Singulair: Targeted Leukotriene Inhibition for Asthma and Allergy Control
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Synonyms
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Singulair (montelukast sodium) is a prescription leukotriene receptor antagonist (LTRA) specifically formulated for the prophylaxis and chronic treatment of asthma, as well as the relief of allergic rhinitis symptoms. It represents a cornerstone in maintenance therapy for reactive airway diseases, offering a non-steroidal mechanism that targets the underlying inflammatory pathways. By selectively blocking cysteinyl leukotriene activity, it reduces bronchoconstriction, vascular permeability, and eosinophil recruitment. This oral medication provides a convenient, once-daily dosing option suitable for adults and pediatric patients down to 12 months of age, making it a versatile tool in the long-term management of chronic inflammatory conditions of the airways.
Features
- Active pharmaceutical ingredient: Montelukast sodium
- Available in 4mg chewable, 5mg chewable, and 10mg film-coated tablet formulations
- Leukotriene D4 (LTD4) receptor selective antagonist
- Once-daily oral administration regimen
- Bioavailability approximately 64% for chewable tablets and 73% for film-coated tablets
- Peak plasma concentration reached in 3-4 hours post-administration
- Extensively metabolized by hepatic cytochrome P450 enzymes (CYP3A4, CYP2C9)
- Mean plasma half-life ranges from 2.7 to 5.5 hours in healthy adults
- Excretion primarily through biliary pathways
Benefits
- Reduces frequency and severity of asthma exacerbations by targeting inflammatory mediators
- Provides complementary anti-inflammatory action to inhaled corticosteroids
- Decreases reliance on rescue bronchodilators for asthma symptom control
- Effectively manages perennial and seasonal allergic rhinitis symptoms
- Prevents exercise-induced bronchoconstriction when administered 2 hours prior to activity
- Offers pediatric-appropriate formulations with favorable safety profiles
Common use
Singulair is indicated for the prophylaxis and chronic treatment of asthma in patients 12 months of age and older. It is particularly valuable for patients who require add-on therapy when low to medium doses of inhaled corticosteroids prove insufficient for complete symptom control. The medication is also approved for the relief of symptoms of allergic rhinitis (seasonal and perennial) in patients aged 2 years and older. Additionally, it is prescribed for the prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older, with administration recommended approximately 2 hours before exercise. Clinical evidence supports its use in reducing nighttime symptoms and improving morning peak expiratory flow rates in asthmatic patients.
Dosage and direction
Asthma and Allergic Rhinitis:
- Adults and adolescents 15 years and older: One 10mg tablet daily, taken in the evening
- Children 6 to 14 years: One 5mg chewable tablet daily, taken in the evening
- Children 2 to 5 years: One 4mg chewable tablet daily, taken in the evening
- Children 12 to 23 months: One 4mg chewable tablet daily, taken in the evening
Exercise-Induced Bronchoconstriction:
- Patients 15 years and older: One 10mg tablet at least 2 hours before exercise
- Patients 6 to 14 years: One 5mg chewable tablet at least 2 hours before exercise
Administration should occur consistently at the same time each day, with or without food. Chewable tablets must be chewed thoroughly before swallowing and are not intended to be swallowed whole. The medication is not intended for the treatment of acute asthma attacks.
Precautions
Patients should be monitored for neuropsychiatric events including agitation, aggression, depression, sleep disturbances, and suicidal ideation. These symptoms have been reported in patients taking Singulair, with some cases resulting in discontinuation of therapy. Regular assessment of asthma control is necessary, as Singulair should not be used as monotherapy for severe persistent asthma or for the treatment of acute asthma exacerbations. Patients should be advised not to discontinue or reduce the dosage of any other asthma medications unless instructed by their physician. Systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, has been reported rarely in association with the reduction of oral corticosteroid therapy. Caution is advised in patients with phenylketonuria, as the chewable tablets contain aspartame.
Contraindications
Singulair is contraindicated in patients with known hypersensitivity to montelukast or any component of the formulation. The medication should not be used for the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. It is not indicated as monotherapy for the treatment and management of exercise-induced bronchospasm in patients who require rescue medication for occasional episodes. Patients with severe hepatic impairment should use caution, though no specific contraindication exists based solely on hepatic function.
Possible side effect
The most common adverse reactions (>5% incidence) include headache, influenza, abdominal pain, cough, and fever. Less frequently reported side effects (>2% incidence) comprise fatigue, dental pain, dizziness, gastroenteritis, dyspepsia, otitis media, pharyngitis, sinusitis, and nasal congestion. Serious but rare adverse events may include hepatic eosinophilic infiltration, hepatitis, and hepatic failure. Neuropsychiatric events have been reported post-marketing, including dream abnormalities, insomnia, anxiety, depression, agitation including aggressive behavior, hallucinations, suicidal thinking and behavior, and tremor. Allergic reactions including anaphylaxis, angioedema, rash, and urticaria have been reported rarely.
Drug interaction
Montelukast is metabolized by CYP450 enzymes, primarily CYP3A4 and CYP2C9. Concomitant administration with potent CYP450 inducers such as rifampin, phenobarbital, or carbamazepine may decrease montelukast plasma concentrations. Gemfibrozil, a strong CYP2C8 inhibitor, can significantly increase montelukast plasma concentrations. No clinically significant interactions have been observed with theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, digoxin, or warfarin. However, monitoring is advised when co-administering with other highly protein-bound drugs, as montelukast is more than 99% bound to plasma proteins.
Missed dose
If a dose is missed, the patient should take it as soon as remembered, unless it is almost time for the next scheduled dose. In such cases, the missed dose should be skipped, and the regular dosing schedule resumed. Patients should not double the dose to make up for a missed administration. Consistency in daily dosing is important for maintaining therapeutic effect, particularly for asthma prophylaxis.
Overdose
Experience with montelukast overdose is limited. In chronic overdose reports, the most common symptoms included abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity. Management should be supportive and symptomatic. There is no specific antidote for montelukast overdose. Hemodialysis does not enhance elimination of montelukast, as the drug is extensively protein-bound. In cases of significant overdose, activated charcoal may be administered if presentation is early after ingestion. Monitoring of vital signs and clinical status is recommended, with particular attention to potential neuropsychiatric manifestations.
Storage
Store at room temperature between 15°C to 30°C (59°F to 86°F). Keep in the original container with the lid tightly closed to protect from moisture and light. Keep out of reach of children. Do not use after the expiration date printed on the packaging. The medication should be stored in a dry place, and the desiccant contained in the bottle should not be removed.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Singulair is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Patients should not initiate, discontinue, or change their dosage without consulting their physician. The complete prescribing information should be reviewed before initiating therapy. Individual results may vary, and not all patients will experience the same benefits or side effects.
Reviews
Clinical studies demonstrate that Singulair significantly improves asthma control scores, reduces nocturnal symptoms, and decreases rescue medication use compared to placebo. In pediatric populations, it shows consistent efficacy in improving asthma symptoms and pulmonary function parameters. For allergic rhinitis, multiple trials confirm reduction in daytime nasal symptoms, nighttime symptoms, and composite symptom scores. Patient-reported outcomes indicate improved quality of life measures in both asthma and allergic rhinitis populations. Long-term extension studies support the maintenance of efficacy over 52 weeks of continuous treatment with a consistent safety profile.