Montex®
Montelukast
Tablet
Allergic rhinitis (perennial or seasonal): Relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients ≥2 years of age and perennial allergic rhinitis in adults and pediatric patients ≥6 months of age. Because the benefits may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis, reserve use for patients who have had an inadequate response or intolerance to alternative therapies.
Asthma, persistent (maintenance therapy): Prophylaxis and chronic treatment of asthma in adults and pediatric patients ≥12 months of age.
Bronchoconstriction, exercise-induced (prevention): Prevention of exercise-induced bronchoconstriction in adults and pediatric patients ≥6 years of age.
Mechanism of Action:
Selective leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma. Cysteinyl leukotrienes are also released from the nasal mucosa following allergen exposure leading to symptoms associated with allergic rhinitis.
Method of Administration:
Allergic rhinitis, perennial or seasonal: 10 mg once daily
Asthma, persistent, maintenance therapy: 10 mg once daily in the evening. Some experts suggest waiting 1 to 2 months before assessing efficacy
Notes
Contraindications:
Hypersensitivity to montelukast or any component of the formulation
Interactions:
Gemfibrozil: May increase the serum concentration of Montelukast. Risk C: Monitor therapy
Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to noninhaled formulations of loxapine. Risk X: Avoid combination
Pregnancy and Lactation:
Based on available data, an increased risk of teratogenic effects has not been observed with montelukast use in pregnancy
In general, breastfeeding is considered acceptable
Warning and Precaution:
- Eosinophilia and vasculitis: In rare cases, patients may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with eosinophilic granulomatosis with polyangiitis (formerly known as Churg-Strauss); these clinical features may include eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy. A causal association between montelukast and these underlying conditions has not been established.
- Acute asthma/bronchospasm: Montelukast is not FDA approved for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Some studies, however, support its use as adjunctive therapy. Appropriate rescue medications should be available. Montelukast treatment should continue during acute asthma exacerbations.
Adverse Reactions:
Dermatologic: Atopic dermatitis (children: ≥2%), dermatitis (children: ≥2%), eczema (children: ≥2%), skin infection (children: ≥2%), skin rash (2%), urticaria (children: ≥2%)
Gastrointestinal: Abdominal pain (children: ≥2%), diarrhea (children and adolescents: ≥2%), dyspepsia (2%), gastroenteritis (2%), nausea (children and adolescents: ≥2%), tooth infection (children: ≥2%), toothache (adolescents and adults: 2%)
Genitourinary: Pyuria (adolescents and adults: 1%)
Hepatic: Increased serum alanine aminotransferase (adolescents and adults: ≥1%), increased serum aspartate aminotransferase (adolescents and adults: 2%)
Infection: Influenza (children and adolescents: ≥2%), varicella zoster infection (children: ≥2%), viral infection (children and adolescents: ≥2%)
Nervous system: Dizziness (adolescents and adults: 2%), fatigue (adolescents and adults: ≤2%), headache (children and adolescents: ≥2%)
Neuromuscular & skeletal: Asthenia (adolescents and adults: ≤2%)
Ophthalmic: Conjunctivitis (children: ≥2%), myopia (children: ≥2%)
Otic: Otalgia (children: ≥2%), otitis (children and adolescents: ≥2%), otitis media (children and adolescents: ≥2%)
Respiratory: Acute bronchitis (children: ≥2%), cough (3%), epistaxis (adolescents and adults: ≥1%), laryngitis (children and adolescents: ≥2%), nasal congestion (adolescents and adults: 2%), pharyngitis (children: ≥2%), pneumonia (children: ≥2%), rhinitis (infective; children: ≥2%), rhinorrhea (children: ≥2%), sinus headache (adolescents and adults: ≥1%), sinusitis (≥1%), upper respiratory tract infection (≥1%)
Storage:
Store below 30ºC and protect from light and moisture.