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PubMed2006

Methemoglobinemia after fiberoptic intubation in a patient with an unstable cervical fracture: a case report.

Methemoglobinemia, a condition associated with cyanosis and diminished pulse oximetry values, has been reported after use of local anesthetics to facilitate fiberoptic intubation. The majority of reports in the literature detail this development during diagnostic procedures such as endoscopy and bronchoscopy. A case of methemoglobinemia in a multiple-injury patient with an unstable compressive-flexion injury of the cervical spine undergoing fiberoptic intubation is presented. A literature review of this entity is also presented. The patient underwent fiberoptic intubation using topical pharyngeal anesthetics before planned cervical corpectomy, strut grafting and instrumentation. He became acutely cyanotic with abruptly diminished pulse oximetry readings. Subsequent blood gas analysis demonstrated methemoglobinemia. Intravenous methylene blue administration led to an uncomplicated resolution of the condition. Surgeons and anesthesiologists who manage such patients should be aware of methemoglobinemia, a rare but potentially fatal complication related to topical airway anesthetics.

4-Aminobenzoic Acid↗
PubMed2004

Evaluation of the corneal effects of topical ophthalmic fluoroquinolones using in vivo confocal microscopy.

PURPOSE: To compare the effects of several fluoroquinolone antibiotics on the corneal epithelium and stroma using in vivo confocal microscopy. METHODS: Five antibiotic solutions were evaluated: 1) 0.3% ofloxacin (Oflox) solution with 0.005% benzalkonium chloride (BAC); 2) 0.3% gatifloxacin (Gati) solution with 0.005% BAC; 3) 0.3% ciprofloxacin (Cipro) solution with 0.006% BAC; 4) 0.5% levofloxacin (Levo) with 0.005% BAC; and 5) 0.5% moxifloxacin (Moxi) solution with no BAC. Preservative-free artificial tears (Tears) were used as a control. New Zealand white rabbits were used for this study (six per solution group). Ten days prior to exposure to any solution, central corneal epithelial thickness and stromal thickness were measured using in vivo confocal microscopy through focusing. Images of the superficial epithelium were also acquired. Both eyes of each rabbit then received one drop of the assigned solution six times the first day and then four times per day for 6 days. On day 7, in vivo confocal microscopy was repeated. RESULTS: A significant decrease in epithelial thickness was induced by 7 days of exposure to Levo, Gati, Oflox, and Cipro (P < 0.05, two-way repeated-measures ANOVA, Tukey test). Tears and Moxi, which do not contain BAC, did not induce significant changes in epithelial thickness. No significant changes in stromal thickness were detected (P = 0.266), and no keratocyte activation was observed for any of the solutions evaluated. CONCLUSION: We have previously used confocal microscopy to establish a correlation between epithelial thinning (due to superficial cell loss) and slight ocular irritation. The results of this study suggest that Moxi induces less damage to the corneal epithelium than other antibiotic solutions, perhaps because it does not contain BAC.

Animals↗
PubMed2007

In vitro assessment of medical device toxicity: interactions of benzalkonium chloride with silicone-containing and p-hema-containing hydrogel contact lens materials.

PURPOSE: To analyze the interactions of benzalkonium chloride (BAK) with silicone-containing (lotrafilcon A and galyfilcon A) and p-HEMA-containing (etafilcon A and vifilcon A) hydrogel contact lenses and to examine the possibility of using sodium fluorescein permeability assay (SFPA), 3-(4,5-dimethylthiazol- 2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay and the bovine lens assay in conjunction with confocal laser scanning microscopy (CLSM) as a battery of in vitro alternatives to evaluate the potential toxicity of soft contact lenses. METHODS: Four soft contact lens types (Focus Monthly [vifilcon A], Focus NIGHT & DAY [lotrafilcon A], ACUVUE Advance With Hydraclear [galyfilcon A], and SUREVUE [etafilcon A]) were soaked for 24 hours in various concentrations of BAK (1%, 0.1%, 0.01%, and 0.001%) in 20-mL glass vials. After 24 hours, the lenses were gently washed in Hanks' Balanced Salt Solution (HBSS), placed in 5 mL of HBSS, and incubated for a total of 7 days at 37 degrees C, 5% CO2. BAK released into HBSS (i.e., the extract) was recovered from the vials and used as the test chemical in the SFPA (epithelium integrity), MTT assay (cellular viability), and the bovine lens assay with CLSM (mitochondrial metabolism and optical properties). The amount of BAK extracted from the various contact lenses was measured using an Abbe refractometer. Negative controls consisted of HBSS and contact lenses subjected to the same conditions as the treated contact lenses, but without BAK. RESULTS: Extracts obtained from soaking Focus Monthly lenses in BAK caused the most damage to the epithelium and mitochondrial metabolism. However, at 0.1% BAK extraction, all lens extracts showed increased levels of back vertex distance variability of the cultured bovine lens. CONCLUSIONS: Unexpectedly, lenses extracted with HBSS showed SFPA and MTT assay responses and an observed effect on the bovine lens epithelium visualized by CLSM, indicating that unknown chemical agents may be leached from contact lens polymers.

