le administered by nebulization shortly before exposure to the precipitating factor. it should be emphasized to the patient that the drug is poorly absorbed when swallowed and is not effective by this route of administration. for additional information, see the accompanying leaflet entitled “ living a full life with asthma” . cromolyn sodium inhalation solution therapy in relation to other treatments for asthma: non-steroidal agents cromolyn sodium inhalation solution should be added to the patient's existing treatment regimen ( e.g. , bronchodilators). when a clinical response to cromolyn sodium inhalation solution is evident, usually within two to four weeks, and if the asthma is under good control, an attempt may be made to decrease concomitant medication usage gradually. if concomitant medications are eliminated or required on no more than a prn basis, the frequency of administration of cromolyn sodium inhalation solution may be titrated downward to the lowest level consistent with the desired effect. the usual decrease is from four to three ampules per day. it is important that the dosage be reduced gradually to avoid exacerbation of asthma. it is emphasized that in patients whose dosage has been titrated to fewer than four ampules per day, an increase in the dose of cromolyn sodium inhalation solution and the introduction of, or increase in, symptomatic medications may be needed if the patient's clinical condition deteriorates. corticosteroids in patients chronically receiving corticosteroids for the management of bronchial asthma, the dosage should be maintained following the introduction of cromolyn sodium inhalation solution. if the patient improves, an attempt to decrease corticosteroids should be made. even if the corticosteroid-dependent patient fails to show symptomatic improvement following cromolyn sodium inhalation solution administration, the potential to reduce corticosteroids may nonetheless be present. thus, gradual tapering of corticosteroid dosage may be attempted. it is important that the dose be reduced slowly, maintaining close supervision of the patient to avoid an exacerbation of asthma. it should be borne in mind that prolonged corticosteroid therapy frequently causes an impairment in the activity of the hypothalamic-pituitary-adrenal axis and a reduction in the size of the adrenal cortex. a potentially critical degree of impairment or insufficiency may persist asymptomatically for some time even after gradual discontinuation of adrenocortical steroids. therefore, if a patient is subjected to significant stress, such as a severe asthmatic attack, surgery, trauma or severe illness while being treated or within one year (occasionally up to two years) after corticosteroid treatment has been terminated, consideration should be given to reinstituting corticosteroid therapy. when respiratory function is impaired, as may occur in severe exacerbation of asthma, a temporary increase in the amount of corticosteroids may be required to regain control of the patient's asthma. it is particularly important that great care be exercised if, for any reason, cromolyn sodium inhalation solution is withdrawn in cases where its use has permitted a reduction in the maintenance dose of corticosteroids. in such cases, continued close supervision of the patient is essential since there may be sudden reappearance of severe manifestations of asthma which will require immediate therapy and possible reintroduction of corticosteroids.

d upon recurrence following readministration, have been reported in less than 1 in 10,000 patients: laryngeal edema, swollen parotid gland, angioedema, bronchospasm, joint swelling and pain, dizziness, dysuria and urinary frequency, nausea, cough, wheezing, headache, nasal congestion, rash, urticaria and lacrimation. other adverse reactions have been reported in less than 1 in 100,000 patients, and it is unclear whether these are attributable to the drug: anaphylaxis, nephrosis, periarteritic vasculitis, pericarditis, peripheral neuritis, pulmonary infiltrates with eosinophilia, polymyositis, exfoliative dermatitis, hemoptysis, anemia, myalgia, hoarseness, photodermatitis, and vertigo. to report suspected adverse reactions, contact micro labs usa, inc. at 1-855-839-8195 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

ynx, swallowed and excreted via the alimentary tract.

day in females. these doses are approximately 18 and 10 times, respectively, the maximum recommended adult human daily inhalation dose on a mg/m 2 basis.

s been assembled and contains cromolyn sodium inhalation solution, hold the mask close to the patient’s face and switch on the device. the patient should breathe in through the mouth and out through the nose in a normal, relaxed manner. nebulization should take approximately five to ten minutes. 1. open the carton, take out rondo tray as shown in (figure 1). figure 1 2. remove the ampule(s) from rondo tray as shown in (figure 2). figure 2 3. open the ampule by twisting off the tabbed top section as shown in (figure 3). figure 3 4. squeeze the contents of the unit-dose ampule into the solution container of your nebulizer (figure 4). figure 4 discard the empty unit-dose ampule. manufactured by: micro labs limited bangalore-560 099, india. manufactured for: micro labs usa, inc. somerset, nj 08873 rev.03/2022 figure 1 figure 2 figure 3 figure 4