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Biomedical subjects

J A Barone

Publications and source records attributed to J A Barone.

34 records · Page 2Linked to original sources
PubMed1987

Pharmacist participation in the management of incidents involving hazardous materials.

The role of the pharmacist as a hazardous materials consultant is described. Pharmacists in a university-affiliated teaching hospital are contacted by either emergency medical services or the emergency department to assist in the management of incidents involving toxic hazardous materials. These incidents can range from major chemical spills or leaks to long-term exposures involving generalized, nonspecific symptoms. An advanced pharmacy resident in emergency medicine is the primary pharmacy contact for hazardous materials consults. The services provided by the clinical pharmacist include identification of the hazardous materials involved, initiation of special precautions for rescue-squad and hospital-based personnel, clinical assessment of the toxicologic problem, and formulation of therapeutic recommendations. Teaching programs have been developed for pharmacy, nursing, and medical students, hospital employees, and emergency-response agencies. Pharmacy participation in the management of hazardous materials incidents has been well received by emergency department physicians and nurses, as well as by rescue personnel. During the period between January 1 and July 1, 1986, the pharmacy was consulted on 66 hazardous materials incidents. Since pharmacists have traditionally been used as information resources for clinical toxicology questions, it follows that their participation can extend into the field of environmental toxicology, specifically involving hazardous materials. The pharmacist's input as a hazardous materials consultant in our institution has been well received, and we believe that pharmacy departments can play an important role in the management of incidents involving hazardous materials.

Consultants↗
PubMed1987

Smoking as a risk factor in noise-induced hearing loss.

We studied the relationship between cigarette smoking and hearing loss among 2,348 noise-exposed white male participants in a hearing conservation program at an aerospace company. Comparisons of risk factors were based on two definitions of hearing loss. In the first, cases were defined as those subjects in the top third of the hearing loss distribution (at 3, 4, and 6 kHz) for their age category, and controls were those subjects in the lowest third of the distribution. The crude relative risks for smokers were significantly elevated (ever smoker: odds ratio = 1.27, p = .02; present smoker: odd ratio = 1.39, P = .002) compared with never smokers. Simultaneous evaluation of several risk factors using multiple logistic regression methods indicated that the effects of smoking, having a noisy hobby, and years worked at the plant were independent factors for hearing loss. Statistically significant trends in risk were observed for the number of pack-years of smoking (P = .007) and current packs per day consumption in present smokers (P = .009). In the second definition, hearing loss cases were defined according to National Institute for Occupational Safety and Health criteria for beginning impairment. By using multiple logistic regression, present smoking was a statistically significant independent predictor of impairment. These results suggest that smokers are at increased risk of noise-induced hearing loss.

Adolescent↗
PubMed1987

Bioavailability of three oral dosage forms of cisapride, a gastrointestinal stimulant agent.

Relative bioavailability of the investigational gastrointestinal stimulant agent cisapride after oral administration was determined in healthy men. Treatments administered were (A) two 5-mg tablets; (B) one 10-mg tablet; (C) 10 mL of a 1-mg/mL suspension; and (D) 10 mL of a 1-mg/mL aqueous reference solution. The study had a randomized four-way, crossover design; drug administration was followed by a standard breakfast. Plasma cisapride concentrations in blood samples drawn over 48 hours were measured by high-performance liquid chromatography. Individual and mean values for bioavailability parameters were subjected to analysis of variance followed by multiple comparison testing. Time to maximum concentration was shortest after administration of the solution. There was a significant difference in mean peak plasma concentrations between treatment A (48.8 +/- 12.8 ng/mL) and treatment D (41.6 +/- 10.6 ng/mL), with treatment A producing a 17.3% higher peak concentration. No significant differences between treatments were found for area under the plasma concentration-time curve. The overall mean elimination half-life was 7.01 hours. The results of the study indicate that the tablet and suspension dosage forms of cisapride are bioequivalent to the reference solution.

Administration, Oral↗
PubMed1986

Safety evaluation of ritanserin--an investigational serotonin antagonist.

Ritanserin is an investigational serotonin-S2 receptor antagonist with activity in a variety of psychiatric disturbances characterized by dysthymia or anxiety. This investigation evaluates acute safety and tolerability of ritanserin in 12 healthy males. Ritanserin 10 mg, 20 mg, and placebo were administered as single doses in a randomized, double-blind, crossover fashion. Treatment effects on vital signs, laboratory tests, a mood evaluation test, electrocardiograms (ECGs), and reported adverse experiences were monitored. Plasma levels were determined at two hours postdose. Results indicated no clinically relevant effects on vital signs, laboratory tests, ECGs, or mood evaluations. Dose proportionality was demonstrated. The incidence of total adverse effects (primarily somnolence and fatigue) after single-dose administration was 25 percent for placebo, 75 percent for 10 mg, and 81.8 percent for 20 mg. There was a relationship between incidence of adverse effects and dose, but no general correlation between plasma levels and severity of adverse experiences. The results indicate that ritanserin is safe and tolerable following acute administration of 10 mg and 20 mg oral doses.

Adolescent↗
PubMed1986

Determination of bioequivalence of psychotropic drugs and concerns involving product interchange.

