cromolyn sodium 100 MG per 5 ML Concentrate for Oral Solution
Generic Name: CROMOLYN SODIUM
Brand Name: Gastrocrom
- Substance Name(s):
- CROMOLYN SODIUM
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.
DRUG 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.
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 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
CLINICAL STUDIES
Four randomized, controlled clinical trials were conducted with GASTROCROM in patients with either cutaneous or systemic mastocytosis; two of which utilized a placebo-controlled crossover design, one utilized an active-controlled (chlorpheniramine plus cimetidine) crossover design, and one utilized a placebo-controlled parallel group design.
Due to the rare nature of this disease, only 36 patients qualified for study entry, of whom 32 were considered evaluable.
Consequently, formal statistical analyses were not performed.
Clinically significant improvement in gastrointestinal symptoms (diarrhea, abdominal pain) were seen in the majority of patients with some improvement also seen for cutaneous manifestations (urticaria, pruritus, flushing) and cognitive function.
The benefit seen with GASTROCROM 200 mg QID was similar to chlorpheniramine (4 mg QID) plus cimetidine (300 mg QID) for both cutaneous and systemic symptoms of mastocytosis.
Clinical improvement occurred within 2-6 weeks of treatment initiation and persisted for 2-3 weeks after treatment withdrawal.
GASTROCROM did not affect urinary histamine levels or peripheral eosinophilia, although neither of these variables appeared to correlate with disease severity.
Positive clinical benefits were also reported for 37 of 51 patients who received GASTROCROM in United States and foreign humanitarian programs.
HOW SUPPLIED
GASTROCROM Oral Concentrate is an unpreserved, colorless solution supplied in a low density polyethylene plastic unit dose ampule with 8 ampules per foil pouch.
Each 5 mL ampule contains 100 mg cromolyn sodium, USP, in purified water.
NDC 0037-0678-08 8 ampules x 5 mL NDC 0037-0678-96 96 ampules x 5 mL GASTROCROM Oral Concentrate should be stored between 15°-30°C (59°-86°F) and protected from light.
Do not use if it contains a precipitate or becomes discolored.
Keep out of the reach of children.
Store ampules in foil pouch until ready for use.
Distributed by: Meda Pharmaceuticals ® 1000 Mylan Blvd Canonsburg, PA 15317 U.S.A.
GASTROCROM is a registered trademark of Meda Pharma S.A.R.L., a Viatris Company.
© 2024 Viatris Inc.
Rev.
06/2024 STW-ME7096-642R02 IN-0678-03
GERIATRIC USE
Geriatric Use Clinical studies of GASTROCROM did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
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.
PEDIATRIC USE
Pediatric Use In adult rats no adverse effects of cromolyn sodium were observed at oral doses up to 6144 mg/kg (approximately 25 times the maximum recommended daily oral dose in adults on a mg/m 2 basis).
In neonatal rats, cromolyn sodium increased mortality at oral doses of 1000 mg/kg or greater (approximately 9 times the maximum recommended daily oral dose in infants on a mg/m 2 basis) but not at doses of 300 mg/kg or less (approximately 3 times the maximum recommended daily oral dose in infants on a mg/m 2 basis).
Plasma and kidney concentrations of cromolyn after oral administration to neonatal rats were up to 20 times greater than those in older rats.
In term infants up to six months of age, available clinical data suggest that the dose should not exceed 20 mg/kg/day.
The use of this product in pediatric patients less than two years of age should be reserved for patients with severe disease in which the potential benefits clearly outweigh the risks.
PREGNANCY
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.
NUSRING MOTHERS
Nursing Mothers It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when GASTROCROM is administered to a nursing woman.
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: 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.