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Pharmaceutics Oct 2021Recent advances have been reported for needle-free local anesthesia in maxillary teeth by administering a nasal spray of tetracaine (TTC) and oxymetazoline, without...
Recent advances have been reported for needle-free local anesthesia in maxillary teeth by administering a nasal spray of tetracaine (TTC) and oxymetazoline, without causing pain, fear, and stress. This work aimed to assess whether a TTC-loaded hybrid system could reduce cytotoxicity, promote sustained permeation, and increase the anesthetic efficacy of TTC for safe, effective, painless, and prolonged analgesia of the maxillary teeth in dental procedures. The hybrid system based on TTC (4%) encapsulated in nanostructured lipid carriers (NLC) and incorporated into a thermoreversible hydrogel of poloxamer 407 (TTC) displayed desirable rheological, mechanical, and mucoadhesive properties for topical application in the nasal cavity. Compared to control formulations, the use of TTC slowed in vitro permeation of the anesthetic across the nasal mucosa, maintained cytotoxicity against neuroblastoma cells, and provided a three-fold increase in analgesia duration, as observed using the tail-flick test in mice. The results obtained here open up perspectives for future clinical evaluation of the thermoreversible hybrid hydrogel, which contains TTC-loaded NLC, with the aim of creating an effective, topical, intranasal, needle-free anesthesia for use in dentistry.
PubMed: 34834175
DOI: 10.3390/pharmaceutics13111760 -
The Journal of Laryngology and Otology Jan 2022This study aimed to summarise the evidence for efficacy of combination treatment of intranasal corticosteroid spray with oxymetazoline hydrochloride nasal spray for...
OBJECTIVE
This study aimed to summarise the evidence for efficacy of combination treatment of intranasal corticosteroid spray with oxymetazoline hydrochloride nasal spray for chronic rhinitis.
METHOD
Nine databases were systematically searched from study inception in September 2016 to 1 June 2020. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement was followed.
RESULTS
A total of 130 studies were screened, and 4 randomised controlled trials comprising 838 patients met inclusion criteria. The study found superior improvement of nasal congestion from onset of treatment to completion in intranasal corticosteroid spray and oxymetazoline hydrochloride groups compared with control groups. Intranasal corticosteroid spray and oxymetazoline hydrochloride use resulted in higher nasal volume (standard error of mean 1, 15.8 + 1.1 ml; p < .03) compared with either placebo (12.1 + 0.9 ml) or oxymetazoline hydrochloride (12.4 + 0.8 ml) alone (p = 0.003).
CONCLUSION
Intranasal corticosteroid spray and oxymetazoline hydrochloride combination treatment may be superior in reducing rhinitis symptoms compared with either intranasal corticosteroid spray or oxymetazoline hydrochloride alone, without inducing rhinitis medicamentosa.
Topics: Administration, Intranasal; Chronic Disease; Glucocorticoids; Humans; Nasal Decongestants; Oxymetazoline; Rhinitis
PubMed: 34702392
DOI: 10.1017/S0022215121003364 -
Clinical Ophthalmology (Auckland, N.Z.) 2021An oxymetazoline 0.1% ophthalmic solution was recently approved for treatment of acquired blepharoptosis in adults. This study's objective was to evaluate the safety...
PURPOSE
An oxymetazoline 0.1% ophthalmic solution was recently approved for treatment of acquired blepharoptosis in adults. This study's objective was to evaluate the safety profile of oxymetazoline 0.1% when administered once daily for 14-84 days.
PATIENTS AND METHODS
Pooled analysis examined safety outcomes from four randomized, double-masked, placebo-controlled clinical trials conducted at 6, 16, 27, and 35 sites, respectively, in the United States. In total, 568 participants with acquired blepharoptosis were evaluated. Median age was 66 years and 74.8% of participants were female. Overall, 375 participants self-administered oxymetazoline 0.1% to both eyes once/day and 193 self-administered placebo (vehicle) daily. Treatment-emergent adverse event (TEAE) rates, severity, and causality were evaluated in the overall population and within participant subgroups defined based on age, race, and ethnicity. Vital signs and ophthalmic findings were evaluated at predefined study visits. Patient-reported treatment tolerability was recorded at study end.
RESULTS
TEAE incidence was similar among participants using oxymetazoline 0.1% (31.2%) or vehicle (30.6%). Nearly all TEAEs were mild-to-moderate, and most were not suspected of being treatment related. Serious TEAEs occurred in four participants receiving oxymetazoline 0.1% and one participant receiving vehicle. Nine and two participants in the oxymetazoline 0.1% and vehicle groups, respectively, discontinued due to a TEAE. Ocular TEAEs occurring in ≥2% of participants receiving oxymetazoline 0.1% were punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, and corneal vital dye staining, with none occurring in >3.5% of participants. TEAE rates were similar across subgroups based on age, race, and ethnicity. No clinically significant mean changes in vital signs or ophthalmologic findings occurred, and >98% of participants rated oxymetazoline 0.1% as causing no/mild discomfort.
