Intal (Inhalation)

Cromolyn is used to prevent asthma symptoms. When taken regularly, cromolyn reduces the number and severity of asthma attacks by lowering inflammation in the lungs. It can also be used just before being exposed to situations or substances (like exercise, allergens such as pollen, aspirin, chemicals, cold air, or air pollutants) that trigger bronchospasm (wheezing or trouble breathing). Cromolyn will not help with an asthma or bronchospasm attack that has already started.

Cromolyn may be used on its own or with other asthma medications, such as bronchodilators (which open up narrowed airways) or corticosteroids (cortisone-like medicines).

Cromolyn inhalation works by targeting specific inflammatory cells in the lungs to stop them from releasing substances that trigger asthma symptoms or bronchospasm.

This medicine is available only with your doctor's prescription.

It is very important that you read and understand the following information. If any of it raises concerns for you, talk to your doctor. Also, if you have any questions or want more information about this medicine or your medical condition, ask your doctor, nurse, or pharmacist.

If your symptoms do not improve within 4 weeks or if your condition gets worse after you start using cromolyn, contact your doctor.

If you are also using a corticosteroid or a bronchodilator for your asthma along with this medicine, do not stop taking the corticosteroid or bronchodilator even if your asthma feels better, unless your doctor advises you to do so.

You may experience dryness of the mouth or throat or throat irritation after using this medicine. Gargling and rinsing your mouth or drinking water after each dose may help reduce these effects.

In deciding to use a medicine, you need to consider the risks against the benefits. This is a decision for you and your doctor. For this medicine, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing the use of cromolyn in children to other age groups, but this medicine is not expected to cause different side effects or problems in children than it does in adults. The inhalation solution form of this medicine should not be used in children younger than 2 years old, and the inhalation aerosol should not be used in children younger than 5 years old.

Geriatric

Many medicines have not been studied specifically in older adults. Therefore, it may not be known if they work the same way they do in younger adults. Although there is no specific information comparing the use of cromolyn inhalation in the elderly to other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Heart disease or
• Irregular heartbeat—The propellants used in the aerosol inhaler may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Difficulty in swallowing
• hives
• increased wheezing or difficulty in breathing
• itching of skin
• low blood pressure
• shortness of breath
• swelling of face, lips, or eyelids
• tightness in chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Coughing
• nausea
• throat irritation or dryness

If you are using the cromolyn inhalation aerosol, you may notice an unpleasant taste. This may be expected and will go away when you stop using the medicine.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Intal
• Intal Inhaler

Available Dosage Forms:

• Solution

Therapeutic Class: Antiasthma

Pharmacologic Class: Mast Cell Stabilizer

Cromolyn oral inhalation is used to help prevent symptoms of asthma or bronchospasm (wheezing or difficulty in breathing). Cromolyn will not relieve an asthma or a bronchospasm attack that has already started. It is important to use cromolyn at regular times as directed by your doctor.

Use cromolyn inhalation only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

Cromolyn inhalation usually comes with patient directions. Read them carefully before using this medicine. If you do not understand the directions that come with the inhaler or if you are not sure how to use the inhaler, ask your health care professional to show you how to use it. Also, ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly.

For patients using cromolyn inhalation aerosol:

• The cromolyn aerosol canister provides about 112 or 200 inhalations, depending on the size of the canister your doctor ordered. You should try to keep a record of the number of inhalations you use so you will know when the canister is almost empty. This canister, unlike some other aerosol canisters, cannot be floated in water to test its fullness.
• When you use the inhaler for the first time, or if you have not used it in a while, the inhaler may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, test or prime it.
• To test or prime the inhaler: Insert the medicine container (canister) firmly into the clean mouthpiece according to the manufacturer's directions. Check to make sure the canister is placed properly into the mouthpiece. Take the cap off the mouthpiece and shake the inhaler three or four times. Hold the inhaler well away from you at arm's length and press the top of the canister, spraying the medicine one time into the air. The inhaler will now be ready to provide the right amount of medicine when you use it.
• To use the inhaler: Using your thumb and one or two fingers, hold the inhaler upright, with the mouthpiece end down and pointing toward you. Take the cap off the mouthpiece. Check the mouthpiece to make sure it is clear. Do not use the inhaler with any other mouthpieces. Gently shake the inhaler three or four times. Hold the mouthpiece away from your mouth and breathe out slowly and completely to the end of a normal breath. Use the inhalation method recommended by your doctor. Open-mouth method: Place the mouthpiece about 1 to 2 inches (2 fingerwidths) in front of your widely opened mouth. Make sure the inhaler is aimed into your mouth so the spray does not hit the roof of your mouth or your tongue. Avoid spraying in eyes. Closed-mouth method: Place the mouthpiece in your mouth between your teeth and over your tongue with your lips closed tightly around it. Make sure your tongue or teeth are not blocking the opening. Tilt your head back a little. Start to breathe in slowly through your mouth. At the same time, press the top of the canister once to get one puff of medicine. Continue to breathe in slowly for 3 to 4 seconds until you have taken a full deep breath. It is important to press down on the canister and breathe in slowly at the same time so the medicine gets into your lungs. This step may be difficult at first. If you are using the closed-mouth method and you see a fine mist coming from your mouth or nose, the inhaler is not being used correctly. Hold your breath as long as you can up to 10 seconds (count slowly to ten). This gives the medicine time to settle into your airways and lungs. Take the mouthpiece away from your mouth and breathe out slowly. If your doctor has told you to inhale more than 1 puff of medicine at each dose, wait about 1 minute between puffs. Then, gently shake the inhaler again, and take the second puff following exactly the same steps you used for the first puff. Breathe in only one puff at a time. When you are finished using the inhaler, wipe off the mouthpiece and replace the cap. Keep track of the number of sprays you have used from the inhaler, and discard the inhaler after the labeled maximum number of sprays has been used.

