INTAL is a prophylactic agent indicated in the management of
patients with bronchial asthma.
In patients whose symptoms are sufficiently frequent to require a continuous program of
medication, INTAL is given by inhalation on a regular daily basis (see DOSAGE
AND ADMINISTRATION). The effect of INTAL is usually evident after several weeks
although some patients show an almost immediate response.
In patients who develop acute bronchoconstriction in response to exposure to exercise, toluene diisocyanate, environmental pollutants, etc., INTAL should be given shortly before exposure to
the precipitating factor (see DOSAGE AND ADMINISTRATION).
DOSAGE AND ADMINISTRATION
For management of bronchial asthma in adults and pediatric patients (two years
of age and over), the usual starting dosage is the contents of one ampule administered
by nebulization four times a day at regular intervals.
Drug stability and safety of INTAL Nebulizer Solution (cromolyn sodium inhalation solution) when mixed with other
drugs in a nebulizer have not been established.
Patients with chronic asthma should be advised that the effect of INTAL therapy
is dependentupon its administration at regular intervals, as directed. INTAL
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
For the prevention of acute bronchospasm which follows exercise or exposure
to cold dry air, environmental agents (e.g., animal danders, toluene diisocyanate,
pollutants), etc., the usual dose is the contents of one ampule 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".
INTAL Therapy in Relation to Other Treatments for Asthma: Non-steroidal
agents: INTAL should be added to the patient's existing treatment
regimen (e.g., bronchodilators). When a clinical response to INTAL 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 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 INTAL 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. 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 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
It is particularly important that great care be exercised if, for any reason, INTAL 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.
INTAL Nebulizer Solution (cromolyn sodium inhalation solution) is a colorless solution supplied in a low density
polyethylene plastic unit dose ampule with 12 ampules per foil pouch. Each 2
contains 20 mg cromolyn sodium, USP, in purified water.
NDC 0585-0673-02.....................60 ampules x 2 mL
NDC 0585-0673-03.....................120 ampules x 2 mL
Store at Controlled Room Temperature 20 to 25ÂºC (68 to 77ÂºF) [see USP].
Protect from light. Do not use if it contains a precipitate or becomes discolored.
Keep out of the reach of children.
Store ampules in foil pouch until ready for use.
Distributed by: King Pharmaceuticals™, Inc. Bristol, TN
37620. Manufactured by: Aventis Pharma, 76580 Le Trait, France. FDA Rev date: