Single Dose Of Medication Research Articles

Intramuscular dexmedetomidine and oral chloral hydrate for pediatric sedation for electroencephalography: A propensity score-matched analysis.

Intramuscular dexmedetomidine can be used for pediatric sedation without requiring intravenous access and has advantages for electroencephalography by inducing natural sleep pathway, but only a limited number of studies compared the efficacy of intramuscular dexmedetomidine with oral chloral hydrate. To compare the efficacy and safety of intramuscular dexmedetomidine and oral chloral hydrate used for sedation during electroencephalography in pediatric patients. We reviewed the medical records of pediatric patients who underwent sedation for electroencephalography between January 2015 and December 2016. Initial doses of dexmedetomidine and chloral hydrate were 3mcg/kg and 50mg/kg, respectively; second doses (1mcg/kg and 50mg/kg, respectively) were administered if adequate sedation was not achieved. Demographic data, time of sedative administration, time of sedation and awakening, and time of arrival at recovery room and discharge were analyzed. Out of a total of 1239 patients, 125 patients had received dexmedetomidine and 1114 had received chloral hydrate. After 1:1 propensity score matching, the dexmedetomidine and chloral hydrate groups each had 118 patients. Testing completion rate with a single dose of medication was higher in the dexmedetomidine group (91.5% vs 71.2%; mean difference [95% CI] 20.3 [10.8-29.9]; P<.0001; Pearson chi-square value=16.09). Sedation onset time was shorter in the dexmedetomidine group as well (16.6±13.0minutes vs 41.5±26.8minutes; mean difference [95% CI] 24.8 [19.1-30.6]; P<.0001; T=8.27). On the contrary, the duration of recovery was longer in the dexmedetomidine group (35.5±40.2minutes vs 18.5±30.7minutes; mean difference [95% CI] 18.6 [8.8-28.5]; P=.0002; T=-2.82). Total residence time was not significantly different between the two groups (125.8±40.6minutes vs 122.1±42.2minutes, mean difference [95% CI] 5.21 [6.1-16.5], P=.3665T=0.04). Intramuscular dexmedetomidine showed higher sedation success rate and shorter time to achieving the desired sedation level compared with oral chloral hydrate and thus may be an effective alternative for oral chloral hydrate in pediatric patients requiring sedation for electroencephalography.

Is intravenous lorazepam really more effective and safe than intravenous diazepam as first-line treatment for convulsive status epilepticus? A systematic review with meta-analysis of randomized controlled trials

Some guidelines or expert consensus indicate that intravenous (IV) lorazepam (LZP) is preferable to IV diazepam (DZP) for initial treatment of convulsive status epilepticus (SE). We aimed to critically assess all the available data on efficacy and tolerability of IV LZP compared with IV DZP as first-line treatment of convulsive SE. Systematic search of the literature (MEDLINE, CENTRAL, EMBASE, ClinicalTrials.gov) to identify randomized controlled trials (RCTs) comparing IV LZP versus IV DZP used as first-line treatment for convulsive SE (generalized or focal). Inverse variance, Mantel-Haenszel meta-analysis to obtain risk ratio (RR) with 95% confidence intervals (CI) of following outcomes: seizure cessation after drug administration; continuation of SE requiring a different drug; seizure cessation after a single dose of medication; need for ventilator support; clinically relevant hypotension. Five RCTs were included, with a total of 656 patients, 320 randomly allocated to IV LZP and 336 to IV DZP. No statistically significant differences were found between IV LZP and IV DZP for clinical seizure cessation (RR 1.09; 95% CI 1.00 to 1.20), continuation of SE requiring a different drug (RR 0.76; 95% CI 0.57 to 1.02), seizure cessation after a single dose of medication (RR 0.96; 95% CI 0.85 to 1.08), need for ventilator support RR 0.93; 95% CI 0.61 to 1.43, and clinically relevant hypotension. Despite its favorable pharmacokinetic profile, a systematic appraisal of the literature does not provide evidence to strongly support the preferential use of IV LZP as first-line treatment of convulsive SE over IV DZP.

