Oxymetazoline Nasal Spray Research Articles

A double-blind comparison between oral pseudoephedrine and topical oxymetazoline in the prevention of barotrauma during air travel

To determine the efficacy of two decongestants (oral pseudoephedrine versus topical oxymetazoline) in the prevention of middle ear barotrauma during air travel, 150 adult volunteers with a history of ear pain during air travel were entered into a randomized, double-blind study conducted at two commercial airports. Each subject received 120 mg pseudoephedrine, oxymetazoline hydrochloride (0.05%), or a double placebo (capsule and nasal spray) administered 30 minutes before flight departure. After arrival at their final destinations, volunteers were asked to complete a questionnaire and return it by mail to investigators. Questions included the intensity and duration of otologic symptoms experienced while flying and possible drug side effects. A total of 124 subjects completed the study; 41 received 120 mg of pseudoephedrine, 42 received oxymetazoline nasal spray, and 41 received a double placebo (capsule and nasal spray). The three treatment groups were similar with regard to age, sex, medical history, and flight profile. Symptoms of barotrauma were reported by 34% of those receiving pseudoephedrine versus 71% of the control group, for a relative risk reduction of 52% (95% confidence interval [CI] 33% to 71%). In contrast, 64% of the oxymetazoline group reported symptoms of barotrauma, for a relative risk reduction of 10% (95% CI, 3% to 17%). These results suggest that treatment with 120 mg pseudoephedrine at least 30 minutes before flying appears to decrease the incidence of barotrauma. Oxymetazoline nasal spray is little more effective than placebo in reducing ear pain and discomfort associated with changing ambient pressures.

Rhinitis medicamentosa: aspects of pathophysiology and treatment.

With modern vasoconstrictors, such as oxy- and xylometazoline, the risk of developing rhinitis medicamentosa (RM) has been considered to be small or even nonexistent. However, recent studies have shown that overuse of these drugs may result in rebound congestion, nasal hyperreactivity, tolerance, and histologic changes of the nasal mucosa. Using rhinostereometry, it has also been shown that the long-term use of the preservative benzalkonium chloride (BKC) in oxymetazoline nasal spray accentuates the severity of rhinitis medicamentosa in healthy volunteers. A nasal decongestant spray composed of a combination of vasoactive substances and BKC has a long-term adverse effect on the nasal mucosa. BKC alone induces mucosal swelling after 30 days use of the nasal spray in healthy subjects, unlike placebo. According to the author, rhinitis medicamentosa can be defined as a condition of nasal hyperreactivity, mucosal swelling, and tolerance that is induced, or aggravated, by the overuse of topical vasoconstrictors with or without a preservative. An adequate treatment of these patients consists of a combination of vasoconstrictor withdrawal and a topical corticosteroid to alleviate the withdrawal process. The underlying nasal disorder must then be treated. Patients with rhinitis medicamentosa who overuse topical decongestants and are able to stop using such drugs should be careful about taking these drugs again, even for a few days. They must be informed about the rapid onset of rebound congestion upon repeated use in order to avoid the return of the vicious circle of nose-drop abuse.

One-week use of oxymetazoline nasal spray in patients with rhinitis medicamentosa 1 year after treatment.

The aim of the present study was to investigate whether patients with rhinitis medicamentosa who stopped using the topical vasoconstrictors may use these drugs again more than 1 year later. Eight patients received oxymetazoline nasal spray containing benzalkonium chloride 3 times daily for 7 days, 13-19 months after they had stopped using nasal decongestant sprays containing benzalkonium chloride. Before starting the course of treatment and after its conclusion, recordings of the mucosal surface positions were made with rhinostereometry, followed by histamine challenge tests. Symptoms of nasal stuffiness were estimated on visual analogue scales (0-100). After 7 days, nasal stuffiness, estimated by symptom scores and measurements of nasal mucosa swelling, was found, as well as an increased histamine sensitivity, which was interpreted as a sign of nasal hyperreactivity. In conclusion, patients with rhinitis medicamentosa who overuse topical decongestants and are able to stop using such drugs should be careful about taking these drugs again, even for a few days. They must be informed about the fast onset of rebound congestion upon repeated use in order to avoid the return of the vicious circle of nose drop abuse.

Cardiac arrest after oxymetazoline nasal spray

Oxymetazoline nasal spray is a potent alpha 1-adrenergic agonist commonly used to vasoconstrict blood vessels in the nasal mucosa. In this incident, oxymetazoline nasal spray 0.025% was administered to a 2-year-old patient during general anesthesia for nasal endoscopy. Severe hypertension with reflex bradycardia progressed to sinus arrest and was successfully treated with atropine and cardiopulmonary resuscitation. Decreasing the dose of oxymetazoline and pretreatment with an anticholinergic is recommended.

