In the U.S.—

In Canada—

Another commonly used name is sodium cromoglycate.

• Antiallergic, systemic
• Mast cell stabilizer

Cromolyn (KROE-moe-lin ) 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, in the following dosage form:

Oral
• Capsules (U.S. and Canada)
• Ampuls (U.S.)

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 oral cromolyn, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to cromolyn. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

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

Pregnancy—Cromolyn has not been studied in pregnant women. However, studies in animals have shown that cromolyn, when given by injection in very large amounts, causes a decrease in successful pregnancies and a decrease in the weight of the animal fetus. Before using this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether cromolyn passes into the breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Although there is no specific information comparing use of oral cromolyn in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults. This medicine 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.

Older adults—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, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other 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 health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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

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 this medicine with fruit juice, milk, or food because they may keep the medicine from working properly.
• It is important to take this medicine 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 this medicine 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.

• 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 this medicine.
    • 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 this medicine.
    • Premature infants—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. Then take any remaining doses for that day at regularly spaced times.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and light, in a tightly closed container.
• Do not store the capsule form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.
• Store ampuls in their foil pouch until you are ready to use them.

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

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 
  
  

Also, check with your doctor as soon as possible if the following side effect occurs:

• Less common
  • Skin rash 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Diarrhea;  headache 
  
  

• Less common
  • Abdominal pain;  irritability;  muscle pain;  nausea;  trouble in sleeping 
  
  

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

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