Cromolyn (Oral Inhalation)

Cromolyn oral inhalation comes as a solution (liquid) to inhale by mouth using a special nebulizer (machine that turns medication into a mist that can be inhaled). When the nebulizer is used to prevent symptoms of asthma, it is usually used 4 times a day. When the nebulizer is used to prevent breathing difficulty caused by exercise, cold and dry air, or by inhaling a substance (trigger), it is usually used 10 to 15 minutes before exercise or before you come into contact with the trigger. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use cromolyn exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Cromolyn controls asthma but does not cure it. Your symptoms may improve soon after you begin using cromolyn, but it may take up to 4 weeks for before you feel the full benefit of the medication. You should use it regularly for it to be effective. If your symptoms have not improved after 4 weeks, tell your doctor. Continue to use cromolyn even if you feel well. Do not stop using cromolyn without talking to your doctor.

Cromolyn oral inhalation helps to prevent asthma attacks (sudden episodes of shortness of breath, wheezing, and coughing) but will not stop an asthma attack that has already started. Your doctor will prescribe a short-acting inhaler to use during asthma attacks.

Before you use cromolyn inhalation for the first time, read the written instructions that come with the nebulizer. Ask your doctor, pharmacist, or respiratory therapist to show you how to use it. Practice using the nebulizer while he or she watches.

To inhale the solution using a nebulizer, follow these steps;

1. Remove one vial of cromolyn solution from the foil pouch. Leave the rest of the vials in the pouch until you are ready to use them.
2. Look at the liquid in the vial. It should be clear and colorless. Do not use the vial if the liquid is cloudy or discolored.
3. Twist off the top of the vial and squeeze all of the liquid into the nebulizer reservoir. If you are using your nebulizer to inhale other medications, ask your doctor or pharmacist if you can place the other medications in the reservoir along with cromolyn.
4. Connect the nebulizer reservoir to the mouthpiece or face mask.
5. Connect the nebulizer to the compressor.
6. Place the mouthpiece in your mouth or put on the face mask. Sit in an upright, comfortable position and turn on the compressor.
7. Breathe in calmly, deeply, and evenly for about 5 to 10 minutes until mist stops forming in the nebulizer chamber.
8. Clean your nebulizer regularly. Follow the manufacturer's directions carefully and ask your doctor or pharmacist if you have any questions about cleaning your nebulizer.

Before using cromolyn,

• tell your doctor and pharmacist if you are allergic to cromolyn, any other drugs, or any of the ingredients in cromolyn nebulizer solution. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or planning to take .
• tell your doctor if you have or have ever had liver or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using cromolyn, call your doctor.

• It is used to treat asthma.
• It may be given to you for other reasons. Talk with the doctor.
• Do not use cromolyn (oral inhalation) to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Trouble breathing.
• Cough that does not go away.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Loose stools (diarrhea).
• Headache.
• Cough.
• Sneezing.
• Bad taste in your mouth.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Asthma: Nebulization solution: Initial: 20 mg 4 times/day; usual dose: 20 mg 3 to 4 times/day

Note: For chronic control of asthma, taper frequency to the lowest effective dose (ie, 4 times/day to 3 times/day to twice daily). Not effective for immediate relief of symptoms in acute asthmatic attacks; must be used at regular intervals for 2 to 4 weeks to be effective.

Prophylaxis of bronchospasm (allergen- or exercise-induced): Nebulization solution: 20 mg (single dose), administer 10 to 15 minutes prior to exercise or allergen exposure

Asthma: Children >2 years and Adolescents: Refer to adult dosing.

Prevention of allergen- or exercise-induced bronchospasm: Children >2 years and Adolescents: Refer to adult dosing.

There are no dosage adjustments provided in manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Oral inhalation: Squeeze contents of the unit-dose vial into the solution container of nebulizer. Nebulization should take approximately 5 to 10 minutes.