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The Journal of Asthma : Official... Dec 2022Neuropsychiatric events (NEs) reported with montelukast during post-marketing surveillance by the US Food & Drug Administration resulted in a 2008 safety alert and a...
OBJECTIVES
Neuropsychiatric events (NEs) reported with montelukast during post-marketing surveillance by the US Food & Drug Administration resulted in a 2008 safety alert and a black box warning in 2020. Our objective was to evaluate montelukast exposure and NEs risk using sequence symmetry analysis.
METHODS
National Veterans Health Administration (VHA) administrative data were used to identify 11 840 patients prescribed incident montelukast during fiscal year 2014. Incident prescribing of neuropsychiatric medication was used as a proxy marker for incident NEs and included antidepressants, benzodiazepines, hypnotics, antipsychotics, mood stabilizers, and buspirone. Symmetry ratios were calculated as the ratio of patients with an incident neuropsychiatric event in the year following montelukast initiation to the year preceding initiation. Exposure counterfactual analyses were used to examine the relationship between potential therapeutic alternatives to montelukast and risk for NEs.
RESULTS
Incident NEs were observed in 2305 patients following montelukast initiation and 2734 patients preceding montelukast initiation (SR 0.84, 95% CI 0.80-0.89). Sensitivity analyses examining each of the 6 sub-types of psychiatric medications also failed to show increased risk of NEs following montelukast initiation. Therapeutic alternatives to montelukast, such as inhaled corticosteroids, were also not associated increased NE risk.
CONCLUSIONS
Initiation of montelukast was not associated with increased risk of a variety of NEs in this sequence symmetry analysis involving adult patients in the VHA. Our findings do not support the hypothesis that NEs are associated with montelukast initiation.
Topics: Humans; Adult; Anti-Asthmatic Agents; Asthma; Acetates; Quinolines
PubMed: 34979844
DOI: 10.1080/02770903.2021.2018705 -
Die Pharmazie Nov 2019The aim of this study was to explore the clinical effect of montelukast sodium chewable tablets combined with inhaled budesonide in the treatment of pediatric asthma and... (Comparative Study)
Comparative Study Randomized Controlled Trial
The aim of this study was to explore the clinical effect of montelukast sodium chewable tablets combined with inhaled budesonide in the treatment of pediatric asthma and its influence on inflammatory factors. One hundred and thirty-five asthmatic children were randomly divided into montelukast sodium group, budesonide group and combined group. Clinical symptoms, lung function, inflammatory factors and immune related indices of patients in each group were observed and recorded. After treatment, the times to disappearance of wheezes, dyspnea, asthma and hospital stay in the combined group were significantly shorter than those in the single-drug group (all p < 0.001). Forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), peak expiratory flow (PEF) were significantly higher than those before treatment, and in the combined group value were significantly higher than in the single-drug group in the same period (all p < 0.001). Tumor necrosis factor-α (TNF-α), interleukin-4 (IL-4), IL-8 and hypersensitive C-reactive protein (hs-CRP) were significantly lower than before treatment, and the combined group was significantly lower than the single-drug group in the same period (all p < 0.05). The number of CD4 and CD3 cells in the combined group was significantly higher than that in the single-drug group, while the number of CD8 + cells and the expression level of immune globulin E (IgE) were significantly lower (all p < 0.05). There was no difference in the incidence of adverse reactions between the groups during treatment (p > 0.05). Six months after treatment, the incidence of asthma in the combined group was significantly lower than that in the single-drug group (both p < 0.05). Montelukast sodium chewable tablets combined with inhaled budesonide can shorten the discomfort duration of asthmatic children and help them restore lung function. Moreover, it reduces the level of inflammatory factors and increases the resistance of children, which is worthy of further promotion and application.
Topics: Acetates; Administration, Inhalation; Administration, Oral; Anti-Asthmatic Agents; Asthma; Budesonide; Child; Child, Preschool; Cyclopropanes; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Inflammation; Male; Quinolines; Respiratory Function Tests; Sulfides; Tablets; Treatment Outcome
PubMed: 31739840
DOI: 10.1691/ph.2019.9582 -
International Journal of Clinical... Dec 2013We report a rare case of montelukast sodium-induced hematuria in a 58-year-old female patient with allergic rhinitis. Renal function returned to normal after drug...
We report a rare case of montelukast sodium-induced hematuria in a 58-year-old female patient with allergic rhinitis. Renal function returned to normal after drug withdrawal. We reviewed 19 case reports of adverse reactions associated with montelukast sodium in mainland China and found that (1) 37% of patients were pediatric patients, (2) psychiatric disorders, rashes and uropoietic organs symptom were common, (3) uropoietic organ symptoms reported in mainland China were very rare abroad. The clinician in China should be vigilant about the adverse reaction of montelukast sodium and further studies are needed to explore the pathogenesis of montelukast-induced uropoietic organ symptoms.
