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At least 19 recordsLinked to original sources
PubMed2002

A comparative study of the side effects between pseudoephedrine in Loratadine plus Pseudoephedrine Sulfate Repetabs Tables and loratadine + pseudoephedrine tablet in treatment of allergic rhinitis in Thai patients.

The objective of the study was to evaluate the adverse reactions of Loratadine plus Pseudoephedrine Sulfate Repetabs Tables (LTD+PSE Repetabs) (Loratadine 5 mg + Pseudoephedrine 120 mg) twice daily with that of loratadine (5 mg) twice daily and pseudoephedrine (60 mg) quarter daily in the treatment of patients with allergic rhinitis. The study was designed as an investigator-blind, parallel group study. In this study, 56 patients were equally separated into 2 groups and treated for 14 days with either LTD+PSE Repetabs or loratadine + pseudoephedrine tablet. Both groups were comparable in age, gender, weight; baseline systolic blood pressure, diastolic blood pressure and pulse rate. The change of systolic blood pressure, diastolic blood pressure, and pulse rate did not reach clinical significance throughout the study period. There was no significant difference in occurrences of insomnia, palpitation, mouth dryness and anxiety. However, the incidence of patients with tremor at day 14 in the loratadine + pseudoephedrine tablet group was significantly higher than the LTD+PSE Repetabs group (39% vs 10.7%, p-value = 0.03). Furthermore, one patient in the loratadine + pseudoephedrine tablet group had to discontinue medication at day 7 due to insomnia. In conclusion, LTD+PSE Repetabs is well tolerated and has fewer adverse effects when compared to the loratadine + pseudoephedrine tablet.

Adolescent↗
PubMed2005

[Simultaneous determination of pseudoephedrine hydrochloride and dextromethorphan hydrobromide in composite pseudoephedrine hydrochloride dry suspension by HPLC].

A simple and reliable reversed-phase high performance liquid chromatographic method (HPLC) for the routine analysis of pseudoephedrine hydrochloride and dextromethorphan hydrobromide in composite pseudoephedrine hydrochloride dry suspension has been established. HPLC determination for the drug was performed in a Lichrospher C6H6 column and detected at 220 nm. Acetonitrile-H2O-H3PO4 (50:50:0.1, v/v, pH 2.5, containing 1 g/L sodium dodecyl sulfate) was used as the mobile phase and the flow rate was 1.2 mL/min. The method was proved to be linear in the ranges of 1.03-206 mg/L and 5-200 mg/L for dextromethorphan hydrobromide and pseudoephedrine hydrochloride, respectively. The relative standard deviations of intra-assay (n = 7) and inter-assay (n = 5) were 1.0% and 1.5% for pseudoephedrine hydrochloride analysis and 1.8% and 2.2% for dextromethorphan hydrobromide analysis. The recoveries of pseudoephedrine hydrochloride and dextromethorphan hydrobromide were 95.7%-98.7% and 100.0%-101.8%, respectively. The method has been successfully applied to the simultaneous determination of pseudoephedrine hydrochloride and dextromethorphan hydrobromide in composite pseudoephedrine hydrochloride dry suspension.

Bronchodilator Agents↗
PubMedDate not supplied

[Comparative assessment of astemizole-pseudoephedrine and loratadine-pseudoephedrine in children with allergic rhinitis].

The purpose of the study was to evaluate the effectiveness and safety of astemizole-pseudoephedrine solution compared to loratadine-pseudoephedrine syrup in the treatment of allergic rhinitis. Fifty children (34 boys and 16 girls) ages between 2 and 7 years were enrolled and randomly assigned to each group. Patients were evaluated before treatment and on the third and seventh days of therapy. Children treated with astemizole-pseudoephedrine had better results with an average effectiveness of 84% compared to 64% for children treated with loratadine-pseudoephedrine. Differences were significant for eye symptoms by medical evaluation and for blocked nose, sneezing and itchy nose according to the patients diary. Both treatment groups started action within 30 minutes after drug intake. 4 hours later, 38% of the patients in the astemizole-pseudoephedrine group and 16% in the loratadine-pseudoephedrine groups had experienced improvement. One patient in the former and three in the latter showed adverse effects.

Anti-Allergic Agents↗
PubMed1982

Comparative bioavailability of d-pseudoephedrine from a conventional d-pseudoephedrine sulfate tablet and from a repeat action tablet.

