Generic name: cromolyn sodium
Dosage form: Inhalant
This dosage information does not include all the information needed to use Intal safely and effectively. See full prescribing information for Intal.
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For management of bronchial asthma in adults and pediatric patients (5 years of age and over) who are able to use the Inhaler, the usual starting dosage is two metered inhalations four times daily at regular intervals. This dose should not be exceeded. Not all patients will respond to the recommended dose and there is evidence to suggest, at least in younger patients, that a lower dose may provide efficacy.
Patients with chronic asthma should be advised that the effect of Intal Inhaler therapy is dependent upon its administration at regular intervals, as directed. Intal Inhaler should be introduced into the patient’s therapeutic regimen when the acute episode has been controlled, the airway has been cleared, and the patient is able to inhale adequately.
For the prevention of acute bronchospasm which follows exercise, exposure to cold, dry air, or environmental agents, the usual dose is two metered inhalations shortly before exposure to the precipitating factor, i.e., within 10 to 15 minutes but not more than 60 minutes.
Intal Inhaler Therapy in Relation to Other Treatments for Asthma:Non-steroidal agents:Intal Inhaler should be added to the patient’s existing treatment regimen (e.g., bronchodilators). When a clinical response to Intal Inhaler 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 Intal Inhaler may be titrated downward to the lowest level consistent with the desired effect. The usual decrease is from two metered inhalations four times daily to three times daily to twice daily. 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 inhalations per day, an increase in the dosage of Intal Inhaler 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 Intal Inhaler. If the patient improves, an attempt to decrease corticosteroids should be made. Even if the corticosteroid-dependent patient fails to show symptomatic improvement following Intal Inhaler 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 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.
For best results, the canister should be at room temperature before use.