rapid drug release upon product tampering because of a higher polymer coating level. All study medications were well tolerated in healthy naltrexone-blocked volunteers.
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Randomized Controlled Trial
[Placebo controlled study of analgesic activity of analgin, paracetamol and dexalgin by electric pulp sensitivity testing].
The aim of the study was to evaluate the analgesic activity of paracetamol, analgin, dexalgin and placebo using electrical pulp sensitivity testing. Blind randomized study was performed on 112 volunteers, 52 men and 70 women aged 19-28 years. ⋯ Height effect was observed at 30 min: 9.4 mkA for analgin, 8.7 mkA for dexalgin, 6.5 mkA for paracetamol and 5.2 mkA for placebo. Paracetamol showed analgesic efficiency close to placebo effect.