Dosing & Uses
Dosage Forms & Strengths
oral concentrate
- 100mg/5mL
Mastocytosis
200 mg PO four times daily; 30 minutes prior to meals; may increase to 40 mg/kg/day if control of symptoms not seen within 2-3 weeks
Food Allergy & Inflammatory Bowel Disease (Off-label)
200 mg PO four times daily; may double dose if effect not satisfactory within 2-3 weeks; not to exceed 400 mg PO four times daily
Administration
Dilute contents of ampule with glass of water; stir well
For systemic mastocytosis administer 30 minutes before meals and bedtime
For food allergy and inflammatory bowel disease administer 15-20 minutes before meals
Dosage Forms & Strengths
oral concentrate
- 100mg/5mL
Mastocytosis
<2 years: Safety and efficacy not established
2-12 years: 100 mg PO four times daily; not to exceed 40 mg/kg/day; give 30 minutes AC and HS
>12 years: As in adults; 200 mg PO four times daily; 30 minutes prior to meals; may increase to <40 mg/kg/day if control of symptoms not seen within 2-3 weeks
Food Allergy & Inflammatory Bowel Disease (Off-label)
<2 years old: Not recommended
2-12 years: 100 mg four times daily initially; may double dose if effect not satisfactory within 2-3 weeks; not to exceed 40 mg/kg/day
>12 years: 200 mg PO four times daily; may double dose if effect not satisfactory within 2-3 weeks; not to exceed 400 mg PO four times daily
Administration
Dilute the contents of ampule with glass of water
For systemic mastocytosis administer 30 minutes before meals and bedtime
For food allergy and inflammatory bowel disease administer 15-20 minutes before meals
Adverse Effects
Frequency Not Defined
Diarrhea
Headache
Angioedema
Premature ventricular contractions
Hypoesthesia
Lightheadedness
Flushing
Palpitation
Erythema
Postprandial
Photosensitivity
Behavior changes
Psychosis
Esophagospasm
Nausea
Abdominal pain
Pancytopenia
Polycythemia
Stomatitis
Neutropenia
Rash
Pruritus
Warnings
Contraindications
Hypersensitivity
Cautions
Severe anaphylactic reactions may occur (rare)
Excreted through biliary and renal routes; monitor closely patients with hepatic/renal insufficiency; decrease dose in patients with impaired renal or hepatic function
Use caution in patients with history of cardiac arrhythmia and hepatic or renal impairment
Oral concentrated solution should not be used for inhalation or injection
Not beneficial in the acute setting
Symptoms may reoccur when tapering or withdrawing the drug; use caution
Pregnancy & Lactation
Pregnancy Category: B
Lactation: Unknown if excreted in breast milk, use caution
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Mast cell stabilizer; inhibits release of histamine, leukotrienes, and slow-reacting substance of anaphylaxis from mast cell by inhibiting degranulation following exposure to reactive antigens
Pharmacokinetics
Bioavailability: 0.5-2%
Peak plasma time: 15 min
Peak plasma concentration: 9 ng/mL
Half-life: 80-90 min
Onset: 2-6 weeks (PO)
Duration: 6 hr
Excretion: Feces (98%, unabsorbed drugs); urine (<0.5%)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| cromolyn nasal - | 5.2 mg/spray (4 %) aerosol |  | |
| cromolyn oral - | 100 mg/5 mL liquid |  | |
| cromolyn oral - | 100 mg/5 mL liquid |  | |
| cromolyn oral - | 100 mg/5 mL liquid |  | |
| cromolyn oral - | 100 mg/5 mL liquid |  | |
| cromolyn inhalation - | 20 mg/2 mL nebulizer soln |  | |
| cromolyn ophthalmic (eye) - | 4 % drops |  | |
| cromolyn ophthalmic (eye) - | 4 % drops |  | |
| Gastrocrom oral - | 100 mg/5 mL liquid |  | |
| Gastrocrom oral - | 100 mg/5 mL liquid |  | |
| Nasalcrom nasal - | 5.2 mg/spray (4 %) aerosol |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
cromolyn nasal
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 (such as 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 have any questions, ask 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 (such as 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 right away. 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 lasts or gets worse after 2 weeks, or if you think you may have a serious medical problem, stop using this medication and get medical help right away. 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 last or get worse, tell your doctor promptly.If your doctor has directed you to use this medication, remember that your doctor 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 right away if you have any serious side effects, including: frequent nosebleeds, sores in the nose, wheezing/chest tightness.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), 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.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.
PRECAUTIONS: 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.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center 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 (such as 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. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Refer to storage information printed on the package. Store at room temperature away from moisture and sunlight. Do not store in the bathroom. Keep all medications 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.
Information last revised May 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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- Compare formulary status to other drugs in the same class.
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