Retrospective Comparison of Intranasal Dexmedetomidine and Oral Chloral Hydrate for Sedated Auditory Brainstem Response Exams.

Satisfactory conditions for auditory brainstem responses (ABR) screening tests for pediatric hearing loss are usually achieved with oral chloral hydrate (CH) sedation. When the US manufacture of this drug was discontinued for business reasons, we developed an alternative sedation regimen using intranasal dexmedetomidine (IN DEX) 4 μg/kg. This institutional review board-approved retrospective study compared the efficacy and adverse effect profiles of these 2 sedative regimens. Medical records of children receiving oral CH or IN DEX for ABR were surveyed for demographic data and times from sedative administration to start and completion of the ABR procedure and recovery times. We also noted if the examination was completed with or without interruptions, failed for inadequate sedation, and if predefined cardiorespiratory adverse events occurred. In the IN DEX cohort, the examination could be completed more frequently with a single dose of medication (P = .002). Satisfactory sedation in these patients permitted an earlier start of both the ABR examination and recovery to the awake status (P < .001 and < .045, respectively). Hypoxia requiring oxygen therapy was more frequent in the CH group. This retrospective study found that IN DEX provides effective sedation for ABR examinations, with the benefits of an ability to begin the test sooner and complete the examination with a single dose, in addition to a decreased incidence of hypoxemia. A randomized controlled trial should test the hypothesis that the IN DEX technique is superior to the well-established standard oral CH regimen.

A prospective, randomized, double-blind trial of intranasal dexmedetomidine and oral chloral hydrate for sedated auditory brainstem response (ABR) testing.

Dexmedetomidine is increasingly used by various routes for pediatric sedation. However, there are few randomized controlled trials comparing the efficacy of dexmedetomidine to other commonly used sedatives. To compare the efficacy of sedation with intranasal dexmedetomidine to oral chloral hydrate for auditory brainstem response (ABR) testing. In this double-blind, double-dummy study, children undergoing ABR testing were randomized to receive intranasal dexmedetomidine 3 mcg · kg(-1) plus oral placebo (Group IN DEX) or oral chloral hydrate 50 mg · kg(-1) plus intranasal saline placebo (Group CH). We recorded demographic data, times from sedative administration to start and completion of testing, quality of sedation, occurrence of predefined adverse events, discharge times, and return to baseline activity on the day of testing. Testing completion rates with a single dose of medication were higher in the IN DEX group (89% vs 66% for CH, odds ratio with 95% confidence intervals 4.04 [1.3-12.6], P = 0.018). The median [95% CI)] time to successful testing start was shorter (25 [20-29] min vs 30 [20-49] min for IN DEX and CH, respectively, log rank test P = 0.02) and the proportion of children whose parents reported a return to baseline activity on the day of testing was greater for the IN DEX than the CH group (89% vs 64%, OR [95% CI] 4.71 [1.34-16.6], P = 0.02). There were no major adverse events in either group and no significant differences in the incidence of minor events. Intranasal dexmedetomidine is an effective alternative to oral chloral hydrate sedation for ABR testing, with the advantages of a higher incidence of testing completion with a single dose, shorter time to desired sedation level, and with significantly more patients reported to return to baseline activity on the same day.

Diclofenac with or without an antiemetic for acute migraine headaches in adults.

