Cromolyn sodium (Oral)

Uses

What is Cromolyn sodium (Oral) used for?

Cromolyn sodium (Oral) is commonly used to treat mastocytosis, a disease that occurs when the body has too many mast cells. These normal body cells release substances (e.g., histamines) that are needed for normal body defense and healing, but when too many mast cells are present, they release too much of these substances. This can lead to symptoms such as diarrhea, stomach/abdominal pain, itching, rash, and flushing. Cromolyn belongs to a class of medications called mast cell stabilizers. It works by preventing mast cells from releasing the substances that can cause these skin and gut problems.

How should I take Cromolyn sodium (Oral)?

Take this medication by mouth 30 minutes before meals and at bedtime, usually 4 times daily or as directed by your doctor. If you are using this drug to prevent a food allergy or for inflammatory bowel disease, your doctor may direct you to take it 15-20 minutes before meals.

Do not swallow the ampules. The contents of the ampules are used to make a solution. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. To make the solution, break open the ampule(s) and squeeze the liquid into a glass of water. Do not mix with fruit juice, soda, milk, or any fluid except plain water. Stir the solution well. Drink all of the solution right away. Do not mix it ahead of time. Do not take the ampules out of their foil pouch until right before using.

Dosage is based on your medical condition and response to therapy.

This medication does not work right away. You need to use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. It may take 2-3 weeks before you see a benefit from this medication. Your doctor may change your dose to find the best dose for you.

Do not use this form of cromolyn for inhalation (e.g., in a nebulizer), in the nose, or by injection. It is for oral use (swallowing) only. It does not work to treat breathing problems, nasal/seasonal allergies, or other allergic reactions.

Inform your doctor if your symptoms do not improve or if they worsen.

How do I store Cromolyn sodium (Oral)?

Cromolyn sodium (Oral) is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Cromolyn sodium (Oral) in the bathroom or the freezer. There may be different brands of Cromolyn sodium (Oral) that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Cromolyn sodium (Oral) down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Cromolyn sodium (Oral)?

Before taking cromolyn, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Cromolyn sodium (Oral) during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this Cromolyn sodium (Oral). This Cromolyn sodium (Oral) is pregnancy risk category B according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk,
• B=No risk in some studies,
• C=There may be some risk,
• D=Positive evidence of risk,
• X=Contraindicated,
• N=Unknown

Side effects

What side effects can occur from Cromolyn sodium (Oral)?

Headache, muscle aches, and diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Cromolyn sodium (Oral)?

Cromolyn sodium (Oral) may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Cromolyn sodium (Oral)?

Cromolyn sodium (Oral) may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Cromolyn sodium (Oral)?

Cromolyn sodium (Oral) may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Cromolyn sodium (Oral).

What is the dose of Cromolyn sodium (Oral) for an adult?

Usual Adult Dose for Asthma – Maintenance

Administer 20 mg (1 vial) via nebulizer 4 times a day at regular intervals

Prophylaxis of acute bronchospasm due to exercise, exposure to cold dry air, or environmental allergens: 20 mg (1 vial) via nebulizer shortly before anticipated exposure.

Comments:

-This drug is a prophylactic agent to be used in patients whose symptoms are sufficiently frequent to require a continuous regimen of medications; the effect is usually evident after several weeks, although some patients show an almost immediate response.

-This drug should not be added to a therapeutic regimen during an acute episode; therapy should be started once asthma is controlled, the airway is cleared, and the patient is able to inhale adequately.

Use: For the management of bronchial asthma

Usual Adult Dose for Systemic Mastocytosis

Initial dose: 200 mg (2 ampules) orally one-half hour before meals and at bedtime

-If satisfactory control is not achieved within 2 to 3 weeks, may increase dose.

Maintenance dose: May reduce dose to the minimum required to maintain adequate control once a therapeutic response has been achieved.

Maximum dose: 40 mg/kg/day

Comment:

-Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.

Use: For the management of patients with mastocytosis.

Renal Dose Adjustments

Use with caution; consider decreasing oral dose in patients with renal impairment.

Liver Dose Adjustments

Use with caution; consider decreasing oral dose in patients with hepatic impairment.

Other Comments

Administration advice:

Orally:

-Take orally 30 minutes before meals and at bedtime.

-Oral liquid is supplied in ampules (100 mg/5 mL) for oral use only; not for inhalation or injection.

-At time of use, break open ampule(s) and squeeze contents into a glass of water; drink all liquid.

Nebulizer:

-Administer via nebulization 4 times a day.

-Solution for nebulization is supplied in vials (20 mg/2 mL) for oral inhalation only; not for injection.

-This drug should be administered via a power driven nebulizer at an airflow of 6 to 8 L/min with a suitable face mask; hand-operated nebulizers are not suitable for administration.

Storage requirements:

-Protect from light; store vials/ampules in foil pouches until ready to use

-Do not use if the solution is discolored or contains a precipitate.

-Stability and safety of this drug when mixed with other drugs in a nebulizer have not been established.

General:

-This is a prophylactic agent and has no role in the acute treatment of asthma.

-Effectiveness is dependent upon administration at regular intervals.

Monitoring:

-Monitor for control of symptoms; once symptoms are controlled, dose may be reduced to the minimum required to maintain the patient with a lower degree of symptomatology.

Patient advice:

-Patients should understand that this drug is a preventative agent, it may take 2 to 4 weeks to see benefit; effectiveness is dependent on regular administration.

-Patients with acute symptoms should seek medical advice promptly.

What is the dose of Cromolyn sodium (Oral) for a child?

Usual Pediatric Dose for Asthma – Maintenance

Age: 2 years or older:

Administer 20 mg (1 vial) via nebulizer 4 times a day at regular intervals

Prophylaxis of acute bronchospasm due to exercise, exposure to cold dry air, or environmental allergens: 20 mg (1 vial) via nebulizer shortly before anticipated exposure

Comments:

-This drug is a prophylactic agent to be used in patients whose symptoms are sufficiently frequent to require a continuous regimen of medications; the effect is usually evident after several weeks, although some patients show an almost immediate response.

-This drug should not be added to a therapeutic regimen during an acute episode; therapy should be started once asthma is controlled, the airway is cleared, and the patient is able to inhale adequately.

Use: For the management of bronchial asthma

Usual Pediatric Dose for Systemic Mastocytosis

Age: 2 to 12 years old:

Initial dose: 100 mg (1 ampule) orally one-half hour before meals and at bedtime

Age: 13 years or older:

Initial dose: 200 mg (2 ampules) orally one-half hour before meals and at bedtime

-If satisfactory control is not achieved within 2 to 3 weeks, may increase dose to no more than 40 mg/kg/day.

Maintenance dose: Once a therapeutic response has been achieved, the dose may be reduced to the minimum required to maintain adequate control.

Maximum dose: 40 mg/kg/day

Comment:

-Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.

-Not recommended for patients less than 2 years of age unless the potential benefits clearly outweigh the risks.

Use: For the management of patients with mastocytosis.

Precautions

Safety and efficacy have not been established in patients younger than 2 years.

How is Cromolyn sodium (Oral) available?

Cromolyn sodium (Oral) is available in the following dosage forms and strengths:

• Oral Concentrate

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Cromolyn sodium (Oral), take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.