Pulmonary - Mast Cell stabilizers

cromolyn sodium (Intal ®) nedocromil (Tilade ®)

cromolyn sodium (Intal ®)  top of page

Inhalation: May be used as an adjunct in the prophylaxis of allergic disorders, including asthma; prevention of exercise-induced bronchospasm
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

Metered spray:
Children 5-12 years: Initial: 2 inhalations 4 times/day; usual dose: 1-2 inhalations 3-4 times/day

Children >/= 12 years and Adults: Initial: 2 inhalations 4 times/day; usual dose: 2-4 inhalations 3-4 times/day

Prevention of allergen- or exercise-induced bronchospasm: Administer 10-15 minutes prior to exercise or allergen exposure but no longer than 1 hour before:

Nebulization solution: Children >2 years and Adults: Single dose of 20 mg

Metered spray: Children >5 years and Adults: Single dose of 2 inhalations
Aerosol, for oral inhalation, as sodium (Intal®): 800 mcg/inhalation (8.1 g) [112 metered inhalations; 56 doses], (14.2 g) [200 metered inhalations; 100 doses]

Solution for nebulization, as sodium (Intal®): 20 mg/2 mL (60s, 120s)

nedocromil  (Tilade ®) top of page

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 system.

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 corticosteroid activity.

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 asthma.

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 preparation.

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)
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National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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David F. McAuley, Pharm.D., R.Ph.  GlobalRPh Inc.
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