The bioavailability of a single dose of d-pseudoephedrine sulfate administered to male volunteers in repeat action tablet form (60 mg d-pseudoephedrine sulfate in the coat and 60 mg d-pseudoephedrine sulfate in the core) was compared with the bioavailability of an equivalent quantity of the drug given as two 60 mg conventional tablets, one given at 0 hour and the second 6 hours later. There was no significant difference (P less than 0.10) between the conventional tablets and the repeat action tablet formulation in area under the plasma concentration-time curve and the maximum plasma concentration of d-pseudoephedrine. Based on the data, we conclude that the repeat action tablet formulation and the conventional tablet are bioequivalent.

Adolescent↗
PubMedDate not supplied

A comparative tolerance study of terfenadine-pseudoephedrine combination tablets and pseudoephedrine tablets in patients with allergic or vasomotor rhinitis.

In this multicentre, double-blind, randomized, parallel group study, 315 patients with allergic or vasomotor rhinitis were treated on a twice daily dosing schedule with either a 60 mg terfenadine-120 mg pseudoephedrine hydrochloride combination or 120 mg pseudoephedrine hydrochloride (extended release) for 2 weeks. No clinically significant differences between the two groups were noted in body weight, temperature, respiration rate or blood pressure following the treatment period. An increase in mean heart rate of approximately 5 beats/min from entry to the final clinic visit was noted in both treatment groups. No clinically significant changes were noted in either treatment group when pre- and post-treatment electrocardiograms were compared. There were also no clinically significant alterations in laboratory values, which included serum chemistry, haematology and urinalysis, within or between either group. The adverse events profiles for both groups were similar. The most frequent adverse event was insomnia, in 40 (25.3%) patients given the terfenadine-pseudoephedrine combination and in 42 (26.8%) of those given pseudoephedrine. No unusual or unexpected adverse events were reported.

Adult↗
PubMedDate not supplied

A randomized controlled trial of cetirizine plus pseudoephedrine versus loratadine plus pseudoephedrine for perennial allergic rhinitis.

The purpose of this study was to compare the safety and efficacy of cetirizine plus pseudoephedrine (C+P) with loratadine plus pseudoephedrine (L+P) in the treatment of perennial allergic rhinitis. This was a double blind, randomized, parallel trial with an active control. Subjects aged 12 to 70 years with perennial allergic rhinitis for at least 2 years were enrolled and randomized to receive either of the active study medications plus a placebo resembling the other, twice daily for 4 weeks. Nasal total symptom scale (NTSS) including sneezing, rhinorrhea, nasal itching and nasal stuffiness is evaluated by subjects daily and at baseline, 2 weeks, and 4 weeks by the investigator as efficacy measurement. A total of 51 eligible patients were enrolled and 45 patients completed the treatment course. Both groups had significant reductions in NTSS after 4 weeks of treatment as assessed by the subjects, but there was no significant difference between the two groups (mean +/- SD) reduction of 4.25 +/- 2.45 with C+P vs. 3.52 +/- 2.41 with L+P, p = 0.215. As assessed by the investigator, sneezing was significantly better at 2 weeks (-1.13 vs. -0.52, p = 0.028) and nasal congestion at 4 weeks (-1.71 vs. -1.19, p = 0.031) in subjects treated with C+P compared to those treated with L+P. There were 37 treatment-related adverse events (5 in 4 subjects in the C+P group and 32 in 16 subjects in the L+P group). It was concluded that both cetirizine plus pseudoephedrine and loratadine plus pseudoephedrine are efficacious for perennial allergic rhinitis in Taiwanese subjects. Relief of sneezing and nasal congestion may be marginally better with the cetirizine preparation, which also seemed to be slightly better tolerated, although the incidence of side effects did not differ significantly.

Adolescent↗
PubMed2003

Efficacy and safety of clemastine-pseudoephedrine-acetaminophen versus pseudoephedrine-acetaminophen in the treatment of seasonal allergic rhinitis in a 1-day, placebo-controlled park study.

