Xylometazoline Nasal Spray Research Articles

The importance of real-world evidence (RWE) using the example of a diclofenac pain relief gel and a xylometazoline nasal spray

Real-world evidence (RWE) studies are gaining increasing importance in medical research because they investigate drug therapy use under everyday conditions. Two recent RWE studies in the field of self-medication exemplify the added value that this methodology offers for the evaluation of medicinal products.

The importance of real-world evidence (RWE) using the example of a diclofenac pain relief gel and a xylometazoline nasal spray

Real-World-Evidence(RWE)-Studien gewinnen in der medizinischen Forschung immer mehr an Bedeutung, da sie den Einsatz einer medikamentösen Therapie unter Alltagsbedingungen untersuchen. Zwei aktuelle RWE-Studien im Bereich der Selbstmedikation zeigen beispielhaft, welchen Mehrwert diese Methodik für die Bewertung von Arzneimitteln liefern kann.

Efficacy and Safety of Xylometazoline Based Nasal Sprays with and Without Lysozyme in The Treatment of Acute Nasopharyngitis

Background: Acute nasopharyngitis is a common condition usually accompanied by nasal congestion. The aim of this study was to compare efficacy and safety of the spray containing xylometazoline and lysozyme with spray containing only xylometazoline in the treatment of acute nasopharyngitis.Methods: Prospective, comparative, post-marketing study was performed on subjects with acute nasopharyngitisdivided into xylometazoline+lysozyme or xylometazoline nasal spray groups. Data collection was performed at the baseline before and 30 minutes after the therapy application and seven days after baseline.Main findings: Out of 173 included subjects, 59 were in the xylometazoline+lysozyme and 114 in the xylometazoline group. In both groups nasal patency was significantly improved 30 minutes after the therapy application (p<0.001). In the xylometazoline+lysozyme group all subjects had nasal decongestion within 20 minutes and this was significantly shorter (p=0.037) compared to xylometazoline group where 16 subjects (14%) needed 20 to 120 minutes for nasal decongestion. All adverse events were mild and there was no significant difference in the number of adverse events between the groups.Principal conclusions: Nasal sprays containing xylometazoline with or without lysozyme were effective and safe in the treatment of acute nasopharyngitis. Nasal spray containing xylometazoline with lysozyme showed a faster effect with significantly shorter time to nose decongestion. All recorded adverse events were mild and there was no difference between the groups in the number of recorded adverse events. Key words: nasopharyngitis, nasal obstruction, lysozyme, xylometazoline,nasal sprays

Use of xylometazoline nasal spray for haemorrhoids risky in pregnancy?

Use of xylometazoline nasal spray for haemorrhoids risky in pregnancy?

Observational study investigating Ectoin\xae Rhinitis Nasal Spray as natural treatment option of acute rhinosinusitis compared to treatment with Xylometazoline

IntroductionSymptomatic relief of acute rhinosinusitis is commonly achieved with nasal decongestants. The current observational study investigated the efficacy and safety of treatment of acute rhinosinusitis with Ectoin® Rhinitis Spray compared to or in combination with Xylometazoline-containing decongesting nasal spray.MethodsPatients with acute rhinosinusitis applied either Ectoin® Rhinitis Spray, Xylometazoline nasal spray or a combination of both products. Rhinosinusitis symptoms were assessed, and nasal oedema and endonasal redness were determined by rhinoscopy. Patient diaries based on the validated SNOT (Sino Nasal Outcome Test) questionnaire evaluated rhinosinusitis parameters over time and influences of the disease on quality of life. Following treatment, investigators and patients judged the efficacy and tolerability.ResultsEctoin® Rhinitis Spray diminished common rhinosinusitis symptoms such as nasal obstruction, nasal secretion, facial pain/headache, and smell/taste impairment. Upon treatment over 7 days, rhinosinusitis sum scores decreased statistically significantly (p < 0.001) by − 64.25%, which was comparable to that achieved with Xylometazoline-containing decongesting nasal spray (− 67.60%). No side effects were observed during treatment with Ectoin® Rhinitis Spray, whereas treatment with Xylometazoline-containing nasal spray resulted in nasal mucosa dryness. Concomitant treatment with both products diminished the development of nasal dryness and required fewer applications of Xylometazoline-containing nasal spray.ConclusionEctoin® Rhinitis Spray is an effective, natural treatment option for acute rhinosinusitis, which may be used as monotherapy or as add-on treatment with a Xylometazoline-containing nasal spray. The concomitant use of Ectoin® Rhinitis Spray might reduce the needed dose of decongestant nasal spray and counteract bothersome side effects such as dry nasal mucosa.Trial registrationThe current study was registered in the ClinicalTrials.gov database under the identifier: NCT03693976 (date of registration: Oct 3, 2018).

