American journal of hospital pharmacy
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The use of rapid intravenous infusions of phenytoin sodium to achieve prompt plasma therapeutic concentrations of phenytoin was studied in adult epileptic patients. Six adult patients who experienced recent tonic-clonic seizures were selected for study. Four of them had not been treated with phenytoin before the study; two were on chronic phenytoin therapy but had subtherapeutic serum levels. ⋯ Adverse effects were minimal and not severe; no cardiotoxicities were noted. Phenytoin half-life was 31.2 +/- 8.4 hours, total plasma clearance was 47.2 +/- 10.7 ml/kg/hr, and volume of distribution was 1.96 +/- 0.46 liters/kg. It is concluded that rapid intravenous infusion of phenytoin appears to be a reasonably safe and effective method of rapidly reaching therapeutic phenytoin concentrations.
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The implications of litigation concerning the authority of FDA in premarket approval of drugs are discussed. Since a recent paper on the Lannett and Pharmadyne decisions, several related court cases have been tried. The principal case discussed in Premo Pharmaceutical Laboratories, Inc. v. ⋯ S., where the FDA's authority to require premarket approval of "me-too" drugs was temporarily thrown into jeopardy by a district court's decision involving Premo's Insulase brand of chlorpropamide tablets. However, an appeal, the decision was reversed and the case dismissed. The courts' opinions for these decisions are discussed, as well as related developments.
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The development and maintenance of an organized system of emergency care in isolated ambulatory health-care centers are described. A system of three community health centers, staffed chiefly by midlevel practitioners (i.e., physician's associates and nurse practitioners), had a need to provide occasional emergency care to patients. Emergency care needed to be provided (for up to one hour) until an ambulance arrived to transport the patient to a hospital. ⋯ Weekly checks of the supplies and medications are conducted. Lists of supplies and medications stocked, and a sample drug monograph, are included in the paper. The program has resulted in more efficient emergency care, including less confusion in executing and documenting treatment.
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A case of methemoglobinemia secondary to topical local anesthetic agents is reported. A 28-year-old, 80-kg white man was admitted to a hospital for respiratory distress two days after an accident. During intubation, Cetacaine (benzocaine, butamben, and tetracaine) spray and Americaine (benzocaine) ointment were used topically for local anesthesia. ⋯ Abnormal hemoglobin variants and NADH-methemoglobin reductase deficiency were ruled out as sources of methemoglobinemia. A discussion of methemoglobinemia, including biochemistry, pathogenesis, symptomatology, and management, is presented. If cyanosis occurs following application of local anesthetics, methemoglobinemia secondary to these drugs should be considered in the differential diagnosis.
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Randomized Controlled Trial Comparative Study Clinical Trial
Lidocaine anesthesia: comparison of iontophoresis, injection, and swabbing.
The duration and depth of anesthesia produced by lidocaine with three methods of administration were studied. To test duration of anesthesia, either lidocaine or placebo was administered by iontophoresis, subcutaneous infiltration, or swabbing to each of three sites 3 cm apart on the flexor surface of each forearm of 27 subjects. ⋯ Lidocaine iontophoresis produced local anesthesia of significantly longer duration (p less than 0.001) than topical application of lidocaine or placebo by any route of administration, but of significatnly shorter duration (p less tahn 0.001) than lidocaine infiltration. The results showed that lidocaine iontophoresis is an effective method of producing local anesthesia for about five minutes without requiring the use of a hypodermic needle and syringe.