FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic
1 FDA, Montelukast
Montelukast, a leukotriene receptor antagonist, was launched 20 years ago in Korea
SINGULAIR® (montelukast sodium) Page 6 of 33 When SINGULAIR® is prescribed for the prevention of exercise-induced bronchoconstriction, patients should be advised to always
Draft Guidance on Montelukast Sodium
The U
Drug Ingredient Brand Example Exempt/Non-Exempt* Special Fill** Peri-Op*** Drug Class Reference in ACOEM Guidelines * Dosage Form Strength: montelukast sodium;
They are supplied in unit of use HDPE bottles and unit of use blisters
Elimination The plasma clearance of montelukast averages 45 mL/min in healthy adults
The U
Rising sales, growing concerns
Montelukast sodium (SingulairTM) is a member of the leukotriene receptor antagonist class
• SINGULAIR 5-mg Chewable Tablets are pink, round, bi-convex-shaped tablets
Los leucotrienos causan inflamación (hinchazón) de las vías respiratorias, lo que puede dificultar la respiración
Montelukast sodium tablets are used to: 1
1 The full-length report, 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Generic Name Montelukast DrugBank Accession Number DB00471 Background
It will decrease the symptoms and the number of acute asthma attacks
fast, irregular, pounding, or racing heartbeat or pulse
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Patients with known acetylsalicylic acid (ASA) sensitivity should continue avoidance of ASA or PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (30 Tablets Bottle) Rising® NDC 57237-255-30
PHARMACIST: Dispense the Medication Guide provided separately to each patient
INDICACIONES TERAPÉUTICAS: Montelukast está indicado en pacientes adultos, niños de 6 meses de edad y mayores para la profilaxis y el tratamiento crónico del asma, incluyendo la prevención de síntomas diurnos y nocturnos, así como el tratamiento de pacientes asmáticos sensibles al ácido acetilsalicílico
ChEBI