Gastrocrom

Pregnancy Category: B

Lactation: Unknown if excreted in breast milk, use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Cromolyn sodium is usually taken 4 times per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Break open the cromolyn sodium ampule and squeeze the liquid into a glass of water. Stir this mixture and drink all of it right away. Do not save for later use.

Take this medicine 30 minutes before each meal, and at bedtime.

Take your doses at regular intervals to keep a steady amount of the drug in your body at all times.

Call your doctor if your symptoms do not improve after 3 weeks of treatment.

Do not change your doses or medication schedule without your doctor's advice.

Store at room temperature away from moisture, heat, and light.

Do not use cromolyn sodium if it looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medication.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

In the U.S.

• Gastrocrom

Available Dosage Forms:

• Capsule
• Solution

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Mast Cell Stabilizer

• It is used to treat mastocytosis.
• It may be given to you for other reasons. Talk with the doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking Gastrocrom as you have been told by your doctor or other health care provider, even if you feel well.
• To gain the most benefit, do not miss doses.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Take 30 minutes before meals and at bedtime.
• Do not swallow ampul. Open it and empty liquid into a glass of water. Mix and drink.
• Read the package insert for more details.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

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.

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.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Protect from light.
• Store in pouch until ready for use.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Gastrocrom®
(cromolyn sodium, USP)
Oral Concentrate

For Oral Use Only – Not for Inhalation or Injection.

How to Use Gastrocrom:
As with all prescription drugs, follow the directions for dosage that your physician recommends.

The effect of Gastrocrom therapy is dependent upon its administration at REGULAR intervals, for as long as recommended by your physician.

Usual Starting Dose:
Adults and Adolescents (13 Years and Older):
Two ampules four times daily, taken one-half hour before meals and at bedtime.

Children 2-12 Years:
One ampule four times daily, taken one-half hour before meals and at bedtime.

Note:
Your physician may decide to increase OR decrease your dosage to achieve optimum results with Gastrocrom. However, do not change your dose or stop taking Gastrocrom without first consulting your physician.

Care & Storage:
Gastrocrom Oral Concentrate should be stored between 15°-30°C (59°-86°F) and protected from light. Do not use if it contains a precipitate (particles or cloudiness) or becomes discolored. Keep out of the reach of children.

Store ampules in foil pouch until ready for use.

Recycling Information: Gastrocrom Oral Concentrate ampules are made with a low density polyethylene plastic (recycling material code: LDPE).

Directions for Use:

1. Open foil pouch by tearing at serrated edge as shown.

2. Remove ampule(s) from the strip.

3. Open the ampule by twisting off the tabbed top section.

4. Squeeze liquid contents into a glass of water. Stir solution. Drink all of the liquid. Discard the empty ampule.

Distributed by:

Meda Pharmaceuticals®
Somerset, New Jersey 08873-4120
MEDA PHARMACEUTICALS and Gastrocrom are registered trademarks of Meda AB or a related entity.
© 2013 Meda Pharmaceuticals Inc.      Rev. 4/2013

STW-ME7096-642R00

IN-0678-01