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PubMed1996

Effect on the nasal mucosa of long-term treatment with oxymetazoline, benzalkonium chloride, and placebo nasal sprays.

A parallel, randomized, double-blind study was performed in 30 healthy subjects to investigate the effects on the nasal mucosa of a 1-month treatment with nasal sprays. Ten subjects received oxymetazoline nasal spray; 10 subjects used a nasal spray containing the preservative benzalkonium chloride, and the others were treated with a placebo nasal spray. The three variables that were studied --nasal mucosal swelling, symptom scores, and nasal reactivity-- were estimated by histamine challenge before and after 28 days of treatment. Rhinostereometry was used to measure nasal mucosal swelling and nasal reactivity. After 28 days of use, benzalkonium chloride spray alone induced an increase in nasal mucosal swelling. At the end of the month, the score for nasal stuffiness was significantly higher for the group treated with oxymetazoline than for those treated with benzalkonium chloride. Oxymetazoline nasal spray induced a pronounced increase in nasal reactivity, which was significantly greater than that induced in the placebo group. Long-term use of placebo and benzalkonium chloride nasal sprays also caused an increase in nasal reactivity, but not to the same extent as with the nasal sprays containing oxymetazoline. The authors concluded that long-term use of oxymetazoline induces a sensation of nasal stuffiness, which may be due to unconscious exaggeration of the degree of nasal stuffiness, induced nasal hyperreactivity, or a combination of both. These factors are probably the main reasons for the prolonged use of nasal decongestive sprays and the development of rhinitis medicamentosa. Benzalkonium chloride induces mucosal swelling, which explains why the presence of this preservative in a decongestant spray aggravates rhinitis medicamentosa.

Administration, Intranasal↗
PubMed2000

Long-term use of preservatives on rat nasal respiratory mucosa: effects of benzalkonium chloride and potassium sorbate.

OBJECTIVES: The preservatives benzalkonium chloride (BZC) and potassium sorbate (PS) are widely used, not only for nasal drops, but also for eyedrops and cosmetics. However, there have been many case reports that consider lesions such as dermatitis or conjunctivitis to be the results of irritation induced by BZC or PS. METHODS: We evaluated the histological changes after the long-term administration of BZC or PS on rat nasal respiratory mucosa. Forty rats were used for the BZC group and 40 rats for PS group. Animals in each group were divided into four subgroups The first subgroup received a low-concentration preservative solution that was commonly used for nasal sprays. The second subgroup received a high-concentration preservative solution that was reported to induce dermatitis in humans. The third and fourth subgroups received a steroid mixed preservative solution of low and high concentrations, respectively. The control group was administrated normal saline. After each group received 1, 2, and 4 weeks of topical administration, the symptomatic and histological changes on H&E stain were observed. RESULTS: Sneezing and nasal rubbing with forelegs were observed in almost all subgroups by the seventh day of treatment. The preservatives induced nasal lesions, including intraepithelial glandular formation, inflammatory cell infiltration, vascular hyperplasia, and edematous change. The symptomatic and histological changes were pronounced with the prolonged duration of administration. Similar results were observed in the steroid mixed-solution groups. In the PS steroid mixed-solution group, however, symptoms and nasal lesions were reduced with the prolonged duration of administration. CONCLUSION: It is our finding that even a low-concentration solution of preservative can lead to nasal lesion. Hence there is a strong need to develop both a preservative that can be safely and widely used and a nasal spray without preservatives.

Animals↗
PubMed2000

Effects of benzalkonium chloride on innate immunity physiology of the human nasal mucosa in vivo.

OBJECTIVE: Benzalkonium chloride (BC) is a preservative commonly used in nasal decongestant sprays. It has been suggested that BC may be harmful to the nasal mucosa. The present study, involving healthy volunteers, examines effects of BC on nasal mucosal end-organ functions. METHODS: Isotonic saline and BC (0.1 mg/mL) were administered acutely to the nasal mucosa using a nasal pool device. Nasal symptoms were determined. Nasal lavage fluid levels of alpha2-macroglobulin and fucose were measured as indices of plasma exudation and glandular secretion, respectively. In addition, BC (0.1 mg/mL) was given as single actuations of 100 microL per nasal cavity three times daily for 10 days. The ability of histamine (0.4 mg/mL) to evoke nasal symptoms and plasma exudation responses was determined before and after the repeated BC administration series. RESULTS: BC produced immediate nasal smart or pain (P < .05), but tolerance to this response developed by repeated administrations. BC increased nasal mucosal output of fucose (P < .05), whereas nasal lavage fluid levels of alpha2-macroglobulin were unaffected. Histamine produced significant symptoms and mucosal exudation of alpha2-macroglobulin (P values < .01), equally before and after the 10 days of BC exposure. CONCLUSIONS: BC in dosages commonly used as preservative in nasal decongestant sprays produced short-term glandular secretion and nasal smart or pain. However, 10 days' frequent exposure to BC was not associated with untoward symptomatic effects, nor was a sensitive mucosal variable such as histamine-induced exudative responsiveness affected by this repeated exposure 1 BC.