CONCLUSION
Once-daily oxymetazoline 0.1% was safe and well tolerated in participants with acquired blepharoptosis when used for 14-84 days. Safety did not appear to differ based on age, race, or ethnicity.
PubMed: 34675472
DOI: 10.2147/OPTH.S322326 -
Pediatrics Nov 2021The over-the-counter nasal decongestant oxymetazoline (eg, Afrin) is used in the pediatric population for a variety of conditions in the operating room setting. Given...
The over-the-counter nasal decongestant oxymetazoline (eg, Afrin) is used in the pediatric population for a variety of conditions in the operating room setting. Given its vasoconstrictive properties, it can have cardiovascular adverse effects when systemically absorbed. There have been several reports of cardiac and respiratory complications related to use of oxymetazoline in the pediatric population. Current US Food and Drug Administration approval for oxymetazoline is for patients ≥6 years of age, but medical professionals may elect to use it short-term and off label for younger children in particular clinical scenarios in which the potential benefit may outweigh risks (eg, active bleeding, acute respiratory distress from nasal obstruction, acute complicated sinusitis, improved surgical visualization, nasal decongestion for scope examination, other conditions, etc). To date, there have not been adequate pediatric pharmacokinetic studies of oxymetazoline, so caution should be exercised with both the quantity of dosing and the technique of administration. In the urgent care setting, emergency department, or inpatient setting, to avoid excessive administration of the medication, medical professionals should use the spray bottle in an upright position with the child upright. In addition, in the operating room setting, both monitoring the quantity used and effective communication between the surgeon and anesthesia team are important. Further studies are needed to understand the systemic absorption and effects in children in both nonsurgical and surgical nasal use of oxymetazoline.
Topics: Age Factors; Child; Child, Preschool; Female; Heart Rate; Humans; Hypertension; Intraoperative Complications; Male; Nasal Decongestants; Off-Label Use; Operating Rooms; Oxymetazoline; Perioperative Care
PubMed: 34607935
DOI: 10.1542/peds.2021-054271 -
Journal of Fluorescence Nov 2021A simple, novel, cost-effective and highly sensitive spectrofluorimetric method was developed for estimation of the nasal decongestant oxymetazoline (OMZ) whether per se...
Utilization of Localized Surface Plasmon Resonance of Silver Nanoparticles for the Spectrofluorimetric Estimation of Oxymetazoline in Dosage Forms: Application to Aqueous Humor.
A simple, novel, cost-effective and highly sensitive spectrofluorimetric method was developed for estimation of the nasal decongestant oxymetazoline (OMZ) whether per se or in its pharmaceutical preparations using colloidal silver nanoparticles (AgNPs). The method is based on the high catalytic potential activity of AgNPs on the fluorescence intensity of OMZ leading to 12-fold increase in its fluorescence intensity. The response was linear over the range of 20.0 to 700.0 ng/mL with lower detection limit of 5.0 ng/mL and limit of quantification of 14.0 ng/mL. The proposed method was applied to the assay of commercial nasal drops, nasal spray and synthetic aqueous humor. Interference likely to be encountered from co-administered drugs was studied. The developed method was optimized and validated as per International Council of Harmonization (ICH). An explanation for the drug-AgNPs interaction was proposed.
Topics: Aqueous Humor; Fluorescence; Metal Nanoparticles; Oxymetazoline; Silver; Spectrometry, Fluorescence; Surface Plasmon Resonance
PubMed: 34524574
DOI: 10.1007/s10895-021-02812-2 -
Optometry and Vision Science : Official... Nov 2021Ptosis is often the hallmark finding in ocular and general myasthenia gravis. Reduction of ptosis has been achieved with oral and topical ocular medications. However,...
SIGNIFICANCE
Ptosis is often the hallmark finding in ocular and general myasthenia gravis. Reduction of ptosis has been achieved with oral and topical ocular medications. However, these medications can result in systemic and ocular adverse effects. A novel eye drop seems to be effective in reducing ptosis while minimizing adverse effects.
PURPOSE
This case report aimed to demonstrate the efficacy of topical oxymetazoline hydrochloride 0.1%, an α-adrenergic agonist, in temporary elimination of ptosis associated with myasthenia gravis.
