Chemically, cromolyn sodium is the disodium salt of 1,3-bis (2-carboxychromon-5-yloxy)-2-hydroxypropane. The empirical formula is C₂₃H₁₄Na₂O₁₁; the molecular weight is 512.34.

Ingredient

Active ingredient (per spray)	Purpose
Cromolyn sodium 5.2 mg	Nasal allergy symptom controller

Inactive ingredients
benzalkonium chloride, edetate disodium, purified water

Last updated on RxList: 4/28/2008

Uses

Nasalcrom® Nasal Spray is used to prevent and relieve nasal symptoms of hay fever and other nasal allergies:

• runny/itchy nose
• sneezing
• allergic stuffy nose

Nasal Solution

Nasalcrom is available in bottles of 13 mL and 26 mL (0.44 and 0.88 FL OZ.). Each fully assembled unit consists of a pump unit and actuator with cover in position on the bottle of nasal solution. The amount of cromolyn sodium in each bottle is: 13 ml - 520 mg (40 mg/ml); 26 ml - 1040 mg (40 mg/ml).

Nasalcrom should be stored between 20°-25°C (68°-77°F). Protect from light. Keep carton and package insert. They contain important instructions

Last updated on RxList: 4/28/2008

Nasal Solution

The most frequent adverse reactions occurring in the 430 patients included in the clinical trials with cromolyn sodium nasal solution were sneezing (1 in 10 patients), nasal stinging (1 in 20), nasal burning (1 in 25), and nasal irritation (1 in 40). Headaches and bad taste were reported in about 1 in 50 patients. Epistaxis, postnasal drip, and rash were reported in less than one percent of the patients. One patient in the clinical trials developed anaphylaxis.

Adverse reactions which have occurred in the use of other cromolyn sodium formulations for inhalation include angioedema, joint pain and swelling, urticaria, cough, and wheezing. Other reactions reported rarely are serum sickness, periarteritic vasculitis, polymyositis, pericarditis, photodermatitis, exfoliative dermatitis, peripheral neuritis, and nephrosis.

Drug Interaction During Pregnancy

Cromolyn sodium and isoproterenol were studied following subcutaneous injections in pregnant mice. Cromolyn sodium alone in doses of 60 to 540 mg/kg (38 to 338 times the human dose) did not cause significant increases in resorptions or major malformations. Isoproterenol alone at a dose of 2.7 mg/kg (90 times the human dose) increased both resorptions and malformations. The addition of cromolyn sodium (338 times the human dose) to isoproterenol (90 times the human dose) appears to have increased the incidence of both resorptions and malformations.

Last updated on RxList: 4/28/2008

Do not use if you are allergic to any of the ingredients.

Nasal Solution: Some patients may experience transient nasal stinging and/or sneezing immediately following instillation of cromolyn sodium nasal solution. Except in rare occurrences, these experiences have not caused discontinuation of therapy.

Ask a doctor before use if you have:

• fever
• discolored nasal discharge
• sinus pain
• wheezing

Information for the Patient

Please read the drug facts label.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long term studies in mice (12 months intraperitoneal treatment followed by 6 months observation), hamsters (12 months intraperitoneal treatment followed by 12 months observation), and rats (18 months subcutaneous treatment) showed no neoplastic effect of cromolyn sodium.

No evidence of chromosomal damage or cytotoxicity was obtained in various mutagenesis studies.

No evidence of impaired fertility was shown in laboratory animal reproduction studies.

Pregnancy

Pregnancy Category B

Reproduction studies with cromolyn sodium administered parenterally to pregnant mice, rats, and rabbits in doses up to 338 times the human clinical dose produced no evidence of fetal malformations. Adverse fetal effects (increased resorptions and decreased fetal weight) were noted only at the very high parenteral doses that produced maternal toxicity. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Pediatric Use

Nasal Solution: Safety and effectiveness in children below the age of 6 years have not been established.

Last updated on RxList: 4/28/2008

There is no clinical syndrome associated with an overdosage of cromolyn sodium. Acute toxicity testing in a wide variety of species has demonstrated an extremely low order of toxicity for cromolyn sodium, regardless of whether administration was parenteral, oral or by inhalation. Parenteral administration in mice, rats, guinea pigs, hamsters and rabbits demonstrated an LD₅₀ in the region of 4000 mg/kg. Intravenous administration in monkeys also indicated a similar order of toxicity. The highest dose administered by the oral route in rats and mice was 8000 mg/kg and at this dose level no deaths occurred. By inhalation, even in long term studies, it proved impossible to achieve toxic dose levels of cromolyn sodium in a range of mammalian species.

Nasal Solution: Cromolyn sodium nasal solution is contraindicated in those patients who have shown hypersensitivity to any of the ingredients.

Last updated on RxList: 4/28/2008

Nasal Solution

In vitro and in vivo animal studies have shown that cromolyn sodium inhibits the degranulation of sensitized mast cells which occurs after exposure to specific antigens. Cromolyn sodium inhibits the release of histamine and SRS-A (the slow-acting substance of anaphylaxis). Rhinitis induced by the inhalation of specific antigens can be inhibited to varying degrees by pretreatment with cromolyn sodium nasal solution.

