Each 5 mL ampule of Cromolyn Sodium Oral Solution, Concentrate 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. Cromolyn Sodium Oral Solution, Concentrate is clear, colorless, and sterile. It is intended for oral use.
Cromolyn Sodium Oral Solution, Concentrate 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.
Published Studies Related to Cromolyn
Efficacy of topical cromolyn sodium 4% on pruritus in uremic nephrogenic
patients: a randomized double-blind study in 60 patients. 
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. 
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 Cromolyn
An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema [Recruiting]
This study is designed to investigate whether topical application of a cromolyn sodium
solution is able to decrease the facial redness seen in patients with papulopustular
rosacea. Previous work in the lab of Dr. Di Nardo on mice has suggested that cromolyn may
be able to have this effect. The study will enroll a total of 10 patients. 5 will randomly
be assigned to receive the cromolyn sodium solution, and the other 5 will be randomly
assigned to receive the placebo solution. All participants will be instructed to apply
their assigned solution twice daily to their face. Patients will return to the clinic 3, 6,
and 8 weeks after the distribution of the solutions to measure the efficacy of their
Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis [Recruiting]
This is a randomized, double-blind, placebo-controlled study of oral cromolyn sodium when
made into a viscous preparation for the treatment of eosinophilic esophagitis.
Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus [Completed]
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.
Cromolyn Detection of Silent Aspiration [Not yet recruiting]
The overall purpose of this project is to develop and validate a simple, non-invasive method
to detect aspiration of gastro-intestinal fluid into the respiratory tract. The
investigators will compare the quantity of cromolyn detected in urine collected overnight
after 4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by
5 healthy control subjects and 10 patients (3-6 with pulmonary fibrosis; and 3-6 either
awaiting or recently undergone lung transplantation) with clinical and laboratory evidence
of GER (gastroesophageal reflux) with microaspiration.
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.