CASE REPORT
A 68-year-old woman with a history of myasthenia gravis and long-standing ptosis in the right eye presented to improve the asymmetrical appearance of her eyelids. One drop of oxymetazoline hydrochloride 0.1% was instilled in the right eye of the patient. Within 2 hours, the ptosis was eliminated, the margin-reflex distance 1 increased by 2.0 mm, and the superior visual field measured by a superior 36-point screening test increased by 15 points. The effect lasted for at least 7 hours. Of note, there was a decrease in elevation of the contralateral nonptotic eyelid that did not receive a drop of oxymetazoline, which might occur only in myasthenia gravis. Further evaluation is warranted.
CONCLUSIONS
Oxymetazoline 0.1% is effective in reducing and potentially eliminating ptosis related to ocular myasthenia gravis for up to 7 hours.
Topics: Aged; Blepharoptosis; Eyelids; Female; Humans; Myasthenia Gravis; Oxymetazoline; Visual Fields
PubMed: 34510144
DOI: 10.1097/OPX.0000000000001800 -
Laryngoscope Investigative... Aug 2021To determine preference patterns for topical anesthesia in patients undergoing endoscopy pre-coronavirus (2019 coronavirus disease [COVID-19]) pandemic and analyze...
OBJECTIVES
To determine preference patterns for topical anesthesia in patients undergoing endoscopy pre-coronavirus (2019 coronavirus disease [COVID-19]) pandemic and analyze outcomes based on preference, using a decision aid format.
METHODS
A decision aid was developed with expert and patient input. New patients presenting to subspecialty clinics over a 2-month pre-COVID-19 period completed a pre-procedure survey about their priorities, then were asked to choose between topical oxymetazoline/lidocaine spray or none. A post-procedure outcome survey followed.
RESULTS
Of 151 patients, 90.1% patients elected to have topical anesthesia. Top patient priorities were "I want the scope to be easy for the doctor" and "I want to be as comfortable as possible." Patients who strongly wanted to avoid medication ( = .002) and bad taste ( = .003) were more likely to select no spray, whereas those who wanted to avoid pain received anesthetic ( = .011). According to the post-procedure assessment, 95.4% of patients were satisfied or strongly satisfied their choice, and this did not correlate with anesthetic vs none.
CONCLUSIONS
Patient preferences are easily elicited and correlate with treatment choices. Most patients chose to have topical anesthetic and were willing to tolerate side effects; however, both patients with and without topical anesthetic were satisfied with their choices. This decision aid can be used to optimize shared decision making in the otolaryngology clinic. Given the aerosolizing potential of both spray and no spray conditions, this insight may be consequential when devising office protocols for post-COVID-19 practice.
LEVEL OF EVIDENCE
II.
PubMed: 34401504
DOI: 10.1002/lio2.604 -
Journal of Cosmetic Dermatology Oct 2021Botulinum toxin A (BoNT-A) has grown tremendously in aesthetic dermatology since 2002 when the United States Food and Drug Administration (FDA) first approved its use... (Review)
Review
BACKGROUND
Botulinum toxin A (BoNT-A) has grown tremendously in aesthetic dermatology since 2002 when the United States Food and Drug Administration (FDA) first approved its use for treating moderate-to-severe glabellar lines. Blepharoptosis, due to local spread of toxin, is a reported side effect of BoNT-A which, although rare, more frequently occurs among inexperienced practitioners.
OBJECTIVES
The purpose of this review is to highlight the causes and management of eyelid ptosis secondary to BoNT-A administration including new anatomic pathways for BoNT-A spread from the brow area to the levator palpebrae superioris muscle.
METHODS
A literature search was conducted using electronic databases (PubMed, Science Direct, MEDLINE, Embase, CINAHL, EBSCO) regarding eyelid anatomy and the underlying pathogenesis, presentation, prevention, and treatment of eyelid ptosis secondary to BoNT-A. Anatomic dissection has been performed to assess the role of neurovascular pedicles and supraorbital foramen anatomic variations.
RESULTS
Blepharoptosis occurs due to weakness of the levator palpebrae superioris muscle. Mean onset is 3-14 days after injection and eventually self-resolves after the paralytic effect of BoNT-A wanes. Administration of medications, such as oxymetazoline hydrochloride or apraclonidine hydrochloride eye drops, anticholinesterase agents, or transdermal BoNT-A injections to the pre-tarsal orbicularis, can at least partially reverse eyelid ptosis. Anatomic study shows that a supraorbital foramen may be present in some patients and constitutes a shortcut from the brow area directly into the orbital roof, following the supraorbital neurovascular pedicle.
CONCLUSION
Providers should understand the anatomy and be aware of the causes and treatment for blepharoptosis when injecting BoNT-A for the reduction of facial wrinkles. Thorough anatomic knowledge of the supraorbital area and orbital roof is paramount to preventing incorrect injection into "danger zones," which increase the risk of eyelid ptosis.