This review is an update of a previously published review in Issue 2, 2012 (Derry 2012a). Migraine is a common, disabling condition and a burden for the individual, health services and society. Many sufferers choose not to, or are unable to, seek professional help and rely on over-the-counter (OTC) analgesics. Diclofenac is an established analgesic, and new formulations using the potassium or epolamine salts, which can be dissolved in water, have been developed for rapid absorption, which may be beneficial in acute migraine. Co-therapy with an antiemetic should help to reduce the nausea and vomiting commonly associated with migraine. To determine the efficacy and tolerability of diclofenac, alone or in combination with an antiemetic, compared to placebo and other active interventions in the treatment of acute migraine headaches in adults. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Oxford Pain Relief Database, ClinicalTrials.gov, and reference lists for studies through 27 September 2011 for the original review and 15 February 2013 for the update. We included randomised, double-blind, placebo-controlled or active-controlled studies, or both, using self administered diclofenac to treat a migraine headache episode, with at least 10 participants per treatment arm. Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate relative risk (or 'risk ratio') and numbers needed to treat to benefit (NNT) or harm (NNH) compared to placebo or a different active treatment. Five studies (1356 participants, 2711 attacks) compared oral diclofenac with placebo, and one also compared it with sumatriptan; none combined diclofenac with a self administered antiemetic. Four studies treated attacks with single doses of medication, and two allowed an optional second dose for inadequate response. Only two studies, with three active treatment arms, provided data for pooled analysis of primary outcomes. For single doses of diclofenac potassium 50 mg versus placebo (two studies), the NNTs were 6.2, 8.9, and 9.5 for pain-free at two hours, headache relief at two hours, and pain-free responses at 24 hours, respectively.Similar numbers of participants experienced adverse events, which were mostly mild and transient, with diclofenac and placebo.There were insufficient data to evaluate other doses of oral diclofenac, or to compare different formulations or different dosing regimens; only one study compared oral diclofenac with an active comparator (oral sumatriptan 100 mg). Oral diclofenac potassium 50 mg is an effective treatment for acute migraine, providing relief from pain and associated symptoms, although only a minority of patients experience pain-free responses. Adverse events are mostly mild and transient and occur at the same rate as with placebo.

Ibuprofen with or without an antiemetic for acute migraine headaches in adults.

This is an updated version of the original review published in Issue 10, 2010 (Rabbie 2010). Migraine is a common, disabling condition and a burden for the individual, health services and society. Many sufferers do not seek professional help, relying instead on over-the-counter analgesics. Co-therapy with an antiemetic should help to reduce symptoms commonly associated with migraine headaches. To determine efficacy and tolerability of ibuprofen, alone or in combination with an antiemetic, compared to placebo and other active interventions in the treatment of acute migraine headaches in adults. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Oxford Pain Relief Database, ClinicalTrials.gov, and reference lists for studies through 22 April 2010 for the original review and to 14 February 2013 for the update. We included randomised, double-blind, placebo- or active-controlled studies using self-administered ibuprofen to treat a migraine headache episode, with at least 10 participants per treatment arm. Two review authors independently assessed trial quality and extracted data. Numbers of participants achieving each outcome were used to calculate relative risk and number needed to treat (NNT) or harm (NNH) compared to placebo or other active treatment. No new studies were found for this update. Nine included studies (4373 participants, 5223 attacks) compared ibuprofen with placebo or other active comparators; none combined ibuprofen with a self-administered antiemetic. All studies treated attacks with single doses of medication. For ibuprofen 400 mg versus placebo, NNTs for 2-hour pain-free (26% versus 12% with placebo), 2-hour headache relief (57% versus 25%) and 24-hour sustained headache relief (45% versus 19%) were 7.2, 3.2 and 4.0, respectively. For ibuprofen 200 mg versus placebo, NNTs for 2-hour pain-free (20% versus 10%) and 2-hour headache relief (52% versus 37%) were 9.7 and 6.3, respectively. The higher dose was significantly better than the lower dose for 2-hour headache relief. Soluble formulations of ibuprofen 400 mg were better than standard tablets for 1-hour, but not 2-hour headache relief.Similar numbers of participants experienced adverse events, which were mostly mild and transient, with ibuprofen and placebo.Ibuprofen 400 mg did not differ from rofecoxib 25 mg for 2-hour headache relief or 24-hour headache relief. We found no new studies since the last version of this review. Ibuprofen is an effective treatment for acute migraine headaches, providing pain relief in about half of sufferers, but complete relief from pain and associated symptoms for only a minority. NNTs for all efficacy outcomes were better with 400 mg than 200 mg in comparisons with placebo, and soluble formulations provided more rapid relief. Adverse events were mostly mild and transient, occurring at the same rate as with placebo.

Diclofenac with or without an antiemetic for acute migraine headaches in adults.