There is a growing debate among researchers and practitioners concerning the validity of the Food and Drug Administration (FDA) standards for establishing generic interchange through assignment of "therapeutically equivalent" designations for noninnovator or generic drugs. This debate has particular significance for psychotropic drugs which are used in the management of patients with severely debilitating mental diseases. Thus, the controversy primarily focuses on the appropriateness of using the FDA's therapeutic equivalence designation as a criterion for interchange. This is particularly important in light of the lack of well-defined standards for bioequivalence studies and in view of the effect of mandatory substitution laws and financial incentives that encourage generic dispensing that can lead to frequent and indiscriminate interchange among multiple generic brands. Specific concerns include the validity of assay techniques for drug in biologic fluids, statistical power analysis, the appropriateness of the "70/70 rule," and the relevance of studies carried out in healthy normal volunteers in the determination of bioequivalence.

Antipsychotic Agents↗
PubMed1985

Critical evaluation of thioridazine bioequivalence.

The phenothiazines have exhibited a history of problems associated with the bioequivalence of solid oral dosage forms. The more recent availability of chemically equivalent forms of thioridazine has raised new and interesting questions about the appropriateness of generic product interchange, even among brands that have been designated "therapeutically equivalent" by the Food and Drug Administration. The scrutiny that has accompanied the consideration of thioridazine products for inclusion into various state generic substitution formularies has offered an opportunity to examine issues involving bioequivalency in considerable detail. Specific bioequivalency concerns relate to: correct analysis of drug in biological fluids; the importance of evaluating active metabolites: single-dose vs. multiple-dose crossover studies; appropriate statistical power analysis; the "70/70" rule, and comparison of product variabilities. Examples of problems are cited to illustrate that significant questions still remain about the appropriate factors that should be used to establish bioequivalency.

Biotransformation↗
PubMedDate not supplied

Combination dihydroergotamine mesylate and heparin sodium with lidocaine HCl. Pharmacokinetics, mechanism of action, clinical efficacy, and adverse effects.

Dihydroergotamine(DHE)-heparin combination offers a unique treatment modality for the prevention of deep vein thrombosis. The combination appears to affect all 3 limbs of Virchow's triad: hypercoagulability, venous stasis, and endothelial damage. In most efficacy studies, data indicated that the combination of DHE 0.5 mg and heparin 5000 IU was superior to low-dose heparin alone. Even when the efficacy of DHE-heparin was the same as that of heparin alone, the use of the combination allowed for a decrease in the heparin dose required.

Biological Availability↗
PubMedDate not supplied

Serum lidocaine concentrations following subcutaneous administration.

Serum lidocaine concentrations were determined following subcutaneous administration for local anesthesia in the management of lacerations in the emergency room setting. Thirty patients received doses of lidocaine hydrochloride 1% solution ranging from 10 to 300 mg. Venous blood samples were drawn 15, 30, 45, and 60 minutes after lidocaine administration. Serum lidocaine determinations were made using an immunoassay system and verified by gas chromatography. There was no evidence of lidocaine absorption from the subcutaneous injection sites. There were no detectable concentrations of lidocaine in any of the patient blood samples. The absorption characteristics of subcutaneously administered lidocaine appear to be altered in traumatized tissue.

Humans↗
PubMedDate not supplied

Food interaction and steady-state pharmacokinetics of itraconazole oral solution in healthy volunteers.

STUDY OBJECTIVES: To evaluate the effect of food on the bioavailability of itraconazole (ITR) hydroxypropyl-beta-cyclodextrin (HP-beta-CD) solution under multiple-dose to steady-state conditions, and to determine the pharmacokinetics of ITR solution at steady state. DESIGN: Open-label, randomized, multiple-dose, crossover study SETTING: University-affiliated health center. PATIENTS: Thirty healthy men randomized to one of two treatment sequences (fasted-fed, fed-fasted). INTERVENTIONS: Subjects were either fasted or fed a standard breakfast before receiving ITR oral solution 200 mg once/day for 15 days. Crossover phases were separated by a 4-week washout period. MEASUREMENTS AND MAIN RESULTS: On day 1, blood samples were collected before the dose (time zero) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours after the dose. Trough samples were obtained before the dose on days 4, 7, 12, 13, and 14. On day 15, samples were obtained at the same times as day 1, and at 36, 48, 72, 96, 168, 240, and 360 hours. Samples were analyzed by high-performance liquid chromatography for ITR and its major metabolite hydroxyitraconazole (OH-ITR). Urine was collected on days 1 and 15 before and 0-8 and 8-24 hours after the dose; HP-beta-CD was measured by size-exclusion chromatography. Mean bioavailabilities of ITR and OH-ITR were 43% and 38% higher, respectively, when ITR solution was taken as a single dose under fasted conditions. With multiple dosing, steady state was achieved by day 14. At steady state, mean bioavailabilities were 29% and 17% higher, respectively, in the fasted state; terminal half-life was similar under fasted and fed conditions (mean 39.8 and 37.5 hrs for ITR, respectively; 27.3 and 26.2 hrs for OH-ITR, respectively). HP-beta-CD was eliminated almost exclusively in urine. CONCLUSION: The bioavailability of ITR and OH-ITR is enhanced when ITR oral solution is given in the fasted state; this was true for both single and multiple dosing to steady state.

2-Hydroxypropyl-beta-cyclodextrin↗