BACKGROUND: Allergic rhinitis afflicts more than 40 million people in the United States and is a leading cause of reduced productivity at work and in school. Patients with allergic rhinitis have a wide range of symptoms that are often treated with oral combination products that contain antihistamines, decongestants, and analgesics. OBJECTIVE: To evaluate the onset of action and the extent of efficacy and safety of a combination (CPA) of clemastine (0.68 mg), pseudoephedrine (60 mg), and acetaminophen (1,000 mg) versus a combination (PA) of pseudoephedrine and acetaminophen versus placebo in the treatment of seasonal allergic rhinitis (SAR). The primary goal was to evaluate the benefit of adding clemastine to the PA combination product to treat the symptoms of SAR. METHOD: A 1-day, multicenter, double-blind, double-dummy, randomized, parallel-group park study was organized, and medication was given at 9:00 AM and 3:00 PM. RESULTS: A total of 298 subjects participated at two outdoor facilities. The primary efficacy outcome was the major symptom complex score averaged over the period of 2 to 5 hours after each dose. Mean absolute and percentage reduction in major symptom complex averaged over the period of 2 to 5 hours in the CPA group was significantly superior to those of either the PA (P < 0.01) or placebo (P < 0.03) groups. Somnolence, fatigue, and nausea were the most common volunteered adverse events; only somnolence was significantly greater after CPA than after either PA or placebo. CONCLUSIONS: Treatment with CPA was safe and highly effective in reducing symptoms associated with SAR. It was more effective than either PA or placebo over most of the postdose observation period.

Acetaminophen↗
PubMedDate not supplied

[Assessment of the clinical efficacy and safety of epinastine plus pseudoephedrine vs loratadine plus pseudoephedrine in perennial allergic rhinitis].

BACKGROUND: Several drugs for the treatment of perennial allergic rhinitis and its symptoms have been investigated since some years ago. These drugs are: steroidal-type immunoregulators, immunotherapy and antihistamines. Because of first generation of the last ones originated several side effects, pharmacological research was oriented to the search of formulas with the same of higher efficacy, but with fewer effects on central nervous system. OBJECTIVE: To compare the efficacy and safety of epinastine 10 mg plus pseudoephedrine 120 mg vs loratadine 5 mg plus pseudoephedrine 120 mg, twice a day, in the treatment of perennial allergic rhinitis. MATERIAL AND METHODS: A comparative, random, open, prospective, longitudinal and multicenter study was made in 62 patients with an average age of 26.17 +/- 9.75 years (13-56 years) with diagnosis of perennial allergic rhinitis, who attended to external consultation of the different departments of allergy of the participant institutions. All patients were submitted to: complete clinical history, physical exploration, measurement of vital signs, nasal exploration, qualification of allergic symptoms and record of daily symptoms. Moreover, washout during a week and pharmacological treatment was given during two weeks. Symptoms referred by patient and findings of physical exploration during the different visits, as well as rhinoscopic findings, were assessed by a scale of five parameters of rhinitis. Tolerance grade of drugs was assessed based on frequency and severity of side effects. RESULTS: According to the basal clinical assessment symptoms qualification of patients of groups of epinastine and loratadine was of 9.12 +/- 2.78 and 7.90 +/- 2.7, respectively. Seven side effects appeared: three cases of somnolence, one of sickness and one of anxiety in patients of group of loratadine and one case of somnolence and one of dysmenorrhea in the subjects of group of epinestine. Although it did not have statistically significant difference, it is clinically important for patients. Frequency of side effects was higher in the loratadine group. CONCLUSION: Both drugs are efficient for the treatment of perennial allergic rhinitis.

Adolescent↗
PubMedDate not supplied

[Serous otitis media. Comparative study of carbinoxamine- pseudoephedrine vs astemizole-pseudoephedrine].

They were studied 48 children of 3 to 8 years old, of two sex (30 male and 18 female), that attended the external service of otolaryngology of the Hospital of the ISSSTE of Nuevo Laredo, Tamaulipas (Mexico) and the private practice of the Allergy Clinic and Otolaringol in Nuevo Laredo, Tamaulipas, of the month of November of 1995 to April of 1996. Some of the side effects observed in the patients treated in the group A (carbinoxamine-P) were: mild sedation and in some instances hyperexcitability and irritability. However, it was not necessary to discontinue the medication or to modify the dose. In the group B (astemizole-P) was observed only excitement and irritability in some instances by hypersensitivity to the pseudoephedrine. It is very important to consider that the adequate and timely treatment in a patient with otitis serous media will permit to avoid sequels that they can cause, in the long run, a meaningful impact in the language and intellectual development of the child.

Astemizole↗
PubMedDate not supplied

Effect of organic cations on the renal tubular secretion of pseudoephedrine in the rat.

