Cromolyn

Generic name: cromolyn sodium (oral)
Brand name: Gastrocrom
Dosage form: oral solution (20 mg/mL)
Drug class: Mast cell stabilizers

Medically reviewed by  A Ras MD.

What is cromolyn?

Cromolyn is a prescription medicine that is used to ease allergy signs. It is used to prevent nose stuffiness.

Description

The active ingredient of cromolyn sodium inhalation solution USP is cromolyn sodium, USP. It is an inhaled anti-inflammatory agent for the preventive management of asthma. Cromolyn sodium, USP is chemically designated as disodium 5,5′- [(2-hydroxytrimethylene)dioxy] bis [4-oxo-4H-1-benzopyran-2-carboxylate]. The molecular formula is C23H14Na2O11; the molecular weight is 512.34. Cromolyn sodium, USP is a water-soluble, odorless, white, hydrated crystalline powder. It is tasteless at first, but leaves a slightly bitter aftertaste. Cromolyn sodium inhalation solution USP is clear, colorless to pale yellow, sterile and has a target pH of 5.5.

The structural formula is:

Each 2 mL vial for oral inhalation use only contains 20 mg cromolyn sodium, USP in water for injection, USP.

Before taking cromolyn, tell your doctor:

• If you are allergic to cromolyn; 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 cromolyn 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 cromolyn?

• Tell all of your health care providers that you take cromolyn. This includes your doctors, nurses, pharmacists, and dentists.
• If you have had any recent nose surgery, injury, ulcers, or sores, talk with your doctor.
• It may take a few weeks to see the full effect.
• Do not use cromolyn to treat a sinus infection, asthma, or cold symptoms.
• This medicine may cause harm if swallowed. If cromolyn is swallowed, call a doctor or poison control center right away.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using cromolyn while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is cromolyn best taken?

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

• Keep taking cromolyn to prevent the allergy. Once signs start, cromolyn will not help.
• Do not take cromolyn by mouth. Use in your nose only. Keep out of your mouth and eyes (may burn).
• Shake well before use.
• Blow your nose before use.
• Close 1 nostril.
• When using, tilt your head forward a little.
• Put nose spray tube into other nostril.
• While breathing in through the nose, press down once to release spray.
• Breathe out from your mouth.
• Spray up the nose only. Do not spray onto the wall joining the two nostrils.

What do I do if I miss a dose?

• Use 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 use 2 doses at the same time or extra doses.

What are the side effects of cromolyn 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.
• Shortness of breath.
• Bad nose irritation.

What are some other side effects of cromolyn?

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:

• Nose irritation.
• Sneezing.
• Stinging.

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 cromolyn?

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• 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

PACKAGE/LABEL DISPLAY PANEL, PART 1 OF 2

• NDC 70556-102-60
• Cromolyn Sodium
  Inhalation Solution USP
• 20 mg/2 mL
• Sterile Unit-Dose Vials
  For Oral Inhalation Use Only
  Not for Injection
  Aqueous Solution for Nebulization
  PRESERVATIVE FREE
• Rx only
• 2 pouches of thirty 2 mL vials each (60 unit-dose vials)