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Concept: Decongestant

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INTRODUCTION: Systemic and topical nasal decongestants are widely used in otorhinolaryngology and general practice for the management of acute rhinosinusitis and as an adjuvant in certain forms of chronic rhinosinusitis. These products, very effective to rapidly improve nasal congestion, are sometimes available over the counter and can be the subject of misuse, which is difficult to control. The Société Française d'ORL has recently issued guidelines concerning the use of these decongestants in the doctor’s office and the operating room. MATERIALS AND METHODS: The review of the literature conducted by the task force studied in detail the concepts of “rebound congestion” and “rhinitis medicamentosa” often reported in a context of misuse, particularly of topical nasal decongestants. The clinical and histopathological consequences of prolonged and repeated use of nasal decongestants have been studied on animal models and healthy subjects. RESULTS: Discordant results have been obtained, as some authors reported a harmful effect of nasal decongestants on the nasal mucosa, while others did not identify any significant changes. No study has been able to distinguish between inflammatory lesions induced by chronic rhinosinusitis and lesions possibly related to the use of nasal decongestants. DISCUSSION: The task force explained the rebound congestion observed after stopping nasal decongestant treatment by return of the nasal congestion induced by rhinosinusitis and rejected the concept of rhinitis medicamentosa in the absence of scientific evidence from patients with rhinosinusitis. CONCLUSION: Nasal decongestants are recommended for the management of acute rhinosinusitis to reduce the consequences of often disabling nasal congestion. They are also recommended during rhinoscopic examination and for preparation of the nasal mucosa prior to endonasal surgery.

Concepts: Sinusitis, Topical, Mucus, Pseudoephedrine, Nasal congestion, Topical decongestant, Rhinitis medicamentosa, Decongestant

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Previous studies suggested that early pregnancy exposure to specific oral decongestants increases the risks of several birth defects. Using January 1993-January 2010 data from the Slone Epidemiology Center Birth Defects Study, we tested those hypotheses among 12,734 infants with malformations (cases) and 7,606 nonmalformed control infants in the United States and Canada. Adjusted odds ratios and 95% confidence intervals were estimated for specific birth defects, with controlling for potential confounders. Findings did not replicate several hypotheses but did support 3 previously reported associations: phenylephrine and endocardial cushion defect (odds ratio = 8.0; 95% confidence interval: 2.5, 25.3; 4 exposed cases), phenylpropanolamine and ear defects (odds ratio = 7.8; 95% confidence interval: 2.2, 27.2; 4 exposed cases), and phenylpropanolamine and pyloric stenosis (odds ratio = 3.2; 95% confidence interval: 1.1, 8.8; 6 exposed cases). Hypothesis-generating analyses involving multiple comparisons identified a small number of associations with oral and intranasal decongestants. Accumulating evidence supports associations between first-trimester use of specific oral and possibly intranasal decongestants and the risk of some infrequent specific birth defects.

Concepts: Statistics, Odds ratio, Interval finite element, Confidence interval, Statistical terminology, Odds, Nuisance parameter, Decongestant

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Phenylephrine hydrochloride (HCl) is a decongestant available in over-the-counter (OTC) medicines. Previously marketed prescription products contained phenylephrine tannate, an extended-release salt, which allowed dosing every 8-12 h. Given the regulatory history that cold medicines marketed before 1962 had limited supporting clinical data, and with widespread replacement of pseudoephedrine by phenylephrine in OTC products over the last ten years, the need for contemporary studies grew. This exploratory crossover study evaluated effects of salt form, acetaminophen, and food on phenylephrine pharmacokinetics and metabolites in healthy adults. Test treatments were 25 mg phenylephrine tannate (equivalent to 10 mg phenylephrine HCl) combined with 200 mg guaifenesin, fasted; 10 mg phenylephrine HCl combined with 650 mg acetaminophen, fasted; and 10 mg phenylephrine HCl, fed. The reference treatment was 10 mg phenylephrine HCl, fasted. Plasma phenylephrine pharmacokinetics and urine metabolites were determined. Although the tannate salt slowed phenylephrine absorption compared with the HCl salt, terminal concentrations were similar, suggesting that products containing the tannate salt should not be dosed less frequently than those containing the HCl salt. The premise that acetaminophen increases phenylephrine bioavailability by competition for presystemic sulfation was corroborated by increased phenylephrine sulfate in urine. Food delayed phenylephrine absorption, but not the total amount absorbed.