Migraine is a common, disabling condition and a burden for the individual, health services and society. Many sufferers choose not to, or are unable to, seek professional help and rely on over-the-counter (OTC) analgesics. Diclofenac is an established analgesic, and new formulations using the potassium or epolamine salts, which can be dissolved in water, have been developed for rapid absorption, which may be beneficial in acute migraine. Co-therapy with an antiemetic should help to reduce the nausea and vomiting commonly associated with migraine. To determine the efficacy and tolerability of diclofenac, alone or in combination with an antiemetic, compared to placebo and other active interventions in the treatment of acute migraine headaches in adults. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Oxford Pain Relief Database, ClinicalTrials.gov, and reference lists for studies through 27 September 2011. We included randomised, double-blind, placebo- and/or active-controlled studies using self administered diclofenac to treat a migraine headache episode, with at least 10 participants per treatment arm. Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate relative risk (or 'risk ratio') and numbers needed to treat to benefit (NNT) or harm (NNH) compared to placebo or a different active treatment. Five studies (1356 participants) compared oral diclofenac with placebo, and one also compared it with sumatriptan; none combined diclofenac with a self administered antiemetic. Four studies treated attacks with single doses of medication, and two allowed an optional second dose for inadequate response. Only two studies, with three active treatment arms, provided data for pooled analysis of primary outcomes. For single doses of diclofenac potassium 50 mg versus placebo (two studies), the NNTs were 6.2, 8.9, and 9.5 for pain-free at two hours, headache relief at two hours, and pain-free responses at 24 hours, respectively.Associated symptoms of nausea, photophobia and phonophobia, and functional disability were reduced within two hours, and similar numbers of participants experienced adverse events, which were mostly mild and transient.There were insufficient data to evaluate other doses of oral diclofenac, or to compare different formulations or different dosing regimens; only one study compared oral diclofenac with an active comparator (oral sumatriptan 100 mg). Oral diclofenac potassium 50 mg is an effective treatment for acute migraine, providing relief from pain and associated symptoms, although only a minority of patients experience pain-free responses. Adverse events are mostly mild and transient and occur at the same rate as with placebo.

Ibuprofen with or without an antiemetic for acute migraine headaches in adults.

Migraine is a common, disabling condition and a burden for the individual, health services and society. Many sufferers do not seek professional help, relying instead on over-the-counter analgesics. Co-therapy with an antiemetic should help to reduce symptoms commonly associated with migraine headaches. To determine efficacy and tolerability of ibuprofen, alone or in combination with an antiemetic, compared to placebo and other active interventions in the treatment of acute migraine headaches in adults. We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies through 22 April 2010. We included randomised, double-blind, placebo- or active-controlled studies using self-administered ibuprofen to treat a migraine headache episode, with at least 10 participants per treatment arm. Two review authors independently assessed trial quality and extracted data. Numbers of participants achieving each outcome were used to calculate relative risk and number needed to treat (NNT) or harm (NNH) compared to placebo or other active treatment. Nine studies (4373 participants, 5223 attacks) compared ibuprofen with placebo or other active comparators; none combined ibuprofen with a self-administered antiemetic. All studies treated attacks with single doses of medication. For ibuprofen 400 mg versus placebo, NNTs for 2-hour pain-free (26% versus 12% with placebo), 2-hour headache relief (57% versus 25%) and 24-hour sustained headache relief (45% versus 19%) were 7.2, 3.2 and 4.0, respectively. For ibuprofen 200 mg versus placebo, NNTs for 2-hour pain-free (20% versus 10%) and 2-hour headache relief (52% versus 37%) were 9.7 and 6.3, respectively. The higher dose was significantly better for 2-hour headache relief than the lower dose. Soluble formulations of ibuprofen 400 mg were better than standard tablets for 1-hour, but not 2-hour headache relief.Associated symptoms of nausea, vomiting, photophobia and phonophobia and functional disability were reduced within 2 hours, and fewer participants used rescue medication with ibuprofen compared with placebo. Similar numbers of participants experienced adverse events, which were mostly mild and transient.Ibuprofen 400 mg did not differ from rofecoxib 25 mg for 2-hour headache relief, 24-hour headache relief or use of rescue medication. Ibuprofen is an effective treatment for acute migraine headaches, providing pain relief in about half of sufferers, but complete relief from pain and associated symptoms for only a minority. NNTs for all efficacy outcomes were better with 400 mg than 200 mg in comparisons with placebo, and soluble formulations provided more rapid relief. Adverse events were mostly mild and transient, occurring at the same rate as with placebo.