Topics: Acetates; Adult; Aged; Aged, 80 and over; Child; Child, Preschool; Cyclopropanes; Female; Hematuria; Humans; Infant; Leukotriene Antagonists; Male; Middle Aged; Quinolines; Sulfides
PubMed: 24131737
DOI: 10.5414/CP201952 -
American Journal of Translational... 2021To investigate efficacy of azelastine hydrochloride combined with montelukast sodium in the treatment of patients with allergic rhinitis.
OBJECTIVE
To investigate efficacy of azelastine hydrochloride combined with montelukast sodium in the treatment of patients with allergic rhinitis.
METHODS
A total of 137 patients with allergic rhinitis in our hospital were divided into two groups, 70 patients in the experimental group received azelastine hydrochloride combined with montelukast sodium treatment, while 67 patients in the control group were given only azelastine hydrochloride treatment. The clinical therapeutic effect, clinical symptom score and serum levels of inflammatory factors were recorded.
RESULTS
The clinical therapeutic effect of the two groups after treatment were improved compared to those without intervention (P < 0.05), and the total effective rate of the experimental group was 94.3% (66/70), which was higher than that of the control group (83.6%). The clinical symptom score (nasal itching, nasal congestion and runny nose) of two groups was decreased after receiving the intervention, and the scores in the experimental group were much lower than the control group after receiving the intervention (P < 0.05). The serum levels of inflammatory factors (IL-6, IL-8 and hsCRP) were obviously lower in the two groups after treatment, and those levels in the experimental group were much lower than the control group after receiving the intervention. Furthermore, after the receiving treatment, the levels of each of the inflammatory and anti-inflammatory factors in the experimental group were significantly ameliorated compared to those in the control group (P < 0.05).
CONCLUSION
Azelastine hydrochloride combined with montelukast sodium can effectively improve clinical symptoms and inflammatory reactions in patients with allergic rhinitis; furthermore, this research provides ideas for clinical practice.
PubMed: 34540080
DOI: No ID Found -
Viruses Apr 2022Coronaviruses (CoVs) consist of a large group of RNA viruses causing various diseases in humans and in lots of animals. Human coronavirus (HCoV) OC43, the prototype of...
Coronaviruses (CoVs) consist of a large group of RNA viruses causing various diseases in humans and in lots of animals. Human coronavirus (HCoV) OC43, the prototype of beta-coronavirus discovered in the 1960s, has been circulating in humans for long time, and infection with other emerging strains of beta-coronavirus (SARS-CoV, SARS-CoV-2, and MERS-CoV) can lead to severe illness and death. In this study, we found that montelukast, a leukotriene receptor antagonist, potently inhibited the infection of HCoV-OC43 in distinct cells in a dose- and time- dependent manner. Additionally, the results showed that montelukast induced release of HCoV-OC43 genomic RNA by disrupting the integrity of the viral lipid membrane, and irreversibly inhibited viral infection. Considering the similarity among HCoV-OC43, MERS-CoV, and SARS-CoV-2, it suggests that montelukast may be a potential candidate for the treatment of human beta-coronavirus infection.
Topics: Acetates; Animals; Coronavirus OC43, Human; Cyclopropanes; Middle East Respiratory Syndrome Coronavirus; Quinolines; SARS-CoV-2; Sulfides; COVID-19 Drug Treatment
PubMed: 35632604
DOI: 10.3390/v14050861 -
Expert Opinion on Pharmacotherapy Mar 2004Montelukast sodium (Singulair, Merck) is a selective and orally-active leukotriene-receptor antagonist (LTRA) that inhibits the cysteinyl leukotriene 1 (CysLT1)... (Review)
Review
Montelukast sodium (Singulair, Merck) is a selective and orally-active leukotriene-receptor antagonist (LTRA) that inhibits the cysteinyl leukotriene 1 (CysLT1) receptor. Montelukast is an effective and well-tolerated preventative treatment for asthma and allergic rhinitis in adults and children. The upper and lower airway show similar inflammatory responses to allergen challenge. Leukotrienes are inflammatory mediators that are known as the slow-reacting substance of anaphylaxis produced by a number of cell types including mast cells, eosinophils, basophils, macrophages and monocytes. Synthesis of these mediators results from the cleavage of arachidonic acid in cell membranes and they exert their biological effects by binding and activating specific receptors. This occurs in a series of events that lead to contraction of the human airway smooth muscle, chemotaxis and increased vascular permeability. These effects have led to their important role in the diseases of asthma and allergic rhinitis. As these agents lead to the production of symptoms in patients that are asthmatic or allergic, the use of LTRAs, particularly montelukast, may seem appropriate. Clinical trials have shown that montelukast is effective and safe in the treatment of patients with asthma, allergic rhinitis or both diseases.
