Cromolyn

KROE-mo-lin

Commonly used brand name(s)

In the U.S.

• Gastrocrom

Available Dosage Forms:

• Capsule


• Solution

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Mast Cell Stabilizer

Uses For cromolyn

Cromolyn is used to treat the symptoms of mastocytosis. Mastocytosis is a rare condition caused by too many mast cells in the body. These mast cells release substances that cause the symptoms of the disease, such as abdominal pain, nausea, vomiting, diarrhea, headache, flushing or itching of skin, or hives.

Cromolyn works by acting on the mast cells in the body to prevent them from releasing substances that cause the symptoms of mastocytosis.

Cromolyn is available only with your doctor's prescription.

Before Using cromolyn

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For cromolyn, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to cromolyn or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of oral cromolyn in children with use in other age groups, cromolyn is not expected to cause different side effects or problems in children than it does in adults. cromolyn is usually used in children two years of age and older. However, it may be used in children younger than two years of age if their disease is severe.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell 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 at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of cromolyn. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease or


• Liver disease—The effects of cromolyn may be increased, which may increase the chance of side effects

Proper Use of cromolyn

Make certain your health care professional knows if you are on any special diet, such as a low-sodium diet. cromolyn contains sodium.

Unless otherwise directed by your doctor, it is best to take oral cromolyn as follows:

• Capsules


• Open the cromolyn capsule(s) and pour all of the powder into one-half glass (4 ounces) of hot water. Stir the solution until the powder is completely dissolved and the solution is clear. Then add an equal amount (one-half glass) of cold water to the solution while stirring.


• Be sure to drink all of the liquid to get the full dose of medicine.


• Do not mix cromolyn with fruit juice, milk, or food because they may keep the medicine from working properly.


• It is important to take cromolyn at regular intervals for best results.

• Ampuls


• Break open the ampul(s) and squeeze contents into a glass of water and stir well.


• Be sure to drink all of the liquid to get the full dose of medicine.


• It is important to take cromolyn at regular intervals for best results.


• Do not use the ampul if it appears cloudy or discolored.

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

Dosing

The dose of cromolyn 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 cromolyn. 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 oral dosage form (capsules and ampuls):
  
  • For symptoms of mastocytosis:
    
    • Adults and children 12 years of age and older—200 milligrams (mg) dissolved or mixed in water and taken four times a day, thirty minutes before meals and at bedtime.
    
    
    • Children 2 to 12 years of age—100 mg dissolved or mixed in water and taken four times a day, thirty minutes before meals and at bedtime. Your doctor may increase the dose if your symptoms are not under control within two to three weeks after you begin taking cromolyn.
    
    
    • Infants and children up to 2 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 20 mg per kilogram (kg) (9.1 mg per pound) of body weight a day. This dose is divided into four doses. Your doctor may increase the dose if your symptoms are not under control within two to three weeks after you begin taking cromolyn.
    
    
    • Premature infants—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of cromolyn, 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.

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using cromolyn

If your symptoms do not improve or if your condition becomes worse, check with your doctor.

cromolyn Side Effects

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

Check with your doctor immediately if any of the following side effects occur:

Rare

• Coughing


• difficulty in swallowing


• hives or itching of skin


• swelling of face, lips, or eyelids


• wheezing or difficulty in breathing

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

Less common

• Skin rash

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

• Diarrhea


• headache

Less common

Note: If the above side effects occur in patients with mastocytosis, they are usually only temporary and could be symptoms of the disease.

• Abdominal pain


• irritability


• muscle pain


• nausea


• trouble in sleeping

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.

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More cromolyn resources

• Cromolyn Use in Pregnancy & Breastfeeding
• Cromolyn Drug Interactions
• Cromolyn Support Group
• 6 Reviews for Cromolyn - Add your own review/rating

• Cromolyn Aerosol Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Cromolyn Sodium Monograph (AHFS DI)


• Gastrocrom Prescribing Information (FDA)


• Gastrocrom Concise Consumer Information (Cerner Multum)


• Gastrocrom Concentrate MedFacts Consumer Leaflet (Wolters Kluwer)


• Intal Prescribing Information (FDA)


• Intal inhalation Concise Consumer Information (Cerner Multum)

Compare cromolyn with other medications

• Asthma, Maintenance
• Inflammatory Bowel Disease
• Systemic Mastocytosis