Gastrocrom Oral Concentrate (cromolyn sodium)Company: Rhone Poulenc Rorer
Approval Status: Approved April 1996
Treatment for: mastocytosis
Areas: Hematology; Immune System
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 body.
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 bedtime.
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 mediators.
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.
Gastrocrom Oral Concentrate Drug Information
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