Animals↗
PubMed2004

Corneal and conjunctival changes caused by commonly used glaucoma medications.

PURPOSE: To evaluate the extent of epithelial corneal and conjunctival changes associated with prolonged use of topical glaucoma medications. METHODS: Thirty eyes of 15 New Zealand white rabbits were randomized to 1 of 6 treatment groups: artificial tears (Refresh Tears, carboxymethyl cellulose 0.5%) BID, brimonidine Purite 0.15% BID, bimatoprost 0.03% QD, dorzolamide 2% BID, timolol maleate 0.5% BID, or latanoprost 0.005% QD for 30 days. Corneal damage was evaluated by scanning electron microscopy and graded on a standard scale by a masked observer. Conjunctival inflammation was evaluated with light microscopy, and inflammatory cells were counted in the epithelium and superficial and deep stroma by a masked observer according to a standard protocol. RESULTS: In the cornea, artificial tears produced significantly less damage than dorzolamide or latanoprost (P = 0.001), and brimonidine Purite produced significantly less damage than dorzolamide, timolol, or latanoprost (P = 0.001). The mean damage scores with bimatoprost were significantly lower than with dorzolamide, timolol, or latanoprost (P = 0.002). In the conjunctiva, the number of inflammatory cells in the epithelium was significantly lower in eyes treated with artificial tears or brimonidine Purite than in eyes treated with timolol or latanoprost (P = 0.042). CONCLUSIONS: Although the adverse effects of glaucoma medications on the ocular surface are likely multifactorial, 1-month treatment with glaucoma medications containing higher levels of benzalkonium chloride (BAK) resulted in greater corneal damage and conjunctival cell infiltration than medications preserved with Purite or with lower levels of BAK. Using glaucoma medications with alternative preservatives or low levels of BAK may help preserve ocular health.

Animals↗
PubMed2006

Are multidose over-the-counter artificial tears adequately preserved?

PURPOSE: To investigate artificial tears containing different preservatives for antimicrobial efficacy. Based on the challenge test outlined in the European Pharmacopoeia, products were tested in their original containers to see whether their component preservative had sufficient activity. METHODS: Five brands of over-the-counter artificial tears each containing different preservatives (benzalkonium chloride/EDTA, parabens, chlorobutanol, silver chloride complex, and Purite-stabilized oxychloro complex) were inoculated with test microorganisms (Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans). Changes in the microbial start concentration with time were followed by plating onto growth media to provide a measure of the preservative efficacy. In another test, artificial tears were applied to paper disks that were then placed onto agar growth media seeded with microorganisms. Zones of inhibition were measured after incubation. RESULTS: Only the brand of artificial tears containing benzalkonium chloride/EDTA satisfied the major criteria for antimicrobial preservation for all the test microorganisms. Only a benzalkonium chloride/EDTA-containing disk placed on agar seeded with S. aureus produced a zone of inhibition in the agar diffusion test. CONCLUSION: The brand of artificial tears containing benzalkonium chloride/EDTA is suitable for sale in countries adopting the monographs of the European Pharmacopoeia. Other brands would only be suitable for sale if justified reasons for not meeting the major criteria for preservative efficacy can be provided.

Benzalkonium Compounds↗
PubMed2007

Travoprost 0.004% with and without benzalkonium chloride: a comparison of safety and efficacy.

