BFAD Okays Montelukast for Kids

The Bureau of Food and Drugs (BFAD) recently approved a new dosage of montelukast sodium for the prevention and chronic treatment of asthma in children ages two to five.

    Montelukast sodium, a product of Merck Sharp & Dohme, is the first asthma controller therapy in 15 years indicated for children as young as two. It was approved in the Philippines in April 1998 as a cherry-flavored chewable tablet for children ages six to 14 and as a tablet for adolescents and adults 15 years and older.

    "If you've heard a young child say 'I can't breathe,' you have some idea of the anguish and frustration felt by the parents of youngsters with asthma," said Dr. Agnes Rico-Mendoza, section head of the Pediatric Pulmonology Department of St. Luke's Medical Center. "Treatment regimens for children ages two to five require the child to cooperate while medicine is administered through a nebulizer," she added.

    Dr. Rico-Mendoza discussed the new approaches in the treatment of childhood asthma during a symposium at the tenth Philippine Academy of Pediatric Pulmonologists annual convention. She explained the benefits of montelukast sodium, its efficacy and tolerability in children two to five years of age.

    Montelukast sodium, which belongs to a class of asthma drugs known as leukotriene receptor antagonists (LTRAs), was the first new asthma drug since inhaled steroids became available two decades ago. The 1998 Global Initiative for Asthma revised guidelines list LTRAs for the treatment of mild-to-moderate persistent asthma, either as stand-alone or an add-on therapy.

    Montelukast sodium works by blocking the action of leukotrienes, which are potent inflammatory mediators in the lungs. With asthma, the amount of leukotrienes increases when a person is exposed to certain irritants, contributing to inflammation and narrowing of airways, which makes it difficult to breathe.