pharmacopeia
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/api/v1/drug/cromolyn

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Biological Response Modifiers; Ion Exchange Activity.

Indications

Sourced from openFDA
  • GASTROCROM is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.ICD-10: R11.2, R51.9

Contraindications

Sourced from openFDA
  • GASTROCROM is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.contraindicated

Dosage & administration

Sourced from openFDA

NOT FOR INHALATION OR INJECTION. SEE DIRECTIONS FOR 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.

Warnings & precautions

Sourced from openFDA

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.

Adverse reactions

Sourced from openFDA

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.

Use in specific populations

Sourced from openFDA

Pregnancy In reproductive studies in pregnant mice, rats, and rabbits, cromolyn sodium produced no evidence of fetal malformations at subcutaneous doses up to 540 mg/kg in mice (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis) and 164 mg/kg in rats (less than the maximum recommended daily oral dose in adults on a mg/m 2 basis) or at intravenous doses up to 485 mg/kg in rabbits (approximately 4 times the maximum recommended daily oral dose in adults on a mg/m 2 basis). 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.

Approval history

Sourced from openFDA
  • Feb 29, 1996NDANDA020479Viatris Specialty
  • Jun 16, 1999ANDAANDA075282Sandoz
  • Jan 18, 2000ANDAANDA075271Teva Pharms
  • Jul 3, 2001ANDAANDA075702Bausch And Lomb
  • Oct 27, 2011ANDAANDA202583Rising
  • Apr 4, 2013ANDAANDA202745Micro Labs Ltd India
  • Oct 16, 2017ANDAANDA209264Ailex Pharms Llc
  • Oct 16, 2017ANDAANDA209453Ailex Pharms Llc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
3,486 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Treatment Failure1,00429%
  2. 2Drug Ineffective3189.1%
  3. 3Fatigue2156.2%
  4. 4Nausea1895.4%
  5. 5Headache1835.2%
  6. 6Diarrhoea1584.5%
  7. 7Dyspnoea1514.3%
  8. 8Off Label Use1514.3%
  9. 9Urticaria1404.0%
  10. 10Dizziness1333.8%
  11. 11Hypersensitivity1313.8%
  12. 12Pruritus1273.6%
  13. 13Pain1223.5%
  14. 14Anaphylactic Reaction1163.3%
  15. 15Malaise1163.3%

Literature

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Recent PubMed references pinned to Cromolyn as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 33 ClinicalTrials.gov registrations naming Cromolyn as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Cromolyn work?
Mechanism-of-action classes: Biological Response Modifiers; Ion Exchange Activity.
What is Cromolyn used for?
According to FDA labeling, Cromolyn carries indications including: GASTROCROM is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Cromolyn?
Cromolyn is classified as Agents for dermatitis, excluding corticosteroids, Antiallergic agents, excl. corticosteroids, Other antiallergics, Mast Cell Stabilizer, Biological Response Modifiers, Ion Exchange Activity, Decreased Histamine Activity, Decreased Histamine Release, Decreased Leukotriene Activity.
What are the brand names for Cromolyn?
Cromolyn is marketed under brand names including Gastrocrom, Nasalcrom.
What are the contraindications for Cromolyn?
Cromolyn labeling lists contraindications including: GASTROCROM is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.. Always consult the full prescribing information and a clinician.
Note. Data for cromolyn is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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