Topics: Blepharoptosis; Botulinum Toxins, Type A; Humans; Neuromuscular Agents; Oculomotor Muscles; Skin Aging
PubMed: 34378298
DOI: 10.1111/jocd.14361 -
Skin Therapy Letter Jul 2021The diagnosis and classification of rosacea has been modified to reflect presenting features. On exclusion of differentials, the diagnosis of rosacea is based on the...
The diagnosis and classification of rosacea has been modified to reflect presenting features. On exclusion of differentials, the diagnosis of rosacea is based on the presence of either (1) phymatous changes, or (2) centrofacial persistent erythema. In their absence, diagnosis can be established by presence of any two of: flushing/transient erythema, papules and pustules, telangiectases, or ocular manifestations. Management of rosacea depends on presenting feature(s), their severity, and impact. General management includes gentle skin care, sun protection, and trigger avoidance. Evidence-based treatment recommendations include topical brimonidine and oxymetazoline for persistent erythema; topical azelaic acid, ivermectin, metronidazole, minocycline and oral doxycycline, tetracycline and isotretinoin for papules and pustules; vascular lasers and light devices for telangiectases; and omega-3 fatty acids and cyclosporine ophthalmic emulsion for ocular rosacea. While surgical or laser therapy can be considered for clinically noninflamed phyma, there are no trials on their utility. Combination therapies include topical brimonidine with topical ivermectin, or topical metronidazole with oral doxycycline. Topical metronidazole, topical ivermectin, and topical azelaic acid are appropriate for maintenance therapy. In conclusion, the updated phenotype approach, based on presenting clinical features, is the foundation for current diagnosis, classification, and treatment of rosacea.
Topics: Brimonidine Tartrate; Dermatologic Agents; Doxycycline; Humans; Metronidazole; Rosacea
PubMed: 34347259
DOI: No ID Found -
Lasers in Surgery and Medicine Dec 2021We evaluated if oxymetazoline therapy combined with 595-nm pulsed dye laser (PDL) will be more beneficial than topical oxymetazoline alone for the improvement of... (Randomized Controlled Trial)
Randomized Controlled Trial
A Randomized Controlled Pilot Study: Combined 595-nm Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride Topical Cream Superior to Oxymetazoline Hydrochloride Cream for Erythematotelangiectatic Rosacea.
BACKGROUND AND OBJECTIVES
We evaluated if oxymetazoline therapy combined with 595-nm pulsed dye laser (PDL) will be more beneficial than topical oxymetazoline alone for the improvement of erythematotelangiectatic rosacea.
STUDY DESIGN/MATERIALS AND METHODS
This was a randomized, controlled, prospective clinical trial approved by an independent Institutional Review Board, which enrolled 34 patients with moderate to severe clinical erythema (CEA) into a two-arm study of PDL with concomitant oxymetazoline cream (Arm 1) and oxymetazoline cream alone (Arm 2). Patients in Arm 1 were treated with 3 monthly laser sessions, which were started after 1 month of topical oxymetazoline cream. Thirty subjects continued with the study, and 25 subjects (Arm 1: 14, Arm 2: 11) completed the 6-month follow-up. With photographic comparison to baseline images, efficacy endpoints were based on clinical on-site grading by both the investigator and the patient, using the grading tools for CEA, Global Aesthetic Improvement (GAI) assessment, vessel size improvement, and subject self-assessment. These scales were assessed at baseline and/or at each clinical follow-up at 1, 2, 3, and 6 months. Subject satisfaction as well as post-treatment immediate response and treatment-associated pain scores were also evaluated.
RESULTS
Statistically significant improvement in CEA was seen in both arms at the 1-, 2-, and 3-month post-baseline visits (P < 0.01). Only Arm 1 presented statistically significant improvement in CEA (P < 0.001) at 6 months post baseline with a mean score of 1.6 (almost clear-mild) compared with 3.2 at baseline. Arm 1 showed significantly greater mean vessel size improvement at 3 months (P < 0.01) and 6 months (P < 0.05) post baseline compared to Arm 2. Significantly greater improvement (P < 0.05) in the investigator GAI score was reported at the 2- and 6-month follow-ups compared with Arm 2. Subject GAI scores showed statistically significant greater improvement in Arm 1 compared with Arm 2 at both the 3- and 6-month follow-ups (P < 0.01). There were no complications or long-term effects associated with PDL or topical oxymetazoline treatments.
CONCLUSION
The prospective trial verifies a safe, enhanced clinical outcome with the combination of PDL therapy and topical oxymetazoline for the treatment of erythematotelangiectatic rosacea patients. Lasers Surg. Med. © 2021 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.
Topics: Humans; Lasers, Dye; Oxymetazoline; Pilot Projects; Prospective Studies; Rosacea; Skin Cream; Treatment Outcome
PubMed: 34233378
DOI: 10.1002/lsm.23439