PURPOSE: To compare the safety and efficacy of travoprost 0.004% without benzalkonium chloride (BAC) to that of the marketed formulation of travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension. METHODS: The study was a double-masked, randomized, parallel group, multicenter, noninferiority design. Adult patients with open-angle glaucoma or ocular hypertension with qualifying intraocular pressure (IOP) on 2 eligibility visits received either travoprost 0.004% with BAC (n=346), or travoprost 0.004% without BAC (n=344) dosed once-daily each evening. Patients were followed for a period of 3 months. IOP measurements at 8 AM, 10 AM, and 4 PM were taken at study visits on week 2, week 6, and month 3. RESULTS: Mean IOP reductions, across all 9 study visits and times ranged from 7.3 to 8.5 mm Hg for travoprost 0.004% without BAC and from 7.4 to 8.4 mm Hg for travoprost 0.004% with BAC. Statistical equivalence was also demonstrated for the comparison of mean IOP changes; 95% confidence limits were within +/-0.8 mm Hg at 9 of 9 study visits and times in both the per protocol and intent-to-treat data sets. Adverse events and the number of patients discontinued owing to adverse events were similar for both treatment groups. Adverse events due to hyperemia occurred in 6.4% and 9.0% of patients treated with travoprost 0.004% without BAC and travoprost 0.004% with BAC, respectively. CONCLUSION: Travoprost 0.004% without BAC is equivalent to travoprost 0.004% with BAC in both safety and efficacy.

Aged↗
PubMed2004

Tongue entrapment in an aluminum juice can.

Tongue entrapment in bottles and cans is rare, but occurs. The following is a case report of a 10-year-old female who got her tongue entrapped in an aluminum juice can. The anatomy of the tongue, complications from injury, and a proposed removal procedure are described.

4-Aminobenzoic Acid↗
PubMed2005

Safety, acceptability, and potential efficacy of a topical penile microbicide wipe.

Innovative, low-cost, and acceptable measures are needed to reduce sexually transmitted infections (STIs) including HIV. Use of a topical microbicide wipe for penile cleaning before and after sex might be effective in preventing STIs. However, evaluation of this simple method has not been done. Two studies were conducted in Malawi to determine the safety, acceptability, and potential efficacy of a benzalkonium chloride topical penile microbicide wipe. The first study was a phase 1 dose-escalating clinical trial among low-risk circumcised or uncircumcised HIV-negative men. The second study was a pilot before-after efficacy study among uncircumcised HIV-negative or -positive men. In the first study 24 circumcised and 27 uncircumcised men were enrolled. During the entire study period, 18 adverse events (AEs) were reported, and 3 AEs were confirmed by physical examination. Acceptability concerns did not increase with dose escalation, and adherence to use of the wipe ranged from 89%-95%. In the second study, 27 men were enrolled. Gram stain and culture tests showed significant reductions in frequency of several organisms after use of the wipe, including STI-associated bacteria. This penile wipe is safe, acceptable, and can decrease the frequency of penile colonization with microorganisms. The clinical relevance remains to be determined in larger clinical trials.

Adolescent↗
PubMed2007

Safety, acceptability, and tolerability of 3 topical microbicides among heterosexual Kenyan men.

OBJECTIVES: To compare the acceptability, tolerability, and safety of 3 topical microbicide formulations (62% ethyl alcohol in emollient gel and 0.1% and 0.4% benzalkonium chloride on a sanitary wipe) for use on male genitalia. DESIGN: This triple-randomized crossover study among men attending a sexually transmitted disease (STD) clinic in Nairobi, Kenya assigned individuals without clinical evidence of an STD to apply products to the penis in a predetermined random order, each for a 2-week period with a 1-week washout period between each product. Men recorded side effects and were examined for adverse events. RESULTS: Of 39 participants, 33 (84%) completed 6 clinic visits plus 3 home visits by community health workers. Participants reported use of 62% ethanol gel and 0.1% and 0.4% benzalkonium on 99%, 99%, and 96% of daily scheduled applications; 99%, 98%, and 97% of preintercourse applications, and 99%, 94%, and 98% of postintercourse applications. All participants said they would recommend all 3 products to a friend; 72% preferred the 62% ethanol gel, 17% the 0.1% benzalkonium, and 11% the 0.4% benzalkonium. One person developed objective signs of a genital ulcer after 14 days of 0.4% benzalkonium wipe use. CONCLUSIONS: Two of the 3 topical microbicides had minimal reported adverse effects, and no adverse effects were observed during use of the ethanol gel, which was preferred by most men.