Pharmacokinetics of two generic co-formulations of lopinavir/ritonavir for HIV-infected children: a pilot study of paediatric Lopimune versus the branded product in healthy adult volunteers

To determine the pharmacokinetic profiles of lopinavir and ritonavir in two newly developed generic co-formulations for HIV-infected children (Lopimune paediatric tablets and granules, 100/25 mg of lopinavir/ritonavir, Cipla Pharmaceuticals), and to compare these with the branded product (Kaletra). This Phase I, comparative, open-label, three-period, single-dose, crossover study was designed as a pilot study to exclude large (>40%) differences in the exposure to lopinavir. Single doses of medication, normalized to 400 mg of lopinavir, were administered on an empty stomach, 1 week apart. A 32 h pharmacokinetic curve was recorded. In an additional part of the study, in five of the same volunteers, a pharmacokinetic curve was recorded after administration of the Lopimune granules and Kaletra oral solution, both with food. Twelve healthy subjects were enrolled (four females). The median (range) age, height and body weight were 24 (21-55) years, 1.79 (1.63-1.95) m and 72 (51-87) kg, respectively. The median [interquartile range (IQR)] AUC(0-t) of lopinavir was 71.8 (48.8-93.5), 38.7 (28.7-52.2) and 58.7 (42.5-79.4) mg.h/L with Kaletra tablets, Lopimune granules and Lopimune paediatric tablets, all taken on an empty stomach, respectively. The respective C(max) values were 7.2 (5.8-8.3), 4.6 (4.1-5.2) and 6.5 (5.0-7.1) mg/L after intake of the different formulations. When comparing the Lopimune formulations with the reference product Kaletra, for all parameters the differences were statistically significant (P <or= 0.015). Ritonavir exposure was also lower after intake of the generic formulations versus Kaletra. When the five subjects took the Lopimune granules or Kaletra solution with food, the median (IQR) AUC(0-t) of lopinavir was 58.5 (55.4-77.6) and 49.6 (39.1-58.1) mg.h/L, respectively. Large differences in pharmacokinetic parameters can be excluded for Lopimune paediatric tablets when compared with the branded product and taken on an empty stomach, and also for Lopimune granules when these are taken with food.

Prolonged bronchoprotection against inhaled methacholine by inhaled BI 1744, a long-acting β 2-agonist, in patients with mild asthma

Long-acting ss(2)-agonists are an established controller medication in asthma. BI 1744 is a novel L\long-acting ss(2)-agonist with a preclinical profile that suggests 24-hour bronchodilation and bronchoprotection may be achieved. To examine the bronchoprotective effects of single doses of BI 1744 against methacholine provocation in subjects with mild asthma. Thirty-one subjects with mild asthma were randomized to receive single doses of BI 1744 (2, 5, 10, 20 microg) or placebo on separate days according to a double-blind, 5-way crossover design. Methacholine challenges were performed at 30 minutes and at 4, 8, 24, and 32 hours after each single dose of medication, and the results were expressed as PC(20) FEV(1). All doses of BI 1744 produced statistically significant increases in the methacholine PC(20) compared with placebo as long as 32 hours. The mean (geometric SEM) methacholine PC(20) 24 hours after dosing with placebo was 1.73 (1.13) mg/mL, which increased after 2 microg to 3.86 (1.14) mg/mL, after 5 microg to 5.67 (1.14) mg/mL, after 10 microg to 9.42 (1.13) mg/mL, and after 20 microg to 13.71 (1.14) mg/mL (all P < .0001). After 32 hours, the methacholine PC(20) value remained significantly increased for all doses. No safety or tolerability concerns were identified. BI 1744 provides significant bronchoprotection against inhaled methacholine for up to 32 hours after single-dose administration.

