Cromolyn Nasal

In the U.S.

• Nasalcrom

Available Dosage Forms:

• Spray

Therapeutic Class: Nasal Agent

Pharmacologic Class: Mast Cell Stabilizer

Along with its needed effects, a medicine 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 as soon as possible if any of the following side effects occur:

• Allergic reaction (coughing
• difficulty in swallowing
• hives or itching
• swelling of face, lips, or eyelids
• wheezing or difficulty in breathing)
• nosebleeds
• skin rash

Some side effects 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:

• Burning, stinging, or irritation inside of nose
• flushing
• increase in sneezing

• Cough
• headache
• postnasal drip
• unpleasant taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• 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 this medicine 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 this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• 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.
• Check with your pharmacist about how to throw out unused drugs.

There are no known significant interactions.

Before using this medication, tell your doctor or pharmacist if you are allergic to cromolyn; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this product: asthma, growths in the nose (nasal polyps).

If you are using this medication for self-treatment, tell your doctor before using this medication if you have any of the following symptoms: fever, yellow/green/discolored fluid from the nose, sinus pain, wheezing.

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

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

Applies to cromolyn nasal: nasal spray

Along with its needed effects, cromolyn nasal 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 as soon as possible if any of the following side effects occur while taking cromolyn nasal:

• Allergic reaction (coughing
• difficulty in swallowing
• hives or itching
• swelling of face, lips, or eyelids
• wheezing or difficulty in breathing)
• nosebleeds
• skin rash

Some side effects of cromolyn nasal 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:

• Burning, stinging, or irritation inside of nose
• flushing
• increase in sneezing

• Cough
• headache
• postnasal drip
• unpleasant taste

No adjustment recommended

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

Consult WARNINGS section for additional precautions.

This drug should be used during pregnancy only if clearly needed. AU TGA pregnancy category: B1 US FDA pregnancy category: B

Animal studies have revealed no evidence of teratogenicity with doses 205 times the maximum human dose. Increased fetal resorption and decreased fetal weight were observed at high parenteral doses that resulted in maternal toxicity. There are no controlled data in human pregnancy. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Maternal systemic absorption of this drug is expected to be very low. While it is unknown if this drug is excreted into milk, if excreted it would be poorly absorbed from the infant's gastrointestinal tract.

Use is considered acceptable; caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available