1. Pseudoephedrine is a weak organic base that undergoes renal tubular secretion. The aim of the present study was to assess whether two other commonly used weak organic bases (cimetidine and morphine) inhibit the renal tubular secretion of pseudoephedrine in the rat isolated perfused kidney. 2. A total of 12 perfusions were performed with four perfusions in each of three treatment groups. In the control group, pseudoephedrine was administered as a bolus dose of [14C]-pseudoephedrine and unlabelled pseudoephedrine to achieve an initial perfusate concentration of 0.4 microg/mL. For the treatment groups, pseudoephedrine was administered as above and cimetidine or morphine was added to the perfusion medium in increasing concentrations of 0.5-12.5 and 0.2-5.0 microg/mL, respectively. 3. The mean (+/-SD) fraction unbound of pseudoephedrine alone in perfusate was 0.866+/-0.014 and was not different (P> 0.05) in the presence of cimetidine or morphine. 4. In control experiments, the renal excretory clearance (CLR) of pseudoephedrine was three-fold greater than glomerular filtration rate (GFR), yielding a ratio consistently greater than unity, which indicates extensive net tubular secretion of pseudoephedrine. The CLR and total clearance of pseudoephedrine were similar, suggesting an absence of renal metabolism of pseudoephedrine. 5. The CLR/GFR ratio for pseudoephedrine was not affected by morphine, but was significantly reduced (P < 0.05) in the presence of cimetidine. 6. The results indicate that cimetidine inhibits the renal tubular secretion of pseudoephedrine.

Adrenergic Agents↗
PubMed1981

Stereospecific radioimmunoassays for d-pseudoephedrine in human plasma and their application to bioequivalency studies.

Antiserum to d-pseudoephedrine was raised in New Zealand White rabbits in response to immunization with a conjugate of bovine serum albumin and d-pseudoephedrine-N-3-propionic acid. The hapten was prepared by reaction of methyl acrylate with d-pseudoephedrine, followed by ester hydrolysis. Sodium boro[3H]hydride reduction of dl-ephedrine gave [alpha-3H]-dl-ephedrine, and a Welsh rearrangement with acetic anhydride followed by deacetylation gave [alpha-3H]-dl-pseudoephedrine, which was used as a radioligand in radioimmunoassay procedures for direct plasma analyses. Three sensitive radioimmunoassay procedures were developed, two using [3H]pseudoephedrine as the radioligand and either adsorption on coated charcoal or polyethylene glycol precipitation for separation of antibody-bound from free radioligand. The third method used an [125I]tyrosine methyl ester analog of pseudoephedrine and charcoal separation, preceded by extraction and derivatization of pseudoephedrine with methyl acrylate. All three assays could detect less than or equal to 2.5 ng of pseudoephedrine/ml. The antiserum was stereospecific, showing low cross-reactivities with l-pseudoephedrine and d- and l-ephedrines. d-Norpseudoephedrine and some other related compounds also had low cross-reactivity in these radioimmunoassay procedures. Excellent agreement was found between pseudoephedrine concentrations in human plasma determined by radioimmunoassay and by a standard GLC method. The utility of radioimmunoassay was illustrated by application of one of these procedures to an assessment of the bioequivalence of immediate- and sustained-release pseudoephedrine formulations in normal volunteers. A sustained-release preparation containing 120 mg of pseudoephedrine hydrochloride given every 12 hr was shown by AUC comparisons to be bioequivalent to an immediate-release tablet (containing 60 mg of pseudoephedrine hydrochloride) given every 6 hr.

Adult↗
PubMed2003

Pseudoephedrine: effects on milk production in women and estimation of infant exposure via breastmilk.

AIMS: To assess the effects of pseudoephedrine on breast blood flow, temperature and milk production, and to estimate the likely infant dose during breastfeeding. METHODS: Eight lactating women (mean age 35 years and weight 69 kg) participated in a single-blind randomized crossover study of 60 mg pseudoephedrine hydrochloride vs placebo. Breast blood flow and surface temperature were measured from 0 to 4 h following the dose, and change in plasma prolactin was measured as the difference between predose and 1 h postdose concentrations. Milk production was measured for 24 h following placebo and pseudoephedrine. Infant dose of pseudoephedrine for a 60-mg dose administered four times daily to the mother was quantified as the product of average steady-state drug concentration in milk and an estimated milk production rate of 0.15 l x kg(-1) x day(-1) and expressed relative to the maternal weight-adjusted dose. RESULTS: There were no physiologically significant changes in breast blood flow or temperature between the placebo and pseudoephedrine periods. The mean change in plasma prolactin was slightly (13.5%), but not significantly lower (t = 1.245, P = 0.253) after pseudoephedrine (1775 mU x l(-1)) compared with placebo (2014 mU x l(-1)). However, the mean milk volume was reduced by 24% from 784 ml x day(-1) in the placebo period to 623 ml x day(-1) in the pseudoephedrine period (difference between means 161 ml x day(-1) (95% CI: 63, 259 ml x day(-1)); t = 3.9, P = 0.006). Assuming maternal intake of 60 mg pseudoephedrine hydrochloride four times daily, the estimated infant dose of pseudoephedrine was 4.3% (95% CI, 3.2, 5.4%) of the weight-adjusted maternal dose. CONCLUSIONS: A single dose of pseudoephedrine significantly reduced milk production. This effect was not attributable to changes in blood flow, but depression of prolactin secretion may be a contributing factor. At the maximum recommended pseudoephedrine doses, the calculated infant dose delivered via milk was < 10% of the maternal dose, and is unlikely to affect the infant adversely. The ability of pseudoephedrine to suppress lactation suggests a novel use for the drug.