Another activity demonstrated in vitrois the capacity of cromolyn sodium to inhibit the degranulation of non-sensitized rat mast cells by phospholipase A and the subsequent release of chemical mediators. An additional in vitro study showed that cromolyn sodium did not inhibit the enzymatic activity of released phospholipase A on its specific substrate.

Cromolyn sodium has no intrinsic bronchodilator, antihistaminic or anti-inflammatory activity.

Cromolyn sodium is poorly absorbed from the gastrointestinal tract. After instillation of cromolyn sodium nasal solution, less than 7% of the total dose administered is absorbed and is rapidly excreted unchanged in the bile and urine. The remainder of the dose is expelled from the nose, or swallowed and excreted via the alimentary tract.

Last updated on RxList: 4/28/2008

Drug Facts Label

Ask a doctor before use if you have

• fever
• discolored nasal discharge
• sinus pain
• wheezing

When using this product

• it may take several days of use to notice an effect. Your best effect may not be seen for 1 to 2 weeks.
• brief stinging or sneezing may occur right after use
• do not use it to treat sinus infection, asthma, or cold symptoms
• do not share this bottle with anyone else as this may spread germs

Stop use and ask a doctor if

• shortness of breath, wheezing, or chest tightness occurs
• hives or swelling of the mouth or throat occurs
• your symptoms worsen
• you have new symptoms
• your symptoms do not begin to improve within two weeks
• you need to use for more than 12 weeks

If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• see package insert on how to use pump
• parent or care provider must supervise the use of this product by young children
• adults and children 2 years and older:
• spray once into each nostril. Repeat 3-4 times a day (every 4-6 hours). If needed, may be used up to 6 times a day.
• use every day while in contact with the cause of your allergies (pollen, molds, pets, and dust).
• to prevent nasal allergy symptoms, use before contact with the cause of your allergies. For best results, start using up to one week before contact.
• if desired, you can use this product with other medicines, including other allergy medicines.
• children under 2 years: Do not use unless directed by a doctor

Last updated on RxList: 4/28/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

CROMOLYN - NASAL

(CROW-mow-lin)

COMMON BRAND NAME(S): Nasalcrom

USES: This medication is used to prevent allergic symptoms in the nose. It reduces stuffy/runny nose, mucus dripping into the back of the throat, itching, and sneezing caused by seasonal allergies (hay fever) and other allergens (e.g., dust mites, pet dander). This medication is not an antihistamine and does not provide immediate relief from allergic symptoms. It should be used before contact with the allergen.

Cromolyn is known as a mast cell stabilizer. It works by preventing the release of certain natural substances (histamine, SRS-A) made by the body that cause allergy symptoms.

Do not use this medication to treat sinus infection, asthma, or cold symptoms.

HOW TO USE: Follow all directions on the product package, or use as directed by your doctor. If you are uncertain about any of the information, consult your doctor or pharmacist.

Use 1 spray in each nostril, usually every 4 to 6 hours (3 to 4 times a day) or as directed by your doctor. Do not use more than 6 times a day. Use every day you are around allergens (e.g., during pollen season).

Gently blow your nose before using this drug. If nasal passages are blocked, a nasal decongestant may be used first to open the passages. Use your finger to close the nostril on the side not receiving the medication. While keeping your head upright, place the spray tip into the open nostril. Spray the medication into the open nostril as you breathe in through your nose. Sniff hard a few times to be sure the medication reaches deep into the nose. Repeat these steps for the other nostril.

Avoid spraying the medication into your eyes. Rinse the spray tip with hot water or wipe with a clean tissue after each use. Make sure that water does not get inside the container. Replace cap after each use.

This medication does not work immediately. It must be used regularly to be most effective. It may take 1 to 2 weeks of regular use to get the full benefit. If your condition persists or worsens after 2 weeks, or if you think you may have a serious medical problem, stop using this medication and seek immediate medical attention. Talk with your doctor if you are still using this medication after 12 weeks.

SIDE EFFECTS: This medication may cause brief stinging/sneezing right after use. If these effects persist or worsen, tell your doctor promptly.

If your doctor has directed you to use this medication, remember that 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.

Stop using this medication and tell your doctor immediately if any of these rare but very serious side effects occur: frequent nosebleeds, sores in the nose, wheezing/chest tightness.

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, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to cromolyn; or to preservatives (e.g., benzalkonium chloride); or if you have any other allergies.

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.

DRUG INTERACTIONS: If you are using this product under your doctor's direction, your doctor or pharmacist may already be aware of possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Doing so may cause the spread of germs.

Avoid allergens that may be the cause of your allergies. Some common allergens include molds, pollen, grasses, weeds, dust mites, and pet dander. This medication works better if started a week before you expect to be exposed to allergens (e.g., a week before your seasonal allergy symptoms usually start).

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Refer to storage information printed on the package. Store at room temperature between 68-77 degrees F (20-25 degrees C) away from moisture and sunlight. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.