Intal (Cromolyn Sodium Inhalation) - Indications and Dosage

Indications and Usage

Intal Inhaler 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 Inhaler is given by inhalation on a regular daily basis. (See DOSAGE AND ADMINISTRATION.) The effect of Intal Inhaler is usually evident after several weeks of treatment, although some patients show an almost immediate response.

If improvement occurs, it will ordinarily occur within the first 4 weeks of administration as manifested by a decrease in the severity of clinical symptoms of asthma, or in the need for concomitant therapy, or both.

In patients who develop acute bronchoconstriction in response to exposure to exercise, toluene diisocyanate, environmental pollutants, known antigens, etc., Intal Inhaler should be used shortly before exposure to the precipitating factor, i.e., within 10 to 15 minutes but not more than 60 minutes. (See DOSAGE AND ADMINISTRATION.) Intal Inhaler may be effective in relieving bronchospasm in some, but not all, patients with exercise induced bronchospasm.

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 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.

How Supplied

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 60793-011-14......................... 14.2 g canister

NDC 60793-011-08.......................... 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 (CFCs).

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

Intal^® is a registered trademark of King Pharmaceuticals, Inc.

Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

Manufactured by: Health Care Specialties Division, 3M Health Care Limited, Loughborough, England LE11 1EP

Made in United Kingdom.

Prescribing Information as of September 2005.

Information for Patients

INTAL^® INHALER (cromolyn sodium inhalation aerosol)

Metered Dose Inhaler

For Oral Inhalation Only

1. Make sure the canister is properly inserted into the Inhaler unit. Take the cover off the mouthpiece. Shake the Inhaler gently. If the mouthpiece cover is not present, the Inhaler should be inspected for the presence of foreign objects.

   

2. Hold Inhaler and breathe out slowly and fully, expelling as much air as possible. Do not breathe into the Inhaler – it could clog the Inhaler valve.

3. Avoid spraying in eyes.

   

4. Place the mouthpiece into your mouth, close your lips around it, and tilt your head back. Keep your tongue below the opening of the Inhaler.

   

5. While breathing in deeply and slowly through the mouth, fully depress the top of the metal canister with your index finger.

   

6. Remove the Inhaler from your mouth. Hold your breath for several seconds, then breathe out slowly. This step is very important. It allows the Intal to spread throughout your lungs. Repeat steps 2-5, then replace the mouthpiece cover.

   

1. Before using the Inhaler for the first time, or if it has not been used for a while, it’s a good idea to test it. Just give the canister one press.

2. It is essential that the canister be pressed at exactly the same time as you breathe in, so it’s worth some time practicing this.

3. The dose delivered from the Inhaler can be seen as a fine white mist. If any of this can be seen escaping from your mouth or nose, then you are not using the Inhaler correctly.

4. To keep your Inhaler in good working order, do not exhale into mouthpiece.

5. Keep the cap on the Inhaler while not in use so that dirt can’t get into it. You can clean the Inhaler by removing the metal canister and rinsing the plastic mouthpiece in warm water. (See CLEANING Instructions.)

6. 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. You should keep track of the number of actuations used from each canister of Intal Inhaler and discard the canister after 112 actuations from the 8.1 gram canister or 200 actuations from the 14.2 gram canister. Before you reach the specified number of actuations, you should consult your physician to determine whether a refill is needed. Just as you should not take extra doses without consulting your physician, you also should not stop using Intal Inhalerwithout consulting your physician.

7. For optimal results, the canister should be at room temperature before use.

HOW TO CHECK CONTENTS OF YOUR CANISTER

Shaking the canister will NOT give you a good estimate of how much medication is left. We have included a convenient check-off chart to assist you in keeping track of medication inhalations used. This will help assure that you receive the labeled number of inhalations present.

Each 8.1 gram Inhaler delivers 112 metered inhalations

Each 14.2 gram Inhaler delivers 200 metered inhalations

Intal^® Inhaler Check-Off Chart

• Retain with medication or affix to convenient location.

• Starting with inhalation #1, check off one circle for each inhalation used.

• DISCARD MEDICATION AFTER THE LABELED NUMBER OF INHALATIONS HAVE BEEN USED

• NEVER IMMERSE THE METAL CANISTER IN WATER

IMPORTANT: Remember— a little time spent taking Intal correctly and regularly can save you from countless attacks of asthma and the upheaval they cause.

It must be used every day as directed by your doctor. Do not stop the treatment or even reduce the dose without consulting your doctor.

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.

DOSAGE: For management of bronchial asthma in adults and children 5 years of age and older, the usual starting dosage is two metered inhalations four times a day at regular intervals. When asthma symptoms are well controlled, your doctor may reduce the dose to three times a day, and sometimes two times a day.

For prevention of acute bronchospasm which follows exercise, exposure to cold, dry air, or environmental agents, the usual dosage is two metered inhalations shortly before exposure to the offending factor.

Use as directed by your physician.

CLEANING: Twice a week, remove the metal canister from the plastic mouthpiece. Wash the mouthpiece in warm water and dry thoroughly before replacing the metal canister. Never immerse the metal canister in water.

STORAGE: 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. Keep out of the reach of children. Avoid spraying in eyes.

Note: The indented statement below is required by the Federal Government’s Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs).

This product contains CFC-12 (dichlorodifluoromethane) and CFC-114 (dichlorotetrafluoroethane), substances which harm the environment by destroying ozone in the upper atmosphere.

Your physician has determined that this product is likely to help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about alternatives, consult with your physician.

Intal^® is a registered trademark of King Pharmaceuticals, Inc.

Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

Manufactured by: Health Care Specialties Division, 3M Health Care Limited Loughborough, England LE11 1EP

Made in United Kingdom.

Prescribing Information as of September 2005.