Singulair (Montelukast Sodium) - Summary

SINGULAIR SUMMARY

What is SINGULAIR¹?

Montelukast sodium, the active ingredient in SINGULAIR, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT₁ receptor.

SINGULAIR is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.

SINGULAIR is indicated for the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older.

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NEWS HIGHLIGHTS

Media Articles Related to Singulair (Montelukast)

ACAAI: Tots with Asthma Benefit from Montelukast (CME/CE)
Source: MedPage Today Allergy & Immunology [2009.11.12]
MIAMI BEACH (MedPage Today) -- Treating asthmatic children as young as 6 months with the leukotriene receptor antagonist montelukast (Singulair) appears effective, according to pooled analyses of two similar randomized clinical trials.

ACAAI: Fluticasone Plus Salmeterol Cuts Exacerbations in Asthma (CME/CE)
Source: MedPage Today Allergy & Immunology [2009.11.12]
MIAMI BEACH (MedPage Today) -- Researchers reported here that pediatric patients with asthma treated with fluticasone propionate plus salmeterol in a fixed-dose combination experienced fewer serious asthma exacerbations and lower costs when compared with the use of inhaled corticosteroids plus montelukast.

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Published Studies Related to Singulair (Montelukast)

Can Montelukast Shorten Prednisolone Therapy in Children with Mild to Moderate Acute Asthma? A Randomized Controlled Trial. [2009.08.03]
OBJECTIVE: To examine whether outpatient post-stabilization therapy with montelukast produces more treatment failures than prednisolone... CONCLUSION: Montelukast does not represent an adequate alternative to corticosteroids after outpatient stabilization in mild to moderate acute asthma. This population should receive oral corticosteroids after discharge.

A randomized study comparing the effect of loratadine added to montelukast with montelukast, loratadine, and beclomethasone monotherapies in patients with chronic asthma. [2009.06]
CONCLUSION: In this study, the addition of loratadine to montelukast produced a small numerical, but not statistically significant, improvement in FEV(1) and, in general, no consistent improvement in other asthma endpoints. No improvement of montelukast + loratadine versus beclomethasone was seen in any endpoint.

Single-dose desloratadine and montelukast and allergen-induced late airway responses. [2009.06]
Montelukast and desloratadine synergistically inhibit the allergen-induced early asthmatic response...

Montelukast in the treatment of duodenal eosinophilia in children with dyspepsia: effect on eosinophil density and activation in relation to pharmacokinetics. [2009.05.11]
BACKGROUND: We have previously demonstrated the clinical efficacy of montelukast in a randomized double-blind controlled cross-over trial in patients with dyspepsia in association with duodenal eosinophilia. The mechanism of this clinical response is unknown but could involve a decrease in eosinophil density or activation... CONCLUSION: The short-term clinical response to montelukast does not appear to result from changes in eosinophil density or activation. Whether the effect is mediated through specific mediators or non-inflammatory cells such as enteric nerves remains to be determined. TRIAL REGISTRATION: ClinicalTrials.gov; NCT00148603.

Montelukast as add-on therapy with inhaled corticosteroids alone or inhaled corticosteroids and long-acting beta-2-agonists in the management of patients diagnosed with asthma and concurrent allergic rhinitis (the RADAR trial). [2009.05]
OBJECTIVE: To evaluate the effectiveness of montelukast as add-on therapy for patients diagnosed with asthma and concurrent allergic rhinitis who remain uncontrolled while receiving inhaled corticosteroid (ICS) monotherapy or ICS/long-acting beta-2-agonist (LABA) therapy in a community practice setting... CONCLUSION: Montelukast add-on therapy is effective for managing asthma and allergic rhinitis symptoms in patients who were previously uncontrolled with ICS or ICS/LABA treatment.

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Clinical Trials Related to Singulair (Montelukast)

Exercise Induced Bronchospasm in Children [Completed]
The purpose of the study is to test how well 2 different medications stop asthma symptoms caused by exercising. The two medications that will be tested are "pretreatment with albuterol" and montelukast (Singulair®). Although both medications are used for treating asthma, we don't know which medicine is better at stopping asthma symptoms caused by exercising.