Benzalkonium chloride in nasal decongestive sprays has a long‐lasting adverse effect on the nasal mucosa of healthy volunteers

Twenty healthy volunteers participated in the present study on the long-term effects of a nasal decongestive spray composed of either a combination of oxymetazoline nasal spray and benzalkonium chloride or of oxymetazoline nasal spray alone. Three months before the present study the participants had undergone treatment with nasal decongestants for 4 weeks. Ten of the subjects had been treated with oxymetazoline nasal spray without benzalkonium chloride and 10 of them had been treated with oxymetazoline nasal spray with benzalkonium chloride. In a double-blind study the subjects who had been treated with oxymetazoline nasal spray and benzalkonium chloride were again treated with the same combination of substances as before, and the subjects who had been treated with oxymetazoline nasal spray alone were also treated again with oxymetazoline nasal spray alone, but on this occasion only for 10 days. Three variables were studied before and after the 10 days of treatment, i.e. nasal mucosa congestion, nasal reactivity and symptom scores. It was found that only the subjects who were treated with the combination of oxymetazoline nasal spray and benzalkonium chloride had increased nasal stuffiness, estimated by symptom scores and measurements of nasal mucosa swelling after 10 days of treatment. It is concluded that a nasal decongestant spray composed of a combination of vasoactive substance and benzalkonium chloride has a long-term adverse effect on the nasal mucosa.

Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers

A randomized double-blind parallel study with 20 healthy volunteers was performed to research the effect of a preservative in a decongestant nasal spray on the development of rhinitis medicamentosa. Ten subjects received oxymetazoline nasal spray with benzalkonium chloride and the others used oxymetazoline nasal spray without the preservative three times daily for 30 days. Before starting the course of treatment and after its conclusion, recordings of the mucosal surface positions were made with rhinostereometry followed by histamine challenge tests. Symptoms of nasal stuffiness were estimated on visual analogue scales (0-100) in the morning and the evening just before using the nasal spray. After 30 days, rebound swelling and nasal stuffiness were found in both groups. In the group receiving oxymetazoline nasal spray with benzalkonium chloride the mean rebound swelling was 1.1 mm and the estimated mean evening symptom score for nasal stuffiness was 43. In the group without benzalkonium chloride the corresponding variables were significantly less marked, with a mean rebound swelling of 0.5 mm (P < 0.05) and a mean evening symptom score of 25 (P < 0.05). The increase in histamine sensitivity in both groups was interpreted as a sign of nasal hyperreactivity. A new type of nasal spray bottle was used that has been shown to prevent bacterial contamination. In conclusion, the long-term use of benzalkonium chloride in oxymetazoline nasal spray accentuates the severity of rhinitis medicamentosa in healthy volunteers.

Randomized Controlled Trial of 3 vs 10 Days of Trimethoprim/Sulfamethoxazole for Acute Maxillary Sinusitis

To compare 14-day outcomes and relapse and recurrence rates among patients with acute maxillary sinusitis randomized to 3-day (3D) vs 10-day (10D) treatment with trimethoprim/sulfamethoxazole (TMP/SMX). University-affiliated Veterans Affairs general medical and acute care clinics. Consecutive patients with sinus symptoms and radiographic evidence of maxillary sinusitis (complete opacity, air-fluid level, or > or = 6 mm of mucosal thickening). Patients were excluded for antibiotic use within the past week, TMP/SMX allergy, symptoms for more than 30 days, or previous sinus surgery. All subjects (n = 80) received oxymetazoline nasal spray 0.05%, two sprays twice daily for 3 days. Subjects were randomly assigned to TMP/SMX double strength: one tablet twice daily for 10 days or one tablet twice daily for 3 days followed by 7 days of placebo. At 7 and 14 days, patients rated their overall sinus symptoms on a Likert scale. Radiographs were scored at baseline and 14 days by radiologists masked to clinical symptoms and treatment assignment. The primary outcome was number of days to "cure" or "much improvement" in sinus symptoms. Patients who were clinical successes by day 14 were assessed for symptomatic relapse or recurrence at 30 and 60 days, respectively. Groups were comparable at randomization: male, 100%; black, 53%; median age, 48 years (interquartile range, 41 to 63 years); symptom duration, 10 days (interquartile range, 6 to 17 days); bilateral maxillary disease, 51%; and radiograph score, 4 (interquartile range, 2 to 4). Outcome assessment was completed in 95% of patients at day 14 (n = 76). Medication side effects and use of nonstudy sinus medications were equal between groups. By 14 days, 77% of 3D subjects and 76% of 10D subjects rated their sinus symptoms as cured or much improved (95% confidence interval for difference, -15% to 17%). Median days to cure/much improvement were 5.0 and 4.5 for the 3D and 10D groups, respectively; distributions of time to cure were not different (P = .34). Radiograph scores improved in both groups compared with baseline (2 points; P < .001), but improvement did not differ between groups (P = .31). Eight percent of 3D subjects and 13% of 10D subjects missed work due to sinus symptoms. Of the 52 patients who were clinical successes at 14 days and completed follow-up, three (11%) of 27 3D subjects and one (4%) of 25 10D subjects relapsed symptomatically by day 30; one (4%) of 27 3D subjects and one (4%) of 25 10D subjects suffered symptomatic recurrence between days 30 and 60 (P = .45 for the relapse and recurrence rates combined). At the 2-week follow-up, clinical symptoms and radiograph scores improved equally following 3 or 10 days of TMP/SMX plus oxymetazoline nasal spray. Symptomatic relapse and recurrence were similar between groups. Three days of antibiotics were as effective as 10 days and, because of the high disease prevalence, hold the potential for substantial cost savings.

