Business Wire - Singulair Now Available For Children with Asthma as Young as 12 Months Old; New Oral Granules Formulation Offers Convenient, Once-A-Day Option
Business Editors/Health & Pharmaceutical Writers
WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Sept. 15, 2003
Merck & Co., Inc. announced today that SINGULAIR(R) (montelukast sodium) is now available by prescription in a new, convenient, once-a-day “oral granules” formulation.
SINGULAIR oral granules (4 mg) can be used once daily in the evening for the prevention and chronic treatment of asthma (Indications and Usage page 9 A) in children aged 12 months to 5 years (PI - Dosing and Administration page 14 A, B). The new formulation represents the first non-steroidal once-daily oral asthma controller available for children as young as 12 months old (Therapy Chart). SINGULAIR oral granules has no distinct taste and is easy to administer.
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SINGULAIR oral granules can be given alone or mixed with a spoonful of applesauce, mashed carrots, rice or ice cream (PI - Dosing and Administration page 14 B, C). These foods should be served cold or at room temperature. After opening the packet, the full dose must be given within 15 minutes and any leftovers must not be stored for future use. Oral granules should not be mixed in a liquid drink.
SINGULAIR oral granules can also be used for the relief of symptoms of seasonal allergies in children aged 2 to 5 years (PI - Indications and Usage page 9 A).
In addition to the new oral granules formulation, SINGULAIR continues to be available for both asthma and seasonal allergies in tablet form.
— 10 mg tablet for adults and children 15 years of age and older
with asthma or seasonal allergies.
— 5 mg cherry chewable tablet for children 6 to 14 years of age
with asthma or seasonal allergies.
— 4 mg cherry chewable tablet for children 2 to 5 years of age
with asthma or seasonal allergies.
— 4 mg oral granules for children with asthma 12 months to 5
years old and for children with seasonal allergies 2 to 5
years of age (PI - Dosing and Administration page 14 A-D).
“When you ask parents how they feel about giving their children daily asthma medication, you will often hear that it is a challenge,” says Gail Shapiro, M.D., clinical investigator at the Northwest Asthma and Allergy Center in Seattle. “SINGULAIR oral granules is very appealing because it is a flavorless option that can be spoon-fed once a day. This new formulation certainly broadens the choices for treating young children with asthma.”
Currently, the most common controller medication for pediatric patients with asthma 12 to 23 months of age is an inhaled corticosteroid administered through a nebulizer machine (IMS Health, NDTI (TM) (National Disease and Therapeutic Index). Based on drug appearances for moving annual total ending March 2003; Pulmicort Respules PI page 1 (use with nebulizer)).
SINGULAIR should not be used for the immediate relief of asthma attacks or to prevent or treat asthma made worse by exercise. Patients who have asthma made worse by exercise should continue to use their existing medications prior to exercise unless instructed otherwise by their doctor and should be advised to have appropriate rescue medication available (PI - Precautions page 9 B, C). While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, SINGULAIR should not be abruptly substituted for inhaled or oral corticosteroids.
SINGULAIR is the No. 1 prescribed asthma controller among allergists and pediatricians in the United States (IMS Health, NPA Plus (TM), January 2001-April 2003). Since 1998, more than 48 million prescriptions of SINGULAIR have been dispensed to patients (IMS Health, NPA Plus (TM), January 1998 - April 2003).
Pediatric asthma in America: a growing health concern
Asthma is one of the most common chronic illnesses among children (American Lung Association (ALA) website, (Asthma in Children Fact Sheet) page 1), affecting more than six million children in the U.S. alone (American Lung Association (ALA) website, (Asthma in Children Fact Sheet) page 1). The disease is on the rise in cities and suburbs alike, and is most prevalent in the inner cities, where asthma rates are often double those found elsewhere (American Lung Association (ALA) website, (Release, “ALA Announces Nationwide Sponsorship of Asthma Education Program for Children”) page 1).
About SINGULAIR
SINGULAIR is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months and older and for the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older (PI - Indications and Usage page 9 A, D). For asthma, SINGULAIR should be taken in the evening (PI - Dosing and Administration page 13 A).
SINGULAIR 4 mg oral granules can be used in appropriate patients with asthma aged 12 months to 5 years and patients with seasonal allergies 2 to 5 years of age. Efficacy of SINGULAIR in patients 12 months to 5 years of age with asthma is based on extrapolation of the demonstrated efficacy in patients 6 years of age and older with asthma.
