Gastrocrom

What is Gastrocrom used for?

Gastrocrom is a prescription medicine that is used to treat mastocytosis. Gastrocrom may be given to you for other reasons.

Description

Each 5 mL ampule of GASTROCROM contains 100 mg cromolyn sodium, USP, in purified water. Cromolyn sodium is a hygroscopic, white powder having little odor. It may leave a slightly bitter aftertaste. GASTROCROM (cromolyn sodium, USP) Oral Concentrate is clear, colorless, and sterile. It is intended for oral use.

Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]. The empirical formula is C23H14Na2O11; the molecular weight is 512.34. Its chemical structure is:

Pharmacologic Category: Mast cell stabilizer

Therapeutic Category: Antiallergic

Before taking Gastrocrom, tell your doctor:

• If you are allergic to Gastrocrom; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Gastrocrom with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Gastrocrom?

• Tell all of your health care providers that you take Gastrocrom. This includes your doctors, nurses, pharmacists, and dentists.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Gastrocrom best taken?

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

• 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 unless your doctor has told you otherwise.
• Do not swallow ampul. Open it and empty liquid into a glass of water. Mix and drink.
• Keep taking Gastrocrom as you have been told by your doctor or other health care provider, even if you feel well.

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.

What are the side effects of Gastrocrom that I need to call my doctor about immediately?

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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of Gastrocrom?

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:

• 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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Gastrocrom?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Protect from light.
• Store in foil pouch until ready for use.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

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