Ischemic Stroke Associated with Chronic Xylometazoline Nasal Spray Misuse

Ischemic Stroke Associated with Chronic Xylometazoline Nasal Spray Misuse

Sympathomimetic drug (xylometazoline) abuse and acute ischemic stroke.

Xylometazoline is a nasal decongestant which stimulates the alpha adrenergic receptors in arterioles of nasal mucosa and produces vasoconstriction. It has a potential to cause stroke due to its sympathomimetic activity. A 54 year male, with history of chronic xylometazoline use presented with acute onset tingling and numbness in left upper limb and lower limb, giddiness in form of imbalance while walking and swaying towards the left side, vertigo and dysphagia, dysarthria, dysphonia. On examination he had absence of pain sensation on left side of the face, decreased power on left upper limb and lower limb with left sided cerebellar signs and truncal ataxia, nystagmus and Horner’ syndrome. MRI brain suggestive of acute left lateral medullary infarct with left vertebral artery stenosis. Hemogram, liver, renal function, 2D ECHO, ECG and Neck vessel angiography were all normal. On revisiting the history, he had a habit of using xylometazoline nasal spray daily for three-four times since last 5-6years which he started to use after he was prescribed it once for an upper respiratory tract infection. So possibility of Xylometazoline associated cerebral vasoconstriction leading to stroke was considered. Dual antiplatelets and statins were prescribed and he was advised to stop xylometazoline. A review of literature shows 5 cases of ischemic stroke reported in association with xylometazoline use out of which 2 were in the posterior circulation territory and 3 were in the middle cerebral artery territory. Xylometazoline abuse can lead to stroke and its over-the-counter availability should be curtailed.

PEDIATRIC NASAL SPRAY SOLUTION: FACTORIAL DESIGN DEVELOPMENT AND EVALUATION

The work was aimed to develope the meter dose formulation of pediatric xylometazoline nasal spray formulation. The 32 factorial design was utilized for development of the pediatric formulation. The independent factors were sodium cholate (X1) and Polyethyleneglycol 400 concentration (X2). The optimized formulation composition consisted of 0.105 g sodium cholate and 1.35 ml polyethyleneglycol 400. The formulation was evaluated for solution parameters like drug content, pH, viscosity, % diffusion, sterility and spray evaluation parameters like spray content uniformity, pump delivery, spray pattern, and weight loss. The results for spray content uniformity were in the range of 95-102 %, while pH in the range of 6.5 ± 0.3. The ovality of spray was 1.118, while perimeter and area of spray pattern were found to be 57.42 mm and 258.8 mm2 respectively for optimized formulation. The least value for repriming was 97.6 % while the extreme value was 102.2 % indicating one actuation was satisfactory for repriming. The results for droplet size test were obtained in the range of 51.63 to 58.90 µm. The formulation along with its container closure was evaluated for its stability up to 12 months at long term conditions. The formulated batch PFE showed better performance for in-vitro drug release with marketed product thus providing another option for treatment of nasal congestion.

Xylometazoline nasal spray solution: novel composition used for treatment of nasal congestion

The preliminary objective of the work is to develop the meter dose formulation of xylometazoline hydrochloride for enhanced effectiveness for nasal decongestion The factorial design was utilized for development of the formulation where sodium cholate X and Polyethyleneglycol concentration X were independent factors The optimized formulation composition consisted of g sodium cholate and ml Polyethyleneglycol independent varibales The formulation was evaluated for solution parameters like assay pH viscosity diffusion sterility content uniformity pump delivery spray pattern and weight loss The percentage diffusion and viscosity was observed plusmn and plusmn centipoise respectively The meter dose nasal formulation provides alternative option for treatment of nasal decongestion which showed comparable results to marketed formulation

A comparative study between amoxicillin + clavulanic acid and levofloxacin in the management of acute maxillary sinusitis at RIMS, Ranchi