Topics: Acetates; Anti-Asthmatic Agents; Asthma; Cyclopropanes; Humans; Leukotriene Antagonists; Membrane Proteins; Quinolines; Randomized Controlled Trials as Topic; Receptors, Leukotriene; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Sulfides
PubMed: 15013935
DOI: 10.1517/14656566.5.3.679 -
Pharmacology 2014Montelukast, a leucotriene receptor antagonist, binds the cysteinyl leucotriene type 1 receptor. Montelukast is commonly prescribed to asthma patients as add-on therapy... (Review)
Review
BACKGROUND
Montelukast, a leucotriene receptor antagonist, binds the cysteinyl leucotriene type 1 receptor. Montelukast is commonly prescribed to asthma patients as add-on therapy to inhaled corticosteroids. Several clinical trials emphasized that montelukast can be considered a safe drug. However, recent evidence reconsidered the benefit/risk ratio of the use of montelukast for both paediatric and adult patients.
SUMMARY
The present review analyzed the previous published case reports regarding montelukast-induced adverse drug reactions (ADRs). They included agitation, anxiety, depression, sleep disturbance, hallucinations, suicidal thinking and suicidality, tremor, dizziness, drowsiness, neuropathies and seizures. The immune system can be involved, in particular, cases of Churg-Strauss syndrome have been published. Furthermore, it can induce hypersensitivity reactions, including anaphylaxis and eosinophilic infiltration. In addition, hepatobiliary, pancreatic and uropoietic disorders have been observed. Some of these cases are characterized by severe prognosis (i.e. neurological deficit and fatal hepatotoxicity). Key Message: The use of montelukast can be burdened by several ADRs, of which physicians should be aware in their clinical practice. A better understanding of the mechanisms causing ADRs after using montelukast could help researchers and clinicians in defining a risk-reduction strategy aimed to lessen montelukast toxicity. More accurate epidemiological studies, in order to discover risk factors favouring montelukast-associated ADRs, are demanded.
Topics: Acetates; Adult; Anti-Asthmatic Agents; Asthma; Child; Cyclopropanes; Humans; Leukotriene Antagonists; Quinolines; Risk Factors; Sulfides
PubMed: 25196099
DOI: 10.1159/000366164 -
American Journal of Health-system... Oct 2009A possible case of montelukast-induced angioedema is reported.
PURPOSE
A possible case of montelukast-induced angioedema is reported.
SUMMARY
A 46-year-old woman with a history of severe allergies, including food allergies, and angioedema was evaluated at the emergency department (ED) for an acute episode of angioedema. Upon arrival at the ED, the patient had severe jaw tightness, facial numbness, uncontrollable cheek lifting, swollen eyes, and a swollen protruding tongue and was unable to catch her breath. Her dyspnea was apparent, and she was unable to talk and instead used hand and face gestures for affirmative and negative responses. The patient was treated with 0.3 mg epinephrine intramuscularly into the right thigh. After treatment, she had a temperature of 37 degrees C, a pulse of 90 beats/ min, a blood pressure value of 100/59 mm Hg, a respiratory rate of 16 breaths/min, and 100% oxygen saturation on room air. After stabilization, she reported that her allergies had been adequately controlled with ebastine 10 mg daily, montelukast 10 mg daily, and vitamins (unspecified). The patient reported that since she started montelukast one month prior, she experienced three similar episodes, the first occurring five days after starting the drug. She mentioned being diagnosed and adequately treated these three times in the ED for angioedema. The patient denied any changes in eating habits or in her medications except for starting montelukast. She was observed at the ED for an hour and then discharged after stabilization on hydroxyzine hydrochloride 25 mg orally daily and fexofenadine hydrochloride 180 mg orally daily. Montelukast was discontinued.
CONCLUSION
A patient developed angioedema four times during one month of treatment with montelukast.
