Singulair now available for asthmatic children as young as 12 months

Singulair now available for asthmatic children as young as 12 months

WHITEHOUSE STATION, N.J., September 15, 2003 -- Merck & Co. announced that Singulair (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  in children aged 12 months to 5 years.

The new formulation represents the first non-steroidal once-daily oral asthma controller available for children as young as 12 months old. Singulair oral granules has no distinct taste and is easy to administer.

Singulair oral granules can be given alone or mixed with a spoonful of applesauce, mashed carrots, rice or ice cream. 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.

In addition to the new oral granules formulation, Singulair continues to be available for both asthma and seasonal allergies in a range of tablet forms:

  • 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 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.

Efficacy of Singulair in patients 2 to 14 years of age with seasonal allergies is based on extrapolation from the demonstrated efficacy in patients aged 15 years and older with seasonal allergies.

Singulair has been evaluated for safety in 124 pediatric patients 12 to 23 months of age. The safety profile of Singulair in a 6-week, double-blind, placebo-controlled clinical study was generally similar to the safety profile in adults and pediatric patients 2 to 14 years of age. Singulair administered once daily at bedtime was generally well tolerated. In pediatric patients 12 to 23 months of age receiving Singulair, the following events occurred with a frequency greater than or equal to 2 percent and more frequently than in pediatric patients who received placebo, regardless of causality assessment: upper respiratory infection, wheezing; otitis media; pharyngitis, tonsillitis, cough; and rhinitis. The frequency of less common adverse events was comparable between Singulair and placebo. Long-term trials evaluating the effect of chronic administration of Singulair on linear growth in pediatric patients have not been conducted.

Source: Merck

Posted: September 2003


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