Adrenergic alpha-Agonists↗
PubMed2005

Efficacy and safety of an extended-release formulation of desloratadine and pseudoephedrine vs the individual components in the treatment of seasonal allergic rhinitis.

BACKGROUND: Antihistamine-decongestant combination products generally provide more benefit than individual components for adequately treating patients who have seasonal allergic rhinitis (SAR) with moderate-to-severe nasal congestion. OBJECTIVE: To compare the effectiveness and safety of a 24-hour, extended-release formulation of desloratadine and pseudoephedrine with the individual components in patients who have SAR with moderate-to-severe nasal congestion. METHODS: Patients with SAR and significant nasal congestion were enrolled in a multicenter, randomized, double-blind, double-dummy study. Patients were randomly assigned for 2 weeks to once-daily treatment with desloratadine-pseudoephedrine, 5/240-mg tablets; desloratadine, 5 mg; or pseudoephedrine, 240 mg. Primary efficacy variables for the antihistamine and decongestant components of desloratadine-pseudoephedrine were morning and evening reflective total symptom score (TSS), excluding nasal congestion, and morning and evening reflective nasal congestion score during the 2-week treatment period, respectively. Secondary variables included morning instantaneous (end-of-interval) TSS (excluding congestion), nasal congestion score, reflective morning and evening individual symptom scores, overall condition of SAR, and therapeutic response. RESULTS: A total of 1121 patients were enrolled in the study, and 1047 patients completed the 2-week study. Desloratadine-pseudoephedrine was significantly more effective than desloratadine or pseudoephedrine monotherapy in reducing morning and evening reflective TSS (excluding nasal congestion) during the entire treatment period. Desloratadine-pseudoephedrine also was significantly more effective in reducing the morning and evening reflective nasal congestion score compared with desloratadine or pseudoephedrine monotherapy. Significant differences were seen between the desloratadine-pseudoephedrine and monotherapy groups for changes in morning instantaneous TSS (excluding nasal congestion) and nasal congestion scores. No unusual or unexpected adverse events were reported. CONCLUSION: Desloratadine-pseudoephedrine, 5/240-mg once-daily tablets, provided additional benefit over desloratadine, 5 mg, or sustained-release pseudoephedrine, 240 mg, monotherapy in the treatment of patients with SAR and moderate-to-severe nasal congestion.

Adolescent↗
PubMedDate not supplied

Efficacy and safety of single and multiple doses of pseudoephedrine in the treatment of nasal congestion associated with common cold.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Administration, Oral↗
PubMed2006

Pseudoephedrine enhances performance in 1500-m runners.

UNLABELLED: Pseudoephedrine is an over-the-counter drug to relieve nasal and sinus congestion. Although it has been suggested that pseudoephedrine could be a stimulant and ergogenic aid, pseudoephedrine was recently removed from the banned substance list by the International Olympic Committee and placed on the monitoring program (from January 2004). It was felt that evidence was lacking for an ergogenic effect, although few studies have investigated the effects of pseudoephedrine on exercise performance. This study, therefore, aimed to investigate the effects of pseudoephedrine on 1500-m running performance. METHODS: In a double-blind, randomized crossover design, seven male athletes completed two 1500-m running trials on an outdoor track after having completed a familiarization trial. All trials were 7 d apart. After a 12-h overnight fast, subjects reported to the laboratory and received a standardized breakfast (energy asymptotically equal to 500 kcal 50% CHO). Subjects were given either 2.5 mg.kg(-1) bw pseudoephedrine or 2.5 mg.kg(-1) bw maltodextrins (placebo) in gelatin capsules 70 min before the start of the warm-up, which started 20 min before they ran 1500 m all-out. Pre- and postexercise blood samples were collected and analyzed for lactate and glucose concentrations, partial pressure of oxygen (PO2) and carbon dioxide (PCO2), and percent oxygen saturation. RESULTS: Pseudoephedrine significantly decreased time to completion of 1500-m time trials in the present study by 2.1% (from 279.65 +/- 4.36 s with placebo to 273.86 +/- 4.36 s with pseudoephedrine) with no reported side effects. No changes in the measured blood parameters were found, suggesting a central effect of pseudoephedrine rather than a metabolic effect. CONCLUSION: The finding was that 2.5 mg.kg(-1) bw pseudoephedrine ingested 90 min preexercise improves 1500-m running performance.

