Home » Drug Information » FDA-Approved Drugs » 2001
Medical Areas: Pediatrics/Neonatology | Pulmonary/Respiratory Diseases
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Pharmacia
Approval Status: Approved April 2001
Treatment Area: Allergic Rhinitis
NasalCrom Nasal Spray has been approved for the treatment of
nasal allergy symptoms, for use in children ages two to five years.
It is the only treatment indicated for all nasal allergy symptoms
that is available over-the-counter (OTC). For best results, this
medication should be taken for one full week before coming in
contact with allergens and should then be taken three to four times
daily.
NasalCrom was first introduced, in 1983, as a prescription
medication for adults. In 1997 it became available OTC for adults
as well as children ages six and older. Unilke other OTC allergy
treatments, NasalCrom does not produce unwanted side effects, such
as drowsiness or jitteriness.
It is estimated that nearly 40 percent of children under the age
of six have allergic rhinitis and that this condition causes more
than 800,000 missed school days in older children.
NasalCrom was evaluated as a treatment for nasal allergy
symptoms in a multi-center, multi-dose, randomized, double-blind
study of 200 children, ages two to six years, who suffer from
allergic rhinitis. Results showed that NasalCrom, after one week of
treatment, was more effective than placebo in alleviating nasal
allergy symptoms. The drug was well tolerated and demonstrated a
side effect profile similar to placebo.
Adverse events associated with the use of cromolyn sodium may
include (but are not limited to) the following:
- Irritation inside of nose
- Flushing
- Increase in sneezing
NasalCrom Nasal Spray (cromolyn sodium) works as a mast-cell
stabilizer, blocking cells in the body from releasing substances
that cause the bronchial tubes to tighten and constrict. Normally,
upon entering the nose, an allergen triggers the mast cells that
line the nasal passages to break down and release histamines, which
cause nasal allergy symptoms. NasalCrom provides a protective layer
that shields mast cells from these allergens.
For additional information on NasalCrom, please visit
Pharmacia.