Topics: Acetates; Angioedema; Cyclopropanes; Female; Humans; Hypersensitivity; Leukotriene Antagonists; Middle Aged; Quinolines; Sulfides
PubMed: 19767375
DOI: 10.2146/ajhp080408 -
Pediatric Allergy and Immunology :... Mar 2014Infants often develop reactive airway diseases subsequent to respiratory syncytial virus (RSV) bronchiolitis. Cysteinyl leukotrienes (cysLTs), a class of lipid mediators... (Meta-Analysis)
Meta-Analysis Review
Infants often develop reactive airway diseases subsequent to respiratory syncytial virus (RSV) bronchiolitis. Cysteinyl leukotrienes (cysLTs), a class of lipid mediators that have been implicated in the pathogenesis of allergic rhinitis and asthma, are released during RSV infection, thereby contributing to the pathogenic changes in airway inflammation. Many pediatric patients, especially those of very young age, continue to have recurrent episodes of lower airway obstruction after bronchiolitis treatment. This study was to systematically review and assessed the efficacy of montelukast for preventing wheezing in patients with post-bronchiolitis. The Cochrane library, PubMed, China National Knowledge Infrastructure (CNKI) periodical databases were screened for studies related to use of montelukast for preventing post-bronchiolitis wheezing published up to 31 December 2012. Randomized controlled trials (RCTs) and quasi-RCTs using montelukast alone as an active intervention in infants up to 24 months of age with post-bronchiolitis were selected. Two authors independently extracted data and assessed trial quality using the recommendations published by the Cochrane Collaboration. The meta-analyses were performed using the Cochrane statistical package RevMan5.0.0. Four trials, containing 1430 infants with confirmed diagnosis of acute bronchiolitis, were analyzed. Patients were administered montelukast at post-bronchiolitis. Three trials showed no effects of montelukast on reducing the incidence of recurrent wheezing risk ratios (RR = 0.78, 95% CI: 0.55-1.12, p = 0.17), while two trials found that montelukast did reduce the frequency of recurrent wheezing and another two trials demonstrated no effects of montelukast on symptom-free days. The pooled montelukast treatment group showed no significant effect on reducing the usage of corticosteroids, as compared to the placebo group (RR = 1.11, 95% CI: 0.85-1.44, p = 0.45). Two trials showed that montelukast significantly decreased serum eosinophil-derived neurotoxin levels, as compared to the control group. In general, the side effects of rash, vomiting, and insomnia caused by montelukast occurred in 1.5% of patients analyzed. The recent evidences indicate that montelukast may reduce the frequency of post-bronchiolitic wheezing without causing significant side effects but that it has no effects on decreasing incidences of recurrent wheezing, symptom-free days, or the associated usage of corticosteroid in post-bronchiolitis patients. The small number of enrolled participants and the inability to pool all clinical outcomes precludes us from making solid recommendations.
Topics: Acetates; Age Factors; Bronchiolitis, Viral; Chi-Square Distribution; Child, Preschool; Cyclopropanes; Humans; Infant; Infant, Newborn; Leukotriene Antagonists; Odds Ratio; Quinolines; Respiratory Sounds; Respiratory Syncytial Virus Infections; Risk Factors; Sulfides; Treatment Outcome
PubMed: 24118637
DOI: 10.1111/pai.12124 -
Journal of AOAC International Sep 2021Concomitant montelukast and bilastine are used as additive therapy for seasonal allergic rhinoconjuctivitis and mild to moderate asthma. According to a literature...
Risk Assessment-Based Enhanced Analytical Quality-by-Design Approach to Eco-Friendly and Economical Multicomponent Spectrophotometric Methods for Simultaneous Estimation of Montelukast Sodium and Bilastine.
BACKGROUND
Concomitant montelukast and bilastine are used as additive therapy for seasonal allergic rhinoconjuctivitis and mild to moderate asthma. According to a literature review, no UV-visible spectrophotometric method has been reported yet for simultaneous estimation of montelukast sodium and bilastine in their combined pharmaceutical dosage forms.
OBJECTIVE
Five different multicomponent spectrophotometric methods were therefore developed and validated for simultaneous estimation of montelukast sodium and bilastine using a risk assessment-based enhanced analytical quality-by-design approach.
METHOD
The identification and assessment of method risk parameters were carried out using the risk priority number ranking and filtering method according to the International Conference on Harmonization (ICH) Q9 guideline. The wavelength for detection and solvents such as 0.1 N NaOH and 0.1 N HCl were found to be critical method parameters for the development of the target methods. The developed methods were validated as per the ICH Q2(R1) guideline.
RESULTS
The developed and validated methods were applied for assay of combined pharmaceutical dosage forms of montelukast sodium and bilastine and results were found to be in good agreement with their label claims.
CONCLUSIONS
The developed methods did not include the usage of any organic solvent and are a good alternative to the costly chromatography method. Hence, the methods are eco-friendly and economical for the simultaneous estimation of bilastine and montelukast sodium.
HIGHLIGHTS
Five multicomponent spectrophotometric methods were developed for simultaneous estimation of montelukast sodium and bilastine using a risk-based analytical quality-by-design approach. An assay of combined tablet dosage forms of montelukast sodium and bilastine was then carried out using the developed methods.
Topics: Acetates; Benzimidazoles; Cyclopropanes; Piperidines; Quinolines; Risk Assessment; Sulfides
PubMed: 34240184
DOI: 10.1093/jaoacint/qsab089