Your doctor may want you to use a spacer device with the inhaler. A spacer makes the inhaler easier to use. It allows more of the medicine to reach your lungs, rather than staying in your mouth and throat.

• To use a spacer device with the inhaler: Attach the spacer to the inhaler according to the manufacturer's directions. There are different types of spacers available, but the method of breathing remains the same with most spacers. Gently shake the inhaler and spacer well. Hold the mouthpiece of the spacer away from your mouth and breathe out slowly and completely. Place the mouthpiece of the spacer into your mouth between your teeth and over your tongue with your lips closed around it. Press down on the canister top once to release one puff of medicine into the spacer. Then, within 1 or 2 seconds, begin to breathe in slowly and deeply through your mouth for 5 to 10 seconds. Count the seconds while inhaling. Hold your breath as long as you can up to 10 seconds (count slowly to 10). Breathe out slowly. Wait a minute between puffs. Then, gently shake the inhaler and spacer again and take the second puff, following exactly the same steps you used for the first puff. Do not spray more than one puff at a time into the spacer. When you are finished using the inhaler, remove the spacer device from the inhaler and replace the cap.

Clean the inhaler, mouthpiece, and spacer at least once a week.

• To clean the inhaler: Remove the canister from the inhaler and set the canister aside. Do not get the canister wet. Wash the mouthpiece, cap, and the spacer in warm soapy water. Rinse well with warm, running water. Shake off the excess water and let the inhaler parts air dry completely before putting the inhaler back together.

For patients using cromolyn capsules for inhalation:

• Do not swallow the capsules. The medicine will not work if you swallow it.
• This medicine is used with a special inhaler, either the Spinhaler or the Halermatic. If you do not understand the directions that come with the inhaler or if you are not sure how to use the inhaler, ask your health care professional to show you how to use it. Also, ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly.
• If you are using cromolyn capsules for inhalation with the Spinhaler: To load the Spinhaler: Make sure your hands are clean and dry. Insert the capsule into the inhaler just before using this medicine. Hold the inhaler upright with the mouthpiece pointing down. Unscrew the body of the inhaler from the mouthpiece. Keep the mouthpiece pointing down and the propeller on the spindle. Remove the foil from the capsule and insert the colored end of the cromolyn capsule firmly into the cup of the propeller. Avoid too much handling of the capsule, because moisture from your hands may make the capsule soft. Make sure the propeller moves freely. Screw the body of the inhaler back into the mouthpiece and make certain that it is fastened well. While keeping the inhaler upright with the mouthpiece pointing down, slide the grey outer sleeve down firmly until it stops. This will puncture the capsule. Then slide the sleeve up as far as it will go. This step may be repeated a second time to make sure the capsule is punctured. To use the Spinhaler: Check to make sure the mouthpiece is properly attached to the body of the inhaler. Hold the inhaler away from your mouth and breathe out slowly to the end of a normal breath. Place the mouthpiece in your mouth, close your lips around it, and tilt your head back. Do not block the mouthpiece with your teeth or tongue. Take a deep and rapid breath. You should hear and feel the vibrations of the rotating propeller as you breathe in. Take the inhaler from your mouth and hold your breath for a few seconds or as long as possible. Hold the inhaler away from your mouth and breathe out slowly and completely to the end of a normal breath. Do not breathe out through the inhaler because this may prevent the inhaler from working properly. Keep taking inhalations of this medicine until all the powder from the capsule is inhaled. A light dusting of powder remaining in the capsule is normal and is not a sign that the inhaler is not working properly. Throw away the empty capsule. Then return the inhaler to the container and replace the lid on the container. To clean the Spinhaler: At least once a week, brush off any powder left sticking to the propeller. Take the inhaler apart and wash the parts of the inhaler with clean, warm water. Wash the inside of the propeller shaft by moving the propeller on and off the steel spindle under water. Shake out the excess water. Allow all parts of the inhaler to dry completely before putting it back together. The Spinhaler should be replaced after 6 months.
• If you are using cromolyn capsules for inhalation with the Halermatic: To load the Halermatic: Make sure your hands are clean and dry. Insert the capsule cartridge into the inhaler just before using this medicine. Remove the mouthpiece cover. Then pull off the mouthpiece. Push a cromolyn capsule cartridge firmly down to the bottom of the slot. Slide the mouthpiece back on the body of the inhaler. Push down slowly as far as the mouthpiece will go. This punctures the capsule cartridge and lifts it into the rotation chamber. Do not repeat this step because the capsule cartridge needs to be punctured only once. To use the Halermatic: Hold the inhaler away from your mouth and breathe out slowly to the end of a normal breath. Place the mouthpiece in your mouth, close your lips around it, and tilt your head back. Do not block the flow of medicine into the lungs with your teeth or tongue. Breathe in quickly and steadily through the mouthpiece. Hold your breath for a few seconds to keep the medicine in the lungs as long as possible. Then take the inhaler away from your mouth. Hold the inhaler well away from your mouth and breathe out to the end of a normal breath. Do not breathe out through the inhaler because this may prevent the inhaler from working properly. Keep taking inhalations of this medicine until all the powder from the capsule is inhaled. A light dusting of powder remaining in the capsule is normal and is not a sign that the inhaler is not working properly. Throw away the empty capsule cartridge. To clean the Halermatic: Brush away powder deposits each day with a brush. When powder deposits build up, wipe them away with a slightly damp cloth. The mouthpiece may be washed separately if necessary. However, do not wet the blue-based body of the inhaler. Be sure the mouthpiece grid is dry before putting the inhaler back together. The Halermatic should be replaced every 6 months.