The Effect of a Benzalkonium Chloride‐Containing Nasal Spray on Human Respiratory Mucosa in vitro as a Function of Concentration and Time of Action

Human respiratory mucosa was exposed to oxymetazoline nasal spray in varying concentrations and for varying periods of time in vitro. The drug destroyed the tissue in a concentration- and time-dependent manner. In the experiments with various concentrations of the spray, some tissue fragments retained their viability throughout the experiment. This number increased parallel to a decrease in concentrations of the test substance. All the tissue fragments exposed to undiluted nose spray underwent severe destructive alterations during the exposure period. These alterations appeared first and were most extensive in those exposed for the longest periods of time. It has previously been demonstrated that the toxic effect of oxymetazoline nasal spray in vitro is probably due to the preservative benzalkonium chloride. The apparent lack of consistency between the toxic effects of benzalkonium chloride in vitro and in vivo is discussed, with special reference to protective systems absent in vitro but present in vivo.

Four-Week Use of Oxymetazoline Nasal Spray (Nezeril(R)) Once Daily at Night Induces Rebound Swelling and Nasal Hyperreactivity

A randomized double-blind parallel study with 20 healthy volunteers was performed to examine the effect of oxymetazoline nasal spray on the development of rhinitis medicamentosa. For 30 days, 10 subjects were given oxymetazoline nasal spray once daily at night and placebo in the morning and at noon, while the others used oxymetazoline nasal spray three times daily. Before and after the course of treatment, the mucosal surface positions were determined with rhinostereometry, followed by histamine challenge tests. In the morning and the evening just before use of the nasal spray, symptoms of nasal stuffiness were evaluated on visual analogue scales (0-100). After 30 days, rebound swelling and nasal stuffiness were found in both groups. In the group receiving oxymetazoline nasal spray once daily at night, the mean rebound swelling was 0.8 mm (p < 0.01) and the estimated mean symptom score for nasal stuffiness in the evening was 43 (p < 0.05). In the group receiving the same nasal spray three times daily, the mean rebound swelling was 1.1 mm (p < 0.01) and the mean evening symptom score was 43 (p < 0.05). The finding of an increase in histamine sensitivity in both groups was taken to indicate nasal hyperreactivity. There was no significant difference in the investigated variables between the two groups. It is concluded that the risk of developing rebound swelling and nasal hyperreactivity remains, whether oxymetazoline nasal spray is used once or three times a day for 30 days.

Decongestion effect and rebound swelling of the nasal mucosa during 4-week use of oxymetazoline.

The aim of this study was to investigate whether long-term use of oxymetazoline induces a rebound swelling of the nasal mucosa and whether the decongestion effect is altered during medication. Eight healthy volunteers had oxymetazoline nasal spray (0.5 mg/ml; 0.1 ml in each nostril, three times daily) for 30 days and registrations of the mucosal surface positions were made using rhinostereometry. Compared to the registrations before the start of medication, no rebound swelling was registered after 10 days. After 30 days, however, a rebound swelling was registered in all subjects (p < 0.001). All of them, then, also reported nasal stuffiness. The decongested position of the nasal mucosa after one single dose of oxymetazoline was the same in the whole study. It is concluded that rhinitis medicamentosa develops after a relatively short time on oxymetazoline, even in healthy volunteers, and that the swelling probably is due to a vasodilatation rather than an edema. The study supports the recommendation that the drug should not be used over periods > 10 days.