Administration, Topical↗
PubMed1982

The effect of ophthalmic preservatives on the healing rate of the rabbit corneal epithelium after keratectomy.

Most ophthalmic preparations contain preservatives. Some are toxic to healthy corneal epithelium or retard healing of corneas from which part or all of the epithelium has been removed leaving an intact basement membrane. In this paper, the effect of commonly used concentrations of benzalkonium chloride (BAC), thimerosal, and ethylenediaminetetracetic acid (EDTA) upon the healing of rabbit corneas after partial lamellar keratectomy is investigated. This model has not been used previously for a study of preservative toxicity. Thimerosal (0.004%), BAC (0.01%), or EDTA (0.1%) applied four times per day had no significant effect on the corneal healing or epithelial migration rates. A slight retardation occurred when BAC (0.01%) and EDTA (0.1%) were used together, while healing failed to occur as long as benzalkonium chloride (0.02%) was administered.

Animals↗
PubMed1991

Effect of rigid gas permeable contact lens wetting solutions on the rabbit corneal epithelium.

This investigation was designed to compare the effects of three rigid gas permeable (RGP) contact lens solutions on the rabbit corneal epithelium. Boston Advance Conditioning Solution, Boston Conditioning Solution, and Allergan Wet-N-Soak, which are preserved with 0.0015% polyaminopropyl biguanide, 0.006% chlorhexidine gluconate, and 0.003% benzalkonium chloride, respectively, were evaluated by scanning (SEM) and transmission electron microscopy (TEM). Our results show that Boston Advance Conditioning Solution is significantly more toxic to the corneal epithelium than either Boston Conditioning Solution or Allergan Wet-N-Soak Plus. This is presumably due to the presence and concentration of the preservative, 0.0015% polyaminopropyl biguanide. Although this study was conducted using rabbits, the results raise clinical concerns for human RGP contact lens wearers.

Animals↗
PubMed1994

Acute effects of chlorobutanol- or benzalkonium chloride-containing artificial tears on the surface features of rabbit corneal epithelial cells.

I examined the epithelial surface, by high resolution scanning electron microscopy, after its recovery from the instillation of artificial tears containing chlorobutanol or benzalkonium chloride. Is the mild epithelial surface compromise observed after occasional use of a chlorobutanol-containing artificial tear more substantial after use of a benzalkonium-containing artificial tear? Two drops of a chlorobutanol- or benzalkonium chloride-containing artificial tear were instilled into the right eye of 6 female gray rabbits (2 kg) at 9:00 p.m. and 9:00 a.m. At the same time six control animals received no eyedrops. All animals were euthanized at 3:00 p.m. and the central region of the corneal epithelium quantitatively assessed using a digitizer pad/computer system. There were up to 5% exfoliating cells evident at the ocular surface in treated rabbits but with no difference between the two products. Controls had no cell exfoliation (< 0.5%). The distribution of surface areas of the squamous cells in the treated eyes was shifted to slightly larger values than in the controls after use of the chlorobutanol-containing product but the number of epithelial cell craters/cell was unchanged from that of the controls. Cell surface areas were shifted to significantly smaller values than controls after use of the benzalkonium chloride-containing product and there were much fewer epithelial cell craters/cell. The results reveal differences in the effects of preservative-containing artificial tears on the squamous cells of the corneal epithelium in a clinically relevant situation.

Administration, Topical↗
PubMed1997

Changes in lactate dehydrogenase activity in bovine corneal stroma and epithelium in response to in vitro toxic challenges in the enucleated eye test.

PURPOSE: To assess whether changes in lactate dehydrogenase (LDH) activity, as a marker of cell damage, could be detected in corneal stroma and corneal epithelium after toxicity measurements using the enucleated eye test (EET). METHODS: The corneal surface of isolated bovine eyes was continuously wetted with commercial balanced salt solution (BSS) over 4 h at 37 degrees C and central corneal thickness (CCT) was measured. Initial 5-min challenges were made with dilute solutions of benzalkonium chloride (up to 0.032%) or NaOH (up to 0.4 M). The residual LDH activity in the corneal epithelium and corneal stroma were then assessed. RESULTS: Dose-dependent increases in CCT of up to 70% were measured. A strong correlation (r = -0.961) was found between increases in CCT and decreases in stromal LDH activity, but the correlation was much less (r = -0.512) for epithelial LDH activity. CONCLUSIONS: LDH activity can be used as one marker for cell integrity in the corneal stroma and epithelium, although dose-dependent correlations may not be high.