Pharmacokinetics of two generic fixed-dose combinations for HIV-infected children (Pedimune Baby &amp; Pedimune Junior) are similar to the branded products in healthy adults

Cipla Pharmaceuticals have developed generic fixed-dose combinations of stavudine, lamivudine and nevirapine for HIV-infected children (Pedimune Baby and Junior). We determined the pharmacokinetic profiles of stavudine, lamivudine and nevirapine in Pedimune and compared these with the branded products. This Phase I, comparative, single-centre, open-label, three-period, single-dose study was designed as a pilot study to exclude large differences in pharmacokinetics. Six healthy males were randomized to the following regimen sequences: ABC; ACB; BCA; BAC; CAB; CBA (A = reference, B = Pedimune Baby, C = Pedimune Junior). Single doses of medication were administered at 3 time points 4 weeks apart. An 8 h pharmacokinetic curve was recorded at day 1 of every cycle after medication intake. In addition, blood samples were taken on days 2, 3, 4, 8 and 15. Non-parametric statistical tests revealed no statistically significant differences in Cmax (0.173 < or = P < or = 0.753) and Tmax (0.317 < or = P < or = 1.000) of stavudine, lamivudine and nevirapine between the two Pedimune formulations and the branded drugs. Also, there were no significant differences in AUC(0-infinity) of stavudine, lamivudine and nevirapine between Pedimune Junior and the branded drugs (0.345 < or = P < or = 0.600) and between Pedimune Baby and the branded drug for nevirapine (P = 0.463). In contrast, the AUC(0-infinity) of stavudine (mean change: +21%; P = 0.046) and lamivudine (mean change: +14%; P = 0.028) differed significantly between Pedimune Baby and the branded drugs, but these changes were considered not clinically significant. The pharmacokinetic profiles of stavudine, lamivudine and nevirapine in Pedimune Baby and Junior are comparable to the branded products. Based on these results, it is acceptable to test the pharmacokinetics and dosing requirements of Pedimune in HIV-infected children.

Advancing vaginal drug delivery

Bacterial vaginosis and vulvovaginal candidiasis are the two most common forms of vaginitis in female patients. Although a variety of effective treatments have been available to eradicate these infections, limitations have lessened the utility of previously available products. Oral therapies are often fraught with systemic adverse reactions, as well as the potential to interact with concomitant medications. Vaginal preparations, although generally perceived as safer, have historically been undesirable for women to use due to their multiple days of dosing; messy, dripping creams; and requisite night-time dosing. Recognising that the therapeutic delivery of the active agent plays a critical role in the overall success of therapy, and attempting to circumvent the weaknesses of traditional vaginal drug delivery while maintaining and even improving safety profiles, a new form of vaginal drug delivery was developed. This unique and proprietary delivery system, with both bioadhesive and sustained release properties, introduces the convenience of a single dose of medication that can be applied at any time, with efficacy rates equivalent to lengthier durations of treatment. This advance in science and technology has now been successfully applied to two products, Gynazole-1® (butoconazole nitrate 2%) and Clindesse™ (clindamycin phosphate 2%) indicated for the treatment of vulvovaginal candidiasis and bacterial vaginosis, respectively, in order to enhance convenience and compliance for the treatment of two very common clinical conditions.

Efficacy and Safety of Single and Multiple Doses of Pseudoephedrine in the Treatment of Nasal Congestion associated with Common Cold

