Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Hematology | Immunology | Family Medicine
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Gastrocrom Oral Concentrate (cromolyn sodium)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Rhone Poulenc Rorer
Approval Status: Approved April 1996
Treatment Area: mastocytosis
Gastrocrom Oral Concentrate has been approved for the treatment
of symptoms associated with mastocytosis, a rare disease caused by
an excess accumulation of mast cells in different parts of the
Previously, subjects had to open tiny capsules and mix the
contents in water. The new oral concentrate form in ampules allows
for easier and quicker mixing and administration. To obtain maximum
therapeutic benefit from Gastrocrom, subjects are advised to adhere
closely and regularly to the recommended dosage and administration,
which for adults (13 years and older), is two ampules mixed into a
glass of cold water, taken four times daily one half hour before
meals and at bedtime. For children from two to 12 years of age, the
recommended dose is one ampule mixed into a glass of cold water,
taken four times daily one half hour before meals and at
The relatively few side effects reported with Gastrocrom in
mastocytosis subjects have been transient, and could represent
symptoms of the disease itself. The most frequently reported during
clinical studies were headache and diarrhea.
Mechanism of Action
Gastrocrom works by inhibiting the release of mast cells
Caused by abnormal accumulation of mast cells in certain
tissues, mastocytosis leads to the release of high concentrations
of histamine, heparin, Prostaglandin D2, and other mediators into
different parts of the body, such as the skin and the
gastrointestinal tract. In many cases, this leads to an
exacerbation of symptoms, including severe abdominal pain, nausea,
vomiting, diarrhea, headaches and occasionally, peptic ulceration.
Other symptoms include flushing, itching and in more severe cases,
hypotension, hypertension, and shock.
While about 5,000 subjects are currently diagnosed with the
disease, the incidence is probably underestimated because the
symptoms are often indicative of other disorders, and therefore
hard to recognize.