Animals↗
PubMed1979

Effects of epinephrine, benzalkonium chloride, and intraocular miotics on corneal endothelium.

Drugs formulated for use both inside and outside of the eye were tested for their potential toxic effects on the corneal endothelium. Commercially available epinephrine 1:1000 was toxic to the corneal endothelium, but solutions diluted fivefold caused no endothelial damage. The toxic agent was the sodium bisulfite 0.1% preservative. Benzalkonium chloride is highly toxic to corneal endothelium in its commonly used concentration of 0.01% and had to be diluted one thousand times to prevent endothelial damage. Ophthalmic medications for extraocular use should never be used intracamerally. Miotics commonly used in surgery during intraocular lens implantation are generally nontoxic to the cornea, though caution is advised in the use of carbachol in patients with preexisting endothelial disease and in patients having procedures in which substantial mechanical trauma to the endothelium may occur.

Animals↗
PubMed2005

Effect of topical nasal steroid sprays on nasal mucosa and ciliary function.

PURPOSE OF REVIEW: This review was conducted to examine current evidence focusing on the effect of nasal steroid sprays on nasal ciliary function. RECENT FINDINGS: Review of current literature suggests that long term effects of topical corticosteroid nasal sprays are safe and fail to cause damage to local nasal structure and function. SUMMARY: The use of corticosteroid nasal sprays for the treatment of allergic rhinitis is widely accepted. Popularity of this class of medications is based on a well-established combination of efficacy, tolerability, and safety. Although current literature suggests that the use of intranasal steroids is indeed safe, increasing indications for prolonged administration continue to fuel debate regarding the long-term effect on local nasal structure and function. The purpose of this article is to review current literature addressing the effects of the components of local intranasal steroid sprays on the structure and function of the nasal mucosa.

Administration, Intranasal↗
PubMed1996

Topical treatments for hydrofluoric acid dermal burns. Further assessment of efficacy using an experimental piq model.

Several topical treatments for hydrofluoric acid dermal burns (Zephiran, calcium acetate and magnesium hydroxide antacid soaks, and calcium gluconate gel) were assessed for efficacy in a pig model. Gross appearance and histopathology of treated and untreated burn sites were evaluated. For superficial burns, Zephiran was most effective; calcium acetate, magnesium hydroxide antacid, and calcium gluconate gel were less effective. For deep burns, gross observations showed that calcium acetate and Zephiran were most efficacious, whereas histopathology indicated comparable efficacy of Zephiran, calcium acetate, and calcium gluconate gel for all skin layers. Magnesium hydroxide antacid demonstrated efficacy only for the subdermis. The clinically beneficial effects of both Zephiran and calcium gluconate gel were affirmed. Although results suggest that calcium acetate and magnesium-containing antacids may be beneficial for human hydrofluoric acid dermal burns, these are not established clinical treatments.

Acetates↗
PubMed2003

Corneal punctate staining with latanoprost, bimatoprost, and travoprost in healthy subjects.

PURPOSE: To evaluate short-term conjunctival and corneal punctate staining with latanoprost, bimatoprost, and travoprost in healthy individuals. MATERIALS AND METHODS: A single centered, active-controlled, three-period crossover comparison that evaluated conjunctival and corneal punctate staining, by grade and individual stains, in healthy subjects after dosing for five days in one eye with latanoprost, bimatoprost, or travoprost. Staining was evaluated at 24-hour trough (Hour 0) and at Hour 1 after dosing. RESULTS: Twenty-eight subjects completed this study. This study found that there was no significant difference by ANOVA for the number of individual corneal punctate stains either at trough (latanoprost 22.6 +/- 25.4, bimatoprost 16.8 +/- 25.6, and travoprost 21.1 +/- 26.0 mm Hg) (P = 0.33) or at 1 hour after dosing (latanoprost 23.8 +/- 26.3 bimatoprost 18.2 +/- 25.2, and travoprost 26.1 +/- 26.1 mm Hg) (P = 0.75) among treatment groups. No significant differences existed among treatment groups in the study eye compared with the non-study eye or to the study eye at Hour 0 or Hour 1 or to the period initiation or baseline visits (P > 0.05). Several significantly different comparisons, inconsistent in nature, were observed for the nasal and temporal conjunctival staining between the treatment groups. There were no differences in unsolicited or solicited adverse events between groups. CONCLUSION: This study suggests that, in healthy subjects after short-term treatment, latanoprost, bimatoprost, and travoprost demonstrate generally similar ocular surface epithelial staining characteristics.