Administration, Cutaneous↗
PubMed1989

Epidermal damage induced by irritants in man: a light and electron microscopic study.

Irritant contact dermatitis may be induced by many chemicals and has a far greater incidence than allergic contact dermatitis. Despite this, it receives relatively little attention and its pathogenesis remains poorly understood. To gain a greater understanding of the interaction of irritants with the skin, we investigated the histopathological changes resulting from the topical application of a series of structurally unrelated irritants. Human volunteers were patch-tested with appropriate concentrations of nonanoic acid, sodium lauryl sulphate, dithranol, benzalkonium chloride, croton oil, and propylene glycol, which produced generally mild to moderate responses. Biopsy specimens were taken after 48 h and examined by light and electron microscopy. Spongiosis and the infiltration of predominantly mononuclear cells were observed in the epidermis of the majority of biopsy specimens, and were particularly pronounced and extensive in croton oil reactions. In addition, several irritants induced distinct and characteristic patterns of keratinocyte damage. Nonanoic acid and sodium lauryl sulphate caused morphologic changes indicative of disturbances in keratinocyte metabolism and differentiation, giving rise to dyskeratosis and parakeratosis respectively, while dithranol induced marked swelling of keratinocytes in the upper epidermis. The results suggest that there is a diversity and specificity in the histopathology of irritant contact dermatitis, reflecting the different ways in which chemicals may interact with components of the skin.

Adult↗
PubMed1993

Differential patterns of epidermal leukocyte infiltration in patch test reactions to structurally unrelated chemical irritants.

In previous studies, we showed that a number of aspects of the histopathology of irritant contact dermatitis are profoundly influenced by the chemical nature of the irritant applied. We report here that this phenomenon also extends to the infiltration of leukocytes into the epidermis. Healthy volunteers were patch tested with the following irritants and their appropriate controls: benzalkonium chloride, sodium lauryl sulphate, croton oil, dithranol, nonanoic acid, and propylene glycol. After visually grading the intensity of the resulting inflammation, biopsies were removed and the major phenotypic classes of leukocytes identified immunocytochemically. Dermal and epidermal cell densities were determined, and the expression of several activation/proliferation antigens studied. We found a similar pattern of cellular infiltration in the dermis of all irritant groups; the densities of most of the cell types rising in line with the intensity of inflammation. Within the epidermis, however, there were marked differences in the patterns of cellular infiltration between the irritant groups, leading to poorer correlations between leukocyte density and visual grading. The greatest disparity occurred between croton oil and nonanoic acid biopsies, the former being characterized by the influx of large numbers of leukocytes, the latter showing remarkably little exocytosis. Infiltration of neutrophils occurred to varying degrees with all irritants, but a disproportionately large number were present in sodium lauryl sulphate biopsies. All control groups showed a rise in CD4+ cells, with distilled water also producing increases in CD11c+ cells and neutrophils. A selective influx of CD25+ cells occurred in the epidermis of both irritant and control groups. Our observations further highlight the heterogeneous nature of irritant contact dermatitis, and confirm previous findings that visually negative control patch tests show marked cellular reactivity.

Anthralin↗
PubMed1994

In vivo effects of interleukin-10 on contact hypersensitivity and delayed-type hypersensitivity reactions.

Interleukin (IL) 10 is a recently discovered cytokine, originally isolated from T-helper 2 (Th2) cells, which inhibits cytokine production of T-helper 1 (Th1) cells. Because Th1 cells appear to be of importance during the contact hypersensitivity reaction (CHS) we hypothesized that IL-10 might modulate the outcome of CHS in vivo. Intraperitoneal injection of murine recombinant IL-10 (1000 ng) into naive mice 24, 72, or 120 h before sensitization by epicutaneous application of 2,4-dinitrofluorobenzene (DNFB) did not affect ear swelling when ears were challenged 5 d later. However, intraperitoneal injection of IL-10 into already sensitized mice 24 h before challenge resulted in a significant suppression of the ear swelling response, suggesting that under the conditions employed IL-10 is able to block the effector phase, but not the induction phase of CHS in vivo. The suppression could be reversed by the concurrent injection of an IL-10 antibody. Moreover, heat inactivation of native IL-10 resulted in loss of the inhibitory capacity. When mice were sensitized by subcutaneous injection of trinitrophenyl-coupled spleen cells (DTH) instead of epicutaneous application of the hapten (CHS), intraperitoneally-injected IL-10 suppressed the effector phase, but also the induction phase of DTH. IL-10 did not inhibit the toxic ear-swelling response induced by topical application of two irritants tested (croton oil or benzalkonium chloride). The capacity of IL-10 to suppress the effector phase of CHS and DTH supports an important role for this cytokine in the downregulation of type IV immune reactions in vivo. The finding that IL-10 suppresses the induction of DTH, but not of CHS, further suggests that CHS and DTH are related but distinct immune reactions.

