montelukast and Diarrhea

Montelukast is a cysteinyl leukotriene receptor antagonist approved for the treatment of asthma for those ages 1 year old to adult. The purpose of this study was to evaluate the pharmacokinetic comparability of a 4-mg dose of montelukast oral granules in patients > or = 6 to < 24 months old to the 10-mg approved dose in adults. This was an open-label study in 32 patients. Population pharmacokinetic parameters included estimates of AUC(pop), C(max), and t(max). Results were compared with estimates from adults (10-mg film-coated tablet [FCT]). Dose selection criteria were for the 95% confidence interval (CI) for the AUC(pop) estimate ratio (pediatric/adult 10 mg FCT) to be within comparability bounds of (0.5, 2.00). The AUC(pop) ratio and the 95% CI for children compared with adults were within the predefined comparability bounds. Observed plasma concentrations were also similar. Based on systemic exposure of montelukast, a 4-mg dose of montelukast appears appropriate for children as young as 6 months of age.

Topics: Acetates; Administration, Oral; Area Under Curve; Asthma; Blood Urea Nitrogen; Chemistry, Pharmaceutical; Child, Preschool; Cyclopropanes; Diarrhea; Half-Life; Humans; Infant; Male; Mastication; Quinolines; Receptors, Leukotriene B4; Sulfides; Tablets

Topics: Acetates; Anti-Allergic Agents; Arylsulfonates; Child; Cyclopropanes; Diarrhea; Diet; Enteritis; Eosinophilia; Food Hypersensitivity; Gastritis; Humans; Male; Quinolines; Sulfides; Sulfonium Compounds; Terfenadine; Treatment Outcome

Previously described treatments used for eosinophilic diseases of the gastrointestinal tract have included dietary restrictions primarily of cow milk protein, anti-inflammatory therapy utilizing suplatast, budesonide and corticosteroids, cromolyn sodium, anti-histamines and oral inhalable steroids. We describe a 12-year-old girl with diarrhea and malabsorption, who was later diagnosed to have eosinophilic gastroenteritis, was unresponsive to standard therapies, but exhibited marked improvement with use of montelukast.

Topics: Acetates; Child; Cyclopropanes; Diagnosis, Differential; Diarrhea; Endoscopy, Gastrointestinal; Enteritis; Eosinophilia; Female; Gastritis; Humans; Leukotriene Antagonists; Malabsorption Syndromes; Quinolines; Sulfides; Treatment Outcome

Topics: Acetates; Adult; Anti-Inflammatory Agents; Cromolyn Sodium; Cyclopropanes; Diarrhea; Drug Therapy, Combination; Enzyme Inhibitors; Exanthema; Female; Flushing; Histamine H2 Antagonists; Humans; Leukotriene Antagonists; Mastocytosis, Systemic; Prednisone; Protein-Tyrosine Kinases; Quinolines; Ranitidine; Staurosporine; Sulfides; Tryptases; Vomiting

Topics: Abdominal Pain; Acetates; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Budesonide; Capillary Permeability; Cough; Cyclopropanes; Diarrhea; Dyspnea; Female; Humans; Lung; Mast Cells; Mastocytosis, Systemic; Middle Aged; Nedocromil; Quinolines; Sulfides

Topics: Acetates; Adult; Androstadienes; Asthma; Churg-Strauss Syndrome; Cyclopropanes; Diagnosis, Differential; Diarrhea; Fluticasone; Glucocorticoids; Heart Failure; Humans; Leukotriene Antagonists; Lung; Male; Muscle Hypotonia; Prednisone; Quinolines; Radiography; Sulfides