Gastrocrom Information
Gastrocrom (Cromolyn sodium)
Gastrocrom (Cromolyn sodium) Description
Each 5 mL ampule of Gastrocrom (Cromolyn sodium) 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) (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-4-1-benzopyran-2-carboxylate]. The empirical formula is CHNaO; the molecular weight is 512.34. Its chemical structure is:
Pharmacologic Category: Mast cell stabilizer
Therapeutic Category: Antiallergic
Gastrocrom (Cromolyn sodium) Clinical Pharmacology
Cromolyn sodium has no intrinsic vasoconstrictor, antihistamine, or glucocorticoid activity.
Cromolyn sodium is poorly absorbed from the gastrointestinal tract. No more than 1% of an administered dose is absorbed by humans after oral administration, the remainder being excreted in the feces. Very little absorption of cromolyn sodium was seen after oral administration of 500 mg by mouth to each of 12 volunteers. From 0.28 to 0.50% of the administered dose was recovered in the first 24 hours of urinary excretion in 3 subjects. The mean urinary excretion of an administered dose over 24 hours in the remaining 9 subjects was 0.45%.
Gastrocrom (Cromolyn sodium) Clinical Studies
Four randomized, controlled clinical trials were conducted with Gastrocrom (Cromolyn sodium) 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 (Cromolyn sodium) 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 (Cromolyn sodium) 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 (Cromolyn sodium) in United States and foreign humanitarian programs.
Gastrocrom (Cromolyn sodium) Indications And Usage
Gastrocrom (Cromolyn sodium) 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.
Gastrocrom (Cromolyn sodium) Contraindications
Gastrocrom (Cromolyn sodium) is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.
Gastrocrom (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.
Gastrocrom (Cromolyn sodium) Precautions
In view of the biliary and renal routes of excretion of Gastrocrom (Cromolyn sodium) , consideration should be given to decreasing the dosage of the drug in patients with impaired renal or hepatic function.
In carcinogenicity studies in mice, hamsters, and rats, cromolyn sodium had no neoplastic effects at intraperitoneal doses up to 150 mg/kg three days per week for 12 months in mice, at intraperitoneal doses up to 53 mg/kg three days per week for 15 weeks followed by 17.5 mg/kg three days per week for 37 weeks in hamsters, and at subcutaneous doses up to 75 mg/kg six days per week for 18 months in rats. These doses in mice, hamsters, and rats are less than the maximum recommended daily oral dose in adults and children on a mg/m basis.
Cromolyn sodium showed no mutagenic potential in Ames Salmonella/microsome plate assays, mitotic gene conversion in and in an cytogenetic study in human peripheral lymphocytes.
In rats, cromolyn sodium showed no evidence of impaired fertility at subcutaneous doses up to 175 mg/kg in males (approximately equal to the maximum recommended daily oral dose in adults on a mg/m basis) and 100 mg/kg in females (less than the maximum recommended daily oral dose in adults on a mg/m basis).
Gastrocrom (Cromolyn sodium) Adverse Reactions
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 (Cromolyn sodium) 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.
Gastrocrom (Cromolyn sodium) Dosage And Administration
NOT FOR INHALATION OR INJECTION. SEE .
The usual starting dose is as follows:
Gastrocrom (Cromolyn sodium) How Supplied
Gastrocrom (Cromolyn sodium) 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 53014-678-70 96 ampules x 5 mL
Gastrocrom (Cromolyn sodium) 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.
Gastrocrom (Cromolyn sodium)
Gastrocrom (Cromolyn sodium)