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Acute rhinosinusitis is an acute viral or bacterial in which there is inflammation of the mucosa of the nose and paranasal sinuses. The aim of study was to compare the efficacy of oral amoxicillin-clavulanate with levofloxacin in the management of acute maxillary sinusitis.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; The present prospective study was conducted in the Department of ENT, Rajendra Institute of Medical Sciences, Ranchi during a period of 8 months i.e. from July 2016 to June 2017. In Group I patients 1 gm of amox­icillin-clavulanate was given two times a day and in Group II, 500 mg of Levo­floxicin was given once a day for a period of 10 days. Patient’s complete demographic details were recorded including name, age and gender. Xylometazoline nasal spray and steam inhalations were given to all the patients. &lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; The mean age of the subjects was 36.43±6.43 years. In both the groups, majority of the subjects were between 36-45 years of age. There were 34.7% (52) in Group I and 38.7% (n=58) in Group II who belonged to this age group. Least number of subjects was those aged more than 48 years. There were 88% subjects (n=132) in group I and 86% (n=129) subjects in Group II in whom complete resolution of symptoms was seen.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; From the above study we can conclude that both amoxicillin–clavulanic acid and levofloxacin are equally efficacious in managing cases of acute sinusitis. In this study there was no difference in the rate and duration of resolution amongst both the groups.&lt;/p&gt;

Safety of the use of xylometazoline nasal spray in young children undergoing lacrimal surgery: an observational study.

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. This was a retrospective analysis of medical notes of children undergoing lacrimal surgery with the use of preoperative intranasal xylometazoline 0.05% over a 5-year period. Twenty-nine children, age 1-6 years (mean 3 years), underwent lacrimal surgery under general anesthesia with preoperative use of intranasal xylometazoline. Topical intranasal 1:10,000 adrenaline was used during surgery in all patients. All children were found to have uneventful surgery and recovery from anesthesia. Xylometazoline 0.05% intranasal use for prelacrimal surgery was found to be effective and safe. Addition of sympathomimetic topical adrenaline (1:10,000) did not impose any risks. The type of general anesthesia may influence the cardiovascular side effects anecdotally recorded during xylometazoline use.

Hypertensive crisis and end-organ damage induced by over-the-counter nasal decongestant abuse

A 34-year-old male presented with blurred vision and frontal headache since 2 months due to papilloedema and hypertensive retinopathy stage IV [ Panel A , fluoroangiography showing peripapillary oedema, cotton wool spots (arrowhead), flame shaped haemorrhages (arrow)]. His blood pressure was 210/120 mmHg. He took no oral medication, but used xylometazoline nasal spray every …

An Evaluation of Active Anterior and Posterior Rhinomanometry in British Adults

In this study, active Anterior Rhinomanometry (ARM) and Posterior Rhinomanometry (PRM) were performed sequentially by 56 normal British Caucasian adults using an on-line Mercury Electronics NR6D Rhinomanometer. Xylometazoline nasal spray was used as a nasal decongestant before the test. In addition, repeated measurements were made on a randomly selected 13 subjects to evaluate the error of the methods. The mean total nasal airway resistance by the anterior method was found to be 0.182 Pa/cm3/s at a reference pressure of 150 Pascals, and by the posterior method 0.166 Pa/cm3/s at a reference pressure of 75 Pascals. These mean values are similar to those reported by other authors for Caucasians. The errors of the methods were found to be smaller than previously reported (Coefficient of variation, ARM = 6.9%; PRM = 7.7%). The total nasal airway resistance was higher during expiration than inspiration, and higher in women than in men. The ARM values were on an average 9% higher than those of the PRM, and the association between the two values was found to be moderate (r = 0.48). The higher ARM mean values could be attributed to inappropriateness of the conventional Ohm's law used in their calculation. For a number of reasons, PRM is considered to be more suitable than ARM for measuring nasal resistance.

Histamine Sensitivity in the Nasal Mucosa during Long-term Use of Xylometazoline in the Doubled Recommended Dose

It has been suggested that the severity of rhinitis medicamentosa is dependent on the length of time the drug has been used, on how frequently it is used, and on the amount administered. It has been reported that a 4-week use of oxymetazoline in the recommended dose induced a rebound swelling and an increased histamine sensitivity as a sign of rhinitis medicamentosa and nasal hyperractivity. In order to study the impact of an increased amount of vasoconstrictor on the histamine sensitivity, nine healthy subjects had xylometazoline nasal spray in the doubled recommended dose (1.0 mg/mL; 0.28 mL in each nostril three times daily) for 30 days. After 10 days on the drug the histamine sensitivity was slightly increased, and after another 20 days the sensitivity was significantly increased compared to that before the start of the medication (P &lt; 0.01). When comparing the results from this study with the corresponding ones from the oxymetazoline study, no difference in the histamine sensitivity was seen. One month after the medication was finished three subjects still had an increased sensitivity to histamine. It was concluded that the doubled recommended dose of xylometazoline did not further increase the elevated histamine sensitivity seen following vasoconstrictor used in recommended dose. The results also indicate that the increased histamine sensitivity was not caused by the preservatives. Finally, the subjects achieved a drug-induced non allergic nasal hyperreactivity (NANH) that in some subjects persisted for a long time.