Adult↗
PubMed2003

Comparison of the short-term effects on the human corneal surface of topical timolol maleate with and without benzalkonium chloride.

PURPOSE: To compare the short-term effects of timolol maleate with and without preservative (0.005% benzalkonium chloride) on pre-corneal tear film stability and corneal epithelial barrier function. SUBJECTS AND METHODS: The study population consisted of 20 healthy volunteers. To obtain baseline values, 7 days before the experiment the non-invasive breakup time of the pre-corneal tear film was measured using a tear specular microscope; corneal fluorescein uptake was measured with a fluorophotometer. Unpreserved or preserved 0.5% timolol was applied to one eye; the contralateral eye was exposed to the other drug. At 30 minutes after instillation, the pre-study tests were repeated. RESULTS: Preserved timolol did, while unpreserved timolol did not, significantly reduce the non-invasive breakup time from the baseline values (baseline and post-exposure values 11.4 and 6.8 seconds, respectively, P = 0.008 for preserved timolol, and 11.7 vs. 11.0 seconds, P = 0.55 for unpreserved timolol). Corneal fluorescein uptake, on the other hand, was significantly increased upon exposure to either preserved or unpreserved timolol (baseline and post-exposure values 37.5 and 82.0 ng/ml, P < 0.001 for preserved timolol, and 35.4 vs. 57.6 ng/ml, P < 0.001 for unpreserved timolol). Preserved timolol exerted the greater effect (P = 0.028). CONCLUSIONS: Exposure to preserved timolol resulted in significant instability in the pre-corneal tear film. Moreover, it disrupted the corneal epithelial barrier function to a greater degree than unpreserved timolol. The elimination of preservatives may be desirable in efforts to protect the integrity of the corneal surface and its interaction with the tear film.

Administration, Topical↗
PubMed2000

Protection of cynomolgus macaque against cervicovaginal transmission of SIVmac251 by the spermicide benzalkonium chloride.

We evaluated the potential effectiveness of a spermicide cationic surfactant, benzalkonium chloride (BZK), to prevent the transmission of simian immunodeficiency virus (SIV) after intravaginal inoculation in 12 cynomolgus macaques. The inoculation procedure involved deposition of 6.7 ivag-AID50 of cell-free SIVmac251 into the receiving vagina, four times over a 2-week period, at the end of the luteal phase of the menstrual cycle. Six randomly selected females received vaginally foam containing BZK (7.37%, wt/wt) before each inoculation (BZK group), whereas the remaining were not pretreated (control group). In controls, 5 animals presented persistent SIV infection and 1 had a transient viremia. The number of uninfected animals was higher in the BZK group (6 of 6) than in controls (0 of 6). These findings demonstrate that BZK placed in the vaginal receptacle prior to SIV inoculation provides a significant protection in vivo. The wide spectrum of antimicrobial activities of BZK (including HIV) in addition to its efficiency to block the transmucosal passage of SIV in the macaque model qualifies this drug as an attractive topical microbicide to prevent sexually transmitted infections in humans.

Animals↗
PubMed2003

Bye-bye benzocaine?

Explore the source record for details and available documents.

4-Aminobenzoic Acid↗
PubMed2004

Eradication by surfactant irrigation of Staphylococcus aureus from infected complex wounds.

Treatment of infected orthopaedic hardware usually requires the removal of the appliance. When the device is removed and immediately replaced, persistent infection frequently complicates this exchange procedure. We modeled the exchange procedure in rats by passing a wire suture through a posterior spinous process and then contaminating the wound with Staphylococcus aureus. We then investigated whether a sequence of surfactant enriched irrigation solutions (Castile soap followed by benzalkonium chloride, sequential surfactant irrigation) had a greater capacity to eradicate Staphylococcus aureus from the experimental wound than did the standard wound irrigant, normal saline. When we left the wire in place through the 2-week course of the study, sequential surfactant irrigation showed only a modest advantage over normal saline (staphylococci recovered from 39% versus 58% of wound cultures respectively). Simple removal of the wire 24 hours after implantation and bacterial contamination prevented wound infection in most animals (with the wire removed, 38% of the animals remained infected versus 85% with the wire left in place), without regard to the irrigation solution. Alternatively, when we removed the wire after 24 hours, irrigated the wound, and then placed a fresh wire back into the wound, sequential surfactant irrigation showed a significant advantage over NS (54% of the animals irrigated with sequential surfactants remained infected versus 100% of the animals irrigated with normal saline). Our findings confirm the importance of a contaminated medical device for promoting foreign body infection; our findings also show that sequential surfactant irrigation has therapeutic value in a rat model of orthopaedic device infection; this irrigation protocol should be studied further as a potential agent for the treatment of infected orthopaedic wounds.

Animals↗