Gastrocrom
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Questions & Answers
Side Effects & Adverse Reactions
WARNINGS: 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
INDICATIONS AND USAGE: 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.
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION: 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 C23H14Na2O11; the molecular weight is 512.34. Its chemical structure is:
Pharmacologic Category: Mast cell stabilizer
Therapeutic Category: Antiallergic
Sources
Gastrocrom Manufacturers
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Meda Pharmaceuticals
![Gastrocrom (Cromolyn Sodium) Liquid [Meda Pharmaceuticals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Gastrocrom | Meda Pharmaceuticals
DOSAGE AND ADMINISTRATION: 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:
Break open ampule(s) and squeeze liquid contents of ampule(s) into a glass of water. Stir solution. Drink all of the liquid. -
Jazz Pharmaceuticals Commercial Corp.
Gastrocrom | Jazz Pharmaceuticals Commercial Corp.
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 YearsOne ampule four times daily, taken one-half hour before meals and at bedtime.
Pediatric Patients Under 2 YearsNot 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 DoseOnce 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.
AdministrationGASTROCROM should be administered as a solution at least 1/2 hour before meals and at bedtime after preparation according to the following directions:
Break open ampule(s) and squeeze liquid contents of ampule(s) into a glass of water. Stir solution. Drink all of the liquid.
![Gastrocrom (Cromolyn Sodium) Solution, Concentrate [Jazz Pharmaceuticals Commercial Corp.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=813b30e9-cfc3-4e21-a4e4-852ed9fd8b5a&name=4b9be863-75cb-4a8c-ba76-4a59ce9d509f-07.jpg)
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