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 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 |  | |
| Nasalcrom nasal - | 5.2 mg/spray (4 %) aerosol |  | |
| cromolyn nasal - | 5.2 mg/spray (4 %) aerosol |  | |
| cromolyn ophthalmic (eye) - | 4 % drops |  | |
| cromolyn ophthalmic (eye) - | 4 % drops |  | |
| Gastrocrom oral - | 100 mg/5 mL liquid |  | |
| Gastrocrom oral - | 100 mg/5 mL liquid |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
cromolyn oral
CROMOLYN LIQUID - ORAL
(CROW-mow-lin)
COMMON BRAND NAME(S): Gastrocrom
USES: This medication is used to treat mastocytosis, a disease that occurs when the body has too many mast cells. These normal body cells release substances (such as 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 TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using cromolyn and each time you get a refill. If you have any questions, consult your doctor or pharmacist.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 (such as 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.
SIDE EFFECTS: Headache, muscle aches, and diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because 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.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.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 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.
DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any 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: 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.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If you have already had your meal, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Keep the ampules in their foil pouches at room temperature between 59-86 degrees F (15-30 degrees C) away from heat and light until ready for use. 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 December 2021. Copyright(c) 2021 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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