Animals↗
PubMed1987

Surfactants cause in vitro chemotaxis and chemokinesis of human neutrophils.

The surfactant sodium lauryl sulfate (SLS) and alkyldimethylbenzylammonium chloride (ADB) cause erythema and leukocyte infiltration on epicutaneous application. To elucidate the mechanism of this inflammatory response, the in vitro effect of the same agents was studied on human neutrophil migration, basophil histamine release, and leukocyte lysosomal enzyme (beta-glucuronidase) release. At concentrations of greater than 0.02%, both surfactants were cytotoxic, as was evident by decreased eosin exclusion, massive histamine and beta-glucuronidase-release, and absent migration of cells. At dilutions of less than 0.002% of both surfactants, viability of cells was normal, and small amounts of histamine and beta-glucuronidase were released at a dilution of 0.001%. The most striking finding was a dose-dependent chemotactic and chemokinetic response at dilutions from 10(-3) to 10(-8)%. These observations offer a possible explanation for the pathomechanisms of irritant dermatitis due to surfactants.

Benzalkonium Compounds↗
PubMed2004

Strong irritants masquerading as skin allergens: the case of benzalkonium chloride.

Chemicals may possess a number of hazards to human health including the ability to cause skin irritation and contact allergy. Identification and characterization of these properties should fall within predictive toxicology, but information derived from human exposure, including clinical experience, is also of importance. In this context, it is of interest to review the case of benzalkonium chloride, a cationic surfactant. This chemical is a well-known skin irritant, but on occasions it has also been reported to have allergenic properties, typically on the basis of positive diagnostic patch test data. Because the accumulated knowledge concerning the properties of a chemical is employed as the basis for its regulatory classification (e.g. in Europe), as well as for informing the clinical community with respect to the diagnosis of irritant versus allergic contact dermatitis (ACD), it is important to distinguish properly which chemicals are simply irritants from those which are both irritant and allergenic on skin. A review of the information on benzalkonium chloride confirms that it is a significant skin irritant. However, both predictive test results and clinical data lead to the conclusion that benzalkonium chloride is, at most, an extremely rare allergen, except perhaps in the eye, but with many supposed cases of ACD being likely to arise from the misinterpretation of patch test data. As a consequence, this substance should not normally be regarded as, or classified as, a significant skin sensitizer.

Benzalkonium Compounds↗
PubMed2005

Contact sensitivity to preservatives in Turkey.

This study was designed to evaluate the frequency of contact sensitivity to 14 common preservatives among patients with contact dermatitis in Turkey. From 2000 to 2004, 308 patients with the diagnosis of contact dermatitis were patch tested in the Department of Dermatology, Ankara University School of Medicine. All patients were patch tested with European standard series. In addition to the four preservatives included in the standard series, patients were also tested with DMDM hydantoin, imidazolidinyl urea, bromonitropropane diol, diazolidinyl urea, thimerosal, propylene glycol, chlorocresol, chloroxylenol, methyldibromoglutaronitrile/phenoxyethanol (MDBGN/PE) and benzalkonium chloride. Out of the 308 patients suspected of having contact dermatitis, 23 patients were found to have positive reactions to one or more preservatives. Preservatives that were the most frequent cause of positive reactions were thimerosal (1.6%), benzalkonium chloride (1.6%), formaldehyde (1.3%) and MDBGN/PE (0.9%). In our study, 65% of the positive reactions were caused by allergens not present in the standard series, such as thimerosal, benzalkonium chloride and MDBGN/PE. Although thimerosal caused a high rate of contact sensitivity, it may not be considered as an important allergen, because clinical relevance could not be found in any of the patients.

Adolescent↗