Cromolyn

Cromolyn sodium is an anti-inflammatory medication. It works by preventing the release of substances in the body that cause inflammation.

Cromolyn sodium inhalation is used to prevent asthma attacks in people with bronchial asthma. Cromolyn sodium is also used to prevent bronchospasm (wheezing, chest tightness, trouble breathing) caused by exercise, pollutants in the air, or exposure to certain chemicals.

Cromolyn sodium inhalation may also be used for other purposes not listed in this medication guide.

Cromolyn sodium is an anti-inflammatory medication. It works by preventing the release of substances in the body that cause inflammation.

Cromolyn sodium oral is used to treat the symptoms of a condition called mastocytosis, which can cause diarrhea, nausea, vomiting, headaches, stomach pain, itchy skin, and flushing (warmth or redness under the skin).

Cromolyn sodium oral may also be used for other purposes not listed in this medication guide.

You should not use this medication if you are allergic to cromolyn sodium.

Before using cromolyn sodium inhalation, tell your doctor if you have heart disease or a heart rhythm disorder, coronary artery disease, kidney disease, or liver disease.

Do not use cromolyn sodium inhalation to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medicine to treat an asthma attack.

Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your doses or stop using cromolyn sodium inhalation without first talking to your doctor. Stopping suddenly or not using enough medicine can make your condition worse.

Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

You should not use this medication if you are allergic to cromolyn.

Before you take cromolyn sodium oral, tell your doctor if you have kidney or liver disease.

Do not give this medication to a child younger than 2 years old without the advice of a doctor.

It is important to use cromolyn sodium regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Contact your doctor if your symptoms do not improve within 2 or 3 weeks of taking this medicine.

You should not use this medication if you are allergic to cromolyn sodium.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using cromolyn sodium inhalation, tell your doctor if you have:

• heart disease or a heart rhythm disorder;
• coronary artery disease;
• kidney disease; or
• liver disease.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether cromolyn sodium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

You should not use this medication if you are allergic to cromolyn.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take cromolyn sodium oral, tell your doctor if you have:

• kidney disease; or
• liver disease.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether cromolyn sodium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to a child younger than 2 years old without the advice of a doctor.

Avoid spraying the inhaler into your face or getting the medication in your eyes.

Do not mix cromolyn sodium inhalation with other medicines in a nebulizer.

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using cromolyn sodium oral.

There may be other drugs that can interact with cromolyn sodium inhalation. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

There may be other drugs that can interact with cromolyn sodium. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

In the U.S.

• Gastrocrom

Available Dosage Forms:

• Capsule
• Solution

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Mast Cell Stabilizer

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

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Applies to cromolyn: oral capsule, oral solution

Other dosage forms:

• inhalation aerosol liquid, inhalation aerosol powder, inhalation capsule, inhalation solution

Along with its needed effects, cromolyn 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 while taking cromolyn:

• 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 while taking cromolyn:

• Skin rash

Some side effects of cromolyn 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:

• Diarrhea
• headache

Note: If the above side effects occur in patients with mastocytosis, they are usually only temporary and could be symptoms of the disease.

• Abdominal pain
• irritability
• muscle pain
• nausea
• trouble in sleeping

Applies to cromolyn: compounding powder, inhalation aerosol with adapter, inhalation solution, nasal spray, oral capsule, oral solution

General

Adverse reactions following use of this drug are rare; headache and diarrhea have been reported following oral use, while cough, nasal congestion, sneezing and wheezing have been reported with oral inhalation.[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis, laryngeal edema[Ref]

Respiratory

Frequency not reported: Pharyngitis, dyspnea, cough, nasal congestion, sneezing, wheezing, nasal itching, nose bleed, nose burning
Postmarketing reports: Bronchospasm, pulmonary infiltrates with eosinophilia, hoarseness[Ref]

Hematologic

Frequency not reported: Polycythemia, neutropenia, pancytopenia
Postmarketing reports: Anemia[Ref]

Genitourinary

Postmarketing reports: Dysuria, urinary frequency[Ref]

Dermatologic

Rare (less than 0.1%): Pruritus, rash
Frequency not reported: Urticaria/angioedema, erythema/burning, photosensitivity, purpura
Postmarketing reports: Photodermatitis, exfoliative dermatitis[Ref]

Gastrointestinal

Rare (0.01% to 0.1%): Abdominal pain, nausea,
Frequency not reported: Diarrhea, constipation, dyspepsia, flatulence, glossitis, stomatitis, vomiting, dysphagia, oesophagospasm, unpleasant taste, stomachache, mild throat irritation
Postmarketing reports: Swollen parotid gland[Ref]

Hepatic

Frequency not reported: Abnormal hepatic function test[Ref]

Cardiovascular

Frequency not reported: Flushing, tachycardia, premature ventricular contractions, palpitations, chest pain
Postmarketing reports: Periarteritic vasculitis, pericarditis[Ref]

Musculoskeletal

Rare (less than 0.1%): Myalgia
Frequency not reported: Arthralgia, stiffness/weakness of legs, lupus erythematosus syndrome
Postmarketing reports: Joint swelling and pain, polymyositis[Ref]

Nervous system

Rare (0.01% to 0.1%): Headache
Frequency not reported: Dizziness, hypoesthesia, paresthesia, migraine, convulsions
Postmarketing reports: Peripheral neuritis[Ref]

Psychiatric

Frequency not reported: Psychosis, anxiety, depression, hallucinations, behavior change, insomnia, nervousness[Ref]

Other

Frequency not reported: Fatigue, malaise, tinnitus
Postmarketing reports: Vertigo[Ref]

Ocular

Postmarketing reports: Lacrimation[Ref]

Some side effects of cromolyn may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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.

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.