Concepts: Pharmacology, Over-the-counter drug, Pseudoephedrine, Rhinitis medicamentosa, Decongestant, Phenylephrine, Sudafed, Decongestants

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This study was designed to prospectively evaluate the role of nebulized hyaluronic acid (HA) administered for 10 days as treatment for patients with rhinitis medicamentosa (RM). RM is a pathological condition of the nasal mucosa induced by prolonged, excessive or improper use of topical decongestants. It is characterized by persistent nasal congestion that can lead the patient to increase the frequency of application and the quantity of the substance being applied, resulting in dependence on topical nasal decongestants. Twenty-five patients were treated with HA nebulized via Spray-sol twice a day for 10-days (T1) (HA Spray-sol treatment group). Subsequently, after 3 days of washout, patients were treated with physiological saline nebulized via Spray-sol twice a day for 10 days. (T2) (saline Spray-sol treatment group). The HA Spray-sol treatment group (tp) significantly improved visual analogue scale (VAS) scores (T0=6.25±1.64 vs T1=3.91±1.30; p less than 0.05), whereas there was no statistically significant difference in the saline Spray-sol treatment group (tp) (p>0.05), results confirmed by the anterior active rhinomanometry (AAR) data (HA Spray-sol tp T0=1.193±0.83 vs T1=0.44±0.25, p less than 0.05; saline Spray-sol tp (p>0.05). An improvement in the Global Rhinitis Score (GRS) was recorded in both groups (T0=15.37±5.16 vs T1=5.54±3.23, p less than 0.05; saline Spray-sol tp T0=15.37±5.16 vs T2=10. 7±5.43; p less than 0.05). Both groups showed a significant reduction in mucosal oedema and nasal secretions. Patients treated with HA Spray-sol reduced or even eliminated (11/25 patients) the use of topical decongestant within 10 days of treatment with HA. The results of this study suggest nebulized topical 9-mg sodium hyaluronate plays a pivotal role in the management of RM.

Concepts: Statistical significance, Topical, Mucus, Pseudoephedrine, Topical decongestant, Rhinitis medicamentosa, Decongestant, Oxymetazoline

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It is common practice to prepare the nasal mucosa with decongestant in children undergoing lacrimal surgery. Xylometazoline 0.05% (Otrivine) nasal spray is commonly used. It has been reported to cause cardiovascular side effects. In the absence of formal guidelines on the safety of the use of nasal decongestants in children, we reviewed our practice to answer the question: How safe is preoperative use of xylometazoline in children undergoing lacrimal surgery? To our knowledge, this is the first study to address the potential side effects of the use of xylometazoline preoperatively in children undergoing lacrimal surgery.

Concepts: Scientific method, Philosophy of science, Mucus, Pseudoephedrine, Topical decongestant, Rhinitis medicamentosa, Decongestant, Topical decongestants

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It is unclear. Pseudoephedrine causes an average increase of 1.2 mm Hg in systolic blood pressure (BP) in patients with controlled hypertension. However, the studies are not adequately powered to provide evidence about whether this rise in systolic BP is linked to patient-oriented outcomes (strength of recommendation: C, multiple randomized controlled trials supporting disease-oriented evidence). Significant variations in BP are defined differently among studies. In addition, we do not have data on chronic use of oral decongestants; the longest time on medication in these trials was 4 weeks.

Concepts: Myocardial infarction, Hypertension, Randomized controlled trial, Blood pressure, Clinical research, Orthostatic hypotension, Prehypertension, Decongestant

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We frequently recommend ipratropium nasal spray in our office, as it is an effective, non-addictive nasal decongestant.

Concepts: Nose, Topical decongestant, Rhinitis medicamentosa, Decongestant

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Ebastine (EBS) has been assayed in its laboratory-prepared co-formulated tablets with either pseudoephedrine hydrochloride (PSU) or phenylephrine hydrochloride (PHR) using isocratic reversed-phase chromatography. Separation was conducted using a 50 mm × 4.6 mm i.d., Chromolith(®) SpeedROD RP-18 end-capped column at ambient temperature. A mobile phase composed of water:acetonitrile in a ratio of 25:75 having a pH of 3.2, has been utilized at 1 mL/min with UV detection at 254 nm for both EBS and PSU and 274 nm for PHR which in turn increased the sensitivity of the proposed method significantly. Symmetric well-separated peaks resulted in a short chromatographic run; <5 min. The proposed method was subjected to detailed validation procedures and proved to be highly sensitive as shown from limit of quantification values which were 4.7, 39.4 and 10.2 μg/mL for EBS, PSU and PHR, respectively. The proposed method was used to analyze EBS in its laboratory-prepared co-formulated tablets; the obtained results were comparable to those resulting from the reference method.

Concepts: Chromatography, High performance liquid chromatography, Analytical chemistry, Pseudoephedrine, Rhinitis medicamentosa, Decongestant, Phenylephrine, Sudafed

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Phenylephrine HCl 10 mg has been used as a nasal decongestant for over 50 years, yet only limited pharmacokinetic and metabolic data are available. The purpose of this study was to evaluate single-dose pharmacokinetics and safety of phenylephrine HCl 10, 20, and 30 mg and to assess cardiovascular tolerability compared with baseline and placebo in healthy volunteers.

Concepts: Pharmacology, Pseudoephedrine, Rhinitis medicamentosa, Decongestant, Phenylephrine

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Oxymetazoline is an over-the-counter nasal decongestant with potent alpha agonist properties. In overdoses as small as 1-2 mL, toxicity can be seen including bradycardia and respiratory depression. We demonstrated that inverting the container increased the volume delivered 20- to 30-fold compared with holding it upright in an in vitro model.

Concepts: Poison, Mucus, Nasal cavity, Pseudoephedrine, Topical decongestant, Decongestant, Oxymetazoline