DOSAGE AND ADMINISTRATION
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 (cromolyn sodium inhalation aerosol) 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
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.
Intal Inhaler is supplied as an aerosol canister which provides 112
metered dose actuations from the 8.1 gram inhaler and 200 metered dose actuations
from the 14.2 gram inhaler. The correct amount of medication in each inhalation
cannot be assured after 112 actuations from the 8.1 gram canister or 200 actuations
from the 14.2 gram canister even though the canister may not feel completely
empty. The canister should be discarded when the labeled number of actuations
have been used.
Each actuation delivers 1 mg cromolyn sodium through the valve and 800 mcg
through the mouthpiece to the patient. The Intal Inhaler canister and
accompanying mouthpiece are designed to be used together. The Intal Inhaler
canister should not be used with other mouthpieces and the supplied mouthpiece
should not be used with other products' canisters. Intal Inhaler is supplied
with a white plastic mouthpiece with blue dust cap and patient instructions.
NDC 0585-0675-01...................14.2 g canister
NDC 0585-0675-02...................8.1 g canister
Store between 15 to 30°C (59 to 86°F). Contents under pressure. Do
not puncture, incinerate, or place near sources of heat. Exposure to temperatures
above 120°F may cause bursting. Avoid spraying in eyes. Keep out of the
reach of children.
Note: The indented statement below is required by the Federal government's
Clean Air Act for all products containing or manufactured with chlorofluorocarbons
WARNING: Contains CFC-12 (dichlorodifluoromethane) and CFC-114 (dichlorotetrafluoroethane),
substances which harm public health and the environment by destroying ozone
in the upper atmosphere.
A notice similar to the above WARNING has been placed in the "Information For The Patient" portion of this package insert under the Environmental Protection Agency's (EPA's) regulations. The patient's warning states that the patient should consult his or her physician if there are questions about alternatives. Rx only
Distributed by: King Pharmaceuticals™, Inc. Bristol, TN
37620. Manufactured by: Health Care Specialties Division, 3M Health Care Limited,
Loughborough, England LE11 1EP. FDA Rev date: 2/11/2004