For patients using cromolyn inhalation solution:

• Cromolyn inhalation solution comes in a small glass container called an ampul. The ampul must be broken gently to empty the contents. If you do not understand the manufacturer's directions, ask your health care professional to show you what to do.
• Do not use the solution in the ampul if it is cloudy or contains particles.
• To break and empty the ampul: The glass ampul is weak at each end so the ends can be broken easily by hand. Hold the ampul away from the nebulizer and your face when you break it. Hold the ampul at an angle and carefully break off the lower end. No solution will come out. Turn the ampul over so the open end faces up. Place a forefinger carefully over the open end. Keep your finger firmly in place and break off the lower end of the ampul. To empty the ampul, hold it over the bowl of the nebulizer unit and remove your finger to let the solution flow out. Throw away any solution left in the nebulizer after you have taken your treatment.
• Use this medicine only in a power-operated nebulizer that has an adequate flow rate and is equipped with a face mask or mouthpiece. Your doctor will advise you on which nebulizer to use. Make sure you understand exactly how to use it. Hand-squeezed bulb nebulizers cannot be used with this medicine. If you have any questions about this, check with your doctor.

For patients using cromolyn oral inhalation regularly (for example, every day):

• In order for cromolyn to work properly, it must be inhaled every day in regularly spaced doses as ordered by your doctor. Up to 4 weeks may pass before you feel the full effects of the medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation aerosol dosage form: For prevention of asthma symptoms: Adults and children 5 years of age or older—2 inhalations (puffs) taken four times a day with doses spaced four to six hours apart. Children up to 5 years of age—Cromolyn inhalation aerosol should not be used in children younger than 5 years of age. For prevention of bronchospasm caused by exercise or a condition or substance: Adults and children 5 years of age or older—2 inhalations (puffs) taken at least ten to fifteen (but not more than sixty) minutes before exercise or exposure to any condition or substance that may cause an attack. Children up to 5 years of age—Cromolyn inhalation aerosol should not be used in children younger than 5 years of age.
• For capsule for inhalation dosage form: For prevention of asthma symptoms: Adults and children 2 years of age or older—20 mg (contents of 1 capsule) used in an inhaler, taken four times a day with doses spaced four to six hours apart. Children up to 2 years of age—The capsule for inhalation should not be used in children younger than 2 years of age. For prevention of bronchospasm caused by exercise or a condition or substance: Adults and children 2 years of age or older—20 mg (contents of 1 capsule) used in an inhaler, taken at least ten to fifteen (but not more than sixty) minutes before exercise or exposure to any condition or substance that may cause an attack. Children up to 2 years of age—The capsule for inhalation should not be used in children younger than 2 years of age.
• For inhalation solution dosage form: For prevention of asthma symptoms: Adults and children 2 years of age or older—20 mg (contents of 1 ampul) used in a nebulizer. This medicine should be used four times a day with doses spaced four to six hours apart. Use a new ampul of solution for each dose. Children up to 2 years of age—Cromolyn inhalation solution should not be used in children younger than 2 years of age. For prevention of bronchospasm caused by exercise or a condition or substance: Adults and children 2 years of age or older—20 mg (contents of 1 ampul) used in a nebulizer. This medicine should be used at least ten to fifteen (but not more than sixty) minutes before exercise or exposure to any condition or substance that may cause an attack. Use a new ampul of solution for each dose. Children up to 2 years of age—Cromolyn inhalation solution should not be used in children younger than 2 years of age.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.