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Concept: Rhinitis medicamentosa

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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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Phenylephrine hydrochloride (PE HCl) is widely used for the treatment of nasal congestion, but efficacy at the 10-mg dose is not known for certain. The Food and Drug Administration has requested that sufficiently powered, multicenter, dose-ranging studies be conducted to assess the efficacy and safety of PE HCl.

Concepts: Rhinitis medicamentosa, Phenylephrine

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An unmet need exists for a safe, tolerable, effective treatment for moderate to severe persistent facial erythema in patients with rosacea. This pivotal phase 3, multicenter, double-blind study evaluated the efficacy and safety of topical oxymetazoline in patients with facial erythema associated with moderate to severe rosacea. Patients were randomly assigned to treatment with oxymetazoline hydrochloride cream 1.0% or vehicle applied once daily for 29 days, and were followed for 28 days posttreatment. The primary efficacy outcome was having at least a 2-grade decrease from baseline on both the Clinician Erythema Assessment (CEA) and the Subject Self-Assessment for rosacea facial redness (SSA) scales (composite success) at 3, 6, 9, and 12 hours postdose on day 29. Safety assessments included treatment-emergent adverse events (TEAEs) and posttreatment worsening of erythema (composite CEA/SSA increase of 1-grade severity from baseline; rebound effect). A total of 440 patients (mean age, 49.5 years; 78.9% females) were randomized (oxymetazoline, n=222; vehicle, n=218); most had moderate erythema. On day 29, significantly greater proportions of oxymetazoline recipients achieved the primary efficacy outcome at each time point (P less than 0.02) and overall (P less than 0.001) compared with vehicle recipients. The incidence of discontinuation due to TEAEs was low in both groups (oxymetazoline group, 1.8%; vehicle group, 0.5%). The most common TEAEs reported during the entire study period were application-site dermatitis, application-site erythema, and headache in the oxymetazoline group (1.4% each), and headache (0.9%) in the vehicle group. Following cessation of treatment, low proportions of patients experienced rebound effect (oxymetazoline group, 2.2%; vehicle group, 1.1%). Oxymetazoline applied to the face once daily for 29 days was effective, safe, and well tolerated in patients with moderate to severe persistent facial erythema of rosacea.

J Drugs Dermatol. 2018;17(1):97-105.

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Concepts: Pharmacology, Clinical trial, Effectiveness, Efficacy, Flushing, Erythema, Topical decongestant, Rhinitis medicamentosa

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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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Nasal blockage is the most bothersome symptom of acute rhinitis. Nasal decongestant sprays containing alpha-sympathomimetics, such as oxymetazoline and xylometazoline, have a rapid onset of action. However, this effect decreases with repeated application and, furthermore, the ciliary function of the nasal mucosa is practically paralyzed. Dexpanthenol promotes cell proliferation and protects the epithelium. Combining these two agents has demonstrated beneficial synergetic effects on the symptoms of acute rhinitis. In a post hoc analysis of a large-scale double-blind, active-controlled study including 152 patients, we could demonstrate that the benefit of added dexpanthenol appears as early as on the third day of the combined application of xylometazoline and dexpanthenol in terms of complete or near-to-complete freedom from symptoms. After 5 days, 47% of the patients were cured under the combined treatment compared with only 1% under xylometazoline monotherapy. These data show that the addition of dexpanthenol to an alpha-sympathomimetic nasal spray not only improves its tolerability but also further increases its effectiveness and leads to expedited cure.

Concepts: Disease, Medical terms, Symptoms, Symptom, Fatigue, Mucus, Nasal spray, Rhinitis medicamentosa

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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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To report 3 patients with corneal decompensation and anterior uveitis within 24 hours of cataract surgery from a single ambulatory surgery center using intracameral lidocaine HCl 1% and phenylephrine 2.5% inadvertently preserved with 10% benzalkonium chloride.

Concepts: Ophthalmology, Chlorides, Rhinitis medicamentosa

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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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To better understand the causes of the exacerbation of rhinitis medicamentosa (RM) induced by oxymetazoline (OMZ) or benzalkonium chloride (BKC), we examined the impact of pretreatment with OMZ or BKC on cultured human nasal epithelial cells. We also examined the effect of mometasone furoate (MF) on the cultured human nasal epithelial cells treated with OMZ or BKC.

Concepts: Protein, Asthma, Messenger RNA, Histamine, Histamine H1 receptor, Benzalkonium chloride, Histamine receptor, Rhinitis medicamentosa