Inhalation: May be used as an adjunct in the prophylaxis of allergic
disorders, including asthma; prevention of exercise-induced bronchospasm
--------------------------- Dosing: Inhalation:
For chronic control of asthma, taper frequency to the lowest effective
dose (ie, 4 times/day to 3 times/day to twice daily):
Nebulization solution: Children >2 years and Adults: Initial: 20 mg 4
times/day; usual dose: 20 mg 3-4 times/day
Nedocromil sodium has been shown to inhibit the in vitro activation of,
and mediator release from, a variety of inflammatory cell types
associated with asthma, including eosinophils, neutrophils, macrophages,
mast cells, monocytes, and platelets. In vitro studies on cells obtained
by bronchoalveolar lavage from antigen-sensitized macaque monkeys show
that nedocromil sodium inhibits the release of mediators including
histamine, leukotriene C4, and prostaglandin D2. Similar studies with
human bronchoalveolar cells showed inhibition of histamine release from
mast cells and beta-glucuronidase release from macrophages.
Nedocromil sodium has been tested in experimental models of asthma using
allergic animals and shown to inhibit the development of early and late
bronchoconstriction responses to inhaled antigen. The development of
airway hyper-responsiveness to nonspecific bronchoconstrictors was also
inhibited. Nedocromil sodium reduced antigen-induced increases in airway
microvasculature leakage when administered intravenously in a model
In humans, nedocromil sodium has been shown to inhibit acutely the
bronchoconstrictor response to several kinds of challenge. Pretreatment
with single doses of nedocromil sodium inhibited the bronchoconstriction
caused by sulfur dioxide, inhaled neurokinin A, various antigens,
exercise, cold air, fog, and adenosine monophosphate.
Nedocromil sodium has no bronchodilator, antihistamine, or
Nedocromil sodium, when delivered by inhalation at the recommended dose,
has no known systemic activity.
Indications and Usage
Tilade Inhaler is indicated for maintenance therapy in the management of
adult and pediatric patients 6 years and older with mild to moderate
Tilade is not indicated for the reversal of acute bronchospasm.
Tilade Inhaler is contraindicated in patients who have shown
hypersensitivity to nedocromil sodium or other ingredients in this
Inhalation: Children >6 years and Adults: 2 inhalations 4 times/day; may
reduce dosage to 2-3 times/day once desired clinical response to initial
dose is observed
Aerosol for inhalation, as sodium (Tilade®): 1.75 mg/activation (16.2 g)
National Institutes of Health, U.S. National Library of Medicine,
DailyMed Database. Provides access to the latest drug monographs submitted to the
Food and Drug Administration (FDA). Please review the latest applicable package insert for
additional information and possible updates. A local search
option of this data can be found here.
Listed dosages are for - Adult patients ONLY. PLEASE READ THE
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