Cromolyn Sodium Inhalation Solution 20 mg/2mL Solution — NDC 76204-028-60 (Billing 76204-0028-60)

Indications and Usage Cromolyn sodium inhalation solution USP 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, cromolyn sodium inhalation solution USP is given by inhalation on a regular daily basis (see DOSAGE AND ADMINISTRATION ). The effect of cromolyn sodium is usually evident after several weeks of treatment, 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., cromolyn sodium 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 vial administered by nebulization four times a day at regular intervals. Drug stability and safety of 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 cromolyn sodium inhalation solution therapy is dependent upon its administration at regular intervals, as directed.

Cromolyn sodium inhalation solution 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 or exposure to cold dry air, environmental agents (e.g., animal danders, toluene diisocyanate, pollutants), etc., the usual dose is the contents of one vial 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 vials 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 vials 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 rega… [Excerpted — this section continues on DailyMed.]

Information for Patients Cromolyn sodium is to be taken as directed by the physician. Because it is preventive medication, it may take up to four weeks before the patient experiences maximum benefit. Cromolyn sodium should be used in a power-driven nebulizer with an adequate airflow rate equipped with a suitable face mask or mouthpiece.

Drug stability and safety of cromolyn sodium inhalation solution when mixed with other drugs in a nebulizer have not been established. For additional information, see the accompanying leaflet entitled Living a Full Life with Asthma.

Living a Full Life with Asthma Patient Instructions Cromolyn Sodium Inhalation Solution, USP You or your child may be among the millions of Americans who have asthma. For most patients, asthma need not limit your lifestyle, if you closely follow the asthma management plan your doctor provides you. Your doctor has given you this instruction sheet to help you learn more about asthma and ways to control it.

WHAT IS ASTHMA? Asthma is a disease that causes patients to have difficulty breathing. Asthma “attacks” occur when the air passages (airways) to the lungs close up, blocking air from passing through.

The closing up is caused by two things: The muscles around the airways tighten (constrict) making the airway narrower, and The passage lining swells and produces larger amounts of mucus (a sticky liquid normally found in airways). This swelling is caused by a certain type of inflammation that can build up in the airways of patients with asthma. Inflammation and the airway sensitivity that results from it cause further attacks to occur. figure 02 WHAT CAUSES THESE ATTACKS?

Asthma experts know that patients with asthma have attacks because their airways are inflamed and over reactive. Their lungs become super-sensitive to certain irritants or “triggers”, such as cold dry air, pollen, smoke, or cat dander. In the presence of such triggers, someone with asthma may have an attack, and attacks may occur more often.

Asthma triggers fall into 6 categories: Substances that cause allergies (pollens, animal dander, molds, house dust, some foods and medicines) Infections that affect breathing (colds, flu) Emotional stress (difficult situations at home, school, or work) Strenuous exercise Irritating gases (chlorine, perfume, tobacco smoke) Sudden changes in temperature or humidity figure 03 HOW TO PREVENT ASTHMA ATTACKS No medicine or procedure will “cure” asthma. The key to asthma relief, therefore, is to prevent attacks and to relieve attack symptoms if they do occur.

A successful prevention plan* will do the following: Keep your activities, including exercise, at normal levels. Keep your lungs functioning normally or at a near-normal level. Prevent symptoms such as coughing or breathlessness that can keep you up at night, or occur in the early morning hours, or after exertion.

Prevent asthma attacks from happening. Avoid unpleasant or harmful side effects that may result from using asthma medicine. The best way to prevent asthma attacks is to avoid the triggers that bother you or your child.

Try to identify the specific things that cause problems for you - things such as certain foods, house dust, or animal dander. Avoiding these triggers may be difficult or unpleasant. You may need to find a new home for a family pet or remove a carpet or a favorite stuffed toy.

Even though these steps are difficult, they may be necessary in order to help prevent asthma attacks. If house dust is a trigger, remove dust-collectors such as feather pillows, mattresses, quilts, and carpets from the bedroom. Mattresses and pillows can be covered with allergen-free covers.

If a certain food triggers attacks, keep it out of your diet. Irritants in the air can be reduced by air conditioning, electrostatic air filters, or small-pore (HEPA) filters. Be careful of certain medicines.

Aspirin and aspirin-like pain relievers, for example, can trigger attacks in some people and should be avoided if they do. *… [Excerpted — this section continues on DailyMed.]

Instructions for the Use of Cromolyn Sodium Inhalation Solution, USP An aqueous solution for nebulization NOT FOR INJECTION For best results, follow these instructions exactly and observe Care and Storage directions. METHOD OF ADMINISTRATION Cromolyn sodium inhalation solution is recommended for use in a power driven nebulizer operated at an airflow rate of 6-8 liters per minute and equipped with a suitable face mask. Hand-operated nebulizers are not suitable for the administration of cromolyn sodium inhalation solution.

Your doctor will advise on the choice of a suitable nebulizer and how it should be used. Do not use any appliance without consulting your doctor. Drug stability and safety of cromolyn sodium inhalation solution when mixed with other drugs in a nebulizer have not been established.

DOSAGE Nebulization should be carried out four times a day at regular intervals, or as directed by your doctor. Use the contents of a fresh vial each time. INHALATION Once the nebulizer has 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.

Remove a single unit-dose vial from strip (Figure 1) Figure 1 2. Open the unit-dose vial by twisting off the tabbed top section (Figure 2). Figure 2 3.

Squeeze the contents of the unit-dose vial into the solution container of your nebulizer (Figure 3). Discard the empty unit-dose vial. Figure 3 figure 07 figure 08 figure 09