Administration, Oral↗
PubMed2000

The psychometric and cardiac effects of pseudoephedrine in the hyperbaric environment.

STUDY OBJECTIVES: To examine the psychometric and cardiac effects of pseudoephedrine at 1 and 3 atmospheres (atm) of pressure (0 and 66 feet of sea water, respectively), and to make recommendations about the agent's safety in the diving environment. DESIGN: Double-blind, placebo-controlled, crossover study. SETTING: Monoplace hyperbaric chamber of a university hospital. SUBJECTS: Thirty active divers (mean age 38 yrs). INTERVENTION: A bank of seven tests was used to assess cognitive function during four different simulated dive combinations: placebo-1 atm, placebo3 atm, pseudoephedrine-1 atm, and pseudoephedrine-3 atm. MEASUREMENTS AND MAIN RESULTS: Heart rate and cardiac rhythm were recorded during all dives. Repeated-measures analysis of variance was used to analyze the effects of pseudoephedrine, depth, and drug-depth interaction. No significant, independent effects of pseudoephedrine were seen on any of the seven psychometric test scores (p>0.05), although the drug tended to increase anxiety scores (p=0.092). Depth resulted in a significant increase in anxiety scores (p=0.021) and a significant decrease in verbal fluency test scores (p=0.041); it had no significant effects on the other five psychometric tests (p>0.05). Pseudoephedrine caused a significant increase (p=0.036) in mean heart rate, and depth caused a significant decrease (p=0.013). Neither pseudoephedrine nor depth affected cardiac rhythm. CONCLUSION: Pseudoephedrine does not cause significant alterations in psychometric performance at 3 atm of pressure that might increase the risk of diving. Depth causes significant adverse effects on anxiety levels and semantic memory at 3 atm. Pseudoephedrine and depth have significant but opposite effects on heart rate; although, these effects are unlikely to be clinically significant during diving. It is unlikely that pseudoephedrine adds significant risk to the diver.

Adult↗
PubMed1999

Pseudoephedrine and air travel-associated ear pain in children.

BACKGROUND: Young children often appear bothered by ear pain during ascent and descent while traveling on commercial airplanes. While pseudoephedrine hydrochloride is effective in decreasing the risk for earache in adults with recurrent air travel-associated ear pain, such use in children has not been studied. OBJECTIVE: To assess the efficacy and side effects of prophylactic pseudoephedrine in children traveling by air. DESIGN: A placebo-controlled, double-blind clinical trial. SUBJECTS AND METHODS: Children aged 6 months to 6 years were included in this study. Pseudoephedrine hydrochloride (1 mg/kg body weight) or placebo was administered 30 to 60 minutes prior to departure on commercial air flights. Caregivers noted historical details and the degree of apparent ear pain, drowsiness, and excitability with ascent and descent. RESULTS: Ninety-one flights involving 50 children were studied, with ear pain being reported in 13 (14%) of flights. Ear pain was not associated with a history of air travel-associated ear pain, recent ear infection, or recent upper airway symptoms. Pseudoephedrine use was not associated with a decrease in ear pain during either ascent (4% with pseudoephedrine vs 5% with placebo; P approximately 1.00) or descent (12% with pseudoephedrine vs. 13% with placebo; P approximately 1.00). Pseudoephedrine use was, however, linked to drowsiness at takeoff (60% with pseudoephedrine vs. 27% with placebo; P = .003) but not at landing (P = .39). Treatment was not associated with excitability at takeoff (P = .09) or landing (P approximately 1.00). CONCLUSIONS: Ear pain is not uncommon in children traveling by commercial aircraft. The predeparture use of pseudoephedrine does not decrease the risk for in-flight ear pain in children but is associated with drowsiness.

Aircraft↗