Pseudoephedrine (60 mg) is widely used as an oral decongestant taken in tablet or syrup formulations every 4-6 hours for the treatment of nasal congestion associated with common cold and allergy. However, there are relatively few studies in the literature that have used objective measures of nasal airway resistance (NAR) to assess the efficacy of pseudoephedrine, and most studies use only a single dose of medication. The present study has the aims of studying the safety and efficacy of a new pseudoephedrine formulation after single and multiple doses in patients with URTI. The study was a double-blind, randomized, parallel-group, placebo-controlled trial conducted over three study days at a single center. Patients suffering from nasal congestion associated with common cold were recruited and total NAR was measured by the technique of posterior rhinomanometry. NAR and subjective scores of nasal congestion were measured at baseline and after dosing with study medication, every hour over a four-hour period on day 1 after a single dose, and on day 3 after multiple doses of medication. Subjective scores of congestion/stuffiness were also made as a summary score at the end of each day of treatment. Two hundred and thirty-eight patients with nasal congestion associated with acute upper respiratory tract infection (URTI), mean age 20 years, were recruited to the study and received treatment. After a single dose on day 1 the pseudoephedrine group had a statistically significant lower area under the NAR curve than placebo (p = 0.006) for the primary efficacy variable area under the NAR curve from 0-3 hours (NAR AUC 0-3h), and similarly for the secondary efficacy variable NAR AUC 0-4h (p = 0.001). On day three after multiple doses, the pseudoephedrine group had a statistically significant lower NAR AUC 0-3h and AUC 0-4h than placebo (p < 0.001), On day 1, the pseudoephedrine group had significantly lower subjective scores for congestion than placebo visual analog scale (VAS) AUC 0-3h (p = 0.029) and similarly for VAS AUC 0-4h (p = 0.021). On day 3, the differences in subjective scores were not significantly different. The mean decrease from baseline of the summary score for congestion/stuffiness over the duration of the study was greater in the pseudoephedrine group compared to the placebo group (p = 0.016). On average, heart rate was between two and four beats per minute greater in the pseudoephedrine group compared to placebo. Five adverse events were reported in both treatment groups and these were deemed to be unrelated to treatment. The results demonstrate that pseudoephedrine is a safe and effective treatment for nasal congestion associated with URTI. The results from the laboratory study on day 1 demonstrate by both objective and subjective measures of nasal congestion that a single dose of 60 mg pseudoephedrine is superior to placebo treatment. Support for the decongestant efficacy of multiple doses of pseudoephedrine is provided by objective measures on day 3 and subjective measures made over three days, but not by the VAS scores on day 3.

Implication of dispensing cups in dosing errors and pediatric poisonings: a report from the American Association of Poison Control Centers.

To characterize reports to poison centers involving liquid medication errors associated with the use of dispensing cups. Case series reported by 16 US poison centers over an eight-day period. Calls to poison control centers, predominantly but not exclusively from homes. Children and adults. Of 34 reported cases, most (79 percent) involved a two- to threefold dosing error, and most (94 percent) involved an error in a single dose of medication. Cough and cold preparations were implicated in 65 percent; acetaminophen elixirs in 18 percent. Three major causes of dosing errors were identified, including teaspoon/tablespoon confusion, assumption that the dispensing cup was the unit of measure, and assumption that the full dispensing cup was the actual dose. Dispensing cup markings should use a single unit of measure, and a uniform labeling system should be implemented. Teaspoon/tablespoon abbreviations should be avoided, and dispensing cup lettering should be more legible. Consumer education is essential to correct the misimpression that the full cup is always the recommended dose.

Urinary tract infections in women

Factors influencing urinary tract infections depend on a balance between bacterial virulence (bacterial adhesion to tissues, hemolysin, and aerobactin) and on the host's defenses (local immunoglobulin production). Predisposing factors for the development of urinary tract infections in women are physiologic changes with aging, use of catheters, and genitourinary operations. Therapy for uncomplicated urinary tract infections usually consists of a single dose of medication for 3 to 7 days, although the 1-day regimen was proved to be quite effective. Treatment of complicated urinary tract infections is by intravenous medications. New drugs for treatment of urinary tract infections are also reviewed.

Single Dose Medication to Create a Self Model Film

An example of videotaped "self modeling" which capitalizes in a unusual way on the effects of a single dose of medication is presented. A single dose of diazepam induced clearly observable one-time changes in a socially withdrawn 5-year-old boy. These behaviors were captured on videotape and subsequently replayed to the subject for succcessful therapeutic self-modeling. Multiple baseline data suggest that neither medication nor self modeling alone would have been sufficient for lasting changes in verbal behavior. This unusual combination of procedures requires further research into its application in other situations.