GASTROCROM SUMMARY
Gastrocrom®
(cromolyn sodium, USP)
Oral Concentrate
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.
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.
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NEWS HIGHLIGHTS
Published Studies Related to Gastrocrom (Cromolyn)
Efficacy of topical cromolyn sodium 4% on pruritus in uremic nephrogenic
patients: a randomized double-blind study in 60 patients. [2012]
pruritus... CONCLUSION: According to our study cromolyn sodium cream 4% was more effective
Effect of oral cromolyn sodium on CKD-associated pruritus and serum tryptase level: a double-blind placebo-controlled study. [2010.05]
BACKGROUND: Generalized pruritus is a significant complication in end-stage renal disease patients. The mechanism is unknown and most treatments are ineffective. This study is the first clinical trial designed to evaluate the effect of cromolyn sodium (CS) on renal itch... CONCLUSION: CS can significantly reduce the severity of pruritus in HD patients, but this effect is not due to a decrease in serum tryptase level.
Effect of oral cromolyn sodium on CKD-associated pruritus and serum tryptase
level: a double-blind placebo-controlled study. [2010]
cromolyn sodium (CS) on renal itch... CONCLUSION: CS can significantly reduce the severity of pruritus in HD patients,
Gamma scintigraphy for testing bioequivalence: a case study on two cromolyn sodium nasal spray preparations. [2008.06.05]
The present work was carried out to study the deposition patterns and clearance of technetium-99m (99mTc) DTPA labeled cromolyn sodium (CS) solutions when administered from two different CS nasal products using gamma scintigraphy. Five healthy volunteers received a single dose with complete crossover design involving treatment A (test formulation) and treatment B (reference formulation).
Promising ternary dry powder inhaler formulations of cromolyn sodium: formulation and in vitro-in vivo evaluation. [2007.06]
Glucose monohydrate and sorbitol were evaluated as alternative carriers to a-lactose monohydrate in dry powder inhalations. Cromolyn sodium (CS) - carrier binary formulae were prepared and tested in vitro by aerosolization via a twin stage impinger using three types of inhaler devices; Spinhaler, Aerolizer and Handihaler...
Clinical Trials Related to Gastrocrom (Cromolyn)
Cromoglicate in Psoriasis [Recruiting]
Cromoglicate in Mastocytosis [Recruiting]
The purpose of this exploratory study is to investigate the clinical efficacy of study drug
(LP0074) in the treatment of Mastocytosis. The trial will be performed as a left/right
comparison study in male/female subjects with mastocytosis, in a prospective,
double-blinded, randomised, single centre setting.
Treatment of Acute Stroke With Cromolyn(Single Dose) [Not yet recruiting]
Mastocytes were proven to have a central rule in their development of the lipoid plaque of
the vascular system. Mastocytes also has an important role in the stabilisation of the
plaque in the building of the brain barrier. Different animal studies show that the
inhibition of the mastocyte activity decreases significantly the risk of secondary bleeding
post ischaemic stroke. It was also shown that post stroke inflammation process was also
blocked by the inhibition of mastocytes. Other studies showed up to 100% decrease in the
brain barrier disruption and post stroke oedema, after treatment with mastocyte inhibitors.
Cromolyn is a synthetic drug which has an anti-allergic effect by inhibition of the
mastocytes. This drug is a well known,safe drug and is the main sub-substance that was used
in the previously mentioned studies.
Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus [Recruiting]
Pruritus is a major disorder among the skin derangements in advanced renal failure. Recent
information suggests that interactions between dermal mast cells and distal ends of
nonmyelinated C fibers may be important in the precipitation and regulation of the sensory
stimuli. Patients having uremic pruritus have been noted to have increased levels of plasma
histamine and tryptase as well as increased numbers of dermal mast cells. Cromolyn sodium is a
mast cell stabilizing agent that inhibits degranulation of mast cells and the release of
histamine, tryptase, and leukotrienes. It is hypothesized that oral cromolyn sodium may
attenuate uremic pruritus by decreasing serum tryptase level.
To Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol [Recruiting]
This is a multicentre, randomised, double-blind, placebo-controlled, 4-way cross-over study.
At each study visit a standardised treadmill test will be performed to provoke EIA. Before
and after the challenge test pulmonary function variables (e. g. forced expiratory volume in
one second (FEV1)) will be measured in order to assess the protective effect of the study
medication.
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