gastrocrom
Gastrocrom (Cromolyn Sodium) is a mast cell stabilizer used to treat Asthma, Bronchial Spasm, Conjunctivitis, Food Hypersensitivity.
Cromolyn Sodium · by Viatris Specialty
Available as a generic: Cromolyn Sodium
⚠ FDA reports a current shortage of the concentrate form — availability differs between suppliers — see drug shortages →Key facts
- Active ingredient
- Cromolyn Sodium
- Drug class
- Mast Cell Stabilizer
- Form
- Liquid
- Strength
- Cromolyn Sodium 100MG/5ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- asthma, bronchial spasm, conjunctivitis
- Manufacturer
- Viatris Specialty
- What the pharmacy pays
- ~$0.60 per ml — not your price
- FDA application
- NDA020479
What is Gastrocrom?
From the FDA label:Each 5 mL ampule of GASTROCROM contains 100 mg cromolyn sodium, USP, in purified water. Cromolyn sodium is a hygroscopic, white powder having little odor. It may leave a slightly bitter aftertaste. GASTROCROM (cromolyn sodium, USP) Oral Concentrate is clear, colorless, and sterile. It is intended for oral use. Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]. The empirical formula is C 23 H 14 Na 2 O 11 ; the molecular weight is 512.34. Its chemical structure is: Pharmacologic Category: Mast cell stabilizer Therapeutic Category: Antiallergic Cromolyn Sodium Structural Formula
How to use
The usual starting dose is as follows: Adults and Adolescents (13 Years and Older) Two ampules four times daily, taken one-half hour before meals and at bedtime. Children 2-12 Years One ampule four times daily, taken one-half hour before meals and at bedtime. Pediatric Patients Under 2 Years Not recommended. If satisfactory control of symptoms is not achieved within two to three weeks, the dosage may be increased but should not exceed 40 mg/kg/day. Patients should be advised that the effect of GASTROCROM therapy is dependent upon its administration at regular intervals, as directed. Maintenance Dose Once a therapeutic response has been achieved, the dose may be reduced to the minimum required to maintain the patient with a lower degree of symptomatology. To prevent relapses, the dosage should be maintained. Administration GASTROCROM should be administered as a solution at least 1/2 hour before meals and at bedtime after preparation according to the following directions: 1. Break open ampule(s) and squeeze liquid contents of ampule(s) into a glass of water. 2. Stir solution. 3. Drink all of the liquid.
Side effects
Most of the adverse events reported in mastocytosis patients have been transient and could represent symptoms of the disease. The most frequently reported adverse events in mastocytosis patients who have received GASTROCROM during clinical studies were headache and diarrhea, each of which occurred in 4 of the 87 patients. Pruritus, nausea, and myalgia were each reported in 3 patients and abdominal pain, rash, and irritability in 2 patients each. One report of malaise was also recorded. To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8406 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Other Adverse Events: Additional adverse events have been reported during studies in other clinical conditions and from worldwide postmarketing experience. In most cases the available information is incomplete and attribution to the drug cannot be determined. The majority of these reports involve the gastrointestinal system and include: diarrhea, nausea, abdominal pain, constipation, dyspepsia, flatulence, glossitis, stomatitis, vomiting, dysphagia, esophagospasm. Other less commonly reported events (the majority representing only a single report) include the following: Skin: pruritus, rash, urticaria/angioedema, erythema/ burning, photosensitivity Musculoskeletal: arthralgia, myalgia, stiffness/weakness of legs Neurologic: headache, dizziness,…
Warnings
Important safety information
The recommended dosage should be decreased in patients with decreased renal or hepatic function. Severe anaphylactic reactions may occur rarely in association with cromolyn sodium administration.
Who should not take Gastrocrom
GASTROCROM is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.
Interactions
Drug Interaction During Pregnancy In pregnant mice, cromolyn sodium alone did not cause significant increases in resorptions or major malformations at subcutaneous doses up to 540 mg/kg (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis). Isoproterenol alone increased both resorptions and major malformations (primarily cleft palate) at a subcutaneous dose of 2.7 mg/kg (approximately 7 times the maximum recommended daily inhalation dose in adults on a mg/m 2 basis). The incidence of major malformations increased further when cromolyn sodium at a subcutaneous dose of 540 mg/kg was added to isoproterenol at a subcutaneous dose of 2.7 mg/kg. No such interaction was observed in rats or rabbits.
Drug class
May treat (source: NIH RxClass)
See how Gastrocrom ranks — best-rated mast cell stabilizer for:
Dosage forms
Liquid
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Gastrocrom treat?
- Gastrocrom (Cromolyn Sodium) may be used to treat asthma, bronchial spasm, conjunctivitis, food hypersensitivity, mastocytosis, perennial allergic rhinitis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Gastrocrom cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.60 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Gastrocrom?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Gastrocrom. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Gastrocrom?
- Gastrocrom is marketed by Viatris Specialty. You can see Viatris Specialty's full profile, rating, and other products on pharmaranks.
- Is Gastrocrom a brand-name or generic drug?
- Gastrocrom is a brand-name product with the active ingredient Cromolyn Sodium. Lower-cost generic equivalents containing Cromolyn Sodium are available — ask your pharmacist.
- Is Gastrocrom available over the counter?
- No. Gastrocrom is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Gastrocrom come in?
- Gastrocrom is currently marketed as liquid, per the FDA's National Drug Code Directory.
- What class of drug is Gastrocrom?
- Gastrocrom is classified as mast cell stabilizer, per the FDA's Established Pharmacologic Class.
- Is Gastrocrom FDA-registered?
- Gastrocrom is on record with the U.S. FDA under application number NDA020479. You can verify this on its official FDA label.
- Is Gastrocrom safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Gastrocrom. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Gastrocrom?
- Gastrocrom's side effects are taken directly from its FDA label. From the label: Most of the adverse events reported in mastocytosis patients have been transient and could represent symptoms of the disease. The most frequently reported adverse events in mastocytosis patients who have received GASTROCROM during clinical studies were headache and diarrhea,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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