The Annals of pharmacotherapy
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Case Reports
Use of subcutaneous lepirudin in an obese surgical intensive care unit patient with heparin resistance.
To report the use of subcutaneous lepirudin in an obese patient with heparin resistance. ⋯ In obese patients or those with heparin resistance, subcutaneous lepirudin can be monitored and the regimen adjusted based on aPTT values. Further studies are warranted to maximize efficacy and define dosing.
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To describe a potentially fatal adverse drug event after administration of morphine to a term neonate. ⋯ A serious adverse event consisting of generalized muscle rigidity and laryngospasm can occur after bolus administration of morphine as well as during continuous infusion. Clinicians should be aware of this possibility.
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Veterans with Medicare managed-care plans have access to pharmacy benefits outside the Veterans Health Administration (VA), but how this coverage affects use of medications for specific disease conditions within the VA is unclear. ⋯ FFS-enrolled veterans were generally less likely to be receiving condition-related medications from the VA, compared with HMO-enrolled veterans with lower levels of prescription drug coverage. Pharmacy prescription coverage within Medicare affects the use of evidence-based medications for specific disease conditions in the VA.
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Comparative Study
Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.
In the US, manufacturers seeking approval to market a generic drug product must submit data demonstrating that the generic formulation provides the same rate and extent of absorption as (ie, is bioequivalent to) the innovator drug product. Thus, most orally administered generic drug products in the US are approved based on results of one or more clinical bioequivalence studies. ⋯ The criteria used to evaluate generic drug bioequivalence studies support the FDA's objective of approving generic drug formulations that are therapeutically equivalent to their innovator counterparts.
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To describe a case of dexmedetomidine use for sedation in a 24-week gestational age premature neonate. ⋯ Dexmedetomidine was an effective sedative and analgesic in a 24-week gestational age neonate treated for refractory agitation while on mechanical ventilation. Based on its documented efficacy for pain and sedation and its favorable adverse effect profile, dexmedetomidine warrants further study as first-line or adjunct therapy with narcotics for sedation in ventilated newborns.