A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease [Completed]
This randomized, double-blind, placebo-controlled trial assessed the efficacy of montelukast in the treatment of adults ≥50 years of age with persistent asthma and/or COPD. Primary outcomes included forced expiratory volume in one-second (FEV1) and daytime asthma symptoms scores. Nocturnal symptoms, asthma control, health-related quality of life, peak flow measurements, and health care utilization were also assessed as secondary outcomes. Participants were recruited from the Kaiser Permanente Northwest member population. One hundred forty-nine subjects were randomized to treatment with montelukast (10 mg per day) or placebo, and were followed for a six-week period. No differences in lung function measures, health-related quality of life, health care utilization, and asthma symptom scores were observed; however, the montelukast group had slightly improved asthma control scores compared to the placebo group.

A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years [Completed]

Montelukast in Acute RSV Bronchiolitis [Completed]
There is evidence of inflammatory mechanisms in RSV bronchiolitis with increased

cysteinyl-leukotrienes (cys-LT). Recently, specific cys-LT receptor antagonists - montelukast

(Singulair©) approved for use in infants as granule sachets, have become available. We evaluated the effect of Singulair© on clinical progress and on cytokine profiles in the acute phase of RSV bronchiolitis.

First Step With Singulair® Therapy [Completed]
In adult patients with mild persistent asthma, singulair® 10 mg will be at least as effective as low dose Inhaled Corticosteroids (ICS) in improving asthma symptom control or satisfaction over a 6 week comparison period.

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PATIENT REVIEWS / RATINGS / COMMENTS

Singulair review by care giver of 4 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Hay fever type allergy reactions
Dosage & duration:		1 tablet disolved in mouth at night taken daily for the period of 4 months
Other conditions:		dry skin- childhood excema
Other drugs taken:		none
		Reported Results
Benefits:		My son attends a preschool with many mulberry trees on the grounds. These trees drop large amounts of pollen right on the children during parts of the year. He would begin to itch all over and develop red splotches on his face. The pediatrician prescribed Singular each night and it has alleviated all his symptoms.
Side effects:		We have not seen any side effects. He is not even made sleepy by this antihisitamine.
Comments:		One tablet disolved in mouth before bed. He dislikes the taste, but we solve that by taking his gummy vitamins immediately after the Singular.

Singulair review by 45 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		asthma
Dosage & duration:		10mg taken daily for the period of several years
Other conditions:		Restless leg syndrome
Other drugs taken:		requip
		Reported Results
Benefits:		I find that this drug effectively eliminates symptoms of restless leg syndrome. When having to sit in one position for extended periods (long air flights, car trips, meetings,) I experience great discomfort and an almost uncontrollable need to move my legs. This drug eliminates all discomfort and compulsion to move. It's terrific!
Side effects:		none
Comments:		I take one pill as needed.

Singulair review by 38 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		Asthma, Allergies
Dosage & duration:		10 mg per day taken once a day for the period of 6 years
Other conditions:		severe asthma, environmental allergies, depression
Other drugs taken:		inhaled cortisteroids, antihistamines, ssri
		Reported Results
Benefits:		some reduction in lung inflammation
Side effects:		Severe mood swings, depression, frequent lung infections
Comments:		I took singulair for years before I realized that it was not really doing much and I strongly suspect that it contributed to my severe depression and mood swings. I have always had severe asthma and allergies and was hospitalized many times as a youngster. I did have allergy shots which I truly think helped with my allergies. When I got older, and inhaled cortisteroids were invented I started taking them, along with Singulair. I was told that it was the "most benign medication that I was on" so I never thought twice about popping that small pill each day. I suffered from frequent chest infections - that is a side effect of the singulair since it blocks the leuketrines that react and cause inflammation. When I was 25, I started having severe mood swings and had to start taking an anti-depressant. I continued the singulair without any thoughts. However, after my third child, we were broke and I was trying to cut some medications down to save money and I stopped the singulair for a while. I did notice that my asthma got worse so I figured oh well, have to start the Singulair again, that's when I started having the severe mood swings again. I started doing some research online and read an article written by a mother who lost her son to suicide and attributed it to the singulair. In my heart of hearts, I truly believe that more attention should be given to this drug, and it's affects on the brain. I am no longer taking it and I am having much better luck with zyrtec.