Gastrocrom

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.

This product is available in the following dosage forms:

• Capsule


• Solution

Before Using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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, 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 .

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

Pregnancy

Breastfeeding

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.

Drug Interactions

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.

Other Interactions

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease or


• Liver diseasea€”The effects of cromolyn may be increased, which may increase the chance of side effects

Proper Use

Make certain your health care professional knows if you are on any special diet, such as a low-sodium diet. This medicine 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 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 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 oral dosage form (capsules and ampuls):
  
  
  
  • For symptoms of mastocytosis:
    
    
    
    • Adults and children 12 years of age and oldera€”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 agea€”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 agea€”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 infantsa€”Use is not recommended .
    
    
    
    
  
  
  
  

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.

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

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

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

• Abdominal pain


• Irritability


• Muscle pain


• Nausea


• Trouble in sleeping

Note: 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 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.