The Annals of pharmacotherapy
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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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Blastomycosis is an endemic mycosis caused by the dimorphic fungus Blastomyces dermatitidis. Although this disease primarily involves the lungs, the clinical spectrum of blastomycosis can range from subclinical infection to extrapulmonary dissemination. The central nervous system (CNS) form of blastomycosis is primarily treated with an amphotericin B formulation, but associated toxicities of this agent preclude its use in some patients. Voriconazole is a broad-spectrum triazole antifungal that has emerged as a potential treatment option for CNS blastomycosis because of its excellent penetration into the cerebrospinal fluid and brain tissue. ⋯ Further studies are needed to fully elucidate the role of voriconazole in the treatment of CNS blastomycosis. It nonetheless may be considered as an azole option for either follow-up therapy after liposomal amphotericin B therapy or as salvage therapy in patients intolerant of amphotericin B or other azoles.
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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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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.