Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 20 February 2017
PRECAUTIONS: In view of the biliary and renal routes of excretion of GASTROCROM, consideration should be given to
Carcinogenesis, Mutagenesis, and
These doses in mice, hamsters, and
Cromolyn sodium showed
Pregnancy: Pregnancy Category B. In reproductive studies in pregnant mice,
There are, however,
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Drug Interaction During Pregnancy: In pregnant mice, cromolyn sodium alone did not cause significant
Nursing Mothers: It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk,
GASTROCROM is administered to a nursing woman.
Pediatric Use: In adult
Plasma and kidney concentrations of cromolyn after oral administration to neonatal
In term infants up to six months of age,
The use of this product in pediatric patients less than two years of age should be reserved for
Geriatric Use: Clinical studies of GASTROCROM did not include
Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
The most frequently reported
One report of
To report SUSPECTED
The majority of these reports involve the gastrointestinal system and include: diarrhea,
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/
tinnitus, lupus erythematosus (LE) syndrome
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
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,
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.
Drink all of the liquid.
|Date Last Revised||23-04-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||MEDA Pharmaceuticals|